Physiotherapy or Acupuncture for Lateral Epicondylitis

Not Applicable

Completed

• Conditions: Lateral Epicondylitis

• Registration Number: NCT02321696
• Lead Sponsor: Oslo University Hospital

Brief Summary

Work-related upper extremity disorders are common problems in working populations in western countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000 patients in general practice, and as high as 15 % of workers in highly repetitive hand task industries.

LE is a painful condition, leading to loss of function of the affected limb. Therefore it can have a major impact on the patient's work and personal life. If untreated, it persists for an average of six to 24 months and associated with significant sickness absence in 5 % of affected working-aged adults. The cost is therefore high, both in terms of loss of productivity and health care utilization.

Many treatments have been advocated in the management of LE, possibly implying that much is unknown about its etiology and how it best should be treated. Systematic reviews have failed to draw any firm conclusions as to what treatment is most effective in managing this condition.

Over the past 10 years acupuncture has gained wider acceptance for treating pain, by both clinicians and consumers of health, and there is some evidence suggesting that acupuncture treatment is effective in of acute symptoms in LE. A recent study supports that also elbow manipulation have a short-term relief of acute symptoms in LE, especially when combined with eccentric exercise. Our study will therefore explore the clinical effectiveness of physiotherapy versus acupuncture treatment of LE, compared with watchful waiting.

Detailed Description

The study design is three armed and randomized, single blinded. The study aims, in a pilot stydy, to test if physiotherapy or acupuncture treatment of lateral epicondylitis, compared with watchful waiting, is useful means in pain relief for patients with lateral epicondylitis.

Study Timeline

• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Study Start: 2015-02
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Lateral epicondylitis LE (duration > 2 weeks)
• Unilateral localization
• Individuals with average pain of NRS 4 or higher during the last week prior to screening
• Aged between 18 and 67 years
• Written informed consent

Exclusion Criteria

• Corticosteroid injections during the last 4 weeks
• Diseases of the central or peripheral nervous system
• Inflammatory rheumatic diseases
• Radio-ulna or radio humeral osteoarthritis
• Unwilling to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Elbow pain on Numeric Rating Scale (0-10)	12 weeks and 1 year	present, worst and lesser pain during the last week, an average score will be calculated

Secondary Outcome Measures

Name	Time	Method
The disabilities of the arm shoulder and hand (quick-DASH)	12 weeks and 1 year	Functional capacity of elbow and arm
Quality of life by EQ-5D	12 weeks and 1 year	Quality of life
Sick listing	12 weeks and 1 year	Number of days patients are sich listed during the 12 week study period
Patients satisfaction; global perceived effect and satistfaction with treatment	12 weeks and 1 year
Use of analgesics	12 weeks and 1 year
Number of treatment sessions	4 weeks

Trial Locations

Locations (1)

Norsk Idrettsmedisinsk Institutt Ullevål; 🇳🇴 Oslo, Norway