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

Myofascial Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241215
• Other study ID #: UCLA#03-03-061-03A
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2005
• Last updated: June 19, 2016
• Start date: June 2003

Study information

• Verified date: June 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervicobrachial Neuralgia
• Fibromyalgia
• Myofascial Pain Syndromes
• Syndrome

Intervention

Drug:
• Botulinum toxin serotype A

Locations

Country	Name	City	State
United States	UCLA Pain Management Center	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Allergan

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical pain rating
Primary	Brief Pain Inventory
Primary	Neck Disability Index
Primary	Cervical range of motion
Primary	Number of trigger points
Primary	Postural exam
Secondary	Pain Diary and medications use
Secondary	Short Form (SF)-36