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Chronic Low Back PainPhase 4NCT00404417

Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain

A Phase 4 study testing Botulinum Toxin A / Botulinum Toxin A in people with Chronic Low Back Pain, run by Walter Reed Army Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Botulinum Toxin A / Botulinum Toxin A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteUnited States
Study dates
Mar 2007to Feb 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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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 back pain.
  • Anesthetic or corticosteroid injection to the lumbosacral spine within 8 weeks of enrollment.
  • Any anesthetic or steroid injections into any back muscles in the 4 weeks prior to enrollment.
  • A prior spine MRI or CT (any region) with evidence of significant pathology of the spinal cord, roots, or elements of the spinal column to include; impingement on the spinal cord or nerve roots, intrinsic pathology of the spinal cord (e.g. syrinx) or nerve roots, evidence of a neoplastic or infectious process involving the spinal cord or nerve roots or structural elements of the spine (e.g. vertebra or intervertebral disks), or any deformities of the bony or supporting elements of the spinal column that deform the spinal cord or the nerve roots. Nonspecific degenerative changes of the spine, Schmorl's nodules, and other similar findings that do not impinge upon or involve the spinal cord or nerve roots will not be considered exclusionary.
  • Signs of radiculopathy on neurological examination.
  • History of back surgery within one year or incomplete resolution of back pain due to a previous surgery (persistence of back pain present prior to surgery, i.e. a surgical failed back, is not exclusionary).
  • 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 patient interview.
  • Any previous use of Botox®, Dysport® or Myobloc®. Previous use of Botox Cosmetic or Myobloc for cosmetic purposes is allowed if the last administration occurred over 6 months prior to enrollment and the injected dose was less than or equal to 30 units (or an equivalent dose of Myobloc). Copies of all records of Botox Cosmetic or Myobloc injection(s) must be provided by the subject prior to enrollment for verification.

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: Botulinum Toxin A for the Treatment of Chronic Lumbar Back Pain: A Prospective Randomized Double-blind Placebo-controlled Crossover Study

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.

Read the detailed description

One hundred sixty subjects will be randomly assigned to one of four arms (placebo/placebo, placebo/Botox, Botox/placebo, Botox/Botox). In the first of two phases, randomized subjects will blindly receive either Botox® (study arms Botox/placebo and Botox/Botox) or placebo (study arms placebo/placebo and placebo/Botox) injection into the lumbar paraspinal muscles. The subjects will be assessed using validated scales for pain and disability prior to injection and monthly thereafter for four months. In the second phase, a second set of lumbar injections will be administered based on the initial randomization and will blindly receive either Botox® (study arms placebo/Botox and Botox/Botox) or placebo (study arms placebo/placebo and Botox/placebo) injection into the lumbar paraspinal muscles. The subjects will again be assessed using the same validated scales for pain and disability, prior to injection and monthly thereafter, but for six months to extend the monitoring period to better define the limits of duration of effect.

This will result in half of the subjects being crossed-over from Botox® to placebo (study arm Botox/placebo) or vice versa (study arm placebo/Botox) and one quarter of subjects receiving two courses of either Botox® alone (Botox/Botox) or placebo alone (placebo/placebo). All subjects will continue to receive medication and/or physiotherapy per standard of care but those treatments will be recorded and controlled for in the data analysis.

Being tested
Botulinum Toxin A / Placebo, Botulinum Toxin A / Botulinum Toxin A, Placebo / Botulinum Toxin A, Placebo / Placebo
Keywords
pain, lumbar
Medical subject headings
Pain

What participants receive

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

  • Botulinum Toxin A / PlaceboDrug

    Also called Botox

    Botulinum Toxin A at first injection / Placebo at second injection

  • Botulinum Toxin A / Botulinum Toxin ADrug

    Also called Botox

    Botulinum Toxin A at first injection / Botulinum Toxin A at second injection

  • Placebo / Botulinum Toxin ADrug

    Also called Botox

    Placebo at first injection / Botulinum Toxin A at second injection

  • Placebo / PlaceboDrug

    Also called Placebo

    Placebo at first injection / Placebo at second injection

Study groups in NCT00404417
Study groupRoleWhat they receive
1ExperimentalBotox/Placebo
Receives: Drug: Botulinum Toxin A / Placebo
2ExperimentalBotox/Botox
Receives: Drug: Botulinum Toxin A / Botulinum Toxin A
3ExperimentalPlacebo/Botox
Receives: Drug: Placebo / Botulinum Toxin A
4Placebo comparatorPlacebo/Placebo
Receives: Drug: Placebo / Placebo

What is being measured

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

  1. relief of chronic low back pain

    Measured: 8 weeks and 24 weeks

Timeline

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

  1. First posted28 Nov 2006 (estimated)
  2. Study startMar 2007
  3. Primary completionFeb 2011 (estimated)
  4. Study completionFeb 2011 (estimated)

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
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00404417
Sponsor's protocol ID
DCI P06-71038
Status last verified
Feb 2010
First submitted
27 Nov 2006
Last updated
2 Mar 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Pope MH, Frymoyer JW, Krag MH. Diagnosing instability. Clin Orthop Relat Res. 1992 Jun;(279):60-7.

    PubMed 1600673

  • 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

  • Cherkin DC, Sherman KJ, Deyo RA, Shekelle PG. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med. 2003 Jun 3;138(11):898-906. doi: 10.7326/0003-4819-138-11-200306030-00011.

    PubMed 12779300

  • Grazko MA, Polo KB, Jabbari B. Botulinum toxin A for spasticity, muscle spasms, and rigidity. Neurology. 1995 Apr;45(4):712-7. doi: 10.1212/wnl.45.4.712.

    PubMed 7723960

  • Aoki KR. Pharmacology and immunology of botulinum toxin serotypes. J Neurol. 2001 Apr;248 Suppl 1:3-10. doi: 10.1007/pl00007816.

    PubMed 11357237

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Botulinum Toxin A / Botulinum Toxin A in people with Chronic Low Back Pain, run by Walter Reed Army Medical Center 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 19 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: status not confirmed, as of the sponsor's last update on 2 Mar 2010. 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?

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?

relief of chronic low back pain (time frame: 8 weeks and 24 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 NCT00404417, which also lists 5 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 2 Mar 2010.

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