TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies - Full Text View

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:

MedlinePlus related topics: Shock Tendinitis

Drug Information available for: Polidocanol

U.S. FDA Resources

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

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:

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. Epub 2009 Dec 9.

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. Epub 2009 Oct 31.

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.

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. Epub 2008 Sep 13. No abstract available.

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.

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.

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.

Knobloch K, Thermann H. [Achilles tendinopathy--modern evidence-based recommendations] MMW Fortschr Med. 2008 Jun 26;150(26-27):46-9; quiz 50. German. No abstract available.

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. Epub 2008 Jul 18.

Knobloch K. The role of tendon microcirculation in Achilles and patellar tendinopathy. J Orthop Surg Res. 2008 Apr 30;3:18.

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. Epub 2007 Oct 30.

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.

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. Epub 2007 May 11.

Knobloch K, Thermann H, Hüfner T. [Achilles tendon rupture--early functional and surgical options with special emphasis on rehabilitation issues] Sportverletz Sportschaden. 2007 Mar;21(1):34-40. German.

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. Epub 2006 Nov 30.

Knobloch K. Eccentric training in Achilles tendinopathy: is it harmful to tendon microcirculation? Br J Sports Med. 2007 Jun;41(6):e2; discussion e2. Epub 2006 Nov 24.

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. Epub 2006 Sep 22.

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 June 18, 2013