Epicondylitis, Lateral HumeralPhase 3NCT00119704
Treatment of Tennis Elbow With Botulinum Toxin
A Phase 3 study testing Botulinum toxin A injection or normal saline in people with Epicondylitis, Lateral Humeral, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicondylitis, Lateral Humeral
- What is being tested?
- Botulinum toxin A injection or normal saline
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 2 sitesHong Kong
- Study dates
- Sep 2002to Mar 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and up
- Pain at the lateral side of the elbow
- Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension
- Pain for longer than 3 months
Who cannot join
- Previous operations (including previous steroid injections for the disorder)
- Nerve entrapment
- Pregnancy and while breast-feeding
- Presence of systemic neuromuscular disorders such as myasthenia gravis
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Prince of Wales Hospital
Shatin, New Territories
North District Hospital
Sheung Shui, New Territories
About this study
Official title: Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial
The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).
Read the detailed description
Tennis elbow (lateral epicondylitis) is a common cause of chronic elbow pain and wrist extensor dysfunction in adults, affecting 1% to 3% of the general population per year.
There is currently no consensus on its optimal treatment with wide-ranging options available. The best available scientific evidence suggests that only topical non-steroidal anti-inflammatory drugs and possibly, oral non-steroidal anti-inflammatory drugs may be useful for short term pain relief, while corticosteroid injections presented both benefits and harms as a short term measure.
Botulinum toxin has been reported in the treatment of lateral epicondylitis with promising results but these studies lack a control group bringing up the question whether recovery was a result of intervention or the natural history of the disease.
Method:
A twin-center, prospective, randomized, double-blind, placebo-controlled trial in which all patients received either a botulinum injection or a placebo saline injection.
Consecutive patients over 18 years old with tennis elbow referred to the outpatient clinic at the investigators' institution will be screened for this study. Eligible patients will be invited to participate in the study.
- Conditions
- Epicondylitis, Lateral Humeral
- Being tested
- Botulinum toxin A injection or normal saline
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A injection or normal salineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
100 mm visual analog scale (VAS)
Secondary outcomes (1)
Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startSep 2002
- Study completionMar 2005
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 Epicondylitis, Lateral HumeralStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- New World Development Company Limited
- Investigators
- Andrew CF Hui, MRCP, Principal investigator, Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119704
- Sponsor's protocol ID
- CRE-2002.354-T
- Status last verified
- Jun 2005
- First submitted
- 6 Jul 2005
- Last updated
- 9 May 2006
- Results posted
- No
Publications
Wong SM, Hui AC, Tong PY, Poon DW, Yu E, Wong LK. Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2005 Dec 6;143(11):793-7. doi: 10.7326/0003-4819-143-11-200512060-00007.
PubMed 16330790
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00119704
- Acronym / sponsor ID
- CRE-2002.354-T
- Conditions
- Epicondylitis, Lateral Humeral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- New World Development Company Limited
- Study start
- Sep 2002
- Study completion
- Mar 2005
- First posted
- 14 Jul 2005 (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 Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).
Detailed description
Tennis elbow (lateral epicondylitis) is a common cause of chronic elbow pain and wrist extensor dysfunction in adults, affecting 1% to 3% of the general population per year.
There is currently no consensus on its optimal treatment with wide-ranging options available. The best available scientific evidence suggests that only topical non-steroidal anti-inflammatory drugs and possibly, oral non-steroidal anti-inflammatory drugs may be useful for short term pain relief, while corticosteroid injections presented both benefits and harms as a short term measure.
Botulinum toxin has been reported in the treatment of lateral epicondylitis with promising results but these studies lack a control group bringing up the question whether recovery was a result of intervention or the natural history of the disease.
Method:
A twin-center, prospective, randomized, double-blind, placebo-controlled trial in which all patients received either a botulinum injection or a placebo saline injection.
Consecutive patients over 18 years old with tennis elbow referred to the outpatient clinic at the investigators' institution will be screened for this study. Eligible patients will be invited to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years and up
- Pain at the lateral side of the elbow
- Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension
- Pain for longer than 3 months
Key exclusion criteria (4 listed)
- Previous operations (including previous steroid injections for the disorder)
- Nerve entrapment
- Pregnancy and while breast-feeding
- Presence of systemic neuromuscular disorders such as myasthenia gravis
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 |
|---|---|---|
| Botulinum toxin A injection or normal saline | Drug | – |
Primary outcome
100 mm visual analog scale (VAS)
1 secondary outcome
Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
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 9 May 2006.
- Results publication: PubMed 16330790Wong SM, Hui AC, Tong PY, Poon DW, Yu E, Wong LK. Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2005 Dec 6;143(11):793-7. doi: 10.7326/0003-4819-143-11-200512060-00007.
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.
Andrew CF Hui, MRCP principal investigator
Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin A injection or normal saline in people with Epicondylitis, Lateral Humeral, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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: finished, as of the sponsor's last update on 9 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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 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?
100 mm visual analog scale (VAS). 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 NCT00119704, 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 9 May 2006.