Physiotherapy or Acupuncture for Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321696
• Other study ID #: 2014/1520
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: December 18, 2017
• Start date: February 2015
• Est. completion date: August 2017

Study information

• Verified date: December 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Device:
• Acupuncture

Other:
• Physiotherapy and eccentric exercise

• Watchful waiting and eccentric exercise

• eccentric exercise

Locations

Country	Name	City	State
Norway	Norsk Idrettsmedisinsk Institutt Ullevål	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elbow pain on Numeric Rating Scale (0-10)	present, worst and lesser pain during the last week, an average score will be calculated	12 weeks and 1 year
Secondary	The disabilities of the arm shoulder and hand (quick-DASH)	Functional capacity of elbow and arm	12 weeks and 1 year
Secondary	Quality of life by EQ-5D	Quality of life	12 weeks and 1 year
Secondary	Sick listing	Number of days patients are sich listed during the 12 week study period	12 weeks and 1 year
Secondary	Patients satisfaction; global perceived effect and satistfaction with treatment		12 weeks and 1 year
Secondary	Use of analgesics		12 weeks and 1 year
Secondary	Number of treatment sessions		4 weeks