Condition category
Injury, Occupational Diseases, Poisoning
Date applied
01/02/2004
Date assigned
02/02/2004
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Povisa Medical Center (Povisa Centro Medico) (Spain)

Sponsor details

Salamanca
5
Vigo
36211
Spain

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes