ClinicalTrials.gg
CompletedNCT00241215Updated Jun 21, 2016

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

A Phase 4 interventional study of Botulinum toxin serotype A in Cervicobrachial Neuralgia and Myofascial Pain Syndromes, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-21.

Sponsored by University of California, Los Angeles · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Cervicobrachial Neuralgia
  • Myofascial Pain Syndromes

Keywords

  • Botulinum toxin serotype A
  • Cervicobrachial syndrome
  • Myofascial pain
  • Cervicothoracic myofascial pain
  • Propulsion
  • Postural abnormality
03

In context

Myofascial Pain Syndromes

1,143 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.

This study's enrollment of 132 is above the median of 60 across 937 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
132 participants (actual)

Interventions

  • DrugBotulinum toxin serotype A
06

What researchers measure

Primary outcomes

  1. Numerical pain rating

  2. Brief Pain Inventory

  3. Neck Disability Index

  4. Cervical range of motion

  5. Number of trigger points

  6. Postural exam

Secondary outcomes

  1. Pain Diary and medications use

  2. Short Form (SF)-36

07

Study locations

1 site
  • UCLA Pain Management Center
    Santa Monica, California 90404, United States
08

References and documents

Publications

  • 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. PubMed 16052120 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00241215
Collaborators
Allergan
Responsible party
F. Michael Ferrante (Principal Investigator, University of California, Los Angeles) — Principal investigator
First posted
Oct 18, 2005
Start date
Jun 2003
Primary completion
Nov 2005
Last update
Jun 21, 2016

Study contacts

F. Michael Ferrante, MD
principal investigator · University of California, Los Angeles
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion