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TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies (TENDOSHOCK)

Primary Purpose

Tendinopathy, Epicondylitis

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Polidocanol
Focused extracorporeal shock wave therapy
Topical NO
Painful eccentric training in Achilles tendinopathy
Painful eccentric training for patella tendinopathy on 25° decline board
Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Achilles Tendon, Patella, Allergy, Necrosis, Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hannover Medical School, Plastic, Hand and Reconstructive Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Achilles tendinopathy

Patella tendinopathy

Epikondylitis

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2010
Last Updated
August 19, 2010
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01185951
Brief Title
TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies
Acronym
TENDOSHOCK
Official Title
TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Epicondylitis
Keywords
Achilles Tendon, Patella, Allergy, Necrosis, Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Achilles tendinopathy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patella tendinopathy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Epikondylitis
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Polidocanol
Intervention Description
Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks
Intervention Type
Device
Intervention Name(s)
Focused extracorporeal shock wave therapy
Intervention Description
Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks
Intervention Type
Drug
Intervention Name(s)
Topical NO
Intervention Description
Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon
Intervention Type
Behavioral
Intervention Name(s)
Painful eccentric training in Achilles tendinopathy
Intervention Description
Painful eccentric training for Achilles tendinopathy on a stair single-stance with 6x15 repetitions per leg and day over at least 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Painful eccentric training for patella tendinopathy on 25° decline board
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar
Intervention Description
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
Primary Outcome Measure Information:
Title
Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect]
Description
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
Time Frame
up to 4 years
Title
Functional impairment of the patella tendon according to the VISA-P score [0=worse, 100=perfect]
Description
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
Time Frame
up to 4 years
Title
Functional impairment due to epicondylitis measured by the DASH score [0=perfect, 100=worse]
Description
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
Time Frame
up to four years
Secondary Outcome Measure Information:
Title
Pain level at rest [VAS 0-10]
Time Frame
up to 4 years
Title
Pain level at exertion [VAS 0-10]
Time Frame
up to 4 years
Title
Patient satisfaction on Likert scale [1-6]
Description
Patient satisfaction on Likert scale from 1=perfect, wholy satisfied, to 6=worst, dissatisfied
Time Frame
up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Knobloch, MD
Organizational Affiliation
Hannover Medical School, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School, Plastic, Hand and Reconstructive Surgery
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19997901
Citation
Knobloch K, Schreibmueller L, Kraemer R, Jagodzinski M, Vogt PM, Redeker J. Gender and eccentric training in Achilles mid-portion tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2010 May;18(5):648-55. doi: 10.1007/s00167-009-1006-7. Epub 2009 Dec 9.
Results Reference
background
PubMed Identifier
19882141
Citation
Osadnik R, Redeker J, Kraemer R, Vogt PM, Knobloch K. Microcirculatory effects of topical glyceryl trinitrate on the Achilles tendon microcirculation in patients with previous Achilles tendon rupture. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):977-81. doi: 10.1007/s00167-009-0958-y. Epub 2009 Oct 31.
Results Reference
background
PubMed Identifier
19567665
Citation
Kraemer R, Knobloch K. A soccer-specific balance training program for hamstring muscle and patellar and achilles tendon injuries: an intervention study in premier league female soccer. Am J Sports Med. 2009 Jul;37(7):1384-93. doi: 10.1177/0363546509333012.
Results Reference
background
PubMed Identifier
18791700
Citation
Knobloch K. Sclerosing polidocanol injections in Achilles tendinopathy in high level athletes. Knee Surg Sports Traumatol Arthrosc. 2008 Nov;16(11):1061-2; author reply 1063. doi: 10.1007/s00167-008-0613-z. Epub 2008 Sep 13. No abstract available.
Results Reference
background
PubMed Identifier
18785416
Citation
Knobloch K, Yoon U, Vogt PM. Acute and overuse injuries correlated to hours of training in master running athletes. Foot Ankle Int. 2008 Jul;29(7):671-6. doi: 10.3113/FAI.2008.0671.
Results Reference
background
PubMed Identifier
18720130
Citation
Knobloch K, Schreibmueller L, Longo UG, Vogt PM. Eccentric exercises for the management of tendinopathy of the main body of the Achilles tendon with or without an AirHeel Brace. A randomized controlled trial. B: Effects of compliance. Disabil Rehabil. 2008;30(20-22):1692-6. doi: 10.1080/09638280701785676.
Results Reference
background
PubMed Identifier
18720121
Citation
Knobloch K, Schreibmueller L, Longo UG, Vogt PM. Eccentric exercises for the management of tendinopathy of the main body of the Achilles tendon with or without the AirHeel Brace. A randomized controlled trial. A: effects on pain and microcirculation. Disabil Rehabil. 2008;30(20-22):1685-91. doi: 10.1080/09638280701786658.
Results Reference
background
PubMed Identifier
18681232
Citation
Knobloch K, Thermann H. [Achilles tendinopathy--modern evidence-based recommendations]. MMW Fortschr Med. 2008 Jun 26;150(26-27):46-9; quiz 50. No abstract available. German.
Results Reference
background
PubMed Identifier
18641371
Citation
Knobloch K, Grasemann R, Spies M, Vogt PM. Midportion achilles tendon microcirculation after intermittent combined cryotherapy and compression compared with cryotherapy alone: a randomized trial. Am J Sports Med. 2008 Nov;36(11):2128-38. doi: 10.1177/0363546508319313. Epub 2008 Jul 18.
Results Reference
background
PubMed Identifier
18447938
Citation
Knobloch K. The role of tendon microcirculation in Achilles and patellar tendinopathy. J Orthop Surg Res. 2008 Apr 30;3:18. doi: 10.1186/1749-799X-3-18.
Results Reference
background
PubMed Identifier
17971505
Citation
Knobloch K, Schreibmueller L, Meller R, Busch KH, Spies M, Vogt PM. Superior Achilles tendon microcirculation in tendinopathy among symptomatic female versus male patients. Am J Sports Med. 2008 Mar;36(3):509-14. doi: 10.1177/0363546507309313. Epub 2007 Oct 30.
Results Reference
background
PubMed Identifier
17549956
Citation
Knobloch K, Kraemer R, Jagodzinski M, Zeichen J, Meller R, Vogt PM. Eccentric training decreases paratendon capillary blood flow and preserves paratendon oxygen saturation in chronic achilles tendinopathy. J Orthop Sports Phys Ther. 2007 May;37(5):269-76. doi: 10.2519/jospt.2007.2296.
Results Reference
background
PubMed Identifier
17496066
Citation
Knobloch K, Spies M, Busch KH, Vogt PM. Sclerosing therapy and eccentric training in flexor carpi radialis tendinopathy in a tennis player. Br J Sports Med. 2007 Dec;41(12):920-1. doi: 10.1136/bjsm.2007.036558. Epub 2007 May 11.
Results Reference
background
PubMed Identifier
17385103
Citation
Knobloch K, Thermann H, Hufner T. [Achilles tendon rupture--early functional and surgical options with special emphasis on rehabilitation issues]. Sportverletz Sportschaden. 2007 Mar;21(1):34-40. doi: 10.1055/s-2007-963040. German.
Results Reference
background
PubMed Identifier
17138636
Citation
Knobloch K, Grasemann R, Spies M, Vogt PM. Intermittent KoldBlue cryotherapy of 3x10 min changes mid-portion Achilles tendon microcirculation. Br J Sports Med. 2007 Jun;41(6):e4. doi: 10.1136/bjsm.2006.030957. Epub 2006 Nov 30.
Results Reference
background
PubMed Identifier
17127721
Citation
Knobloch K. Eccentric training in Achilles tendinopathy: is it harmful to tendon microcirculation? Br J Sports Med. 2007 Jun;41(6):e2; discussion e2. doi: 10.1136/bjsm.2006.030437. Epub 2006 Nov 24.
Results Reference
background
PubMed Identifier
16998082
Citation
Knobloch K, Grasemann R, Jagodzinski M, Richter M, Zeichen J, Krettek C. Changes of Achilles midportion tendon microcirculation after repetitive simultaneous cryotherapy and compression using a Cryo/Cuff. Am J Sports Med. 2006 Dec;34(12):1953-9. doi: 10.1177/0363546506293701. Epub 2006 Sep 22.
Results Reference
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TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

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