Contact information
Type
Scientific
Primary contact
Dr Francisco J Juan
ORCID ID
Contact details
Salamanca
5
Vigo
36211
Spain
+34 986 413 144
j.juan@arrakis.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Whibotulin
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Whiplash cervical injuries
Intervention
Randomised, prospective, double blind, placebo-controlled study comparing Botox® with placebo.
The study evaluates the efficacy and safety of Botox® in patients with musculoskeletal pain after whiplash associated disorders.
1. Subjective pain
2. Assessment of disability due neck pain with the Neck Pain Disability Index
3. Assessment of Range Of neck Motion (ROM), using CROM® Cervical Range of Motion Instrument
4. Assessment of health status
Intervention type
Drug
Phase
Not Specified
Drug names
Botulinum toxin-A
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2004
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with grade II Whiplash Associated Disorders (WAD) of Quebec Task Force (QTF)-WAD
2. Neck pain secondary to cervical whiplash injury with musculoskeletal signs of greater than three months
3. Aged greater than 18 years
4. Lack of response to conventional physical and medical therapy
Musculoskeletal signs:
1. Palpable band, spot tenderness, and jump sign in cervical muscles or restricted range of motion in cervical spine
2. Demonstrated precipitation of neck pain with external pressure over the occipital or cervical region on affected side
3. Myofascial pain of cervical muscles
4. Experienced pain on maneuver of stretching
5. Trigger point with associated referred pain
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
160
Participant exclusion criteria
1. Serious somatic or psychiatric illness
2. Anticoagulation therapy
3. Myasthenia gravis
4. Pregnancy or breast-feeding
5. Abnormal anatomy
6. Rheumatoid disease or radiculopathy
7. Need for regular analgesic for severe pain
Recruitment start date
01/01/2004
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Spain
Trial participating centre
Salamanca, 5
Vigo
36211
Spain
Funders
Funder type
Hospital/treatment centre
Funder name
Povisa Medical Center (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15018625
Publication citations
-
Protocol
Juan FJ, Use of botulinum toxin-A for musculoskeletal pain in patients with whiplash associated disorders [ISRCTN68653575]., BMC Musculoskelet Disord, 2004, 5, 5, doi: 10.1186/1471-2474-5-5.