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Treatment of Lateral Elbow Tendinopathy

Primary Purpose

Epicondylitis, Lateral Humeral

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Strength Training
Placebo
Cortico-Steroid Injection. Depomedrol 40mg/1ml.
Dry Needling
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis, Lateral Humeral

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pain around the lateral part of the elbow joint for more than 4 weeks.
  2. Pain on palpation of the proximal part of the common extensor tendon.
  3. Pain reproduced with resisted dorsiflexion of the wrist.
  4. Dash score > 30.
  5. Ultrasonographic appearance consistent with lateral elbow tendinopathy (irregular appearance of the tendon, hypo-/hyper-echoic changes, pathological doppler signal, increased tendon thickness).

Exclusion Criteria:

  • 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

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Strength Training + Placebo

Strength Training + Cortico-Steroid Inj.

Strength Training + Dry Needling

Arm Description

Strength 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: 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: 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.

Outcomes

Primary Outcome Measures

Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).

Secondary Outcome Measures

Change in muscle strength measurements. Area under the strength measurements versus time curve (AUC)
Including isometric wrist extension force and isometric grip strength.
Change in ultrasonographic appearance of tendon pathology associated with tendinopathy.
Week 0-2, 30 and 56. Including: 1) Irregular appearance of the tendon, 2) Hypo-/hyper-echoic changes, 3) Pathological doppler signal, 4) Tendon thickness.

Full Information

First Posted
July 9, 2015
Last Updated
July 21, 2020
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02521298
Brief Title
Treatment of Lateral Elbow Tendinopathy
Official Title
Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 5, 2020 (Actual)
Study Completion Date
April 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The prevalence of lateral elbow tendinopathy is prevalence of 1-3%, with a peak incidence between 35-50 years of age (Green et al., 2002). The main symptoms are pain over the lateral humeral epicondyle upon palpation and pain full resisted dorsiflexion of the wrist. Ultrasonographic changes include hyper-/hypo-echoic areas and increased doppler signal in the most proximal part of the common extensor tendon. The condition is often self-limiting, however full recovery often takes months to years and recurrence is common. Several different treatment modalities are used in order to increase tendon healing and decrease time to recovery. Deep transverse friction massage showed no significant effect on pain, grip strength or function relative to other physiotherapy modalities (Brosseau et al., 2002). Anti-inflammatory treatment with NSAID's or corticosteroids is typically effective in the short term, however on a longer term there is a poorer outcome than with other treatment strategies including exercise (Coombes et al., 2010). Surgery does not seem to have any beneficial effect (Buchbinder et al., 2011), and there are no conclusive data regarding the use of orthotic devises for the treatment of lateral elbow tendinopathy (Struijs et al., 2002). Eccentric exercise of the extensor muscles has been shown to reduced pain, increase muscle strength, and decrease tendon thickness and time to return to sport (Croisier et al., 2007). Loading of human tendon leads to increased tendon collagen synthesis, and interestingly, tendon tissue sampling (biopsies), which causes a minor trauma to the tendon has been shown to increase the level of growth factors locally and stimulate tendon collagen synthesis (Magnusson et al., 2010). It is hypothesized that both minimal tissue damage and anti-inflammatory treatment could increase tendon healing and decrease time to recovery, when combined with mechanical loading.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis, Lateral Humeral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength Training + Placebo
Arm Type
Active Comparator
Arm Description
Strength 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.
Arm Title
Strength Training + Cortico-Steroid Inj.
Arm Type
Experimental
Arm Description
Strength 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.
Arm Title
Strength Training + Dry Needling
Arm Type
Experimental
Arm Description
Strength 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.
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Cortico-Steroid Injection. Depomedrol 40mg/1ml.
Intervention Type
Procedure
Intervention Name(s)
Dry Needling
Primary Outcome Measure Information:
Title
Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).
Time Frame
Baseline, week 17, 30, and 56.
Secondary Outcome Measure Information:
Title
Change in muscle strength measurements. Area under the strength measurements versus time curve (AUC)
Description
Including isometric wrist extension force and isometric grip strength.
Time Frame
Baseline, week 17, 30, and 56.
Title
Change in ultrasonographic appearance of tendon pathology associated with tendinopathy.
Description
Week 0-2, 30 and 56. Including: 1) Irregular appearance of the tendon, 2) Hypo-/hyper-echoic changes, 3) Pathological doppler signal, 4) Tendon thickness.
Time Frame
Baseline, week 30, and 56.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kjaer, M.D., PhD.
Organizational Affiliation
Bispebjerg Hospital, University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
11869671
Citation
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.
Results Reference
background
PubMed Identifier
12519601
Citation
Brosseau 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.
Results Reference
background
PubMed Identifier
20970844
Citation
Coombes 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.
Results Reference
background
PubMed Identifier
17224433
Citation
Croisier 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.
Results Reference
background
PubMed Identifier
20308995
Citation
Magnusson 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.
Results Reference
background
PubMed Identifier
11869609
Citation
Struijs 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.
Results Reference
background
PubMed Identifier
35867777
Citation
Couppe 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.
Results Reference
derived

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Treatment of Lateral Elbow Tendinopathy

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