NCT02321696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

December 17, 2014

Last Update Submit

December 18, 2017

Conditions

Lateral Epicondylitis

Keywords

physiotherapymanual therapyacupunctureeccentric exercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    12 weeks and 1 year

  • Quality of life by EQ-5D

    12 weeks and 1 year

  • Sick listing

    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

  • +1 more secondary outcomes

Study Arms (3)

Acupuncture and eccentric exercise

EXPERIMENTAL

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: AcupunctureOther: eccentric exercise

Physiotherapy and eccentric exercise

EXPERIMENTAL

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

Watchful waiting and eccentric exercise

ACTIVE COMPARATOR

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

Other: Watchful waiting and eccentric exercise

Interventions

AcupunctureDEVICE
Acupuncture and eccentric exercise
Physiotherapy and eccentric exerciseOTHER
Physiotherapy and eccentric exercise
Watchful waiting and eccentric exerciseOTHER
Watchful waiting and eccentric exercise
eccentric exerciseOTHER
Acupuncture and eccentric exercise

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norsk Idrettsmedisinsk Institutt Ullevål

Oslo, Norway

Location

Related Publications (1)

  • 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.

    PMID: 31516727DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Acupuncture TherapyPhysical Therapy ModalitiesWatchful Waiting

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsRehabilitationOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Astrid Wahl, PhD

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of FORMI

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

February 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

December 20, 2017

Record last verified: 2017-12

Locations

NO(1)