Treatment of Lateral Elbow Tendinopathy

Epicondylitis, Lateral Humeral Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521298
• Other study ID #: H-15002993
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: April 5, 2020

Study information

• Verified date: July 2020
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 5, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Elbow Tendinopathy
• Epicondylitis, Lateral Humeral
• Tendinopathy
• Tennis Elbow

Intervention

Other:
• Strength Training

Procedure:
• Placebo

Drug:
• Cortico-Steroid Injection. Depomedrol 40mg/1ml.

Procedure:
• Dry Needling

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

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. Review. Update in: Cochrane Database Syst Rev. 2014;11:CD003528. — View 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. Review. — View 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. Epub 2007 Jan 15. — View 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;(1):CD003527. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disability questionnaire: DASH-score. Area under the DASH-score versus time curve (AUC).		Baseline, week 17, 30, and 56.
Secondary	Change in muscle strength measurements. Area under the strength measurements versus time curve (AUC)	Including isometric wrist extension force and isometric grip strength.	Baseline, week 17, 30, and 56.
Secondary	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.	Baseline, week 30, and 56.