TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

Phase 2

• Conditions: Tendinopathy; Epicondylitis
• Interventions: Drug: Polidocanol; Device: Focused extracorporeal shock wave therapy; Drug: Topical NO; Behavioral: Painful eccentric training in Achilles tendinopathy; Behavioral: Painful eccentric training for patella tendinopathy on 25° decline board; Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar

• Registration Number: NCT01185951
• Lead Sponsor: Hannover Medical School

Brief Summary

Athletic tendinopathies of the upper and lower extremity are often therapeutically challenging. Colour and Power-Doppler-ultrasound visualizes pathological neovessels in painful tendons, which are associated with pain-mediating nerve fibres in such tendinopathies. These neovessels are represented by an increased capillary blood flow at the point of pain. Painful eccentric training reduces pain and improves function in Achilles tendinopathy substantially (evidence level Ib). Shock wave therapy in combination with eccentric training is superior to eccentric training alone (evidence level Ib). Long-term results suggest a collagen induction and reduced pain following topical glyceryl trinitrate (NO) (evidence level Ib). Colour- and Power-Doppler-guided sclerosing therapy using polidocanol reduces pain, improves function and may lead to tendon remodelling (evidence level Ib). Pain-restricted sport beyond pain level 5/10 during therapy is recommended (evidence level Ib). 3x10min of cryotherapy reduce pain and capillary blood flow (evidence level Ib). The role of proprioceptive training in tendinopathy has to be determined in future randomized-controlled trials (evidence level II).

The investigators thought to evaluate the combination of the aforementioned individually successfully therapeutic options in athletes to shorten the recovery period and return to play interval.

Detailed Description

Interventions:

Combined Power-Doppler-guided sclerosing therapy using Polidocanol (0.5%, 2ml) in 6-8 week intervals combined with extracorporeal focused shockwave therapy (STORZ Duolith 2000impulses 0.25mJ/mm2) every 6-8weeks plus painful daily eccentric training plus daily topical NO

Study Timeline

• Study Start: 2007-01
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-19
• Last Update Submitted: 2010-08-19
• Study First Posted: 2010-08-20
• Last Update Posted: 2010-08-20
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy)
• patella tendinopathy
• elbow tendinopathy
• informed consent

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Exclusion Criteria

• no informed consent
• no painful tendons
• allergy against Polidocanol
• current treatment with Marcumar

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Achilles tendinopathy	Focused extracorporeal shock wave therapy	Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Achilles tendinopathy	Painful eccentric training in Achilles tendinopathy	Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Patella tendinopathy	Focused extracorporeal shock wave therapy	Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Patella tendinopathy	Topical NO	Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Patella tendinopathy	Painful eccentric training for patella tendinopathy on 25° decline board	Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Epikondylitis	Focused extracorporeal shock wave therapy	Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Epikondylitis	Topical NO	Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Epikondylitis	Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar	Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Achilles tendinopathy	Topical NO	Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Achilles tendinopathy	Polidocanol	Patients suffering both, insertional and midportion Achilles tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Patella tendinopathy	Polidocanol	Patients suffering patella tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.
Epikondylitis	Polidocanol	Patients suffering both, lateral (tennis elbow) or medial (golfers' elbow) elbow tendinopathy seeking medical help. All patients were evaluated with a standardized Power-Doppler ultrasound to detect the level of neovascularisation at the point of pain.

Primary Outcome Measures

Name	Time	Method
Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect]	up to 4 years	Score of patient-related outcome measure: Achilles tendon: VISA-A \[0=worse, 100=perfect\] derived from eight validated questions on pain and function during activities of daily living
Functional impairment of the patella tendon according to the VISA-P score [0=worse, 100=perfect]	up to 4 years	Score of patient-related outcome measure: Patella tendon: VISA-P \[0=worse, 100=perfect\] derived from eight validated questions on pain and function during daily activities
Functional impairment due to epicondylitis measured by the DASH score [0=perfect, 100=worse]	up to four years	Score of patient-related outcome measure: Epicondylitis: DASH score \[0=perfect, 100=worse\] derived from 30 validated questions regarding the impairment in activities of daily living

Secondary Outcome Measures

Name	Time	Method
Pain level at rest [VAS 0-10]	up to 4 years
Pain level at exertion [VAS 0-10]	up to 4 years
Patient satisfaction on Likert scale [1-6]	up to 4 years	Patient satisfaction on Likert scale from 1=perfect, wholy satisfied, to 6=worst, dissatisfied

Trial Locations

Locations (1)

Hannover Medical School, Plastic, Hand and Reconstructive Surgery; 🇩🇪 Hannover, Germany