Manual Therapy to Treat Acute Whiplash Injury

This study has been completed.
Sponsor:
Collaborators:
Universidad de Granada
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
Adelaida María Castro-Sánchez, Universidad de Almeria
ClinicalTrials.gov Identifier:
NCT01825460
First received: March 27, 2013
Last updated: September 22, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine the short-term effects of a manual therapy protocol on pain, disability and cervical range of motion in individuals with acute whiplash injury.


Condition Intervention
Whiplash Injuries
Other: Manual Therapy Protocol
Other: Two manual techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-Term Effects of a Manual Therapy Protocol

Resource links provided by NLM:


Further study details as provided by Universidad de Almeria:

Primary Outcome Measures:
  • Change on Numerical Pain Rating Scale [ Time Frame: At baseline and 2 weeks ] [ Designated as safety issue: No ]
    The numerical pain rating scale is used to record the patient´s current level of neck pain.


Secondary Outcome Measures:
  • Neck disability index [ Time Frame: At baseline and 2 weeks ] [ Designated as safety issue: No ]
    The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache.

  • Cervical Range of Motion [ Time Frame: At baseline and 2 weeks ] [ Designated as safety issue: No ]
    Cervical range of motion is assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90º of flexion, and buttocks positioned against the back of the chair.

  • Tampa scale for kinesiophobia [ Time Frame: At baseline and 2 weeks ] [ Designated as safety issue: No ]
    The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.


Enrollment: 60
Study Start Date: April 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual Therapy Protocol
A protocol with five techniques on thoracic area applied twice a week.
Other: Manual Therapy Protocol
The manual therapy protocol consists in the application of the following techniques: stretching diaphragm, Inhibition for phrenic center, Neuromuscular technique, technique jones and balance technique functional.
Active Comparator: Two manual techniques
Two manual therapies on thoracic area applied twice a week.
Other: Two manual techniques
The two manual techniques applied to control group are: inhibition for phrenic center and neuromuscular technique.

Detailed Description:

Design: Randomized clinical trial. Objectives: to determine the short-term effects of a a manual therapy protocol on pain, disability and cervical range of motion in individuals with acute whiplash injury.

Methods and measures: sixty patients will be randomly assigned to 1 of 2 groups: the experimental group received a manual therapy protocol and the placebo group received two manual therapy techniques. Neck pain, disability and cervical range of motion data will be collected at baseline and 24-hr after the last manual therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome variable.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To met Quebec Task Force Classification of WAD II- neck pain symptoms and musculoskeletal signs.
  • No evidence of conduction loss on clinical neurological examination.

Exclusion Criteria:

  • Concussion during the motor vehicle accident.
  • Loss of consciousness.
  • Head or upper quadrant injury during the accident.
  • Sought treatment prior to their accident for neck pain.
  • A previous history of whiplash
  • Neck pain
  • Headaches
  • Psychiatric or psychologic condition
  • Neurologic or circulatory disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01825460

Locations
Spain
Adelaida María Castro-Sánchez
Almeria, Spain, 04120
Sponsors and Collaborators
Universidad de Almeria
Universidad de Granada
Universidad Rey Juan Carlos
Investigators
Study Director: Adelaida M Castro-Sánchez, PhD University of Almeria
  More Information

Publications:

Responsible Party: Adelaida María Castro-Sánchez, PhD (Lecturer), Universidad de Almeria
ClinicalTrials.gov Identifier: NCT01825460     History of Changes
Other Study ID Numbers: UAL-326
Study First Received: March 27, 2013
Last Updated: September 22, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Universidad de Almeria:
Cervical spine
Neck pain
Manual therapy
Controlled clinical trial

Additional relevant MeSH terms:
Whiplash Injuries
Wounds and Injuries
Neck Injuries

ClinicalTrials.gov processed this record on April 16, 2014