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Corticosteroid, Autologous blood or Polidocanol injections guided by ultrasound in the management of tennis elbow: a randomised clinical pilot trial. (The CAP trial)

Corticosteroid, Autologous blood or Polidocanol injections guided by ultrasound in the management of tennis elbow: a randomised clinical pilot trial. (The CAP trial)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000398606
Acronym
The CAP trial
Enrollment
45
Registered
2014-04-11
Start date
2012-01-02
Completion date
2013-09-27
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study aims to compare the efficacy of corticosteroid vs. autologous blood vs. sclerosant injection for the treatment of tennis elbow in order to see which treatment modality incurs the most benefit.

Interventions

Ultrasound Guided Injection techniques: Corticosteroid injection The Common extensor tendon is assessed with ultrasound for tear and tendinopathy and if required the skin is marked with a texta over the abnormal area. The skin is prepared with a chlorhexidine wash. With Ultrasound guidance, using a 25 g needle the CEO tendon substance and superficial surface is infiltrated with 3ml of 0.5% Xylocaine. With a second 25 g needle and syringe, 1 ml Celestone chronodose and 1ml of Marcaine is injec

Ultrasound Guided Injection techniques: Corticosteroid injection The Common extensor tendon is assessed with ultrasound for tear and tendinopathy and if required the skin is marked with a texta over the abnormal area. The skin is prepared with a chlorhexidine wash. With Ultrasound guidance, using a 25 g needle the CEO tendon substance and superficial surface is infiltrated with 3ml of 0.5% Xylocaine. With a second 25 g needle and syringe, 1 ml Celestone chronodose and 1ml of Marcaine is inject with ultrasound guidance into the abnormal tendon substance and also along the superficial tendon surface. Autologous Blood Injection (ABI) The Common extensor tendon was assessed with ultrasound for tear and tendinopathy and if required the skin was marked with a texta over the abnormal area. The skin is prepared with a chlorhexidine wash. Using Ultrasound guidance a 25 g needle is inserted and 3ml of 0.5% Xylocaine is injected into the abnormal area and superficial to the tendon. Multiple dry needling punctures of the tendon are performed at this time to cause local bleeding. 3 ml of autologous blood is drawn from a cubital fossa vein of the other elbow. This blood is mixed with 1ml of Marcaine and injected into the tendon with ultrasound guidance via a second 25 g needle and syringe targeting the abnormal area. Sclerosant Injection The Common extensor tendon is assessed with ultrasound for tear and tendinopathy. The distribution of neovascularity is assessed. The neovascularity arises medial to the CEO from the radial collateral branch of the profunda artery and radial recurrent artery. The neovascularity then courses from medial to lateral superficial to the CEO. The sites of neovascularity are marked on the skin with a texta. The skin is prepared with a chlorhexidine wash. With ultrasound guidance between 2-4ml of Polidocanol is injected via a 25 g needle into the neovascularity superficial to the tendon. The neovacularity is targeted from lateral to medial back to the normal artery. Care is taken to inject the only the neovascularity outside the tendon. Polidocanol is not injected into the tendon substance and also is not injected too superficially to avoid causing skin necrosis. In the sclerosant and ABI groups, injections are repeated at four weeks. Physiotherapy Protocol: All participants will be given an information sheet outlining activity modification and taught a home eccentric exercise program.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria is the presence of lateral elbow pain, which was exacerbated by activities involving wrist extension and gripping, as reported by the patient, as well as a clinical diagnosis of tennis elbow, which included elbow pain on resisted wrist and/or middle finger extension and tenderness in the area of the lateral epicondyle for more than two months.

Exclusion criteria

Exclusion criteria is elbow pain for less than two months, limitation of movement with passive forearm pronation, supination, flexion and/or extension that may indicate radioulnar joint synovitis or osteoarthritis, upper limb neurological symptoms or signs that may indicate cervical radiculopathy, and corticosteroid injection, autologous blood or scleosant injection to the common extensor tendon within the previous three months. Patients meeting the inclusion and exclusion criteria above, will be referred for power Doppler ultrasound investigation. Participants without evidence of neovascularisation on power ultrasound will be excluded from further participation in the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026