Use of botulinum toxin-A for musculoskeletal pain in patients with whiplash associated disorders

ISRCTN	ISRCTN68653575
DOI	https://doi.org/10.1186/ISRCTN68653575
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Francisco J Juan
Scientific

Salamanca, 5
Vigo
36211
Spain

Phone	+34 986 413 144
Email	j.juan@arrakis.es

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	Whibotulin
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Botulinum toxin-A
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2004
Completion date	01/01/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	160
Key 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
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2005

Salamanca, 5

Vigo
36211
Spain

Povisa Medical Center (Povisa Centro Medico) (Spain)
Hospital/treatment centre

Salamanca, 5
Vigo
36211
Spain

"ROR"	https://ror.org/043m85342

Hospital/treatment centre

Povisa Medical Center (Spain)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	13/02/2004		Yes	No