Manual Therapy to Treat Acute Whiplash Injury

Sponsor
Universidad de Almeria (Other)
Overall Status
Completed
CT.gov ID
NCT01825460
Collaborator
Universidad de Granada (Other), Universidad Rey Juan Carlos (Other)
60
1
2
5
11.9

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Manual Therapy Protocol
  • Other: Two manual techniques
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Short-Term Effects of a Manual Therapy Protocol
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Change on Numerical Pain Rating Scale [At baseline and 2 weeks]

    The numerical pain rating scale is used to record the patient´s current level of neck pain.

Secondary Outcome Measures

  1. Neck disability index [At baseline and 2 weeks]

    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.

  2. Cervical Range of Motion [At baseline and 2 weeks]

    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.

  3. Tampa scale for kinesiophobia [At baseline and 2 weeks]

    The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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, Universidad de Almeria

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Adelaida María Castro-Sánchez, PhD (Lecturer), Universidad de Almeria
ClinicalTrials.gov Identifier:
NCT01825460
Other Study ID Numbers:
  • UAL-326
First Posted:
Apr 5, 2013
Last Update Posted:
Sep 24, 2013
Last Verified:
May 1, 2013
Keywords provided by Adelaida María Castro-Sánchez, PhD (Lecturer), Universidad de Almeria
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2013