Treatment of Lateral Elbow Tendinopathy

July 21, 2020 updated by: Simon Doessing, M.D., PhD, Bispebjerg Hospital

Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Strength Training + Placebo

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.
Other: Strength Training
Procedure: Placebo
Experimental: Strength Training + Cortico-Steroid Inj.

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.
Other: Strength Training
Drug: Cortico-Steroid Injection. Depomedrol 40mg/1ml.
Experimental: Strength Training + Dry Needling

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.
Other: Strength Training
Procedure: Dry Needling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).
Time Frame: Baseline, week 17, 30, and 56.
Baseline, week 17, 30, and 56.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle strength measurements. Area under the strength measurements versus time curve (AUC)
Time Frame: Baseline, week 17, 30, and 56.
Including isometric wrist extension force and isometric grip strength.
Baseline, week 17, 30, and 56.
Change in ultrasonographic appearance of tendon pathology associated with tendinopathy.
Time Frame: Baseline, week 30, and 56.
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.
Baseline, week 30, and 56.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Study Director: Michael Kjaer, M.D., PhD., Bispebjerg Hospital, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 5, 2020

Study Completion (Actual)

April 5, 2020

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

August 9, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15002993

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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