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

NCT ID: NCT00241215

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30

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:

1. inclusion of confounding conditions in the proband group, and

2. 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.

Conditions

Cervicobrachial Neuralgia; Myofascial Pain Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Botulinum toxin serotype A

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients aged 18-65 years.

2. Patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks

3. Patients have numerical pain rating of 4 or greater

4. 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

5. Subjects willing to discontinue all pain medications except ibuprofen and a non-opioid rescue medication for the duration of the study.

6. 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

1. Subjects currently taking schedule II narcotics

2. No new non-pain medications or change in non-pain medications within 2 months of screening or throughout the study

3. Pregnant or breastfeeding women

4. Use of investigational drugs within one month of study

5. Involvement in litigation surrounding neck pain

6. Significant medical or psychiatric disease

7. Patients with clinical depression (Beck's Depression score)

8. Alcohol or drug abuse, in the opinion of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

F. Michael Ferrante

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

F. Michael Ferrante, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Pain Management Center

Santa Monica, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16052120 (View on PubMed)

Other Identifiers

UCLA#03-03-061-03A

Identifier Type: -

Identifier Source: org_study_id