NCT00282958

Brief Summary

To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

February 1, 2003

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

First QC Date

January 25, 2006

Last Update Submit

March 4, 2015

Conditions

Subacute Cervical PainSubacute Upper Back Pain

Outcome Measures

Primary Outcomes (1)

  • NDI, VAS, SF-36

Interventions

Botulinum Toxin type a (Botox)DRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female 18 y/o or greater,
  • Subacute bilateral cervical/ upper back pain, pain of longer than 2 months and shorter than 6 months duration,
  • VAS pain score of 5 or greater for the cervical/ upper back pain for 4 week period before injection,
  • If female or child bearing potential, concurrent use of a reliable method of contraception.

You may not qualify if:

  • Known allergy or sensitivity to Botulinum toxin type A.
  • 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, or any other significant disease that might interfere with neuromuscular function
  • Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function
  • Pregnancy, breast feeding, or planned pregnancy
  • Acute or operative pathology on cervical MRI
  • History of treatment for gatro-esophageal reflux disease
  • Abnormal finding on 3-oz water swallowing test on the initial screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Elaine Date, MD

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

  • Henry Lew, MD, Ph.D

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

February 1, 2003

Study Completion

July 1, 2006

Last Updated

March 5, 2015

Record last verified: 2015-03