Overview

This trial is active, not recruiting.

Condition lateral epicondylitis
Treatments cryostimulation, conservative care
Sponsor Université du Québec à Trois-Rivières
Start date September 2014
End date September 2015
Trial size 40 participants
Trial identifier NCT02308514, CER-14-203-07.08

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Active Comparator)
this group of patients will receive the conservative care: myofascial point release and radial head mobilisation
conservative care myofascial release
manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.
(Experimental)
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.
cryostimulation
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.
conservative care myofascial release
manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.

Primary Outcomes

Measure
Visual Analog Pain Scale
time frame: at inclusion - ninth visit - 3 months after last treatment

Secondary Outcomes

Measure
pain free grip strength
time frame: at inclusion - ninth visit - 3 months after last treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
Principal investigator Nadia Richer Richer, M.Sc.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Université du Québec à Trois-Rivières.