Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain
Unknown statusPhase 4NCT00404417
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study will assess the efficacy and the duration of efficacy of Botulinum toxin A (Botox®) injected into the lumbar paraspinal muscles for reducing pain and disability in subjects suffering from chronic low back pain of six months duration or longer and arising from an identifiable muscle strain injury or back trauma. The treatment modality and techniques used are based on a successful prior 4 month open-labeled pilot study done by this research group, but will employ a prospective double-blind, randomized, cross-over design to control for any placebo or mechanical trigger-point injection effects. Subjects will also be assessed for a longer duration to better define the duration of efficacy.
Study details
- Official title
- Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain: A Prospective Randomized Double-blind Placebo-controlled Crossover Study
- Conditions
- Interventions
- Drug: Botulinum Toxin A / Placebo
- Drug: Botulinum Toxin A / Botulinum Toxin A
- Drug: Placebo / Botulinum Toxin A
- Drug: Placebo / Placebo
- Sponsor
- Walter Reed Army Medical Center
- Start date
- 2007-03
- Primary completion
- 2011-02
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Active duty military, retired military or other DoD healthcare beneficiaries of either sex, aged 18-70 years, with symptoms of chronic back pain. * A clear history of an identifiable muscle strain or back trauma preceding the chronic pain. * Current pain duration \> 6 months. * MRI of the affected spine area to define potential or serious pathology as per standard of care. * Written informed consent and written authorization for use or release of health and research study information. * Normal neurological examination without evidence of radiculopathy. * VAS score minimum of 4 cm or reaches an average of 4 cm out of 10 cm at least 4 days a week, 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 70 years * Concomitant use of amino glycoside 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 Botulinum Toxin A (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 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 recent alcohol or substance abuse. * Known, uncontrolled systemic disease. * Participation in the 30 days preceding enrollment or during the duration of this study in another investigational drug or device study. * 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 Axis II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into study * Duration of back pain \< 6 months. * Thoracic or cervical spine pain in the absence of low …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00404417