TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Hannover Medical School.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01185951
First received: August 17, 2010
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Tendinopathy
Epicondylitis
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect] [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    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] [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    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] [ Time Frame: up to four years ] [ Designated as safety issue: No ]
    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:
  • Pain level at rest [VAS 0-10] [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Pain level at exertion [VAS 0-10] [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Patient satisfaction on Likert scale [1-6] [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    Patient satisfaction on Likert scale from 1=perfect, wholy satisfied, to 6=worst, dissatisfied


Enrollment: 114
Study Start Date: January 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185951

Locations
Germany
Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Karsten Knobloch, MD Hannover Medical School, Germany
  More Information

Publications:

Responsible Party: PD Dr. Karsten Knobloch, Plastic, Hand and Reconstructive Surgery, Hannover Medical School, Germany
ClinicalTrials.gov Identifier: NCT01185951     History of Changes
Other Study ID Numbers: TENDOSHOCK-2010
Study First Received: August 17, 2010
Last Updated: August 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Achilles Tendon
Patella
Allergy
Necrosis
Infection

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Polidocanol
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014