The Effectiveness of Osteopathic Treatment in Cervical Whiplash.

NCT06334978 | Completed

• 1 other identifier: 1-2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction. Whiplash is common after road traffic accidents and affects millions of people worldwide; 50% develop chronic symptoms and 15% have their ability to work compromised. The aim of this study was to evaluate an osteopathic intervention in whiplash and determine whether pain, mobility and quality of life improve with respect to conventional treatment. Methodology. A randomised, controlled clinical trial between 13/01/2021\_10/08/2022 conducted at Hospital San Juan de Dios del Aljarafe. The control group followed the hospital's protocol, and the experimental group also received an osteopathic intervention. Statistical analysis: Statistical Package for the Social Sciences (SPSS-vs27.0); intra-subject comparison: Student's t-test for dependent samples, Wilcoxon's test; inter-group comparisons: Student's t-test for independent samples, Mann-Whitney U, chi-squared.

Conditions

Whiplash Injury of Cervical Spine; Osteopathia; Quality of Life; Chronic Pain Syndrome

Keywords

Whiplash Injury of Cervical Spine; Osteopathia; Quality of Life; Chronic pain; Functionality

Outcome Measures

Primary Outcomes (3)

• Cervical Pain

  Pain measured with the "visual analogue scale" (scale: 0-10)

  3 measurements: Just before starting the study, at 21 days and at 4 weeks.

• Quality of life in Whiplash Disability

  Quality of life measured with the Whiplash Disability Questionnaire (scale: 0-130)

  3 measurements: Just before starting the study, at 21 days and at 4 weeks.

• Functionality-Neck Disability Index

  Functionality measured with the Neck Disability Index (scale: 0-100). Each question is measured on a scale from 0 (no disability) to 5 (most disabled), and an overall score of 100 is calculated by adding the score for each item and multiplying by two. A higher NDI score means greater perceived patient disability due to neck pain. The "minimally clinically important change" by patients has been found to be 5 or 10%.

  3 measurements: Just before starting the study, at 21 days and at 4 weeks.

Secondary Outcomes (2)

• Number of sites

  4 measurements: Just before starting the study, at 7 days, at 21 days and at 4 weeks.

• Number of analgesics

  4 measurements: Just before starting the study, at 7 days, at 21 days and at 4 weeks.

Other Outcomes (2)

• Measuring mobility using inclinometry

  2 measurements: Just before starting the study, at 4 weeks

• Measurement of pressure pain using algometry

  2 measurements: Just before starting the study, at 4 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Techniques used: the dog technique in flexion, scalene muscle energy technique, Jones' first rib adjustment, first rib trust in posterior subluxation, occipitomastoid thrust, Sutherland's posterior needle-scratch, SBS decompression, semi-direct thrust for the sacrum, Sutherland's sacrum, posterior occipital condyle thrust, SBS equilibration.

Other: Osteopathic intervention

Control Group

NO INTERVENTION

Conventional treatment

Interventions

Osteopathic intervention OTHER

The experimental group received the same treatment as the control group and one osteopathic intervention per week for the 21 days of the study (days 2, 9 and 16). Each session was performed on a different day from the conventional treatment to prevent interactions. The physiotherapist performed an osteopathic assessment involving a static/dynamic inspection and palpation and other osteopathic tests: Mitchell test, Quick Scanning, standing flexion (Piedallu) test, Gillet test, sphenobasilar synchondrosis (SBS) test, sutural palpation test and diaphragm test. Techniques used: the dog technique in flexion, scalene muscle energy technique, Jones' first rib adjustment, first rib trust in posterior subluxation, occipitomastoid thrust, Sutherland's posterior needle-scratch, SBS decompression, semi-direct thrust for the sacrum, Sutherland's sacrum, posterior occipital condyle thrust, SBS equilibration.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients diagnosed with WAD grade II (Quebec classification),
• aged between 18 and 55 years,
• who started physiotherapy treatment less than 10 days prior to joining the trial,
• and who agreed to join the trial and provided informed consent.

You may not qualify if:

• Patients with a history of neck pain in the previous three months (other than the whiplash),
• or with a prior history of WAD,
• or who had previously received osteopathic treatment for WAD,
• Pregnant women,
• patients suspected to be simulating or exaggerating their symptoms for financial reasons,
• those who presented difficulties carrying out the evaluation correctly due to their culture or a language barrier.
• Patients with a history of chest, head or upper limb surgery,
• those diagnosed with a neurological condition (such as congenital or diabetic polyneuritis, or any neurological condition),
• or rheumatic alterations (such as osteoarthritis, arthritis, ankylosing spondylitis, etc.),
• or malformations or surgical interventions that prevented correct conduct of the evaluation test
• and/or contraindications for the application of osteopathic and/or conventional treatment.

Sponsors & Collaborators

• Hospital San Juan de Dios del Aljarafe de Sevilla: lead
• Hospital Universitario Virgen Macarena: collaborator
• University of Seville: collaborator

Study Sites (1)

María Victoria RUIZ ROMERO

Bollullos de la Mitación, Sevilla, 41110, Spain

Location

MeSH Terms

Conditions

Bone Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• José Larios Ortega, Graduate

  Physiotherapy Unit. Rehabilitation Service. Hospital San Juan de Dios del Aljarafe.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was blinded: patients were unaware of the group to which they had been assigned. Patient evaluations at the start and end were performed by a physiotherapist different to the one performing the intervention, who was also unaware of the patient assignment. The same person performed all therapies for both the control and intervention groups and was unaware of the pre-intervention measurements. The statistician who analysed the data was also unaware of the group to which each patient belonged.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled clinical trial

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 28, 2024
• Study Start: January 13, 2021
• Primary Completion: July 10, 2022
• Study Completion: August 10, 2022
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)