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NCT Number: NCT02321696

Physiotherapy or Acupuncture for Lateral Epicondylitis

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.

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Key information

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norsk Idrettsmedisinsk Institutt Ullevål

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

Physiotherapy and eccentric exercise

Other

Watchful waiting and eccentric exercise

Other

Eccentric exercise

Other

Primary outcomes

  1. Elbow pain on Numeric Rating Scale (0-10)

    Time frame: 12 weeks and 1 year

    present, worst and lesser pain during the last week, an average score will be calculated

Secondary outcomes

  1. The disabilities of the arm shoulder and hand (quick-DASH)

    Time frame: 12 weeks and 1 year

    Functional capacity of elbow and arm

  2. Quality of life by EQ-5D

    Time frame: 12 weeks and 1 year

    Quality of life

  3. Sick listing

    Time frame: 12 weeks and 1 year

    Number of days patients are sich listed during the 12 week study period

  4. Patients satisfaction; global perceived effect and satistfaction with treatment

    Time frame: 12 weeks and 1 year

  5. Use of analgesics

    Time frame: 12 weeks and 1 year

  6. Number of treatment sessions

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

Clinical Comparative Effect of Physiotherapy or Acupuncture Treatment of Lateral Epicondylitis; a Randomized Controlled Pilot Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2014
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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