Physiotherapy or Acupuncture for Lateral Epicondylitis

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

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.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Device: Acupuncture; Other: eccentric exercise; Other: Physiotherapy and eccentric exercise; Other: Watchful waiting and eccentric exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Norsk Idrettsmedisinsk Institutt Ullevål

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The disabilities of the arm shoulder and hand (quick-DASH)	Functional capacity of elbow and arm	12 weeks and 1 year
Quality of life by EQ-5D	Quality of life	12 weeks and 1 year
Sick listing	Number of days patients are sich listed during the 12 week study period	12 weeks and 1 year
Patients satisfaction; global perceived effect and satistfaction with treatment		12 weeks and 1 year
Use of analgesics		12 weeks and 1 year
Number of treatment sessions		4 weeks

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Study Director: Astrid Wahl, PhD, University of Oslo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: acupuncture; manual therapy; physiotherapy; eccentric exercise
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 2014/1520