Effectiveness of Botulinum Toxin Injection in the Tennis... | NCT00437762

Studies
Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

NCT00437762

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

May 14, 2026Actual

Enrollment

61Actual

Phase

Phase 3

Conditions

Tennis Elbow

Interventions

Botulinum Toxin A Injection
Placebo injection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Feb 19, 2007

First Submission Date that Met QC Criteria

Feb 20, 2007

First Posted Date

Feb 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

Name	Class
Ipsen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.

Detailed Description

Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months..
Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection
Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
Inclusion criteria : tennis elbow during more than 6 months ; signature of consent
Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism
Study plan: randomized parallel groups
Number of subjects : 60

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Botulinum Toxin A Injection	Drug: Botulinum Toxin A Injection
2	Placebo Comparator	Placebo injection	Drug: Placebo injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin A Injection	Drug	Botulinum Toxin A Injection	1
Placebo injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Principal criteria of assessment is pain intensity three months after injection.		at 3 month

Secondary Outcomes

Measure	Description	Time Frame
pain intensity		to day 30, 90,180, 365
Number of painful days		to day 30, 90,180, 365
Number of associated treatments.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Tennis elbow during more than 6 months
Signature of consent

Exclusion Criteria:

Less than 18 years old
Osteoarthritis elbow
Referred cervical pain
Fibromyalgia
Pregnancy
Myasthenia
Polymyositis
SLA
Anticoagulant treatment
Aminosides
Diabetes
Alcoholism
Previous botulinum toxin A injections

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathieu DE SEZE, MD	University Hospital, Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.		Bordeaux		330076	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29141611	Result	Cogne M, Petit H, Creuze A, Liguoro D, de Seze M. Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial. BMC Musculoskelet Disord. 2017 Nov 15;18(1):454. doi: 10.1186/s12891-017-1816-6.
29762276	Result

ID	Term
D000070639	Elbow Tendinopathy
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases