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Completed

NCT Number: NCT02521298

Treatment of Lateral Elbow Tendinopathy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength training

Other

Placebo

Procedure

Cortico-Steroid Injection. Depomedrol 40mg/1ml.

Drug

dry needling

Procedure

Primary outcomes

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

    Time frame: Baseline, week 17, 30, and 56.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2015
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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