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Manual Therapy to Treat Acute Whiplash Injury

Primary Purpose

Whiplash Injuries

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy Protocol
Two manual techniques
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Injuries focused on measuring Cervical spine, Neck pain, Manual therapy, Controlled clinical trial

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adelaida María Castro-Sánchez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Therapy Protocol

Two manual techniques

Arm Description

A protocol with five techniques on thoracic area applied twice a week.

Two manual therapies on thoracic area applied twice a week.

Outcomes

Primary Outcome Measures

Change on Numerical Pain Rating Scale
The numerical pain rating scale is used to record the patient´s current level of neck pain.

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2013
Last Updated
September 22, 2013
Sponsor
Universidad de Almeria
Collaborators
Universidad de Granada, Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT01825460
Brief Title
Manual Therapy to Treat Acute Whiplash Injury
Official Title
Short-Term Effects of a Manual Therapy Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
Collaborators
Universidad de Granada, Universidad Rey Juan Carlos

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries
Keywords
Cervical spine, Neck pain, Manual therapy, Controlled clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy Protocol
Arm Type
Experimental
Arm Description
A protocol with five techniques on thoracic area applied twice a week.
Arm Title
Two manual techniques
Arm Type
Active Comparator
Arm Description
Two manual therapies on thoracic area applied twice a week.
Intervention Type
Other
Intervention Name(s)
Manual Therapy Protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Two manual techniques
Intervention Description
The two manual techniques applied to control group are: inhibition for phrenic center and neuromuscular technique.
Primary Outcome Measure Information:
Title
Change on Numerical Pain Rating Scale
Description
The numerical pain rating scale is used to record the patient´s current level of neck pain.
Time Frame
At baseline and 2 weeks
Secondary Outcome Measure Information:
Title
Neck disability index
Description
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.
Time Frame
At baseline and 2 weeks
Title
Cervical Range of Motion
Description
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.
Time Frame
At baseline and 2 weeks
Title
Tampa scale for kinesiophobia
Description
The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.
Time Frame
At baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida M Castro-Sánchez, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Study Director
Facility Information:
Facility Name
Adelaida María Castro-Sánchez
City
Almeria
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23465963
Citation
Elliott JM, Kerry R, Flynn T, Parrish TB. Content not quantity is a better measure of muscle degeneration in whiplash. Man Ther. 2013 Dec;18(6):578-82. doi: 10.1016/j.math.2013.02.002. Epub 2013 Mar 5.
Results Reference
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PubMed Identifier
23432939
Citation
Smith J, Bolton PS. What are the clinical criteria justifying spinal manipulative therapy for neck pain?- a systematic review of randomized controlled trials. Pain Med. 2013 Apr;14(4):460-8. doi: 10.1111/pme.12041. Epub 2013 Feb 22.
Results Reference
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PubMed Identifier
23295018
Citation
Humphreys BK, Peterson C. Comparison of outcomes in neck pain patients with and without dizziness undergoing chiropractic treatment: a prospective cohort study with 6 month follow-up. Chiropr Man Therap. 2013 Jan 7;21(1):3. doi: 10.1186/2045-709X-21-3.
Results Reference
background
PubMed Identifier
23115473
Citation
Isabel de-la-Llave-Rincon A, Puentedura EJ, Fernandez-de-Las-Penas C. Clinical presentation and manual therapy for upper quadrant musculoskeletal conditions. J Man Manip Ther. 2011 Nov;19(4):201-11. doi: 10.1179/106698111X13129729551985.
Results Reference
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PubMed Identifier
22959229
Citation
Pedler A, Motlagh H, Sterling M. Laterality judgments are not impaired in patients with chronic whiplash associated disorders. Man Ther. 2013 Feb;18(1):72-6. doi: 10.1016/j.math.2012.07.006. Epub 2012 Sep 5.
Results Reference
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PubMed Identifier
22947552
Citation
Stone AM, Vicenzino B, Lim EC, Sterling M. Measures of central hyperexcitability in chronic whiplash associated disorder--a systematic review and meta-analysis. Man Ther. 2013 Apr;18(2):111-7. doi: 10.1016/j.math.2012.07.009. Epub 2012 Sep 1.
Results Reference
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PubMed Identifier
22464187
Citation
Goldsmith R, Wright C, Bell SF, Rushton A. Cold hyperalgesia as a prognostic factor in whiplash associated disorders: a systematic review. Man Ther. 2012 Oct;17(5):402-10. doi: 10.1016/j.math.2012.02.014. Epub 2012 Mar 29.
Results Reference
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PubMed Identifier
21955671
Citation
Oddsdottir GL, Kristjansson E. Two different courses of impaired cervical kinaesthesia following a whiplash injury. A one-year prospective study. Man Ther. 2012 Feb;17(1):60-5. doi: 10.1016/j.math.2011.08.009. Epub 2011 Sep 28.
Results Reference
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PubMed Identifier
21796089
Citation
Picelli A, Ledro G, Turrina A, Stecco C, Santilli V, Smania N. Effects of myofascial technique in patients with subacute whiplash associated disorders: a pilot study. Eur J Phys Rehabil Med. 2011 Dec;47(4):561-8. Epub 2011 Jul 28.
Results Reference
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PubMed Identifier
21406332
Citation
Verhagen AP, Lewis M, Schellingerhout JM, Heymans MW, Dziedzic K, de Vet HC, Koes BW. Do whiplash patients differ from other patients with non-specific neck pain regarding pain, function or prognosis? Man Ther. 2011 Oct;16(5):456-62. doi: 10.1016/j.math.2011.02.009. Epub 2011 Mar 13.
Results Reference
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PubMed Identifier
21367648
Citation
Stokell R, Yu A, Williams K, Treleaven J. Dynamic and functional balance tasks in subjects with persistent whiplash: a pilot trial. Man Ther. 2011 Aug;16(4):394-8. doi: 10.1016/j.math.2011.01.012. Epub 2011 Mar 1.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Manual Therapy to Treat Acute Whiplash Injury

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