NCT00404417

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 2, 2010

Status Verified

February 1, 2010

Enrollment Period

3.9 years

First QC Date

November 27, 2006

Last Update Submit

March 1, 2010

Conditions

Chronic Low Back Pain

Keywords

painlumbar

Outcome Measures

Primary Outcomes (1)

  • relief of chronic low back pain

    8 weeks and 24 weeks

Study Arms (4)

1

EXPERIMENTAL

Botox/Placebo

Drug: Botulinum Toxin A / Placebo

2

EXPERIMENTAL

Botox/Botox

Drug: Botulinum Toxin A / Botulinum Toxin A

3

EXPERIMENTAL

Placebo/Botox

Drug: Placebo / Botulinum Toxin A

4

PLACEBO COMPARATOR

Placebo/Placebo

Drug: Placebo / Placebo

Interventions

Botulinum Toxin A / PlaceboDRUG

Botulinum Toxin A at first injection / Placebo at second injection

Also known as: Botox
1
Botulinum Toxin A / Botulinum Toxin ADRUG

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

Also known as: Botox
2
Placebo / Botulinum Toxin ADRUG

Placebo at first injection / Botulinum Toxin A at second injection

Also known as: Botox
3
Placebo / PlaceboDRUG

Placebo at first injection / Placebo at second injection

Also known as: Placebo
4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 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.
  • Signs of radiculopathy on neurological examination.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Medical Center

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

Location

Related Publications (5)

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

    PMID: 1600673BACKGROUND

  • 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: 7877388BACKGROUND

  • 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.

    PMID: 12779300BACKGROUND

  • 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.

    PMID: 7723960BACKGROUND

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

    PMID: 11357237BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Kevin R Cannard, 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
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 28, 2006

Study Start

March 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 2, 2010

Record last verified: 2010-02

Locations

US(1)