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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02521298
Enrollment
60
Registered
2015-08-13
Start date
2015-10-31
Completion date
2020-04-05
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epicondylitis, Lateral Humeral

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.

Interventions

OTHERStrength Training
PROCEDUREPlacebo
DRUGCortico-Steroid Injection. Depomedrol 40mg/1ml.
PROCEDUREDry Needling

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026