Achilles TendinopathyPhase 2/3NCT00835939
Treatment for Achilles Tendinopathy
A Phase 2/3 study testing 25% Dextrose and 1% Lidocaine, Lidocaine and sclerotherapy in people with Achilles Tendinopathy and Achilles Tendon Enthesopathy, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether sclerotherapy using a 25% dextrose and 1% lidocaine solution is an efficacious treatment for patients with chronic Achilles tendinopathy who have failed a home based, heavy load eccentric training program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendinopathy, Achilles Tendon Enthesopathy, Mid-Portion Achilles Tendinopathy
- What is being tested?
- 25% Dextrose and 1% Lidocaine, Lidocaine and sclerotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Jan 2010
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years of age and older with a minimum of 3 months of clinically determinant history and symptoms (pain) consistent with unilateral Achilles tendinopathy (enthesitis or mid-portion) as diagnosed by a sport medicine physician.
- Participants are not required to have tried other treatments, however, those who have tried other treatments (except injection treatments) including, but not restricted to, oral NSAIDs, topical NSAIDs, shoe modifications, and physical/athletic therapy will not be restricted from the study
- Provide informed consent for the controlled longitudinal study and RCT
Who cannot join
- Individuals with physical ailments precluding them from performing the eccentric training program
- Worker's Compensation Board (WCB) and elite athletes (varsity, national and professional level).
- Individuals younger than 18 years of age will be excluded from this trial due to the complicating factors of musculoskeletal immaturity and the lack of relevant research of Achilles tendinopathy and neovascular bundles in this population.
- Previous Achilles tendon rupture of the tendon in question
- Individuals that have received any type of injection in or around the Achilles tendon
- Known allergy to dextrose based sclerosing agent or other contraindications
- Known allergy to Lidocaine
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether sclerotherapy using a 25% dextrose and 1% lidocaine solution is an efficacious treatment for patients with chronic Achilles tendinopathy who have failed a home based, heavy load eccentric training program.
Read the detailed description
The purpose of this research project is to optimize the clinical outcome of patients with Achilles tendinopathy. Patients who fail a standardized physical therapy regiment (eccentric training protocol) will be randomly allocated into two groups with one group receiving an injection of hypertonic glucose and Lidocaine (sclerosing solution) and the other receiving an injection of Lidocaine (control). Neovascularisation (growth of new blood vessels and nerves into a damaged area of the tendon) appears to be associated with pain and subsequently a decrease in function and use of the affected tendon. Results of an observational study in Sweden revealed that in all patients for which eccentric training was unsuccessful neovascularisation was present. Sclerosis of neovessels appears to be successful in removing the pain associated with Achilles tendinopathy in both mid-portion and enthesitis patients. However, there are no studies that have administered this technique to a homogenous patient population in a prospective, controlled and randomized manner. In addition, there are no studies that have compared the effects of eccentric training in healthy individuals versus patients with painful Achilles tendinopathy in a controlled longitudinal study. It is expected that patients for whom eccentric training is unsuccessful and who subsequently receive sclerosing therapy will show a statistically significant improvement in pain and function.
- Conditions
- Achilles Tendinopathy, Achilles Tendon Enthesopathy, Mid-Portion Achilles Tendinopathy, Insertional Achilles Tendinopathy, Non-Insertional Achilles Tendinopathy
- Being tested
- 25% Dextrose and 1% Lidocaine, Lidocaine, sclerotherapy
- Keywords
- Achilles, Tendinopathy, Sclerotherapy, Neovascularisation, sports medicine, interventional radiology
- Medical subject headings
- Tendinopathy, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25% Dextrose and 1% LidocaineDrug
Up to 3 injections provided to neovessels outside of the tendon
LidocaineDrug
Up to 3 injections provided to neovessels outside of the tendon
sclerotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 25% Dextrose and 1% Lidocaine | Active comparator | Not described Receives: Drug: 25% Dextrose and 1% Lidocaine; Procedure: sclerotherapy |
| Lidocaine | Placebo comparator | Not described Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute for Sport Assessment - Achilles
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Secondary outcomes (3)
100 mm Visual Analog Scale
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Tegner Activity Scale
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Number of Neovessels
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startSep 2007
- Primary completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Sport Science Association of Alberta (SSAA)
- Investigators
- J Preston Wiley, MD, MPE, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835939
- Sponsor's protocol ID
- UC-20903-RR
- Status last verified
- Feb 2009
- First submitted
- 3 Feb 2009
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT00835939
- Acronym / sponsor ID
- UC-20903-RR
- Conditions
- Achilles Tendinopathy, Achilles Tendon Enthesopathy, Mid-Portion Achilles Tendinopathy, Insertional Achilles Tendinopathy, Non-Insertional Achilles Tendinopathy
- Keywords
- Achilles, Tendinopathy, Sclerotherapy, Neovascularisation, sports medicine, interventional radiology
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Sport Science Association of Alberta (SSAA)
- Study start
- Sep 2007
- Primary completion
- Jan 2010 (estimated)
- First posted
- 4 Feb 2009 (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.
The purpose of this study is to determine whether sclerotherapy using a 25% dextrose and 1% lidocaine solution is an efficacious treatment for patients with chronic Achilles tendinopathy who have failed a home based, heavy load eccentric training program.
Detailed description
The purpose of this research project is to optimize the clinical outcome of patients with Achilles tendinopathy. Patients who fail a standardized physical therapy regiment (eccentric training protocol) will be randomly allocated into two groups with one group receiving an injection of hypertonic glucose and Lidocaine (sclerosing solution) and the other receiving an injection of Lidocaine (control). Neovascularisation (growth of new blood vessels and nerves into a damaged area of the tendon) appears to be associated with pain and subsequently a decrease in function and use of the affected tendon. Results of an observational study in Sweden revealed that in all patients for which eccentric training was unsuccessful neovascularisation was present. Sclerosis of neovessels appears to be successful in removing the pain associated with Achilles tendinopathy in both mid-portion and enthesitis patients. However, there are no studies that have administered this technique to a homogenous patient population in a prospective, controlled and randomized manner. In addition, there are no studies that have compared the effects of eccentric training in healthy individuals versus patients with painful Achilles tendinopathy in a controlled longitudinal study. It is expected that patients for whom eccentric training is unsuccessful and who subsequently receive sclerosing therapy will show a statistically significant improvement in pain and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25% Dextrose and 1% Lidocaine | Active comparator | Drug: 25% Dextrose and 1% Lidocaine, Procedure: sclerotherapy |
| Lidocaine | Placebo comparator | Drug: Lidocaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years of age and older with a minimum of 3 months of clinically determinant history and symptoms (pain) consistent with unilateral Achilles tendinopathy (enthesitis or mid-portion) as diagnosed by a sport medicine physician.
- Participants are not required to have tried other treatments, however, those who have tried other treatments (except injection treatments) including, but not restricted to, oral NSAIDs, topical NSAIDs, shoe modifications, and physical/athletic therapy will not be restricted from the study
- Provide informed consent for the controlled longitudinal study and RCT
Key exclusion criteria (7 listed)
- Individuals with physical ailments precluding them from performing the eccentric training program
- Worker's Compensation Board (WCB) and elite athletes (varsity, national and professional level).
- Individuals younger than 18 years of age will be excluded from this trial due to the complicating factors of musculoskeletal immaturity and the lack of relevant research of Achilles tendinopathy and neovascular bundles in this population.
- Previous Achilles tendon rupture of the tendon in question
- Individuals that have received any type of injection in or around the Achilles tendon
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 |
|---|---|---|
| 25% Dextrose and 1% LidocaineUp to 3 injections provided to neovessels outside of the tendon | Drug | 25% Dextrose and 1% Lidocaine |
| LidocaineUp to 3 injections provided to neovessels outside of the tendon | Drug | Lidocaine |
| sclerotherapy | Procedure or surgery | 25% Dextrose and 1% Lidocaine |
Primary outcome
Victorian Institute for Sport Assessment - Achilles
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
3 secondary outcomes
100 mm Visual Analog Scale
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Tegner Activity Scale
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year
Number of Neovessels
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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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.
J Preston Wiley, MD, MPE principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 25% Dextrose and 1% Lidocaine, Lidocaine and sclerotherapy in people with Achilles Tendinopathy and Achilles Tendon Enthesopathy, run by University of Calgary at 1 site in Canada.
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 3 inclusion and 7 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 4 Feb 2009. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Victorian Institute for Sport Assessment - Achilles (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2009.