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

NCT00384371 | Terminated Phase 4 DMC

• 1 other identifier: DCI P05-71030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

back; pain

Outcome Measures

Primary Outcomes (1)

• Significant reduction of low back pain

  8 weeks

Secondary Outcomes (1)

• Significant reduction in long term disability

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Botulinum Toxin A

Drug: Botulinum Toxin A

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Botulinum Toxin A DRUG

Botulinum Toxin A

Also known as: Botox

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Department of Defense: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Related Publications (6)

• Wipf JE, Deyo RA. Low back pain. Med Clin North Am. 1995 Mar;79(2):231-46. doi: 10.1016/s0025-7125(16)30065-7.

  PMID: 7877388 BACKGROUND

• Frymoyer JW. Predicting disability from low back pain. Clin Orthop Relat Res. 1992 Jun;(279):101-9.

  PMID: 1534720 BACKGROUND

• Polo KB, Jabbari B. Effectiveness of botulinum toxin type A against painful limb myoclonus of spinal cord origin. Mov Disord. 1994 Mar;9(2):233-5. doi: 10.1002/mds.870090221.

  PMID: 8196691 BACKGROUND

• Rand MJ, Whaler BC. Impairment of sympathetic transmission by botulinum toxin. Nature. 1965 May 8;206(984):588-91. doi: 10.1038/206588a0. No abstract available.

  PMID: 5319286 BACKGROUND

• Haig AJ, LeBreck DB, Powley SG. Paraspinal mapping. Quantified needle electromyography of the paraspinal muscles in persons without low back pain. Spine (Phila Pa 1976). 1995 Mar 15;20(6):715-21.

  PMID: 7604348 BACKGROUND

• Foster L, Clapp L, Erickson M, Jabbari B. Botulinum toxin A and chronic low back pain: a randomized, double-blind study. Neurology. 2001 May 22;56(10):1290-3. doi: 10.1212/wnl.56.10.1290.

  PMID: 11376175 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Jack W Tsao, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: June 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 5, 2009

Record last verified: 2009-03

Locations

US (1)