Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study

Study Overview
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Brief Summary
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In this study the investigators want to measure the impact or effects of adding cryostimulation to the conservative care of chronic lateral epicondylitis. The rapid fall in skin temperature above the injured tissues is presume to have a positive effect in the healing process. The combination of conservative care and cryostimulation could then be appreciated. The investigators chose to measure these effects with 3 elements: visual analog pain scale, validated elbow questionnaire and pain free grip strength. This pilot study consist in a two arm design, each arm including 15 patients.

Detailed Description
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Lateral epicondylitis is one of the most prevalent upper limb conditions that can affect up to 1-3% of the active population. Invalidity and health care costs incurred by this condition are posing a real challenge to our societies knowing that the natural history of the lateral epicondylitis can last from 1 to 2 years. Many therapies have been tested and so far none has proven conclusive when used alone so far (Blanchette and Normand 2011). The use of cryostimulation is widespread in the sport scene without strong literature supporting its evidence. The aim of this study is to quantify the effects of cryostimulation when added to conservative care in the treatment of chronic lateral epicondylitis. Thirty (30) patients will be divided randomly in two groups: The control group (n=15) will receive conservative care including myofascial trigger points (involved forearm) and radial head mobilisations (Bergmann & Peterson, 2010). The experimental group (n=15) will receive the cryostimulation and the conservative treatment as mentioned above. A total of eight treatments will be given to each patient; the whole protocol lasting four to six weeks. The treatments will be delivered by experienced and trained clinicians in cryostimulation and myofascial treatment protocols. The effects of the two treatment protocols will be monitored by a validated elbow questionnaire (PRTEE, (Rompe, Overend et al. 2007)), a visual analog pain scale and the pain free grip strength at three moments: at inclusion, at the ninth visit and 3 months after the last treatment.

Official Title
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Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Device: cryostimulation
* Other: conservative care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have pain at lateral elbow (lateral epicondylitis) for at least six months Pain must not come from trauma Painful palpation of the lateral epicondyle At least one out of two positive test: Cozen's, Mill's Exclusion Criteria: Fibromyalgia Diabetes Patient taking more than three medications at the time of inclusion Cervical radiculopathy Painful shoulder Cold intolerance / allergies Smoking Cortisone infiltration at the painful lateral epicondyle in the month previous to the inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conservative care<br>this group of patients will receive the conservative care: myofascial point release and radial head mobilisation | Other: conservative care<br>* manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.<br>* Other names: myofascial release;|
| Experimental: cryostimulation<br>this group of patients will receive the conservative care :myofascial point release and radial haed mobilisation and the cryostimulation (30-40 second of cold air application (-70 celsius degree) in order to lower skin temperature around the lateral epicondyle at 4 celsius degree. | Device: cryostimulation<br>* pressurized cold air (-70 celsius degree) is blown on the skin surface surrounding the lateral epicondyle, creating a rapid decrease in ski temperature. In a 30-40 sec exposition, skin temperature can drop to 4 celsius degree. this rapid decrease is presumed to have a positive healing effect.<br>Other: conservative care<br>* manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.<br>* Other names: myofascial release;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale | Subjects will be asked to rate their average pain for the last 24 hours on a scale ranging from 0 to 10 | at inclusion - ninth visit - 3 months after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain free grip strength | we will use a hand-held dynamometer to mesure the painfree grip strength of the subjets. Subjects will be asked to gradually increase the grip stregth while the elbow is extented and arm along side of the body. They will be asked to stop when pain is felt. We will take three mesures with each elbow, left and right. | at inclusion - ninth visit - 3 months after last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryostimulation