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Low Back PainPhase 4NCT00384371

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

A Phase 4 study testing Botulinum Toxin A in people with Low Back Pain, run by United States Department of Defense at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Botulinum Toxin A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jun 2008to Sep 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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).

Who cannot join

  • 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.
Show all 18Show fewer
  • 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®.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307

Other trials in United States

About this study

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.

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.

Read the 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.

Conditions
Low Back Pain
Being tested
Botulinum Toxin A, Placebo
Keywords
back, pain
Medical subject headings
Low Back Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum Toxin ADrug

    Also called Botox

    Botulinum Toxin A

  • PlaceboDrug

    Placebo

Study groups in NCT00384371
Study groupRoleWhat they receive
1ExperimentalBotulinum Toxin A
Receives: Drug: Botulinum Toxin A
2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Significant reduction of low back pain

    Measured: 8 weeks

Secondary outcomes (1)

  1. Significant reduction in long term disability

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2006 (estimated)
  2. Study startJun 2008
  3. Primary completionSep 2011 (estimated)
  4. Study completionSep 2011 (estimated)

Why it stopped: Funding was unable to be secured for this study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00384371
Sponsor's protocol ID
DCI P05-71030
Status last verified
Mar 2009
First submitted
4 Oct 2006
Last updated
5 Mar 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 7877388

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

    PubMed 1534720

  • 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.

    PubMed 8196691

  • 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.

    PubMed 5319286

  • 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.

    PubMed 7604348

  • 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.

    PubMed 11376175

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Botulinum Toxin A in people with Low Back Pain, run by United States Department of Defense at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding was unable to be secured for this study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Significant reduction of low back pain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00384371, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2009.

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