Cold Therapy Clinical Research Overview

RESEARCH OVERVIEW COLD THERAPY

This interactive presentation gives an overview of published research on Cryotherapy

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Non-specific areas

Haemophilia

Rheumatoid Arthritis

Shoulder Surgery

Rheumatoid Arthritis

Shoulder Surgery

Recovery in Sports

Proprioception

Elbow Surgery

Proprioception

Elbow Surgery

General

Knee Arthroscopy

ACL Reconstruction

Total Knee Arthroplasty (TKA)

Ankle Injury

Achilles Microcirculation

Ankle Injury

Achilles Microcirculation

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UPPER EXTREMITY

Elbow Arthrolysis

Yu 2015

Aircast Cryo/Cuff

Shoulder Surgery

Gabiatti 2023

Systematic Review

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KNEE/ACL SURGERY

Knee Arthroscopy

Martin 2001

Stålman 2011

Martin 2001

Aircast Cryo/Cuff

Stålman 2011

Gatewood 2016

Song 2016

Gatewood 2016

Song 2016

Systematic Review

ACL

Shelbourne 1994

Schröder 1994

Yonetani 2022

Shelbourne 1994

Schröder 1994

Yonetani 2022

Aircast Cryo/Cuff

Hart 2014

Ice packs

Kotsifaki 2023

Raynor 2005

Kotsifaki 2023

Raynor 2005

Reviews/Guidelines

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KNEE/HIP ARTHROPLASTY

Total Knee Arthroplasty (TKA)

Holmström 2005

Belsey 2024

Kullenberg 2006

Holmström 2005

Belsey 2024

Aircast Cryo/Cuff

Kullenberg 2006

Demoulin 2012

Bech 2015

Donjoy Iceman

Aggarwal 2023

Wyatt 2023

Ni 2015

Aggarwal 2023

Wyatt 2023

Ni 2015

Systematic Reviews

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ACHILLES AND ANKLE

Achilles Microcirculation

Knobloch 2008

Knobloch 2006

Knobloch 2008

Knobloch 2006

Aircast Cryo/Cuff

Ankle Injury

Knobloch 2006b

Mora 2002

Aircast Cryo/Cuff

Knobloch 2006b

Mora 2002

Bleakley 2006

Ice pack

Bleakley 2006

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NON-SPECIFIC

Rheumatoid Arthritis

Guillot 2014

Systematic Review

Haemophilia

d’Young 2008

Aircast Cryo/Cuff

General

Klintberg 2021

Muaddi 2021

Klintberg 2021

Muaddi 2021

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SPORTS RECOVERY AND PERFORMANCE

Recovery in Sports

Alexander 2021

Review

Effects on Sports Performance/Proprioception

Houten 2017

Aircast Cryo/Cuff

Houten 2017

Bishop 2014

Ice pack

Bishop 2014

Bleakley 2012

Systematic Review

Bleakley 2012

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Yu 2015.

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Yu SY, Chen S, Yan HD, Fan CY. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study. Arch Phys Med Rehabil. 2015 Jan;96(1):1-6.

Design: Prospective, single-blinded, randomised controlled study

Subjects: 59 participants (27 women, 32 men) who received elbow arthrolysis.

Methods: Patients were randomly assigned into 2 groups:

1. Cryotherapy group (n=31, cryotherapy using the Aircast Cryo/Cuff plus standard care),

Control group (n=28, standard care).

The Cryo/Cuff system was used for at least 3 sessions of 60min/d for 1 week starting from the day of operation. In the control group, same standard care without cryotherapy treatment. Outcomes included: VAS scores, Blood loss, analgesic consumption, elbow ROM, and Mayo Elbow Performance Score (MEPS).

Results:

Key message: The Aircast Cryo/Cuff was effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis, however it did not affect blood loss, ROM, or elbow function.

• VAS scores were significantly lower in the cryotherapy group during the first 7 Postoperative days, both at rest and in motion (P<.05). • There were no significant differences between the 2 groups in VAS scores at 2 weeks and 3 months after surgery. • Less sufentanil was consumed by the cryotherapy group than the control group for pain relief (P<.01). • No significant differences were found in blood loss, ROM, and MEPS between the 2 groups (P>.05).

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VAS scores were significantly lower in the cryotherapy group ( Cryo/Cuff ) during the first 7 Postoperative days, both at rest and in motion (P<.05).

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Gabiatti 2023.

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Gabiatti AJB, Hillesheim GB, Gomildes MZ, Bertoncello D, Buzanello MR, Bertolini GRF. Cryotherapy in Postoperative Shoulder Surgery: A Systematic Review. Ther Hypothermia Temp Manag. 2023 Dec 19..

Design: Systematic Review

Methods: The review included six randomized clinical trials, involving a total of 233 patients who underwent various shoulder surgeries. Cryotherapy was applied using different methods, including Cryo/Cuff , Cryoton®, Polar Care 300, and ice packs. Outcomes included: Postoperative pain, skin temperature, study quality and risk of bias.

Results:

Key message: Cryotherapy appears to be a promising adjunctive treatment for postoperative shoulder pain, although the existing evidence has some limitations, including small sample sizes and methodological concerns.

• Cryotherapy was generally effective in reducing PO shoulder pain.

• However, one study found no significant difference in pain outcomes between the cryotherapy group and control group. • Three studies demonstrated a decrease in intra-articular and skin temperatures with cryotherapy application. • A risk of bias analysis revealed some concerns in the overall risk of bias for five studies, with one study considered to have a high risk of bias. • Although publication bias assessment was not conducted due to the limited number of included studies, it was noted that the studies exhibited heterogeneity in terms of population, intervention methods, and outcome measures.

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Stålman 2011.

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Stålman A, Berglund L, Dungnerc E, Arner P, Felländer-Tsai L. Temperature- sensitive release of prostaglandin E₂ and diminished energy requirements in synovial tissue with postoperat ive cryotherapy: a prospective randomized study after knee arthroscopy. J Bone Joint Surg Am. 2011 Nov 2;93(21):1961-8.

Design: Prospective Randomised Study Subjects: 40 patients undergoing knee arthroscopy Methods: 20 patients (50%) were randomized to receive postoperative cooling and compression ( Aircast Cryo/Cuff ). Outcomes included: Postoperative pain (VAS), knee temperature, microdialysis (to assess blood flow, metabolic rate). Results: • Application of the cooling and compression device after knee arthroscopy significantly lowered the temperature in the operatively treated knee. • The temperature at each of the locations (skin, joint capsule, and intra- articularly) in the operatively treated knee was significantly lower in the Cryo/Cuff group than in the untreated group. • The cryo/cuff appeared to decrease inflammation , as indicated by a temperature-sensitive decrease in the PGE2 concentration. • The hypothermia also decreased the metabolic rate of the synovial tissue and thus decreased energy requirements. The authors note that this reduced metabolic activity confers a protective effect on ischemic tissue.

Key message: Significant decrease of knee temperature and associated pain & inflammation marker PGE2 with postop Knee Cryo/Cuff application.

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• No effect of the compression and cooling on postoperative pain was detected, potentially due to a small sample size and the procedure performed (in comparison to ACL reconstruction or Arthroplasty).

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Martin 2001.

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Martin SS, Spindler KP, Tarter JW, Detwiler K, Petersen HA. Cryotherapy: an effective modality for decreasing intraarticular temperature after knee arthroscopy. Am J Sports Med. 2001 May-Jun;29(3):288-91.

Design: Prospective Study

Subjects: 17 patients who underwent knee arthroscopy

Methods: patients were divided into 2 groups after the arthroscopy :

• Treatment group : 12 patients were immediately treated with cryotherapy ( Aircast Cryo/Cuff ) for 2 hours. • Control group : 5 control patients were treated without ice for the 1st hour and then had ice applied for the 2nd hour. Outcomes included: intra-artcicular temperatures continually recorded every minute for 2 hours (by a thermocouple probe)

Key message: Significant decrease of intraarticular temperature of the knee after arthroscopy with Aircast Cryo/Cuff application.

Results:

• The temperature in the treatment group declined significantly, by 2.2°C over the 1st hour and by 0.79°C over the 2nd hour. • The temperature in the control group increased significantly, by 5,0°C over the 1st hour; after ice was applied, the temperature fell significantly, by 4,0°C. • The difference between the temperature decrease in the treatment group and the increase in the control group at 60 minutes was 7,1°C (P = 0.0001).

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Gatewood 2016.

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Gatewood CT, Tran AA, Dragoo JL. The efficacy of post-operative devices following knee arthroscopic surgery: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2017 Feb;25(2):501-516.

Design: Systematic review

Methods: A systematic search was performed on: PubMed; Scopus; MEDLINE; EMBASE; PEDro; SportDiscus; and CINAHL databases (1995-2015) for clinical trials using device modalities following arthroscopic knee surgery: cryotherapy, continuous passive motion (CPM), neuromuscular electrical stimulation (NMES), surface electromyographic (sEMG) biofeedback and shockwave therapy (ESWT). Outcomes included: Muscle strength, ROM, swelling, blood loss, pain relief & narcotic use, knee function, patient satisfaction, length of stay.

Key message: Cryotherapy application in post-operative protocols for knee arthroscopy can effectively mitigate pain and decrease narcotic consumption, while sEMG and NMES can both serve as useful adjuncts to recover quadriceps muscle function and improve knee function.

Results:

• 25 studies were included in this systematic review, 19 of which found a significant difference in outcomes. • For alleviating pain and decreasing narcotic consumption following arthroscopic knee surgery, cryo-compression devices are more effective than traditional icing alone, though not more than compression alone. • sEMG biofeedback and NMES improve quadriceps strength and overall knee functional outcomes following knee surgery.

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• There is limited evidence regarding the effects of ESWT.

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Song 2016.

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Song M, Sun X, Tian X, Zhang X, Shi T, Sun R, Dai W. Compressive cryotherapy versus cryotherapy alone in patients undergoing knee surgery: a meta-analysis. Springerplus. 2016 Jul 13;5(1):1074.

Design: Meta-analysis of randomised controlled trials.

Methods: 10 RCTs were selected, including 522 patients who underwent knee surgery. Outcomes included: Pain intensity (visual analog scale), Swelling (knee circumference measured using tape), Adverse events (thermal injury such as frostbite and transient nerve palsy).

Results:

Key message: Cold + Compression is more beneficial for reduction of pain and swelling at the early postoperative period for knee surgery than cold alone.

• Patients who underwent compressive cryotherapy tended to have less pain than patients who underwent cryotherapy alone at postoperative day (POD) 2 and POD3 • Compressive cryotherapy had a strong tendency towards less swelling over cryotherapy alone at POD1 and POD2. • However, there was no significant difference between compressive cryotherapy and cryotherapy alone at the intermediate stage of rehabilitation after knee surgery.

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• No postoperative adverse reactions occurred in all included studies.

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Schröder 1994

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Schröder D, Pässler HH. Combination of cold and compression after knee surgery. A prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 1994;2(3):158-65.

Design: Prospective Randomised Study

Subjects: 44 patients (aged 15-40 years) who were planned to undergo ACL reconstruction.

Methods: subjects were randomly assigned to:

• Control group (n=23): receiving traditional ice therapy (ICE) postoperatively (ice bags 3 times per day). • Study group (n=21): receiving Aircast Cryo/Cuff treatment (CC) after surgery during the 14-day hospital stay. Outcomes included: Girth, ROM, pain score (VAS), consumption of analgesics on postop days 1, 2, 3, 6, 14, and 28. Functional knee score at 12 weeks postop.

Key message: Aircast Cryo/Cuff treatment was significantly more effective than traditional ice packs for improving pain and returning to full ROM and function.

Results:

• In the CC group, significantly less swelling was observed (P < 0.035).

• CC patients also reported less pain and had a significantly reduced consumption of analgesics (P <0.04). • On all examination days, ROM in the CC group was up to 17 degrees greater than in the ICE group (P <0.02).

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• The functional knee score was significantly higher in the CC group (P = 0.025) than in the ICE group.

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Cryo/Cuff patients had significantly better ROM and a significantly higher functional knee score

Flexion ROM

Extension deficit

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Shelbourne 1994

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Shelbourne, K.D., 1994. Postoperative cryotherapy for the knee in ACL reconstructive surgery. Orthopaedics (International Edition), Vol. 2, No. 2, pp. 165-170.

Design: Prospective Study Subjects: 400 consecutive patients who underwent ACL reconstruction. Methods: Patients were allocated to three groups: 1. 100 patients were treated with the hot/ice thermal blanket 2. 100 patients were treated with crushed ice bags 3. 200 patients were treated with the Aircast Cryo/Cuff . Outcomes included: Narcotic use (number of injected and oral narcotics administered), length of hospitalization. Results: • Patients using the Cryo/Cuff required significantly less pain medication postoperatively than patients treated with crushed ice. • Days of hospitalization were significantly lower in the Cryo/Cuff group than in the crushed ice or hot/ice groups. • The Cryo/Cuff did not interfere with ambulation and can be kept in place while the patient is upright. Hot/Ice and crushed ice must be temporarily discontinued during ambulation. • Regarding cost effectiveness, Hot/Ice is the most expensive, Cryo/Cuff the second and crushed ice is the least expensive.

Key message: More effective post-operative pain reduction and shorter hospital stay was found with the Aircast Cryo/Cuff than with the application of ice only. Additionally, the Cryo/Cuff was less expensive and as effective as Hot/Ice thermal blankets.

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Yonetani 2022

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Yonetani Y, Kurokawa M, Amano H, Kusano M, Kanamoto T, Tanaka Y, Horibe S. The Wound Dressing Influenced Effectiveness of Cryotherapy After Anterior Cruciate Ligament Reconstruction: Case-Control Study Comparing Gauze Versus Film Dressing. Arthrosc Sports Med Rehabil. 2022 Mar 8;4(3):e965-e968.

Design: Case-Control Study

Subjects: 60 arthroscopic ACL reconstruction patients with an autogenous patellar tendon.

Methods: Subjects were assigned to 2 groups.

• Control group: The surgical wound was covered with 5 sheets of gauze with an elastic bandage (n=30),

• Film group: Polyurethane semipermeable transparent film dressing was used (n=30)

After 1 hour of cooling using the Cryo/Cuff device, the knee was chilled with an ice bag every 2 hours until the next morning. Outcomes included: pain severity/analgesic use (24 post-op), drainage over 2 days, ROM at 21 days, Change of hemoglobin concentration and C-reactive protein at 1 & 7 days.

Key message: Film dressing enhanced the effect of the Aircast Cryo/Cuff and Ice bags with respect to pain control, wound drainage, and inflammation immediately after surgery compared with traditional gauze dressing with elastic wrap.

Results:

• The number of patients who used an analgesic was 18 in the control group and 7 in the film group (P = .003). • The amount of drainage was 165.2 ± 72.9 mL in the control group and 289.7 ± 77.6 mL in the film group (P < .001). • The postoperative CRP value was 0.77 ± 0.65 mg/dL at 1 day in the control group and 0.39 ± 0.42 mg/dL in the film group (P = .009). • No statistical difference was seen for hemoglobin concentration at 1 or 7 days, CRP at 7 days or range of motion at 21 days.

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Hart 2014

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Hart JM, Kuenze CM, Diduch DR, Ingersoll CD. Quadriceps muscle function after rehabilitation with cryotherapy in patients with anterior cruciate ligament reconstruction. J Athl Train. 2014 Nov-Dec;49(6):733- 9.

Design: Cross-Sectional Study Subjects: 30 patients with reconstructed ACLs who were at least 6 months post-index surgery and had measurable quadriceps arthrogenic muscle

inhibition (AMI) (central activation ratio less than 90%). Methods: patients were randomly assigned to receive:

• 20 minutes of knee-joint cryotherapy (ice bags),

• 1 hour of therapeutic rehabilitation exercises,

• or cryotherapy followed by exercises. Outcomes included: Quadriceps Hoffmann reflex, Normalized maximal voluntary isometric contraction torque (knee extension), Central activation ratio using the superimposed-burst technique, Patient-reported outcomes. Results: • After the 2-week intervention period, patients who had cryotherapy + exercises had higher normalized maximal voluntary isometric contraction torques (P = .002, Cohen d effect size = 1.4) compared with those who received cryotherapy alone (P = .16, d = 0.58) or performed exercise alone (P = .16, d = 0.30).

Key message: After ACL reconstruction, patients with AMI who received cryotherapy immediately before performing rehabilitation exercises experienced greater strength gains than those who performed cryotherapy or exercises alone.

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Kotsifaki 2023

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Kotsifaki R, Korakakis V, King E, Barbosa O, Maree D, Pantouveris M, Bjerregaard A, Luomajoki J, Wilhelmsen J, Whiteley R. Aspetar clinical practice guideline on rehabilitation after anterior cruciate ligament reconstruction. Br J Sports Med. 2023 May;57(9):500-514.

Design: Consensus Statement/Clinical Practice Guideline Methods: A Guideline Development Group systematically searched and reviewed evidence using randomised clinical trials and systematic reviews to evaluate the effectiveness of rehabilitation interventions and guide clinicians and patients on the content of the optimal rehabilitation protocol after ACLR. Results: • Exercise interventions should be considered the mainstay of ACLR rehabilitation. However, little evidence on the dose-response relationship between volume/intensity of exercise and outcomes. • Physical therapy modalities are helpful in the early phase of rehabilitation when pain, swelling and ROM limitations are present, allowing earlier pain- free commencement of exercise rehabilitation. • Cryotherapy therapy is recommended, with cold+compression being more effective than cold only. • NMES is recommended to optimize muscle activation and minimize muscle atrophy, with NMES integrated with functional exercises providing optimal strength gains. • While there is a very low level of certainty for most components of rehabilitation, most of the recommendations provided in this guideline were agreed to by expert clinicians.

Key message: According to Aspetar guidelines, cold + compression therapy and NMES are recommended in the early postop rehab protocol.

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Cryotherapy and NMES recommended as part of the clinical practice guideline.

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Raynor 2005

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Raynor MC, Pietrobon R, Guller U, Higgins LD. Cryotherapy after ACL reconstruction: a meta-analysis. J Knee Surg. 2005 Apr;18(2):123-9.

Design: Meta-analysis.

Methods: Electronic databases and bibliographic references of relevant articles were used to identify all relevant randomized clinical trials comparing cryotherapy to a placebo group after ACL reconstruction.

Outcomes included: Postoperative drainage, Range of motion, Pain.

Results:

• 7 randomized clinical trials were included in the meta-analysis.

Key message: Cryotherapy reduces postoperative pain significantly and is therefore beneficial in the postoperative management of knee surgery.

• Patients undergoing cryotherapy experienced significantly less pain during the early postoperative period. • The reduction in postoperative fluid drainage and improvement of postoperative range of motion were both nonsignificant. • As the cryotherapy apparatus is fairly inexpensive, easy to use, has a level of patient satisfaction, and is rarely associated with adverse events, it is justified in the postoperative management of knee surgery.

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Kullenberg 2006

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Kullenberg B, Ylipää S, Söderlund K, Resch S. Postoperative cryotherapy after total knee arthroplasty: a prospective study of 86 patients. J Arthroplasty. 2006 Dec;21(8):1175-9.

Design: Prospective randomised controlled trial.

Subjects: 86 consecutive patients undergoing unilateral TKA.

Methods: patients were randomized to

• Treatment with Aircast Cryo/Cuff for 3 days after TKR (41 patients)

• Standard treatment: epidural analgesia for 3 days, followed by NSAIDs and opioids (45 patients). Outcomes included: Pain (VAS). Analgesic consumption, ROM for flexion and extension (Pre, day 1 post-op, discharge, 3 weeks post-op, weight bearing, total time in hospital.

Key message: Better pain control, ROM improvement and shorter hospital stay with the Aircast Cryo/Cuff after TKA.

Results:

• VAS pain scores and analgesic consumption were equal in both groups. Pain control for patient and nursing staff was easier with cold compression. • ROM at discharge was 75° in cold compression group vs. 63° in control group. By 3 weeks follow-up, ROM was 99° vs. 88° respectively. • Mean time in hospital averaged 4.8 days in the cold compression group and 6.2 days for the control group. This means cost savings: the list price of the Cryo/Cuff is 50 euros, while 24 hours of orthopaedic hospital care costs 325 euros.

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• Weight load in the operated leg was equal in both groups.

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Holmström 2005

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Holmström A, Härdin BC. Cryo/Cuff compared to epidural anesthesia after knee unicompartmental arthroplasty: a prospective, randomized and controlled study of 60 patients with a 6-week follow-up. J Arthroplasty. 2005 Apr;20(3):316-21.

Design: Prospective randomised controlled study.

Subjects: 60 patients with a diagnosis of osteoarthrosis undergoing primary, unicondylar knee arthroplasty and were scheduled to follow the present knee- rehabilitation program were considered for the trial.

Methods: 61 knees were randomized into 3 groups:

1. Aircast Cryo/Cuff : traditional analgesics + CC applied immediately after skin closure and before release of the tourniquet. Treatment continued without interruption for 48 hours. 2. Epidural anaesthesia (EDA): traditional analgesics + continuous EDA administration for 48 hours

Key message: Aircast Cryo/Cuff is a viable alternative for pain management after TKA, because in this study it was as effective as epidural anaesthesia for pain reduction, while well tolerated, non-invasive and risk-free.

Control: received only traditional analgesics

Outcomes included: blood loss, pain (rest/in-motion), morphine consumption, swelling, ROM.

Results:

• No significant difference between groups was detected with respect to subjective pain, bleeding, swelling, range of motion, and function. • The consumption of morphine was, however, significantly higher in the control group the first 24 hours than both the EDA group ( P < .001) and the Cryo/cuff group ( P = .028).

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• There was no significant difference in morphine consumption between the 2 treatment groups.

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Belsey 2024

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Belsey J, Reid A, Paine E, Faulkner J. A randomised crossover trial of five cryocompression devices' ability to reduce skin temperature of the knee. PLoS One. 2024 Jan 16;19(1):e0296634.

Design: Randomised Crossover Trial.

Subjects: 32 healthy adult participants were recruited

Methods: Skin temperature was measured by a thermocouple every 5 minutes during a 30-minute treatment with one of five different cryocompression devices (Physiolab S1, GameReady, Cryo/Cuff , VPulse, and a Gel Wrap). Outcomes included: Changes in skin temperature. Comfort was also recorded for each device.

Results:

Key message: The Aircast Cryo/Cuff achieved the second highest positive comfort rating (90%), however only the Physiolab S1 and Gameready devices were capable of reducing skin temperature of the knee within the target range of 10-15°C.

• The Physiolab S1, VPulse and GameReady reduced skin temperature significantly at each time point for the first 15 minutes of treatment to 16.1 ˚C, 21.6˚C, 16.7˚C, respectively. • The Cryo/Cuff reduced skin temperature significantly for the first five minutes of the treatment to 24.2˚C; temperature reduction continued after but not significantly. • Only the Physiolab S1 and GameReady were within the target therapeutic range at 30 minutes (13.9˚C and 13.0˚C). Mean skin temperatures for the VPulse, Cryo /Cuff, and Gel Wrap were 17.2˚C, 17.0˚C, and 19.9C, respectively. • 90% reported a positive comfort rating for the Cryo/Cuff, with no negative ratings given. Other devices: 86.7% (Physiolab S1 & Vpulse), 53.3% (GameReady),96.7% (Gel Wrap).

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Demoulin 2012

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Demoulin C, Brouwers M, Darot S, Gillet P, Crielaard JM, Vanderthommen M. Comparison of gaseous cryotherapy with more traditional forms of cryotherapy following total knee arthroplasty. Ann Phys Rehabil Med. 2012 May;55(4):229-40. English, French.

Design: Randomised Study

Subjects: 66 patients undergoing primary unilateral TKA

Methods: On preoperative day 1, patients were randomized into three groups;

• Gaseous cryotherapy (GC),

• Cold pack (CP),

• Cryo/Cuff.

All patients received cold therapy starting from postoperative day (POD) 2 and the therapy continued until the last hospitalization day. Outcomes included: knee pain intensity, mobility and girth measurements on preoperative day 1 and POD 7. Skin temp was measured on POD7 pre and post cold application.

Key message: Although skin temperature was significantly lower with gaseous cryotherapy, it was not more beneficial than routinely used strategies (Cryo/Cuff and gel packs) for pain intensity or knee ROM.

Results:

• Although skin temperature dropped to 14°C following GC versus 22 to 24°C for the other two applications (P<0.05), the three groups did not differ at POD7 regarding the three primary outcomes. • Following surgery, range of motion of the operated knee further decreased (P < 0.05) in all groups. There was no significant difference between groups. • The between-group comparisons at baseline revealed no significant difference with regard to pain intensity. • Following surgery, pain increased significantly in the CP (P < 0.05) and GC groups (P < 0.01) whereas it remained stable in the Cryo/Cuff group.

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Following surgery, pain increased significantly in the CP (P < 0.05) and GC groups (P < 0.01) whereas it remained stable in the CC (Cryo/Cuff) group.

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Bech 2015

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Belsey J, Reid A, Paine E, Faulkner J. A randomised crossover trial of five cryocompression devices' ability to reduce skin temperature of the knee. PLoS One. 2024 Jan 16;19(1):e0296634.

Design: Randomised Control Trial (RCT)

Subjects: A sample of 78 patients undergoing Total Knee Arthroplasty (TKR).

Methods: Participants were randomised into 2 groups:

• Intervention group ( Donjoy Iceman ) (n=37): Applied by the surgeon in the operating room immediately after surgery and remained in place for 48 hours. • Control group (Ice bags (n=34): Received ice bags at a frequency requested by the patient (usual care) for 48 hours. Outcomes included: Pain intensity (NPRS), passive ROM (PROM), nausea/vomiting, opioid use, blood loss, function, hospital length of stay, compliance and satisfaction.

Key message: Although there was no additional benefit of using the Donjoy Iceman over ice bags for pain reduction, TKA patients using the device were significantly more satisfied, used the device more consistently, day and night, and were more likely to recommend this method of cooling.

Results:

• No significant differences in the primary outcome (pain intensity measured via NPRS) were observed between control and intervention groups.

• However, patients in the intervention group were:

• Significantly more satisfied (8.4 vs. 6.0, p=0.002);

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• Used the device significantly more consistently, day and night (85.7% vs. 29.6% and 87.6% vs. 30.8%, respectively, p<0.001);

• Significantly more likely to recommend this method of cooling (96.8% vs. 68.0%, p=0.004).

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Aggarwal 2023 | TKA

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Aggarwal A, Adie S, Harris IA, Naylor J. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2023 Sep 14;9(9):CD007911.

30 However, the certainty of evidence was low due to bias, indirectness, imprecision and inconsistency. More well-designed RCTs are needed. Design: Systematic Review ( Cochrane ) Methods: randomised controlled trials or controlled clinical trials comparing cryotherapy with or without other treatments (such as compression, regional nerve block or continuous passive motion) to no treatment, or the other treatment alone, following TKR for osteoarthritis were included. Outcomes included: blood loss, pain, knee ROM, knee function, adverse events, analgesia use, swelling, length of stay, quality of life, activity level. Results: • Different comparisons of cryotherapy and controls (with/without compression) were performed by subgrouping studies in each analysis. • Subgroup analysis noted a trend in favour of interventions combining cold and compression for blood loss, pain, analgesia uses and swelling. • For combined blood loss, the mean difference (MD) was 0.84 mL less blood loss (95% CI 1.61 less to 0.06 more; P = 0.03) in the combined cold and compression group. • For pain at post-operative day two, the MD was 1.88 points less (95% CI 2.52 less to 1.24 less; P < 0.001) in the combined cold and compression group • For combined analgesic use, the SMD was 0.30 units lower (95% CI 0.59 lower to 0.00; P = 0.05) within the cold and compression group • For change in knee swelling at mid-patella between postop days 2-6, the MD was 7.63 mm less (95% CI 12.52 to 2.75 mm less; P = 0.002) in the combined group. •

Key message: Subgroup analysis noted a trend in favour of interventions combining cold and compression for blood loss, postoperative pain (day 2), analgesia use and swelling at mid patella (days 2-6).

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Wyatt 2023 | TKA

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Wyatt PB, Nelson CT, Cyrus JW, Goldman AH, Patel NK. The Role of Cryotherapy After Total Knee Arthroplasty: A Systematic Review. J Arthroplasty. 2023 May;38(5):950-956.

Design: Systematic Review

Methods: A strategic keyword search of Medline, Cochrane, Embase, and CINAHL retrieved randomized controlled trials examining cryotherapy following TKA published between February 1, 2017, and February 24, 2022.

Outcomes included: Pain ratings, knee/limb swelling, opioid use, and ROM.

Results

• Six studies were selected for inclusion in this review.

Key message: Cryotherapy's role after TKA appears to be in decreasing opioid consumption primarily in the first postoperative week.

• Opioid use was significantly decreased in cryotherapy groups compared to non-cryotherapy groups within the first postoperative week only (P < .05). • This effect may be augmented by the use of computer-assisted (temperature regulated) cryotherapy devices, compared to other modalities including ice packs.

• Pain ratings also decrease, but this decrease may not be clinically relevant.

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• Cryotherapy appears to confer no consistent benefit to ROM and swelling at any time point. • Computer-assisted cryotherapy may be associated with decreased opioid consumption after TKA compared to traditional ice packs.

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Ni 2015 | TKA

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Ni SH, Jiang WT, Guo L, Jin YH, Jiang TL, Zhao Y, Zhao J. Cryotherapy on postoperative rehabilitation of joint arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3354-61.

Design: Systematic Review

Methods: Comprehensive literature searches of several databases including Cochrane Library, MEDLINE, and Embase were performed. Randomised controlled trials that compared the experimental group received any form of cryotherapy with any control group after joint arthroplasty were included.

Outcomes included: Postoperative blood loss, adverse events, pain.

Key message: Cryotherapy significantly reduces blood loss after TKA without increasing the risk of adverse events.

Results:

• 10 trials comprised 660 total knee arthroplastys and 3 trials comprised 122 total hip arthroplastys (THAs) met the inclusion criteria. • Blood loss was significantly decreased by cryotherapy (Mean difference (MD) = -109.68; P = 0.03), especially in TKA patients.

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• Cryotherapy did not increase the risk of adverse effect (P>0.05)

• Cryotherapy decreased pain at the second day of postoperative (MD = -1.32; P = 0.0003) but did not decreased pain at the first and third day of postoperative (P>0.05).

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Knobloch 2008

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Knobloch K, Grasemann R, Spies M, Vogt PM. Midportion achilles tendon microcirculation after intermittent combined cryotherapy and compression compared with cryotherapy alone: a randomized trial. Am J Sports Med. 2008 Nov;36(11):2128-38.

Design: Randomized in vivo laboratory study.

Subjects: 60 subjects were randomized for either combined cryotherapy/compression ( Cryo/Cuff , n = 30) or cryotherapy alone (KoldBlue, n = 30;) with intermittent 3 × 10-minute application. Methods: Midportion Achilles tendon microcirculation was determined. This cryotherapy application was scheduled with the intention to create a sort of preconditioning. Ischemic preconditioning is the cyclic change of ischemia followed by reperfusion, which has been shown to protect the tissue from further ischemic damage

Results:

• Capillary bloodflow: both Cryo/Cuff and KoldBlue significantly reduced superficial and deep capillary tendon blood flow within the first minute of application without a significant difference throughout all 3 applications. However, during recovery, superficial and deep capillary blood flow was reestablished significantly faster using Cryo/Cuff .

Key message: Combined cryotherapy and compression (Cryo/Cuff) is superior to cryotherapy alone regarding the Achilles tendon microcirculation.

• Tendon oxygen saturation was reduced in both groups significantly within the first 3 minutes

of application, with significantly stronger effects using Cryo/Cuff. Cryo/Cuff led to significantly higher tendon oxygenation in superficial and deep tissue compared with KoldBlue during all recoveries ("preconditioning"). • Postcapillary venous filling pressures were significantly reduced in both groups during application; however, Cryo/Cuff led to significantly, but marginally, lower pressures. • Complications: none of the 60 enrolled participants had any skin burns or nerve palsies, such as paresthesias or paresis, caused by either device during or after application.

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Knobloch 2006

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Knobloch K, Grasemann R, Jagodzinski M, Richter M, Zeichen J, Krettek C. Changes of Achilles midportion tendon microcirculation after repetitive simultaneous cryotherapy and compression using a Cryo/Cuff. Am J Sports Med. 2006 Dec;34(12):1953-9.

Design: In-vivo laboratorystudy Subjects: 26 healthy participants were included.

34 • Oxygen saturation: Superficial tendon oxygen saturation dropped significantly up to -70%. There was significant increase during the recovery period up to +83% of the baseline level. At 8-mm tendon depth, cryo-compression preserved local oxygen with -4% of the baseline level and small but significant increased oxygen saturation of up to +13% during the recovery period. • Complications: None of the subjects had any skin burns or nerve palsies caused by the Cryo/Cuff. • Postcapillary venous filling pressures are diminished during Cryo/Cuff application favoring capillary venous outflow: up to 67% pressure reduction at 2mm and up to 79% pressure reduction at 8mm. • Increased postcapillary filling pressure indicates venous congestion with decreased clearance of local capillary metabolic end products. Facilitation of the postcapillary venous clearance is therefore beneficial in a microcirculatory view. Methods: Each subject underwent 3 10-minute applications of the Cryo/Cuff , followed by a 10- minute recovery period. A continuous real-time assessment of parameters of Achilles tendon midportion microcirculation was performed with a laser Doppler spectrophotometry system. Results: • Capillary blood flow: Superficial (2mm) capillary blood flow was significantly reduced by 94%, with increased flow during recovery periods of up to 20%. Deep flow (8mm) was significantly reduced by 78% without increase during recovery periods. • To speculate on tendinopathic or injured patients, one could think that cryo-compression might decrease the pathologically increased capillary flow at the point of pain in Achilles tendinopathy and limit bleeding on the capillary level in injured patients.

Key message: Cryo/Cuff exerts beneficial effects on the microcirculatory level of the midportion of the Achilles tendon with decreased capillary blood flow, preserved deep tendon oxygen saturation, and facilitated venous capillary outflow.

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Knobloch 2006b

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Knobloch K, Kraemer R, Lichtenberg A, Jagodzinski M, Gosling T, Richter M, Krettek C. Microcirculation of the ankle after Cryo/Cuff application in healthy volunteers. Int J Sports Med. 2006 Mar;27(3):250-5.

Design: Prospective experimental study. Subjects: 21 healthy volunteers Methods: The Aircast Cryo/Cuff ankle device was applied with continuous assessment of parameters of ankle microcirculation, Outcomes included: Tissue oxygen saturation, relative postcapillary venous filling pressures, and microcirculatory blood flow at 2- and 8-mm tissue depths Results: • Superficial tissue oxygen saturation immediately dropped with 52% within the first 2 minutes after Cryo/Cuff activation with a consecutive slow decrease of 32% after 30 minutes. • Deep tissue oxygen saturation did not change within 30 min of Cryo/Cuff application.

Key message: The Cryo/Cuff device has significant effects on ankle microcirculation in healthy volunteers with no complications - effects that are desirable in the treatment of acute soft-tissue injuries.

• Superficial postcapillary venous filling pressures showed an immediate and sustained decrease with 39% after Cryo/Cuff application within 4 minutes. • Deep postcapillary venous filling pressures dropped within the first 4 minutes of Cryo/Cuff application with 20%. • Superficial microcirculatory blood flow decreased significantly (-69%) • Deep microcirculatory blood flow at 8mm tissue depth significantly decreased (- 47%) over the 30 minutes. • Non of the patients had any skin burns or nerve palsies, such as paresthesias or paresis, caused by the Cryo/Cuff.

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Mora 2002

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Mora S, Zalavras CG, Wang L, Thordarson DB. The role of pulsatile cold compression in edema resolution following ankle fractures: a randomized clinical trial. Foot Ankle Int. 2002 Nov;23(11):999-1002.

Design: Randomized controlled clinical trial

Subjects: 24 patients with displaced ankle fractures awaiting surgery.

Methods: Patients were randomized into a study (n=11) or a control group (n=13). • In the study group patients had a Aircast Cryo/Cuff device applied to their ankle and remained at bed rest with the extremity elevated while awaiting surgery. • In the control group patients remained in a posterior molded splint instead of the PCC device. Outcomes included: Baseline circumferential measurements of the ankle, 24- hour increments to evaluate edema resolution, patient satisfaction.

Key message: The Cryo/Cuff was well tolerated and resulted in a significantly greater reduction of ankle circumference compared to splinting and elevation alone. The addition of compression augments the effectiveness of cryotherapy by increasing the extracellular hydrostatic pressure, thus decreasing edema formation.

Results:

• The Cryo/Cuff resulted in a significantly greater reduction of ankle circumference compared to splinting and elevation alone at 24h (2.9% vs. 0.6%), 48h (4.4% vs. 1.7%), and 72h (4.9% vs. 1.6%) after its application. • The Cryo/Cuff was well tolerated : patients were all satisfied or very satisfied with the device (median score = 4).

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Bleakley 2006

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Bleakley CM, McDonough SM, MacAuley DC, Bjordal J. Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing protocols. Br J Sports Med. 2006 Aug;40(8):700-5; discussion 705.

Design: Randomised double blind comparative study with 6-weeks follow-up. Subjects: 89 subjects (44 sportsmen and 45 members of the public) who had sustained a mild/moderate ankle sprain within the previous 48 hours. Methods: Subjects were randomly allocated to one of two treatment groups: • Standard ice application (n=46): 20 minutes continuous ice pack treatment performed every 2 hours. • Intermittent ice application (n=43): Ice pack applied for a 10 minutes, followed by no-ice for 10 minutes, before reapplying ice for a further 10 minutes. This was repeated every 2 hours. Outcomes included: Function, pain (VAS), swelling, and ankle function at baseline, 1, 2-, 3-, 4- and 6-weeks post injury. Results: • Subjective ankle function, swelling and pain at rest values significantly improved over the entire follow-up period. However, there was no significant difference between the standard and intermittent treatment protocols. • Pain on activity values significantly decreased at each time point during the 6 week follow up period. Pain values reduced significantly more between baseline and week 1 in the intermittent group, compared to the standard group. • Adverse effects : there were no reported incidences of skin burns, nerve palsies or any other potential deleterious effects, throughout the duration of the trial.

Key message: Cryotherapy significantly improves pain, swelling and function in acute ankle sprains. Intermittent applications may enhance the therapeutic effect of ice in pain relief after acute soft tissue injury, in the early stages of rehabilitation.

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Guillot 2014

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Guillot X, Tordi N, Mourot L, Demougeot C, Dugué B, Prati C, Wendling D. Cryotherapy in inflammatory rheumatic diseases: a systematic review. Expert Rev Clin Immunol. 2014 Feb;10(2):281-94.

Design: Systematic Review

Methods: Studies including non-operated and non-infected arthritic patients treated with local cryotherapy or whole-body cryotherapy we selected. 6 studies including 257 rheumatoid arthritis (RA) patients were included for pooling the data. Outcomes included: Pain (VAS), DAS-28 score (disease activity), molecular pathways.

Key message: Cryotherapy reduces pain, disease activity and inflammation in Rheumatoid Arthritis and should be included in treatment protocols as adjunct therapy.

Results:

• Significant decreases in pain visual analogic scale (mm) and 28-joint disease activity score after chronic cryotherapy in RA patients. • For molecular pathways, local cryotherapy induces an intrajoint temperature decrease, which might downregulate several mediators involved in joint inflammation and destruction (cytokines, cartilage- degrading enzymes, proangiogenic factors), but studies in RA are rare.

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d’Young 2008

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d'Young AI. Domiciliary application of CryoCuff in severe haemophilia: qualitative questionnaire and clinical audit. Haemophilia. 2008 Jul;14(4):823-7.

Design: Qualitative questionnaire study.

Subjects: 12 patients, either with severe haemophilia A/B or with VWD (von Willebrand's disease) Methods: Patients were asked to use the Aircast Cryo/Cuff device as part of the PRICE regime immediately following the onset of knee-, ankle- or elbow bleeds for the next one year. The Cryo/Cuff protocol consisted of short applications (15 minutes) during the day, repeated every 1-2 hours. Outcomes included: Qualitative questionnaire to determine the perceived benefit or any adverse reactions to the device after 1-year use.

Key message: Reduced pain and swelling and no adverse effects with Cryo/Cuff treatment of haemarthroses in severe haemophilia.

Results:

• All patients reported that the application protocol was easy to follow, they were able to apply the device as per the PRICE regime and they were able to tolerate it for the recommended period. • All the patients felt that the device had a significant impact on alleviation of pain and return to pre-bleed status. • 78% of the patients felt that the device led to a significant reduction in swelling around the affected joint.

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• No other adverse effects were reported by participants in this study.

• When asked to assess the overall perceived benefit in the management of knee-, ankle- or elbow haemarthroses, all patients either agreed or strongly agreed that the CryoCuff was beneficial to them compared with the year prior to the study when it had not been used.

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