TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

Study Overview
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Brief Summary
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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
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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

Official Title
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TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies

Conditions
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Tendinopathy, Epicondylitis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy) patella tendinopathy elbow tendinopathy informed consent Exclusion Criteria: no informed consent no painful tendons allergy against Polidocanol current treatment with Marcumar

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Achilles tendinopathy<br>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. | Drug: Polidocanol<br>* Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks<br>Device: Focused extracorporeal shock wave therapy<br>* Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks<br>Drug: Topical NO<br>* Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon<br>Behavioral: Painful eccentric training in Achilles tendinopathy<br>* Painful eccentric training for Achilles tendinopathy on a stair single-stance with 6x15 repetitions per leg and day over at least 12 weeks<br>|
| Active Comparator: Patella tendinopathy<br>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. | Drug: Polidocanol<br>* Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks<br>Device: Focused extracorporeal shock wave therapy<br>* Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks<br>Drug: Topical NO<br>* Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon<br>Behavioral: Painful eccentric training for patella tendinopathy on 25° decline board<br>* Painful eccentric training for patella tendinopathy on a 25° decline board single-stance with 6x15 repetitions per leg and day over at least 12 weeks<br>|
| Active Comparator: Epikondylitis<br>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. | Drug: Polidocanol<br>* Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks<br>Device: Focused extracorporeal shock wave therapy<br>* Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks<br>Drug: Topical NO<br>* Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon<br>Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar<br>* Painful eccentric training for elbow tendinopathy using a green coloured Thera-Band Flex-Bar with painful supination and pronation with 6x15 repetitions per day over at least 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect] | 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 | up to 4 years | 
| Functional impairment of the patella tendon according to the VISA-P score [0=worse, 100=perfect] | 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 | up to 4 years | 
| Functional impairment due to epicondylitis measured by the DASH score [0=perfect, 100=worse] | 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 | up to four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | Patient satisfaction on Likert scale from 1=perfect, wholy satisfied, to 6=worst, dissatisfied | up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles Tendon, Patella, Allergy, Necrosis, Infection