Pilot Study to Assess the Efficacy of Botulinum Toxin A Treatments on Pain and Disability in Sub-Acute Low Back Pain

This study has been terminated.
(Funding was unable to be secured for this study)
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00384371
First received: October 4, 2006
Last updated: March 4, 2009
Last verified: March 2009
  Purpose

This study will test the hypothesis that Botulinum toxin A (BOTOX®) treatment reduces pain and disability in subjects suffering from sub-acute low back pain due to an identifiable muscle strain or back trauma occurring 6 to 16 weeks prior to enrollment. The study will also delineate the duration of medication effect and control for any placebo or mechanical trigger-point injection effect by employing a prospective, double-blind, placebo-controlled design.


Condition Intervention Phase
Low Back Pain
Drug: Botulinum Toxin A
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study to Assess the Efficacy of Botulinum Toxin A (BOTOX®) Treatment of Paravertebral Muscles on Pain and Disability in Subjects Suffering From Sub-Acute Low Back Pain.

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Significant reduction of low back pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Significant reduction in long term disability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Botulinum Toxin A
Drug: Botulinum Toxin A
Botulinum Toxin A
Other Name: Botox
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo
Other Name: Placebo

Detailed Description:

This study will assess the efficacy of Botulinum Toxin A (BOTOX®) injected into the lumbar paravertebral muscles for reducing pain and disability in subjects suffering from sub-acute low back pain (duration 6 to 16 weeks) arising from an identifiable muscle strain injury or back trauma. The treatment modality and techniques used are based upon three successful prior open-labeled pilot studies done by this research group investigating the effect of BOTOX® on relief of chronic low back pain. This study, however, will employ a prospective, double-blind, randomized, placebo controlled trial to control for any placebo or mechanical trigger-point injection effects. Subjects will also be assessed for 6 months to define the duration of efficacy of BOTOX®. Sixty subjects will be randomly assigned to one of two arms. There will be two parts to this study. In the first both groups will receive either BOTOX® or placebo injection into the lumbar paravertebral muscles. The subjects will be assessed using validated scales for pain and disability prior to injection and weekly to monthly thereafter for three months. Subjects who improve will have a single follow-up visit at 6 months while those subjects who do not improve will enter the second, open-label part where they will receive BOTOX® injection and be monitored weekly to monthly for the next 3 months, giving a total subject participation period of 6 months. All subjects will continue to receive any medication or physiotherapy per standard of care but those treatments will be recorded and controlled for in the data analysis.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects, 18 to 60 years of age, active duty military.
  • Written informed consent and written authorization for use or release of health and research study information.
  • Clear history of an identifiable muscle strain or trauma preceding the onset of low back pain.
  • No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
  • Normal neurological examination without evidence of radiculopathy.
  • History of low back pain lasting 6 to 16 weeks from the time of injury or strain.
  • VAS score minimum of 5 cm at time of entry into study.
  • Ability to follow study instructions and likely to complete all required visits.
  • Negative urine pregnancy test prior to the administration of study medication (for females of childbearing potential) (if applicable).

Exclusion Criteria:

  • Age less than 18 or greater than 60.
  • Not active duty.
  • Concomitant use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
  • Any medical condition that may put the subject at increased risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that might interfere with neuromuscular function or produce a similar type of low back pain.
  • Females who are pregnant, breast-feeding, or planning a pregnancy during the study, or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
  • Known allergy or sensitivity to any of the components in the study medication.
  • Evidence of alcohol or substance abuse in 6 months prior to enrollment.
  • Systemic medical conditions (such as thyroid disease, hypertension, bleeding disorders, diabetes, cancers, etc.) that are not currently medically managed or controlled.
  • Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study.
  • Duration of low back pain < 6 weeks or > 16 weeks.
  • Thoracic or cervical spine pain in the absence of sub-acute low back pain.
  • Anesthetic or corticosteroid injection to the lumbosacral spine within 8 weeks of enrollment.
  • Spine MRI (any region) positive for acute pathology or evidence of radiculopathy on neurological examination.
  • History of back surgery within one year or incomplete resolution of back pain due to a previous injury or surgery.
  • Subjects involved in litigation, seeking significant disability for low back pain, or with evident secondary gain as determined by the neurologist through chart review and subject interview.
  • Any previous use of BOTOX®, Dysport®, or Myobloc®.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384371

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Investigators
Principal Investigator: Jack W Tsao, MD Walter Reed Army Medical Center
  More Information

Publications:
Responsible Party: CDR Jack W. Tsao, MD, DPhil, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00384371     History of Changes
Other Study ID Numbers: DCI P05-71030
Study First Received: October 4, 2006
Last Updated: March 4, 2009
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
back
pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014