- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03774121
Cryoneurolysis for the Management of Chronic Pain in Patients With Knee Osteoarthritis
Cryoneurolysis for the Management of Chronic Pain in Patients With Knee Osteoarthritis; A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND Pain is the principal symptom in knee osteoarthritis (OA) and results in a considerable amount of years lived with disability, emotional distress and has significant socioeconomic consequences. Knee OA in particular, has a high prevalence rate compared to other types of OA, and is also present in the younger working age population. The treatment of knee OA typically focuses on pain relief, however the effects of current conservative treatment options remain small to moderate and most are associated with side effects. In many cases patients alternatively may be subjected to partial/total knee arthroplasty (TKA). TKA is considered to be an effective treatment for end-stage knee osteoarthritis however more than 20% of patients receiving TKA, experience persistent and unchanged pain post-surgery. Reviewing these results, focus should be on low-risk, minimally invasive therapies. Novel advances in the field of cryoneurolysis are in that respect promising. Cryoneurolysis has made it possible to apply low temperatures to a target percutaneous peripheral nerve, causing Wallerian degeneration. This has been shown to provide pain relief in a variety of chronic pain conditions. Recently, Radnovich et al. (2017) targeted the genicular nerves to reduce pain in patients with knee OA. The authors reported significant pain relief in patients with knee OA for up to 150 days. The authors reported expected adverse effects, that were transient, with mild severity, requiring no further intervention. These results might suggest that cryoneurolysis treatment is a safe procedure, that may reduce both pain and symptoms in patients with knee OA. Further prospective randomized controlled studies, with adequate power are needed to confirm the efficacy and safety of cryoneurolysis treatment in patients with knee OA.
In Denmark, a neuromuscular exercise program (GLA:D) has been implemented, for the treatment of knee and hip OA in clinical practice. Recent studies show that exercise reduce pain and improve function in people with knee or hip OA. Despite of these reports the beneficial effects remains moderate with difficulties in maintaining these effects at long-term follow-up and includes a significant discontinuation rate for patients reporting high pain levels. In this line, pain and muscle weakness, among others, have been reported to be major barriers for physical exercise. The application of cryoneurolysis treatment as an effective pain reducing treatment prior to a standardized exercise program could perhaps provide significant pain relief, resulting in improved adherence, exercise effectiveness and long-term benefits of both therapies.
The primary objective of the current project is to determine the effectiveness of cryoneurolysis in its proposed ability to decrease pain in patients with knee osteoarthritis. The secondary objective is to evaluate the safety and effectiveness of cryoneurolysis in its ability to improve outcomes in the GLA:D program to potentially delay or avoid surgical intervention.
We hypothesize that cryoneurolysis in combination with GLA:D will be a safe and effective therapeutic option with few side effects to reduce pain in patients with knee osteoarthritis and may post pone surgical intervention.
TRIAL DESIGN This study is a randomized, controlled, trial (RCT) designed to test the efficacy of cryoneurolysis treatment in patients with knee osteoarthritis followed by a neuromuscular exercise program (GLA:D). The patients will be randomly allocated in either a cryoneurolysis intervention group (CRYO) or a sham group (SHAM) and will be assessed at baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up. The tests will include both patient-reported outcomes (PRO) and objective functional measurements.
RECRUITMENT AND SAMPLE SIZE Patients with pain and knee OA confirmed by radiography, are referred to GLA:D by their general practitioner prior to assessment of surgery eligibility at the hospital. The current project will recruit these patients in collaboration with selected general practitioners in the Region of Southern Denmark. According the Region of Southern Denmark, an average of 270 patients participate in the GLA:D program every year. Based on this estimation and considering the eligibility criteria to participate in the current project, recruitment will continue for up to 1 year.
The planned number of trial participants is based on the assumed superiority of the cryoneurolysis treatment over control. Estimating the sample size for a two-sample means test with a level of significance at 0.05, assuming a common standard deviation (SD) of 30 in VAS pain intensity scores indicates that for the intention-to-treat (ITT) population, 74 individuals is required to obtain a power of at least 80% to establish a minimal clinically significant difference (MCSD) of 20 in VAS pain scores. The MCSD and common standard deviation is based on previous findings with a similar patient group and intervention. With an expected drop-out rate of 20%, a total of 94 individuals will be included in the project, 47 in each group.
ALLOCATION AND BLINDING Randomization will be performed as computer-generated block randomization with a 1:1 allocation ratio using random block sizes of 2, 4 and 6 in either group CRYO or group SHAM. The randomization restrictions will not be disclosed to ensure allocation concealment and the sequence will be performed by an external co-investigator.
To account for the placebo effect and reduce the risk of bias, the patients, therapists and data-manager will be blinded to the allocation. Blinding will be assured using a sham trial that includes the same procedures as cryoneurolysis treatment but without any freezing temperatures. Thus, visible marks as a result of the procedures in both groups will be similar.
INTERVENTIONS Diagnostic nerve block. All patients reporting a decrease of ≥ 50 % in VAS pain scores at least 15 min after a diagnostic nerve block of the genicular nerves.
Cryoneurolysis. The current project involves the novel application and test of cryoneurolysis, in the treatment of OA related pain. The rationale behind this method, is based on previous reports showing that low temperature conditions can alter nerve function. This technology allows for reversible destruction of nerves, also known as Wallerian degeneration, that prevents nerve signaling and potentially alleviate pain and motor dysfunction in a number of medical conditions. A probe will be inserted percutaneously at the target anterior femoral cutaneous nerve and infrapatellar branch of the saphenous nerve guided by ultrasound visualization to accurately determine the location of the nerve and to account for adjacent neurovascular structures and variations in anatomical structures. The target locations are drawn directly on the patients' skin prior to treatment along which a dose of local anesthetic will be injected subcutaneously before treatment. Cryoneurolysis at each target site requires 2-4 freeze cycles with a duration of 3 mins, and with thaw cycles between 20-40 seconds. A temperature probe will be inserted adjacent to the target nerve and cryoneurolysis-probe to ensure a controlled cooling effect and to control nerve damage. The sham intervention includes a similar procedure but using a sham probe.
GLA:D. SHAM and CRYO will both participate in the GLA:D program, which is a standard education and exercise program for patients with osteoarthritis in Denmark. The program is performed in groups and with the supervision of an experienced physiotherapist specialized in training of musculoskeletal disorders and has a duration of 8 weeks.
STATISTICAL METHODS The treatment groups will be examined for comparability based on baseline demographic and prognostic measures. An Intention-To-Treat (ITT) analysis will be used for all allocated patients and a mixed effects model will be used on the continuous outcome measures to determine the effects of cryoneurolysis treatment from baseline to post treatment and follow-ups [Between groups factor: CRYO vs SHAM, within groups factor: time]. The model will use robust estimation methods to account for outliers. Finally, a multiple imputation approach will be used in case of missing data. All P-values < 0.05 will be considered statistically significant.
ETHICS AND SIGNIFICANCE The project will be conducted according to the declaration of Helsinki and will be registered in ClinicalTrials.gov. The Project has been approved by the Regional Committee on Health Research Ethics for Southern Denmark (S-20180089).
Cryoneurolysis could potentially provide an effective, safe and minimally invasive option to treat pain in OA patients. The potential benefits include increased functional capacity and quality of life as a result of significant pain relief and improved benefits of physical exercise, ultimately postponing or making surgical intervention unnecessary. Finally, an important perspective, is the application of cryoneurolysis in other areas - such as managing pain, related to surgery, to improve rehabilitation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Region Of Southern Denmark
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Esbjerg, Region Of Southern Denmark, Denmark, 6700
- Hospital of Southwest Jutland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Referred to GLA:D by a physician.
- Age ≥ 18y
- Chronic knee pain for a minimum duration of 6 months.
- Pain intensity ≥ 40mm on a 100mm visual analogue scale (VAS).
- Radiographic confirmation of osteoarthritis; Grade 2-4 changes according to the Kellgren Lawrence classification system
- A decrease of ≥ 50 % in VAS scores with diagnostic genicular nerve block.
- Written and oral understanding of Danish.
Exclusion Criteria:
- History of systemic inflammatory conditions such as rheumatoid arthritis.
- Previous recipient of cryoneurolysis for the knee.
- Use of hyaluronic acid within the previous 30 days.
- Injection of corticosteroid within the previous 3 months.
- Clinical significant structural abnormities affecting locomotion and knee function aside from osteoarthritis and which might cause chronic knee pain.
- Body mass index ≥ 18 and ≤ 40 kg/m
- In treatment for other pain conditions.
- Pregnancy
- Coagulopathy
- Uncontrolled serious disease (cancer, diabetes, etc.)
- Disease associated with reactions to cold, such as cryoglobulinemia, cold urticarial and Renaud's syndrome.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CRYO
Subjected to Cryoneurolysis treatment and Neuromuscular training (GLA:D).
|
A cryoprobe will be inserted percutaneously and freeze the target nerves (infrapatellar branch of the saphenous nerve & anterior femoral cutaneous nerve) guided by ultrasound visualization.
Other Names:
The GLA:D program, is a standard education and exercise program for patients with osteoarthritis in Denmark.
The program is performed in groups and with the supervision of an experienced physiotherapist specialized in training of musculoskeletal disorders.
|
Sham Comparator: SHAM
Subjected to similar procedures as CRYO, but without freezing temperatures.
Subjected to Neuromuscular training (GLA:D).
|
The GLA:D program, is a standard education and exercise program for patients with osteoarthritis in Denmark.
The program is performed in groups and with the supervision of an experienced physiotherapist specialized in training of musculoskeletal disorders.
The sham intervention includes a similar procedure but without freezing temperatures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in NRS knee pain intensity score
Time Frame: Change in NRS pain score, between baseline and two weeks post surgery
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NRS consists of a numerical, from 0 to 10, anchored by two verbal descriptors, "no pain" for the score of zero and "worst pain imaginable" for the score of 10.
NRS is a self-reported tool where the respondent is asked their current pain intensity.
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Change in NRS pain score, between baseline and two weeks post surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain location
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Pain location as drawn by the patient.
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in Functional Performance Evaluated by the 30 second chair-stand test.
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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The outcome is the total number of complete chair stands performed for the duration of the task (one chair stand represents a stand followed by a sit movement).
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in use of Analgesics
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Use of analgesics from medical records
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Number of Adverse effects
Time Frame: Reported adverse effects 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Pre-defined and unexpected adverse effects
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Reported adverse effects 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in Pain type
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in pain type using prespecified pain definitions
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in Functional Performance Evaluated by the 40m fast-paced walk test.
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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The outcome is expressed as speed.
i.e. walking distance (40m) divided by the time to perform the task (s).
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in Functional Performance Evaluated by the 9 step stair test.
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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The outcome is the total time to perform the task (s).
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in Functional Performance Evaluated by Maximum Voluntary Contraction
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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As measured in moment force of the knee extensors (Nm)
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in Quality of Life using the Quality of Life questionnaire (EQ5D)
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression.
An health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state.
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in self-rated health using the Quality of Life questionnaire (EQ5D)
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in the subscale "Pain" using the Knee injury and Osteoarthritis Score (KOOS score)
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) us calculated for each subscale.
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in the subscale "other Symptoms" using the Knee injury and Osteoarthritis Score (KOOS score)
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) us calculated for each subscale.
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in the subscale "Function in daily living (ADL)" using the Knee injury and Osteoarthritis Score (KOOS score)
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
|
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) us calculated for each subscale.
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in the subscale "Function in sport and recreation (Sport/Rec)" using the Knee injury and Osteoarthritis Score (KOOS score)
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
|
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) us calculated for each subscale.
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Change in the subscale "Knee related Quality of Life (QoL)" using the Knee injury and Osteoarthritis Score (KOOS score)
Time Frame: Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
|
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL).
A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) us calculated for each subscale.
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Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- SUNDERLAND S. A classification of peripheral nerve injuries producing loss of function. Brain. 1951 Dec;74(4):491-516. doi: 10.1093/brain/74.4.491. No abstract available.
- Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016 Aug;13(8):713-25. doi: 10.1080/17434440.2016.1204229. Epub 2016 Jul 13.
- Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.
- Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
- Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.
- Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.
- Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.
- O'Brien T, Breivik H. The impact of chronic pain-European patients' perspective over 12 months. Scand J Pain. 2012 Jan 1;3(1):23-29. doi: 10.1016/j.sjpain.2011.11.004.
- Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126.
- Nygaard NB, Koch-Jensen C, Vaegter HB, Wedderkopp N, Blichfeldt-Eckhardt M, Gram B. Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial. BMC Musculoskelet Disord. 2021 Feb 26;22(1):228. doi: 10.1186/s12891-021-04102-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CryoKnee01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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