Clinical trial NCT02321696: Physiotherapy or Acupuncture for Lateral Epicondylitis
Official title: Clinical Comparative Effect of Physiotherapy or Acupuncture Treatment of Lateral Epicondylitis; a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: physiotherapy
manual therapy
acupuncture
eccentric exercise
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2014-12-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Elbow pain on Numeric Rating Scale (0-10)
timeFrame: 12 weeks and 1 year
Secondary outcomes:
measure: The disabilities of the arm shoulder and hand (quick-DASH)
timeFrame: 12 weeks and 1 year
measure: Quality of life by EQ-5D
timeFrame: 12 weeks and 1 year
measure: Sick listing
timeFrame: 12 weeks and 1 year
measure: Patients satisfaction; global perceived effect and satistfaction with treatment
timeFrame: 12 weeks and 1 year
measure: Use of analgesics
timeFrame: 12 weeks and 1 year
measure: Number of treatment sessions
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norsk Idrettsmedisinsk Institutt Ullevål
Study officials:
affiliation: University of Oslo
name: Astrid Wahl, PhD
role: STUDY_DIRECTOR
References:
citation: Bostrom K, Maehlum S, Cvancarova Smastuen M, Storheim K. Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial. Pilot Feasibility Stud. 2019 Sep 7;5:110. doi: 10.1186/s40814-019-0490-x. eCollection 2019.