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

Université du Québec à Trois-Rivières

Status: Unknown

Conditions: Lateral Epicondylitis

Treatments: Other: conservative care; Device: cryostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02308514

CER-14-203-07.08

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

conservative care

Active Comparator group

Description:

this group of patients will receive the conservative care: myofascial point release and radial head mobilisation

Treatment:

Other: conservative care

cryostimulation

Experimental group

Description:

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.

Treatment:

Other: conservative care

Device: cryostimulation