Skip to main content
OpenTrials
Completed

NCT Number: NCT06389188

Effectiveness of Cervical Osteopathic Manipulation in Patients With Whiplash

To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Whiplash Behavior Motor Activity Neck Injuries Whiplash Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari de Terrassa.

Terrassa, Barcelona, 08227, Spain

About this study

A prospective, single-blind, parallel group, randomized, will be carried out in the physiotherapy service of the Clinic Hospital of Terrassa with the participation of the rehabilitation, radiology, traumatology and surgery services.

Patients will be recruited from emergency services of the Clinic Hospital of Terrassa and randomly divided into two groups MAN-Group and RHB-Group, using the random number generator of a statistical program (SPSS), to receive 3 and 20 treatment sessions, respectively.

The treatment protocol was carried out during four weeks, and both interventions occurred over the same time period. In both treatment groups, patients started sessions during the first two week after the traffic car collision.

MAN-Group were treated with cervical spine manipulation with SAT, after specialized physical therapists assessed there was no risk of vertebro-basilar injuries following the International Framework. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study).

The RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks. The exercises were performed five times (30 seconds interval each time) in a sitting position.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients between 18-60 years of age Who went to the emergency service after suffering a traffic car collision being the driver of the car.

With acute WL grade II WAD diagnosis, made by physicians from the traumatology service (with neck pain by whiplash trauma with objective findings but no radiculopathy).

Referred to the hospital rehabilitation service

Exclusion criteria

Any other symptomatology different to neck pain and other coexisting medical conditions which could severely restrict participation in the study.

Treatment and study plan

RHB Group

Procedure

The RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks

Primary outcomes

  1. Subjective pain intensity

    Time frame: At baseline and at week 2, 4 and follow-up.

    Neck pain intensity was assessed with a Visual Analogue Scale (VAS) to measure the amount of pain experienced by a subject from both groups on a continuum from 0 to 100 mm. Scores can range from 0 (no pain) to 100 (worst imaginable pain)19,20. This method has been proven to be a reliable, generalizable and internally consistent measure of clinical and experimental neck pain

  2. Neck specific disability

    Time frame: At baseline and at week 2, 4 and follow-up.

    Neck-specific disability was measured with Neck Disability Index (NDI). The NDI is a valid measurement of disability in neck pain disorders. It is widely used and it has shown good reliability and validity in WAD studies. NDI scores can range from 0% (no limitation on activity) to 100% (worst possible disability).

Secondary outcomes

  1. Cervical range of motion (CROM)

    Time frame: At baseline and at week 2 and week 4.

    Neck range of motion was tested with the CROM Instrument. All cervical motions and subsequent measurements were performed according to the manufacturer's specifications and were reproduced exactly for each trial with a single examiner performing all measurements. CROM were assessed in a relaxed sitting position, hips and knees positioned at 90º angles and buttocks positioned against the back of the chair. The goniometer was placed on the top of the head and was set in the neutral position.

  2. Cervical lordosis Cobb angle

    Time frame: At baseline and at week 4.

    Cobb angle (COBB) method was measured to assess cervical lordosis (Cobb C2-C7) as the angle between the horizontal line on the lower endplate of C2 and a horizontal line on the lower endplate of C7. A clinically normal cervical lordosis has been described as a Cobb angle of 31-40 degrees, with subjects in standing and eyes focused straight ahead. A cervical lordosis of less than 20◦ from C2 to C7 has been shown to be related to cervical dysfunction and pain.

  3. Hospital anxiety and depression scale

    Time frame: At baseline and at week 4 and follow-up.

    HADS was used to determine the levels of anxiety and depression experienced by participants. HADS has 14 items and it was designed for the evaluation of anxiety and depression in non-psychiatric outpatient hospital services. The entire sum for both HADS anxiety and HADS depression levels ranges from 0 to 21. A score equal to or more than 10 indicates clinically significant symptoms of anxiety or depression.

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Consorci Sanitari de Terrassa

Registry information

Official study title

Effectiveness of Cervical Osteopathic Manipulation Techniques of High Velocity and Low Amplitude in Patients With Whiplash- Associated Disorders

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.