search
Back to results

Manual Therapy Dosage Factorial Study

Primary Purpose

Whiplash Injuries

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Mobilization
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Injuries focused on measuring WAD II, WAD III, mobilization, dosage, acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days, neck pain

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days)
  • pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache
  • pain intensity must be at or above 30 mm on a 100 mm visual analogue scale
  • must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months.

Exclusion Criteria:

  • arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
  • conditions that make the provision of neck exercise unsafe

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

A

B

C

D

F

G

H

J

K

L

E

I

Arm Description

Zero treatment/3 weeks

Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks

Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks

Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks

Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks

Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks

Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks

Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks

Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks

Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks

Zero treatment/6 weeks

Zero treatment/12 weeks

Outcomes

Primary Outcome Measures

Quantitative Sensory Testing (QST)
Current Perception Threshold (CPT)
Neck Walk Index (NWI)
Cyclical Reach and Grasp Test (CRGT)
Muscle Biology (cytokine analyses)
Central Breathing Control Test
Neck Disability Index
Pain Intensity - Visual Analogue Scale (VAS)

Secondary Outcome Measures

Global Perceived Effect (GPE)
Disabilities of the Arm, Shoulder, and Hand (DASH)
Pain Threshold and Pain Tolerance Algometry
Head Flexion Endurance
Range of Motion
Quality of Life (SF-36v2)

Full Information

First Posted
November 19, 2007
Last Updated
September 22, 2015
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), National Institutes of Health (NIH), University of Western Ontario, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT00560807
Brief Title
Manual Therapy Dosage Factorial Study
Official Title
Manual Therapy Dosage Factorial Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped because the study never received funding
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), National Institutes of Health (NIH), University of Western Ontario, Canada

4. Oversight

5. Study Description

Brief Summary
This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology. Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. The dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect. All patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. All patient participants will receive supervised exercise and advice for the full 12 weeks. All patients will be provided with an instructional CD and exercise brochure to reinforce the whole program. Follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36). Hypothesis: During recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries
Keywords
WAD II, WAD III, mobilization, dosage, acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days, neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm Description
Zero treatment/3 weeks
Arm Title
B
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks
Arm Title
C
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks
Arm Title
D
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks
Arm Title
F
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks
Arm Title
G
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks
Arm Title
H
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks
Arm Title
J
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks
Arm Title
K
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks
Arm Title
L
Arm Type
Active Comparator
Arm Description
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks
Arm Title
E
Arm Type
No Intervention
Arm Description
Zero treatment/6 weeks
Arm Title
I
Arm Type
No Intervention
Arm Description
Zero treatment/12 weeks
Intervention Type
Procedure
Intervention Name(s)
Mobilization
Intervention Description
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Primary Outcome Measure Information:
Title
Quantitative Sensory Testing (QST)
Time Frame
Within 24 weeks
Title
Current Perception Threshold (CPT)
Time Frame
Within 24 weeks
Title
Neck Walk Index (NWI)
Time Frame
Within 24 weeks
Title
Cyclical Reach and Grasp Test (CRGT)
Time Frame
Within 24 weeks
Title
Muscle Biology (cytokine analyses)
Time Frame
Within 24 weeks
Title
Central Breathing Control Test
Time Frame
Within 24 weeks
Title
Neck Disability Index
Time Frame
Within 24 weeks
Title
Pain Intensity - Visual Analogue Scale (VAS)
Time Frame
Within 24 weeks
Secondary Outcome Measure Information:
Title
Global Perceived Effect (GPE)
Time Frame
Within 24 weeks
Title
Disabilities of the Arm, Shoulder, and Hand (DASH)
Time Frame
Within 24 weeks
Title
Pain Threshold and Pain Tolerance Algometry
Time Frame
Within 24 weeks
Title
Head Flexion Endurance
Time Frame
Within 24 weeks
Title
Range of Motion
Time Frame
Within 24 weeks
Title
Quality of Life (SF-36v2)
Time Frame
within 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days) pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache pain intensity must be at or above 30 mm on a 100 mm visual analogue scale must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months. Exclusion Criteria: arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy conditions that make the provision of neck exercise unsafe
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy C MacDermid, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1C7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Manual Therapy Dosage Factorial Study

We'll reach out to this number within 24 hrs