Tennis ElbowPhase 3DCLENCT00497913
Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis
A Phase 3 study testing NaCl 0.9% and Botulinum Toxin A in people with Tennis Elbow, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- NaCl 0.9% and Botulinum Toxin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIran
- Study dates
- Aug 2007to Apr 2008
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain: pain will be assessed as the physician touches lateral epicondyle or passively flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger against resistance. Individuals who fulfill two or more of above will be considered to have lateral epicondylitis.
- Symptom duration: should be at least 6 months.
- Previous trial of complete course of physiotherapy and corticosteroid injection.
Who cannot join
- Rheumatoid arthritis
- Generalized polyarthritis
- Local elbow arthritis
- Simultaneous medial epicondylalgia
- Bilateral lateral epicondylitis
- Neurologic deficits (abnormal light touch sensation, deep tendon reflexes abnormality, radicular pain, radial nerve entrapment, signs of nerve root compression, decreased muscle force, multiple sclerosis, seizures)
Show all 12Show fewer
- The use of corticosteroid in last 30 days
- Simultaneous use of drugs other than acetaminophen or physical therapy in the course of study
- Pregnancy
- Breast-feeding
- Previous hand surgery
- Having a hobby or job that needs finger extension
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis.
Read the detailed description
Some studies valued the effectiveness of botulinum toxin. There is a great amount of controversy on the amount of botulinum toxin injected and the location of the injection. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo at a new injection site at the forearm in the treatment of chronic tennis elbow unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized controlled trial.
- Conditions
- Tennis Elbow
- Being tested
- NaCl 0.9%, Botulinum Toxin A
- Keywords
- Tennis Elbow, Botulinum Toxin
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 0.9%Drug
Botulinum Toxin ADrug
Also called Dysport
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Botulinum Toxin A |
| B | Placebo comparator | Not described Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest
Measured: 4 months
Secondary outcomes (5)
Patients subjective feeling of improvement.
Measured: 4 months
Tenderness on lateral epicondyle
Measured: 4 months
Pain sensation on resisted wrist extension, and passive wrist flexion
Measured: 4 months
Pain-free grip strength, and pinch strength
Measured: 4 months
Maximal grip strength, and pinch strength
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Seyed Mohammad J Mortazavi, M.D., Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497913
- Sponsor's protocol ID
- 85-02-53-4207
- Acronym
- DCLE
- Status last verified
- Apr 2008
- First submitted
- 6 Jul 2007
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Espandar R, Heidari P, Rasouli MR, Saadat S, Farzan M, Rostami M, Yazdanian S, Mortazavi SM. Use of anatomic measurement to guide injection of botulinum toxin for the management of chronic lateral epicondylitis: a randomized controlled trial. CMAJ. 2010 May 18;182(8):768-73. doi: 10.1503/cmaj.090906. Epub 2010 Apr 26.
PubMed 20421357
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT00497913
- Acronym / sponsor ID
- DCLE / 85-02-53-4207
- Conditions
- Tennis Elbow
- Keywords
- Tennis Elbow, Botulinum Toxin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 9 Jul 2007 (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 a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis.
Detailed description
Some studies valued the effectiveness of botulinum toxin. There is a great amount of controversy on the amount of botulinum toxin injected and the location of the injection. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo at a new injection site at the forearm in the treatment of chronic tennis elbow unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Botulinum Toxin A |
| B | Placebo comparator | Drug: NaCl 0.9% |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain: pain will be assessed as the physician touches lateral epicondyle or passively flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger against resistance. Individuals who fulfill two or more of above will be considered to have lateral epicondylitis.
- Symptom duration: should be at least 6 months.
- Previous trial of complete course of physiotherapy and corticosteroid injection.
Key exclusion criteria (12 listed)
- Rheumatoid arthritis
- Generalized polyarthritis
- Local elbow arthritis
- Simultaneous medial epicondylalgia
- Bilateral lateral epicondylitis
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 |
|---|---|---|
| NaCl 0.9% | Drug | B |
| Botulinum Toxin AAlso: Dysport | Drug | A |
Primary outcome
Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest
Time frame: 4 months
5 secondary outcomes
Patients subjective feeling of improvement.
Time frame: 4 months
Tenderness on lateral epicondyle
Time frame: 4 months
Pain sensation on resisted wrist extension, and passive wrist flexion
Time frame: 4 months
Pain-free grip strength, and pinch strength
Time frame: 4 months
Maximal grip strength, and pinch strength
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2008.
- Derived from this study: PubMed 20421357Espandar R, Heidari P, Rasouli MR, Saadat S, Farzan M, Rostami M, Yazdanian S, Mortazavi SM. Use of anatomic measurement to guide injection of botulinum toxin for the management of chronic lateral epicondylitis: a randomized controlled trial. CMAJ. 2010 May 18;182(8):768-73. doi: 10.1503/cmaj.090906. Epub 2010 Apr 26.
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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.
Seyed Mohammad J Mortazavi, M.D. study director
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NaCl 0.9% and Botulinum Toxin A in people with Tennis Elbow, run by Tehran University of Medical Sciences at 1 site in Iran.
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 12 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: finished, as of the sponsor's last update on 23 Apr 2008. 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 Iran. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest (time frame: 4 months). 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 NCT00497913, which also lists 1 linked publication.
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 23 Apr 2008.