Treatment of Lateral Elbow Tendinopathy
Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo
1 other identifier
interventional
60
1 country
1
Brief Summary
This study investigates the treatment effect on lateral elbow tendinopathy of strength training in combination with cortico-steroid injection, dry-needling or placebo in a double-blinded randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2020
CompletedJuly 22, 2020
July 1, 2020
4.5 years
July 9, 2015
July 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).
Baseline, week 17, 30, and 56.
Secondary Outcomes (2)
Change in muscle strength measurements. Area under the strength measurements versus time curve (AUC)
Baseline, week 17, 30, and 56.
Change in ultrasonographic appearance of tendon pathology associated with tendinopathy.
Baseline, week 30, and 56.
Study Arms (3)
Strength Training + Placebo
ACTIVE COMPARATORStrength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8. Placebo: Ultrasound-guided subcutaneous injection of 2 ml isotonic saline over the proximal part of the common extensor tendon origin using a 0,8 mm needle. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image.
Strength Training + Cortico-Steroid Inj.
EXPERIMENTALStrength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8. Cortico-Steroid Injection: Ultrasound-guided injection of 1 ml depomedrol 40 mg/ml + 1 ml lidocaine 10 mg/ml deep to the proximal part of the common extensor tendon origin using a 0,8 mm needle. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image.
Strength Training + Dry Needling
EXPERIMENTALStrength Training: 2 weeks after the inclusion, the patients are instructed in heavy slow resistance exercise by a physiotherapist. Exercise is continued 3 times/week for the following 12 weeks, with supervised follow-up at week 4, 8 and 12. Exercise consists of wrist extension, flexion and supination/pronation. Starting at 3 x 15 repetition maximum, gradually increasing in weight to 3 x 6 repetition maximum from week 8. Dry Needling: Ultrasound-guided penetration of the proximal part of the common extensor tendon origin is repeated 10 times using a 0,8 mm needle, followed by subcutaneous injection of 2 ml isotonic saline superficial to the tendon. No-touch technique is used, and the patient is blinded with regards to the content of the syringe and the ultrasound-image.
Interventions
Eligibility Criteria
You may qualify if:
- Pain around the lateral part of the elbow joint for more than 4 weeks.
- Pain on palpation of the proximal part of the common extensor tendon.
- Pain reproduced with resisted dorsiflexion of the wrist.
- Dash score \> 30.
- Ultrasonographic appearance consistent with lateral elbow tendinopathy (irregular appearance of the tendon, hypo-/hyper-echoic changes, pathological doppler signal, increased tendon thickness).
You may not qualify if:
- American Society of Anesthesiologists (ASA) \> 2 (mild systemic disease).
- Patients with symptoms consistent with differential diagnoses such as:
- referred pain,
- radiohumeral synovitis and bursitis,
- posterior interosseous nerve entrapment (radial tunnel syndrome),
- osteoarthritis of the elbow, and
- prior injections or acupuncture around the elbow joint within the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Related Publications (7)
Green S, Buchbinder R, Barnsley L, Hall S, White M, Smidt N, Assendelft W. Acupuncture for lateral elbow pain. Cochrane Database Syst Rev. 2002;2002(1):CD003527. doi: 10.1002/14651858.CD003527.
PMID: 11869671BACKGROUNDBrosseau L, Casimiro L, Milne S, Robinson V, Shea B, Tugwell P, Wells G. Deep transverse friction massage for treating tendinitis. Cochrane Database Syst Rev. 2002;(4):CD003528. doi: 10.1002/14651858.CD003528.
PMID: 12519601BACKGROUNDCoombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21.
PMID: 20970844BACKGROUNDCroisier JL, Foidart-Dessalle M, Tinant F, Crielaard JM, Forthomme B. An isokinetic eccentric programme for the management of chronic lateral epicondylar tendinopathy. Br J Sports Med. 2007 Apr;41(4):269-75. doi: 10.1136/bjsm.2006.033324. Epub 2007 Jan 15.
PMID: 17224433BACKGROUNDMagnusson SP, Langberg H, Kjaer M. The pathogenesis of tendinopathy: balancing the response to loading. Nat Rev Rheumatol. 2010 May;6(5):262-8. doi: 10.1038/nrrheum.2010.43. Epub 2010 Mar 23.
PMID: 20308995BACKGROUNDStruijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.
PMID: 11869609BACKGROUNDCouppe C, Dossing S, Bulow PM, Siersma VD, Zilmer CK, Bang CW, Hoffner R, Kracht M, Hogg P, Edstrom G, Kjaer M, Magnusson SP. Effects of Heavy Slow Resistance Training Combined With Corticosteroid Injections or Tendon Needling in Patients With Lateral Elbow Tendinopathy: A 3-Arm Randomized Double-Blinded Placebo-Controlled Study. Am J Sports Med. 2022 Aug;50(10):2787-2796. doi: 10.1177/03635465221110214. Epub 2022 Jul 22.
PMID: 35867777DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Kjaer, M.D., PhD.
Bispebjerg Hospital, University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PhD
Study Record Dates
First Submitted
July 9, 2015
First Posted
August 13, 2015
Study Start
October 1, 2015
Primary Completion
April 5, 2020
Study Completion
April 5, 2020
Last Updated
July 22, 2020
Record last verified: 2020-07