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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neck Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014