Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2015-02-28
2017-08-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Acupuncture and eccentric exercise
Treatment will be performed according to traditional Chinese methods (STRICTA: Standards for reporting interventions in controlled trials of acupunc-ture). Therapists will select points frequently recommended for the treatment of LE. As local point, LI11 and LI10 over the muscular origin of the lateral extensor group of the forearm will be used, and LU5 in the cubical region. LI4 and TE5 will be regional points for pain therapy in the upper limb, GB34 will be used as a distal point for treatment of tendinosis in general, and ST36 for treatment of pain. Needles will be inserted down to the musculature and obtaining De Qi sensation and will remain in situ for 20 min. All patients will receive four treatment sessions; this may be extended to eight depending on patient's pain report and the therapists' clinical evaluation. Maximum treatment period is 4 weeks. Patients will also be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward.
Acupuncture
eccentric exercise
Physiotherapy and eccentric exercise
Manual techniques as gliding mobilization of elbow, therapists are spezialised in manual therapy. At least four treatment sessions will be performed, but depending on the patient's perceived intensity of pain and the therapists' clinical evaluation, a maximum of eight treatment session can be given. All treatment session will be performed during a period of maximum 4 weeks.
In addition, patients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward.
Physiotherapy and eccentric exercise
Watchful waiting and eccentric exercise
Patients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward.
Watchful waiting and eccentric exercise
Interventions
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Acupuncture
Physiotherapy and eccentric exercise
Watchful waiting and eccentric exercise
eccentric exercise
Eligibility Criteria
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Inclusion Criteria
* 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
* Diseases of the central or peripheral nervous system
* Inflammatory rheumatic diseases
* Radio-ulna or radio humeral osteoarthritis
* Unwilling to participate
18 Years
67 Years
ALL
No
Sponsors
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University of Oslo
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Kjersti Storheim
Head of FORMI
Principal Investigators
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Astrid Wahl, PhD
Role: STUDY_DIRECTOR
University of Oslo
Locations
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Norsk Idrettsmedisinsk Institutt Ullevål
Oslo, , Norway
Countries
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References
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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.
Other Identifiers
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2014/1520
Identifier Type: -
Identifier Source: org_study_id