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Physiotherapy or Acupuncture for Lateral Epicondylitis

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ClinicalTrials.gov Identifier: NCT02321696
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Kjersti Storheim, 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.


Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Device: Acupuncture Other: Physiotherapy and eccentric exercise Other: Watchful waiting and eccentric exercise Other: eccentric exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Comparative Effect of Physiotherapy or Acupuncture Treatment of Lateral Epicondylitis; a Randomized Controlled Pilot Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: Acupuncture
Other: eccentric exercise
Experimental: 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.

Other: Physiotherapy and eccentric exercise
Active Comparator: Watchful waiting and eccentric exercise
Patients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward.
Other: Watchful waiting and eccentric exercise



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321696


Locations
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Norway
Norsk Idrettsmedisinsk Institutt Ullevål
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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Study Director: Astrid Wahl, PhD University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kjersti Storheim, Head of FORMI, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02321696     History of Changes
Other Study ID Numbers: 2014/1520
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Keywords provided by Kjersti Storheim, Oslo University Hospital:
physiotherapy
manual therapy
acupuncture
eccentric exercise
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries