Clinical trial NCT01185951: TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies
Official title: TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tendinopathy
Epicondylitis
Keywords: Achilles Tendon
Patella
Allergy
Necrosis
Infection
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect]
timeFrame: up to 4 years
measure: Functional impairment of the patella tendon according to the VISA-P score [0=worse, 100=perfect]
timeFrame: up to 4 years
measure: Functional impairment due to epicondylitis measured by the DASH score [0=perfect, 100=worse]
timeFrame: up to four years
Secondary outcomes:
measure: Pain level at rest [VAS 0-10]
timeFrame: up to 4 years
measure: Pain level at exertion [VAS 0-10]
timeFrame: up to 4 years
measure: Patient satisfaction on Likert scale [1-6]
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Study officials:
affiliation: Hannover Medical School, Germany
name: Karsten Knobloch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.