Plain English Summary
Background and study aims
Whiplash is a neck injury caused by a sudden movement forward, backward or sideways movement of the head. It often happens after a sudden impact from, for example, a road traffic accident and results in damage to the ligaments and tendons in the neck. Road traffic accidents and their effects on social-health costs are an important problem for society. Whiplash and whiplash associated disorders (WAD for example pain, reduced range of neck movement, neurological damage and even fracture) are the number one reason for people visiting the emergency room after being involved in a road traffic accident. Osteopathic high velocity, low amplitude (HVLA) techniques, and mobilization techniques of the cervical spine, either alone or combined with other treatments, are methods used to treat neck problems. Both treatments result in similar short term changes, but there is not enough data to assess their long-term effects, making it difficult to develop the best technique and when and how long the treatments should be applied. The aim of this study is to precisely and objectively contribute to the knowledge available on how good HVLA techniques are at treating whiplash and WAD. HVLA techniques are compared with other physiotherapy techniques, looking at how long the treatments are needed, the degree of pain relief they offer, how much they improve the function and mobility of the spine and analysing radiological changes in cervical curvature.
Who can participate?
Patients aged 18 to 65 with WAD admitted to the Osteopathic Centre in Terrassa.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in the study group receive HVLA treatment and the control group receive conventional manual osteopathic therapy and therapeutic exercises. The results from the two groups are then compared to assess how well they treat whiplash and WAD.
What are the possible benefits and risks of participating?
Participants are unlikely to directly benefit from the study, but the results could help future sufferers of whiplash, resulting in better management of their symptoms and avoiding excessive procedures. The risks associated with this study are rare and generally mild, but include some neurodegenerative reactions (sweating, low blood pressure, feeling sick and/or rapid heart rate) during, or immediately after, the therapy.
Where is the study run from?
Health Consortium of Terrassa (Spain)
When is the study starting and how long is it expected to run for?
May 2014 to December 2015
Who is funding the study?
The Osteopathic Centre, Terrassa and the Health Consortium of Terrassa (Consorci Sanitari de Terrassa) (Spain)
Who is the main contact?
Mr Joan Parera
Joanpt1@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Mr Joan Parera
ORCID ID
http://orcid.org/0000-0002-3969-2433
Contact details
Sant Marian 99 5-2
Terrassa
08221
Spain
-
joanpt1@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Research project on the effectiveness of cervical OSTEOpathic manipulation techniques of high velocity and low amplitude in patients with whiplash-associated disorders: a Randomized Controlled single-blind Trial
Acronym
OSTEO-RCT
Study hypothesis
Patients who have suffered cervical whiplash, specific osteopathic techniques to adjust the treatment, of high velocity and low amplitude (SAT-HVLA) of the cervical spine, obtain better results than those treated with combined treatments found in cervical therapeutic exercise manuals.
Ethics approval
Ethics Committee at the Health Consortium of Terrassa - Terrassa Hospital (Consorci Sanitari de Terrassa Hospital de Terrassa), 20/12/2013
Study design
Randomized controlled single-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Whiplash associated disorders (WAD)
Intervention
The participants are randomised to two groups:
1. Treatment: The technique of choice, will be the Specific Adjusting Technique (SAT). This is a High Velocity Low Amplitude Technique, whose objective is to reverse the injury caused by the trauma.
Throughout the trial we will make three interventions with SAT (one every two weeks)
In the first intervention, we will manipulate the upper cervical segment (C2/C3)
In the second intervention, we will manipulate the low cervical segment (C5/C6)
In the third intervention, we will manipulate the upper thoracic segment (T1/T2)
2. Control: The participants will receive conventional treatment, consisting in manual therapy techniques and therapeutic exercises, over four weeks.
Participants are followed up at 11 days, 30 days, and 110 days after treatment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Current primary outcome measures as of 01/02/2017:
1. Functionality (disability), measured using the Northwick Park Neck Pain Questionnaire (NPQ) at baseline, 11 days, 30 days, and 110 days after treatment
2. Cervical mobility, measured using the Cervical Range Of Motion Instrument (CROM) at baseline, 11 days, 30 days, and 110 days after treatment
3. Radiological changes in the cervical curvature, measured using the Cobb method (COOB) at baseline and 30 days after treatment
Previous primary outcome measures:
1. Functionality, measured using the Northwick Park Neck Pain Questionnaire (NPQ)
2. Cervical mobility, measured using the Cervical Range Of Motion Instrument (CROM)
3. Radiological changes in the cervical curvature (CA)
Secondary outcome measures
Current secondary outcome measures as of 01/02/2017:
1. Pain, measured using the Visual Analogue Scale (VAS) at baseline, 11 days, 30 days, and 110 days after treatment
2. Anxiety, measured using the Hospital Anxiety and Depression Scale (HAD) at baseline, 30 days, and 110 days after treatment
3. Depression, measured using the Hospital Anxiety and Depression Scale (HAD) at baseline, 30 days, and 110 days after treatment
Previous secondary outcome measures:
1. Quality of life
2. Mobility of the cervical spine
3. Lordosis of the cervical spine
Overall trial start date
22/05/2014
Overall trial end date
31/12/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients ages 18 to 65 years presenting whiplash syndrome (WAD)
2. They must have radiological studies (A-P and lateral projections) with previous signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
148
Participant exclusion criteria
1. Chronic cervical pain
2. Bone pathology
3. Systemic pathologies (acute infections, cancerous or inflammatory processes)
Recruitment start date
22/05/2014
Recruitment end date
01/07/2015
Locations
Countries of recruitment
Spain
Trial participating centre
The Osteopathic Centre, Terrassa (Centre d'osteopatia Terrassa)
08224
Spain
Sponsor information
Organisation
The Osteopathic Centre, Terrassa (Centre d'osteopatia Terrassa) (Spain)
Sponsor details
Pintor Torras 2 1-2
Terrassa
08224
Spain
-
osteo@osteopatiaterrassa.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Osteopathic Centre, Terrassa (Centre d'osteopatia Terrassa) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Health Consortium of Terrassa (Consorci Sanitari de Terrassa) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal in 2017.
IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/06/2017
Participant level data
To be made available at a later date
Results - basic reporting
See additional file ISRCTN87221762_BasicResults_31Jan17.docx
Publication summary
Publication citations
Additional files
- ISRCTN87221762_BasicResults_31Jan17.docx Uploaded 15/02/2017