TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies (TENDOSHOCK)

August 19, 2010 updated by: Hannover Medical School

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School, Plastic, Hand and Reconstructive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Karsten Knobloch, MD, Hannover Medical School, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimate)

August 20, 2010

Study Record Updates

Last Update Posted (Estimate)

August 20, 2010

Last Update Submitted That Met QC Criteria

August 19, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENDOSHOCK-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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