Clinical trial NCT02308514: Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
Official title: Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: cryostimulation
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: at inclusion - ninth visit - 3 months after last treatment
Secondary outcomes:
measure: pain free grip strength
timeFrame: at inclusion - ninth visit - 3 months after last treatment
Other outcomes:
measure: Patient Rated Tennis Elbow
timeFrame: at inclusion - ninth visit - 3 months after last treatment
Locations:
city: Trois-Rivières
country: Canada
facility: Clinique universitaire de chiropratique
state: Quebec
Study officials:
affiliation: Clinique universitaire de chiropratique
name: Nadia Richer Richer, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanchette MA, Normand MC. Impairment assessment of lateral epicondylitis through electromyography and dynamometry. J Can Chiropr Assoc. 2011 Jun;55(2):96-106.
citation: Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.
citation: Mourot L, Cluzeau C, Regnard J. Hyperbaric gaseous cryotherapy: effects on skin temperature and systemic vasoconstriction. Arch Phys Med Rehabil. 2007 Oct;88(10):1339-43. doi: 10.1016/j.apmr.2007.06.771.
citation: Dingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18.
citation: Coombes BK, Bisset L, Vicenzino B. Thermal hyperalgesia distinguishes those with severe pain and disability in unilateral lateral epicondylalgia. Clin J Pain. 2012 Sep;28(7):595-601. doi: 10.1097/AJP.0b013e31823dd333.