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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02308514
Enrollment
40
Registered
2014-12-04
Start date
2014-09-30
Completion date
2016-12-31
Last updated
2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Epicondylitis

Keywords

cryostimulation

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.

Interventions

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.

manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.

Sponsors

Université du Québec à Trois-Rivières
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Pain Scaleat inclusion - ninth visit - 3 months after last treatmentSubjects will be asked to rate their average pain for the last 24 hours on a scale ranging from 0 to 10

Secondary

MeasureTime frameDescription
pain free grip strengthat inclusion - ninth visit - 3 months after last treatmentwe 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.

Other

MeasureTime frameDescription
Patient Rated Tennis Elbowat inclusion - ninth visit - 3 months after last treatmentThe questionnaire will be filled in by patients at the beginning of the three evaluations: inclusion, ninth visit and 3 months after last treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026