Condition category
Musculoskeletal Diseases
Date applied
14/05/2014
Date assigned
21/07/2014
Last edited
21/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 our 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 will be 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 trial, but the results of this study could help future sufferers of whiplash, resulting in better management of their symptoms and avoiding excessive diagnostic, clinical and therapeutic 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

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 below 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Assess the effectiveness of the osteopathic techniques by Specific Adjusting Treatment, high velocity, low amplitude (SAT-HVLA) in adults affected by WAD
2. Functionality measured by Northwick Park Neck Pain Questionnaire (NPQ)
3. Cervical mobility (CROM)
4. Radiological changes in the cervical curvature (CA)

Secondary outcome measures

Compare the effectiveness of the osteopathic techniques with other physical therapy techniques.
1. Improvement of quality of life.
2. Mobility of the cervical spine.
3. Changes in 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

Patients with:
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

31/12/2015

Locations

Countries of recruitment

Spain

Trial participating centre

Sant Marian 99 5-2
Terrassa
08221
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

http://www.osteopatiaterrassa.com

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes