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

May 10, 2016 updated by: Nadia Richer, Université du Québec à Trois-Rivières
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G9A 5H7
        • Clinique universitaire de chiropratique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conservative care
this group of patients will receive the conservative care: myofascial point release and radial head mobilisation
Other: conservative care
manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.
Other Names:
  • myofascial release
Experimental: cryostimulation
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.
Other: conservative care
manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.
Other Names:
  • myofascial release
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at inclusion - ninth visit - 3 months after last treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain free grip strength
Time Frame: at inclusion - ninth visit - 3 months after last treatment
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Rated Tennis Elbow
Time Frame: at inclusion - ninth visit - 3 months after last treatment
The questionnaire will be filled in by patients at the beginning of the three evaluations: inclusion, ninth visit and 3 months after last treatment
at inclusion - ninth visit - 3 months after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec à Trois-Rivières

Investigators

  • Principal Investigator: Nadia Richer Richer, M.Sc., Clinique universitaire de chiropratique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-14-203-07.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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