Clinical trial NCT06389188: Effectiveness of Cervical Osteopathic Manipulation in Patients with Whiplash
Official title: Effectiveness of Cervical Osteopathic Manipulation Techniques of High Velocity and Low Amplitude in Patients with Whiplash- Associated Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash
Keywords: manual therapy
manipulation
physical therapy
exercises
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Consorci Sanitari de Terrassa
First posted: 2024-04-29
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective pain intensity
timeFrame: At baseline and at week 2, 4 and follow-up.
measure: Neck specific disability
timeFrame: At baseline and at week 2, 4 and follow-up.
Secondary outcomes:
measure: Cervical range of motion (CROM)
timeFrame: At baseline and at week 2 and week 4.
measure: Cervical lordosis Cobb angle
timeFrame: At baseline and at week 4.
measure: Hospital anxiety and depression scale
timeFrame: At baseline and at week 4 and follow-up.
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa.
state: Barcelona
Study officials:
affiliation: Clinical Research Centre d'Osteopatia Terrassa. Consorci Sanitari de Terrassa
name: Joan Parera-Turull, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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