Study to Evaluate the Efficacy of Botulinum Toxin Serotyp... | NCT00241215

Studies
Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome

NCT00241215

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Jun 21, 2016Estimated

Enrollment

132Actual

Phase

Phase 4

Conditions

Cervicobrachial Neuralgia
Myofascial Pain Syndromes

Interventions

Botulinum toxin serotype A

Countries

United States

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

Jun 2016

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

Jun 2003

Primary Completion Date

Nov 2005Actual

Completion Date

Not provided

First Submitted Date

Oct 17, 2005

First Submission Date that Met QC Criteria

Oct 17, 2005

First Posted Date

Oct 18, 2005Estimated

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

Jun 19, 2016

Last Update Posted Date

Jun 21, 2016Estimated

Name	Class
Allergan	INDUSTRY

Description Module

Brief Summary

Several studies have previously examined the use of botulinum toxin serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from:

inclusion of confounding conditions in the proband group, and
inability to identify predictors of response.

This study attempts to define the characteristics of responders to botulinum serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome).

Detailed Description

Design: Single-center, double-blind, placebo-controlled, enriched trial.

Subjects will wash-out of their existing pain medications at least 2 weeks prior to baseline visit. At baseline, patients with a Numerical Pain Rating of 4 or greater will be injected with Botulinum Toxin Serotype A. At 14 weeks postinjection, those who at the 6 weeks post-injection visit had at least a 50% decrease in their pain outcome measures will be randomized into one of two treatment groups. Group 1 will receive a second BTX injection while group 2 will receive an injection of saline and both groups will be followed for an additional 6 weeks.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin serotype A	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numerical pain rating
Brief Pain Inventory
Neck Disability Index
Cervical range of motion
Number of trigger points
Postural exam

Secondary Outcomes

Measure	Description	Time Frame
Pain Diary and medications use
Short Form (SF)-36

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients aged 18-65 years.
Patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks
Patients have numerical pain rating of 4 or greater
Patients willing to adhere to a physical therapy program of 2-3 visits for myofascial release and also home stretching exercises for the length of the study
Subjects willing to discontinue all pain medications except ibuprofen and a non-opioid rescue medication for the duration of the study.
Women of child-bearing potential must be using a reliable means of contraception and have a negative urine pregnancy test prior to injection of BOTOX.

Exclusion Criteria:

Subjects currently taking schedule II narcotics
No new non-pain medications or change in non-pain medications within 2 months of screening or throughout the study
Pregnant or breastfeeding women
Use of investigational drugs within one month of study
Involvement in litigation surrounding neck pain
Significant medical or psychiatric disease
Patients with clinical depression (Beck's Depression score)
Alcohol or drug abuse, in the opinion of the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
F. Michael Ferrante, MD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Pain Management Center		Santa Monica	California	90404	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16052120	Result	Ferrante FM, Bearn L, Rothrock R, King L. Evidence against trigger point injection technique for the treatment of cervicothoracic myofascial pain with botulinum toxin type A. Anesthesiology. 2005 Aug;103(2):377-83. doi: 10.1097/00000542-200508000-00021.

ID	Term
D020968	Brachial Plexus Neuritis
D009209	Myofascial Pain Syndromes

ID	Term
D020516	Brachial Plexus Neuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases