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Clinical Trials/NCT02308514
NCT02308514
Unknown
Not Applicable

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

Université du Québec à Trois-Rivières1 site in 1 country40 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lateral Epicondylitis
Sponsor
Université du Québec à Trois-Rivières
Enrollment
40
Locations
1
Primary Endpoint
Visual Analog Pain Scale
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nadia Richer

Nadia Richer, M.Sc., DC, clinician professor

Université du Québec à Trois-Rivières

Eligibility Criteria

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
  • Patient taking more than three medications at the time of inclusion
  • Cervical radiculopathy
  • Painful shoulder
  • Cold intolerance / allergies
  • Cortisone infiltration at the painful lateral epicondyle in the month previous to the inclusion

Outcomes

Primary Outcomes

Visual Analog Pain Scale

Time Frame: at inclusion - ninth visit - 3 months after last treatment

Subjects will be asked to rate their average pain for the last 24 hours on a scale ranging from 0 to 10

Secondary Outcomes

  • pain free grip strength(at inclusion - ninth visit - 3 months after last treatment)

Study Sites (1)

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