Tennis ElbowPhase 3NCT02767635
Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia
A Phase 3 study testing Botox-Epic, Botox-Tend and triamcinolone acetonide (Steroid) in people with Tennis Elbow, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia. 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?
- Botox-Epic, Botox-Tend and triamcinolone acetonide (Steroid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Dec 2016
- 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
- spontaneous local pain over lateral epicondyle of the affected elbow for more than six months and failure to respond to previous physical therapy or oral medications,
- local tenderness around the lateral epicondyle, and
- pain elicited or aggravated by resisted contraction of the wrist or middle finger extensors.
Who cannot join
- local steroid injection within the past six months,
- coexisting elbow arthritis or arthralgia,
- previous trauma or surgery history over the lateral epicondyle,
- pregnancy or lactation, and
- other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox injection.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
Tainan, Taiwan, 138
Richard Lin, Tel: 886-6-2353535 ext. 2666, richelin@mail.ncku.edu.tw
About this study
Official title: Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study
The aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia.
Read the detailed description
Lateral epicondylalgia or tennis elbow is a common painful elbow disorder with a prevalence of 1% to 3% in the general population and has a higher rate up to 14.5% in strenuous jobs. Botulinum toxin type A injection was an emerging option in treating lateral epicondylalgia. In this study, the patients were randomly assigned into three groups:
- Botox-Epic group received 20 units of Botox injection into lateral epicondyle;
- Botox-Tend group had 20 units of Botox injected into tender point of muscles;
- Steroid group had 40mg of triamcinolone injected into lateral epicondyle.
The aim of this randomized controlled study was to compare the effects of injection with corticosteroid and botulinum toxin type A via two different sites in patients with lateral epicondylalgia.
- Conditions
- Tennis Elbow
- Being tested
- Botox-Epic, Botox-Tend, triamcinolone acetonide (Steroid)
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox-EpicDrug
Also called onabotulinumtoxinA
injected 20 units of Botox into lateral epicondyle in Botox-Epic group
Botox-TendDrug
Also called onabotulinumtoxinA
injected 20 units of Botox into tender point of muscles in Botox-Tend group
triamcinolone acetonide (Steroid)Drug
Also called steroid
injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group
| Study group | Role | What they receive |
|---|---|---|
| Botox-Epic group | Experimental | 20 units of Botox injection into lateral epicondyle in Botox-Epic group Receives: Drug: Botox-Epic |
| Botox-Tend group | Experimental | 20 units of Botox injected into tender point of muscles in Botox-Tend group Receives: Drug: Botox-Tend |
| Steroid group | Active comparator | 40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group Receives: Drug: triamcinolone acetonide (Steroid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain assessed on the visual analogue scale
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcomes (2)
Change of grip strength by dynamometer
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Change of self-assessment by Patient-Rated Tennis Elbow Evaluation
Measured: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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.
- More trials run by National Cheng-Kung University HospitalThe 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
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ching Lin, National Cheng-Kung University Hospital
- Investigators
- Yu-Ching Lin, MD, MSc, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767635
- Sponsor's protocol ID
- BR-100-108
- Status last verified
- May 2016
- First submitted
- 6 May 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guo YH, Kuan TS, Chen KL, Lien WC, Hsieh PC, Hsieh IC, Chiu SH, Lin YC. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study. Arch Phys Med Rehabil. 2017 Jan;98(1):36-42. doi: 10.1016/j.apmr.2016.08.475. Epub 2016 Sep 22.
PubMed 27666156
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02767635
- Acronym / sponsor ID
- BR-100-108
- Conditions
- Tennis Elbow
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 May 2016 (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 aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia.
Detailed description
Lateral epicondylalgia or tennis elbow is a common painful elbow disorder with a prevalence of 1% to 3% in the general population and has a higher rate up to 14.5% in strenuous jobs. Botulinum toxin type A injection was an emerging option in treating lateral epicondylalgia. In this study, the patients were randomly assigned into three groups:
- Botox-Epic group received 20 units of Botox injection into lateral epicondyle;
- Botox-Tend group had 20 units of Botox injected into tender point of muscles;
- Steroid group had 40mg of triamcinolone injected into lateral epicondyle.
The aim of this randomized controlled study was to compare the effects of injection with corticosteroid and botulinum toxin type A via two different sites in patients with lateral epicondylalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botox-Epic group | Experimental | Drug: Botox-Epic20 units of Botox injection into lateral epicondyle in Botox-Epic group |
| Botox-Tend group | Experimental | Drug: Botox-Tend20 units of Botox injected into tender point of muscles in Botox-Tend group |
| Steroid group | Active comparator | Drug: triamcinolone acetonide (Steroid)40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- spontaneous local pain over lateral epicondyle of the affected elbow for more than six months and failure to respond to previous physical therapy or oral medications,
- local tenderness around the lateral epicondyle, and
- pain elicited or aggravated by resisted contraction of the wrist or middle finger extensors.
Key exclusion criteria (5 listed)
- local steroid injection within the past six months,
- coexisting elbow arthritis or arthralgia,
- previous trauma or surgery history over the lateral epicondyle,
- pregnancy or lactation, and
- other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox injection.
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 |
|---|---|---|
| Botox-EpicAlso: onabotulinumtoxinAinjected 20 units of Botox into lateral epicondyle in Botox-Epic group | Drug | Botox-Epic group |
| Botox-TendAlso: onabotulinumtoxinAinjected 20 units of Botox into tender point of muscles in Botox-Tend group | Drug | Botox-Tend group |
| triamcinolone acetonide (Steroid)Also: steroidinjected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group | Drug | Steroid group |
Primary outcome
Change of pain assessed on the visual analogue scale
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
2 secondary outcomes
Change of grip strength by dynamometer
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Change of self-assessment by Patient-Rated Tennis Elbow Evaluation
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Derived from this study: PubMed 27666156Guo YH, Kuan TS, Chen KL, Lien WC, Hsieh PC, Hsieh IC, Chiu SH, Lin YC. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study. Arch Phys Med Rehabil. 2017 Jan;98(1):36-42. doi: 10.1016/j.apmr.2016.08.475. Epub 2016 Sep 22.
- Individual participant dataSharing planned: No
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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.
Yu-Ching Lin, MD, MSc principal investigator
National Cheng-Kung University Hospital
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 Botox-Epic, Botox-Tend and triamcinolone acetonide (Steroid) in people with Tennis Elbow, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 5 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 10 May 2016. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ching Lin, MD, MSc (886-6-2353535 ext. 5258, richelin@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain assessed on the visual analogue scale (time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 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 NCT02767635, 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 10 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.