TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

NCT01185951 | Unknown Phase 2

• 1 other identifier: TENDOSHOCK-2010
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy; Epicondylitis

Keywords

Achilles Tendon; Patella; Allergy; Necrosis; Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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]

  up to 4 years

Study Arms (3)

Achilles tendinopathy

ACTIVE COMPARATOR

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; Device: Focused extracorporeal shock wave therapy; Drug: Topical NO; Behavioral: Painful eccentric training in Achilles tendinopathy

Patella tendinopathy

ACTIVE COMPARATOR

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; Device: Focused extracorporeal shock wave therapy; Drug: Topical NO; Behavioral: Painful eccentric training for patella tendinopathy on 25° decline board

Epikondylitis

ACTIVE COMPARATOR

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; Device: Focused extracorporeal shock wave therapy; Drug: Topical NO; Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar

Interventions

Polidocanol DRUG

Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks

Achilles tendinopathy; Epikondylitis; Patella tendinopathy

Focused extracorporeal shock wave therapy DEVICE

Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks

Achilles tendinopathy; Epikondylitis; Patella tendinopathy

Topical NO DRUG

Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon

Achilles tendinopathy; Epikondylitis; Patella tendinopathy

Painful eccentric training in Achilles tendinopathy BEHAVIORAL

Painful eccentric training for Achilles tendinopathy on a stair single-stance with 6x15 repetitions per leg and day over at least 12 weeks

Achilles tendinopathy

Painful eccentric training for patella tendinopathy on 25° decline board BEHAVIORAL

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

Patella tendinopathy

Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar BEHAVIORAL

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

Epikondylitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy)
• patella tendinopathy
• elbow tendinopathy
• informed consent

You may not qualify if:

• no informed consent
• no painful tendons
• allergy against Polidocanol
• current treatment with Marcumar

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School, Plastic, Hand and Reconstructive Surgery

Hanover, 30625, Germany

Location

Related Publications (17)

• 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.

  PMID: 19997901 BACKGROUND

• 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.

  PMID: 19882141 BACKGROUND

• 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.

  PMID: 19567665 BACKGROUND

• 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.

  PMID: 18791700 BACKGROUND

• 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.

  PMID: 18785416 BACKGROUND

• 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.

  PMID: 18720130 BACKGROUND

• 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.

  PMID: 18720121 BACKGROUND

• 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.

  PMID: 18681232 BACKGROUND

• 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.

  PMID: 18641371 BACKGROUND

• 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.

  PMID: 18447938 BACKGROUND

• 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.

  PMID: 17971505 BACKGROUND

• 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.

  PMID: 17549956 BACKGROUND

• 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.

  PMID: 17496066 BACKGROUND

• 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.

  PMID: 17385103 BACKGROUND

• 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.

  PMID: 17138636 BACKGROUND

• 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.

  PMID: 17127721 BACKGROUND

• 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.

  PMID: 16998082 BACKGROUND

MeSH Terms

Conditions

Tendinopathy; Patella Fracture; Hypersensitivity; Necrosis; Infections

Interventions

Polidocanol; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Knee Fractures; Fractures, Bone; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Karsten Knobloch, MD

  Hannover Medical School, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 20, 2010
• Study Start: January 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 20, 2010

Record last verified: 2010-08

Locations

DE (1)