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

NCT00241215 | Completed Phase 4

• 1 other identifier: UCLA#03-03-061-03A
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Cervicobrachial Neuralgia; Myofascial Pain Syndromes

Keywords

Botulinum toxin serotype A; Cervicobrachial syndrome; Myofascial pain; Cervicothoracic myofascial pain; Propulsion; Postural abnormality

Outcome Measures

Primary Outcomes (6)

• Numerical pain rating

• Brief Pain Inventory

• Neck Disability Index

• Cervical range of motion

• Number of trigger points

• Postural exam

Secondary Outcomes (2)

• Pain Diary and medications use

• Short Form (SF)-36

Interventions

Botulinum toxin serotype A DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Allergan: collaborator

Study Sites (1)

UCLA Pain Management Center

Santa Monica, California, 90404, United States

Location

Related Publications (1)

• 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.

  PMID: 16052120 RESULT

MeSH Terms

Conditions

Brachial Plexus Neuritis; Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuritis; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• F. Michael Ferrante, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 18, 2005
• Study Start: June 1, 2003
• Primary Completion: November 1, 2005
• Last Updated: June 21, 2016

Record last verified: 2016-06

Locations

US (1)