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Physiotherapy or Acupuncture for Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Acupuncture
Physiotherapy and eccentric exercise
Watchful waiting and eccentric exercise
eccentric exercise
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring physiotherapy, manual therapy, acupuncture, eccentric exercise

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norsk Idrettsmedisinsk Institutt Ullevål

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Acupuncture and eccentric exercise

Physiotherapy and eccentric exercise

Watchful waiting and eccentric exercise

Arm Description

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.

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.

Patients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward.

Outcomes

Primary Outcome Measures

Elbow pain on Numeric Rating Scale (0-10)
present, worst and lesser pain during the last week, an average score will be calculated

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2014
Last Updated
December 18, 2017
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT02321696
Brief Title
Physiotherapy or Acupuncture for Lateral Epicondylitis
Official Title
Clinical Comparative Effect of Physiotherapy or Acupuncture Treatment of Lateral Epicondylitis; a Randomized Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
physiotherapy, manual therapy, acupuncture, eccentric exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture and eccentric exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy and eccentric exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Watchful waiting and eccentric exercise
Arm Type
Active Comparator
Arm Description
Patients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Type
Other
Intervention Name(s)
Physiotherapy and eccentric exercise
Intervention Type
Other
Intervention Name(s)
Watchful waiting and eccentric exercise
Intervention Type
Other
Intervention Name(s)
eccentric exercise
Primary Outcome Measure Information:
Title
Elbow pain on Numeric Rating Scale (0-10)
Description
present, worst and lesser pain during the last week, an average score will be calculated
Time Frame
12 weeks and 1 year
Secondary Outcome Measure Information:
Title
The disabilities of the arm shoulder and hand (quick-DASH)
Description
Functional capacity of elbow and arm
Time Frame
12 weeks and 1 year
Title
Quality of life by EQ-5D
Description
Quality of life
Time Frame
12 weeks and 1 year
Title
Sick listing
Description
Number of days patients are sich listed during the 12 week study period
Time Frame
12 weeks and 1 year
Title
Patients satisfaction; global perceived effect and satistfaction with treatment
Time Frame
12 weeks and 1 year
Title
Use of analgesics
Time Frame
12 weeks and 1 year
Title
Number of treatment sessions
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Wahl, PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
Norsk Idrettsmedisinsk Institutt Ullevål
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
31516727
Citation
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.
Results Reference
derived

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Physiotherapy or Acupuncture for Lateral Epicondylitis

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