Effectiveness of Cervical Osteopathic Manipulation in Patients with Whiplash

NCT06389188 | Completed

• 1 other identifier: JVT003
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash

Keywords

manual therapy; manipulation; physical therapy; exercises

Outcome Measures

Primary Outcomes (2)

• Subjective pain intensity

  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

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

• Neck specific disability

  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).

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

Secondary Outcomes (3)

• Cervical range of motion (CROM)

  At baseline and at week 2 and week 4.

• Cervical lordosis Cobb angle

  At baseline and at week 4.

• Hospital anxiety and depression scale

  At baseline and at week 4 and follow-up.

Study Arms (2)

Experimental: MAN Group

EXPERIMENTAL

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).

Procedure: RHB Group

MAN Group

ACTIVE COMPARATOR

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).

Procedure: RHB Group

Interventions

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

Experimental: MAN Group; MAN Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Consorci Sanitari de Terrassa: collaborator

Study Sites (1)

Consorci Sanitari de Terrassa.

Terrassa, Barcelona, 08227, Spain

Location

Related Publications (15)

• 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.

  PMID: 26514296 BACKGROUND

• 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.

  PMID: 30218881 BACKGROUND

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

  PMID: 20566153 BACKGROUND

• 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.

  PMID: 28622487 BACKGROUND

• 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.

  PMID: 7604354 BACKGROUND

• 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.

  PMID: 26196127 BACKGROUND

• 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).

  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.

  PMID: 25315016 BACKGROUND

• 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.

  PMID: 29233141 BACKGROUND

• 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.

  PMID: 25454684 BACKGROUND

• 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.

  PMID: 30711003 BACKGROUND

• 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.

  PMID: 27690834 BACKGROUND

• 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.

  PMID: 27014532 BACKGROUND

• 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.

  PMID: 19251077 BACKGROUND

• 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.

  PMID: 20510644 BACKGROUND

MeSH Terms

Conditions

Whiplash Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Behavior

Study Officials

• Joan Parera-Turull, PhD.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion: October 5, 2024
• Study Completion: October 28, 2024
• Last Updated: February 7, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)