TendinopathyPhase 2TENDOSHOCKNCT01185951
TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies
A Phase 2 study testing Polidocanol, Focused extracorporeal shock wave therapy and Topical NO in people with Tendinopathy and Epicondylitis, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendinopathy, Epicondylitis
- What is being tested?
- Polidocanol, Focused extracorporeal shock wave therapy and Topical NO
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy)
- patella tendinopathy
- elbow tendinopathy
- informed consent
Who cannot join
- no informed consent
- no painful tendons
- allergy against Polidocanol
- current treatment with Marcumar
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Hanover, 30625
About this study
Official title: TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies
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.
Read the 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
- Conditions
- Tendinopathy, Epicondylitis
- Being tested
- Polidocanol, Focused extracorporeal shock wave therapy, Topical NO, Painful eccentric training in Achilles tendinopathy, Painful eccentric training for patella tendinopathy on 25° decline board
- Keywords
- Achilles Tendon, Patella, Allergy, Necrosis, Infection
- Medical subject headings
- Tendinopathy, Patella Fracture, Hypersensitivity, Necrosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolidocanolDrug
Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks
Focused extracorporeal shock wave therapyDevice
Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks
Topical NODrug
Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon
Painful eccentric training in Achilles tendinopathyBehavioural
Painful eccentric training for Achilles tendinopathy on a stair single-stance with 6x15 repetitions per leg and day over at least 12 weeks
Painful eccentric training for patella tendinopathy on 25° decline boardBehavioural
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
Painful eccentric training for elbow tendinopathy using Thera-Band Flex-BarBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Polidocanol; Device: Focused extracorporeal shock wave therapy; Drug: Topical NO; Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: up to four years
Secondary outcomes (3)
Pain level at rest [VAS 0-10]
Measured: up to 4 years
Pain level at exertion [VAS 0-10]
Measured: up to 4 years
Patient satisfaction on Likert scale [1-6]
Patient satisfaction on Likert scale from 1=perfect, wholy satisfied, to 6=worst, dissatisfied
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJan 2007
- Primary completionAug 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Karsten Knobloch, MD, Principal investigator, Hannover Medical School, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185951
- Sponsor's protocol ID
- TENDOSHOCK-2010
- Acronym
- TENDOSHOCK
- Status last verified
- Aug 2010
- First submitted
- 17 Aug 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1007/s00167-009-1006-7. Epub 2009 Dec 9.
PubMed 19997901Osadnik 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.
PubMed 19882141Kraemer 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.
PubMed 19567665Knobloch 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.
PubMed 18791700Knobloch 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.
PubMed 18785416Knobloch 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.
PubMed 18720130Knobloch 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.
PubMed 18720121Knobloch 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.
PubMed 18681232Knobloch 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.
PubMed 18641371Knobloch 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.
PubMed 18447938Knobloch 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.
PubMed 17971505Knobloch 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.
PubMed 17549956Knobloch 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.
PubMed 17496066Knobloch 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.
PubMed 17385103Knobloch 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.
PubMed 17138636
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENDOSHOCK-2010 - Combined Sclerosing Therapy, Extracorporeal Shockwave Therapy, Eccentric Training and Topical Glyceryl Trinitrate for Athletic Tendinopathies
- ClinicalTrials.gov ID
- NCT01185951
- Acronym / sponsor ID
- TENDOSHOCK / TENDOSHOCK-2010
- Conditions
- Tendinopathy, Epicondylitis
- Keywords
- Achilles Tendon, Patella, Allergy, Necrosis, Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Achilles tendinopathy | Active comparator | Drug: Polidocanol, Device: Focused extracorporeal shock wave therapy, Drug: Topical NO, Behavioral: Painful eccentric training in Achilles tendinopathyPatients 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. |
| Patella tendinopathy | Active comparator | Drug: Polidocanol, Device: Focused extracorporeal shock wave therapy, Drug: Topical NO, Behavioral: Painful eccentric training for patella tendinopathy on 25° decline boardPatients 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. |
| Epikondylitis | Active comparator | Drug: Polidocanol, Device: Focused extracorporeal shock wave therapy, Drug: Topical NO, Behavioral: Painful eccentric training for elbow tendinopathy using Thera-Band Flex-BarPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Painful tendons at the Achilles tendon (both insertional and mid-portion tendinopathy)
- patella tendinopathy
- elbow tendinopathy
- informed consent
Key exclusion criteria (4 listed)
- no informed consent
- no painful tendons
- allergy against Polidocanol
- current treatment with Marcumar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolidocanolPower-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks | Drug | Achilles tendinopathy, Epikondylitis, Patella tendinopathy |
| Focused extracorporeal shock wave therapyFocused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks | Device | Achilles tendinopathy, Epikondylitis, Patella tendinopathy |
| Topical NOTopical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon | Drug | Achilles tendinopathy, Epikondylitis, Patella tendinopathy |
| Painful eccentric training in Achilles tendinopathyPainful eccentric training for Achilles tendinopathy on a stair single-stance with 6x15 repetitions per leg and day over at least 12 weeks | Behavioural | Achilles tendinopathy |
| Painful eccentric training for patella tendinopathy on 25° decline boardPainful eccentric training for patella tendinopathy on a 25° decline board single-stance with 6x15 repetitions per leg and day over at least 12 weeks | Behavioural | Patella tendinopathy |
| Painful eccentric training for elbow tendinopathy using Thera-Band Flex-BarPainful 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 | Behavioural | Epikondylitis |
Primary outcome
Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect]
Time frame: up to 4 years
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
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
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
- Background: PubMed 19997901Knobloch 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.
- Background: PubMed 19882141Osadnik 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.
- Background: PubMed 19567665Kraemer 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.
- Background: PubMed 18791700Knobloch 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.
- Background: PubMed 18785416Knobloch 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.
- Background: PubMed 18720130Knobloch 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.
- Background: PubMed 18720121Knobloch 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.
- Background: PubMed 18681232Knobloch 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.
- Background: PubMed 18641371Knobloch 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.
- Background: PubMed 18447938Knobloch 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.
- Background: PubMed 17971505Knobloch 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.
- Background: PubMed 17549956Knobloch 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.
Related trials for Tendinopathy
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karsten Knobloch, MD principal investigator
Hannover Medical School, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polidocanol, Focused extracorporeal shock wave therapy and Topical NO in people with Tendinopathy and Epicondylitis, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional impairment of the Achilles tendon using VISA-A score [0=worse, 100=perfect] (time frame: up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01185951, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2010.