Effectiveness of Cervical Osteopathic Manipulation in Patients with Whiplash

NCT ID: NCT06389188

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-10-28

Brief Summary

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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

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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.

Conditions

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Whiplash

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Experimental: MAN Group

MAN-Group were treated with cervical spine manipulation with SAT. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study).

Group Type EXPERIMENTAL

RHB Group

Intervention Type 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

MAN Group

MAN-Group were treated with cervical spine manipulation with SAT. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study).

Group Type ACTIVE_COMPARATOR

RHB Group

Intervention Type 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

Interventions

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RHB Group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari de Terrassa

OTHER

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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JOSE VICENTE TOLEDO MARHUENDA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Parera-Turull, PhD.

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Centre d'Osteopatia Terrassa. Consorci Sanitari de Terrassa

Locations

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Consorci Sanitari de Terrassa.

Terrassa, Barcelona, Spain

Site Status

Countries

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Spain

References

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Peolsson A, Landen Ludvigsson M, Tigerfors AM, Peterson G. Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study. Arch Phys Med Rehabil. 2016 Feb;97(2):189-95. doi: 10.1016/j.apmr.2015.10.087. Epub 2015 Oct 26.

Reference Type BACKGROUND
PMID: 26514296 (View on PubMed)

De Rosario H, Vivas MJ, Sinovas MI, Page A. Relationship between neck motion and self-reported pain in patients with whiplash associated disorders during the acute phase. Musculoskelet Sci Pract. 2018 Dec;38:23-29. doi: 10.1016/j.msksp.2018.09.004. Epub 2018 Sep 6.

Reference Type BACKGROUND
PMID: 30218881 (View on PubMed)

Rasmussen C, Stenager E, Nielsen CV. [Social, economic and cultural aspects of whiplash syndrome]. Ugeskr Laeger. 2010 Jun 14;172(24):1815-7. Danish.

Reference Type BACKGROUND
PMID: 20566153 (View on PubMed)

Walton DM, Elliott JM. An Integrated Model of Chronic Whiplash-Associated Disorder. J Orthop Sports Phys Ther. 2017 Jul;47(7):462-471. doi: 10.2519/jospt.2017.7455. Epub 2017 Jun 16.

Reference Type BACKGROUND
PMID: 28622487 (View on PubMed)

Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine (Phila Pa 1976). 1995 Apr 15;20(8 Suppl):1S-73S. No abstract available.

Reference Type BACKGROUND
PMID: 7604354 (View on PubMed)

Wiangkham T, Duda J, Haque S, Madi M, Rushton A. The Effectiveness of Conservative Management for Acute Whiplash Associated Disorder (WAD) II: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. PLoS One. 2015 Jul 21;10(7):e0133415. doi: 10.1371/journal.pone.0133415. eCollection 2015.

Reference Type BACKGROUND
PMID: 26196127 (View on PubMed)

7. Regal Ramos, R.J. Síndrome de latigazo cervical: Características epidemiológicas de los pacientes evaluados en la unidad médica de valoración de incapacidades de Madrid. Medicina y Seguridad del Trabajo 225:348-360 (2011).

Reference Type BACKGROUND

Pajediene E, Janusauskaite J, Samusyte G, Stasaitis K, Petrikonis K, Bileviciute-Ljungar I. Patterns of acute whiplash-associated disorder in the Lithuanian population after road traffic accidents. J Rehabil Med. 2015 Jan;47(1):52-7. doi: 10.2340/16501977-1892.

Reference Type BACKGROUND
PMID: 25315016 (View on PubMed)

Peolsson A, Landen Ludvigsson M, Peterson G. Neck-specific exercises with internet-based support compared to neck-specific exercises at a physiotherapy clinic for chronic whiplash-associated disorders: study protocol of a randomized controlled multicentre trial. BMC Musculoskelet Disord. 2017 Dec 12;18(1):524. doi: 10.1186/s12891-017-1853-1.

Reference Type BACKGROUND
PMID: 29233141 (View on PubMed)

Peterson G, Dedering A, Andersson E, Nilsson D, Trygg J, Peolsson M, Wallman T, Peolsson A. Altered ventral neck muscle deformation for individuals with whiplash associated disorder compared to healthy controls - a case-control ultrasound study. Man Ther. 2015 Apr;20(2):319-27. doi: 10.1016/j.math.2014.10.006. Epub 2014 Oct 15.

Reference Type BACKGROUND
PMID: 25454684 (View on PubMed)

Peolsson A, Karlsson A, Ghafouri B, Ebbers T, Engstrom M, Jonsson M, Wahlen K, Romu T, Borga M, Kristjansson E, Bahat HS, German D, Zsigmond P, Peterson G. Pathophysiology behind prolonged whiplash associated disorders: study protocol for an experimental study. BMC Musculoskelet Disord. 2019 Feb 2;20(1):51. doi: 10.1186/s12891-019-2433-3.

Reference Type BACKGROUND
PMID: 30711003 (View on PubMed)

Elkin BS, Elliott JM, Siegmund GP. Whiplash Injury or Concussion? A Possible Biomechanical Explanation for Concussion Symptoms in Some Individuals Following a Rear-End Collision. J Orthop Sports Phys Ther. 2016 Oct;46(10):874-885. doi: 10.2519/jospt.2016.7049.

Reference Type BACKGROUND
PMID: 27690834 (View on PubMed)

Church EW, Sieg EP, Zalatimo O, Hussain NS, Glantz M, Harbaugh RE. Systematic Review and Meta-analysis of Chiropractic Care and Cervical Artery Dissection: No Evidence for Causation. Cureus. 2016 Feb 16;8(2):e498. doi: 10.7759/cureus.498.

Reference Type BACKGROUND
PMID: 27014532 (View on PubMed)

Haldeman S, Carroll L, Cassidy JD, Schubert J, Nygren A. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders: executive summary. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S7-9. doi: 10.1016/j.jmpt.2008.11.005. No abstract available.

Reference Type BACKGROUND
PMID: 19251077 (View on PubMed)

Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL; COG. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther. 2010 Aug;15(4):315-33. doi: 10.1016/j.math.2010.04.002. Epub 2010 May 26.

Reference Type BACKGROUND
PMID: 20510644 (View on PubMed)

Other Identifiers

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JVT003

Identifier Type: -

Identifier Source: org_study_id

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