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

NCT ID: NCT02308514

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Lateral Epicondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conservative care

this group of patients will receive the conservative care: myofascial point release and radial head mobilisation

Group Type: ACTIVE_COMPARATOR

conservative care

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

cryostimulation

Intervention Type: DEVICE

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.

conservative care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

conservative care

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

Intervention Type: OTHER

Other Intervention Names

myofascial release

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: lead

Responsible Party

Nadia Richer

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadia Richer Richer, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Clinique universitaire de chiropratique

Locations

Clinique universitaire de chiropratique

Trois-Rivières, Quebec, Canada

Countries

Canada

References

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

Reference Type: BACKGROUND

PMID: 21629462 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17254903 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17908579 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23335238 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22699135 (View on PubMed)

Other Identifiers

CER-14-203-07.08

Identifier Type: -

Identifier Source: org_study_id