Overview

This trial is active, not recruiting.

Conditions tendinopathy, epicondylitis
Treatments 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
Phase phase 2
Sponsor Hannover Medical School
Start date January 2007
End date August 2010
Trial size 114 participants
Trial identifier NCT01185951, TENDOSHOCK-2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
polidocanol
Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks
focused extracorporeal shock wave therapy
Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks
topical no
Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon
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)
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.
polidocanol
Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks
focused extracorporeal shock wave therapy
Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks
topical no
Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon
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)
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.
polidocanol
Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks
focused extracorporeal shock wave therapy
Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks
topical no
Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon
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

Primary Outcomes

Measure
Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect]
time frame: up to 4 years
Functional impairment of the patella tendon according to the VISA-P score [0=worse, 100=perfect]
time frame: up to 4 years
Functional impairment due to epicondylitis measured by the DASH score [0=perfect, 100=worse]
time frame: up to four years

Secondary Outcomes

Measure
Pain level at rest [VAS 0-10]
time frame: up to 4 years
Pain level at exertion [VAS 0-10]
time frame: up to 4 years
Patient satisfaction on Likert scale [1-6]
time frame: up to 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies
Principal investigator Karsten Knobloch, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Hannover Medical School.