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

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02308514
• Other study ID #: CER-14-203-07.08
• Status: Active, not recruiting
• Phase: N/A
• First received: November 26, 2014
• Last updated: May 10, 2016
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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.

Other:
• conservative care
manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.

Locations

Country	Name	City	State
Canada	Clinique universitaire de chiropratique	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Blanchette MA, Normand MC. Impairment assessment of lateral epicondylitis through electromyography and dynamometry. J Can Chiropr Assoc. 2011 Jun;55(2):96-106. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Rated Tennis Elbow	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	No
Primary	Visual Analog Pain Scale	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	No
Secondary	pain free grip strength	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	No