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Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

Primary Purpose

Whiplash Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise and education once/week for 6 weeks
Exercise and education twice/week for 6 weeks
Exercise and education 3 times/week for 6 weeks
Manual therapy once/week for 3 weeks
Manual therapy twice/week for 3 weeks
Manual therapy 3 times/week for 3 weeks
Manual therapy once/week for 6 weeks
Manual therapy twice/week for 6 weeks
Manual therapy 3 times/week for 6 weeks
Sponsored by
Jordan Miller, Graduate Student
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Injuries focused on measuring whiplash, neck pain, manual therapy, exercise, dosage

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults ≥ 21 years
  • main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache.
  • pain intensity must be ≥ 12/40 on the 4-item pain scale (P4).

Exclusion Criteria:

  • non-mechanical sources of neck pain or over-riding comorbidity listed below:
  • rheumatoid arthritis
  • neurological diseases
  • fractures
  • dislocation
  • rheumatoid arthritis
  • upper motor neuron dysfunction or malignancy
  • pregnant women
  • closed head injury
  • on steroid-based medications within the past 6 months.

Sites / Locations

  • McMaster Univervisty
  • Lifemark Health, Hamilton
  • Western University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Duration 6 weeks, frequency 3/week

Duration 6 weeks, Frequency twice/week

Duration 6 weeks, Frequency once/week

Duration 3 weeks, Frequency 3 times/week

Duration 3 weeks, Frequency twice/week

Duration 3 weeks, frequency once/week

Duration 0 weeks, Frequency 3 times/week

Duration 0 weeks, Frequency twice/week

Duration 0 weeks, Frequency once/week

Arm Description

Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for 6 weeks

Exercise and education twice/week for 6 weeks Manual therapy twice/week for 6 weeks

Exercise and education once/week for 6 weeks Manual therapy once/week for first 6 weeks

Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for first 3 weeks

Exercise and education twice/week for 6 weeks Manual therapy twice/week for first 3 weeks

Exercise and education once/week for 6 weeks Manual therapy once/week for first 3 weeks

Exercise and education 3 times/week for 6 weeks No manual therapy

Exercise and education twice/week for 6 weeks. No manual therapy

Exercise and education once/week for 6 weeks No manual therapy

Outcomes

Primary Outcome Measures

Feasibility
As a pilot study, the main outcome of interest is feasibility. This includes: ability to train assessors and health care providers, time it takes to complete all assessments, ability to recruit 12 patients within 1 year, and completeness of data collected.
Pain
Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.
Function
Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.

Secondary Outcome Measures

Fidelity
As a pilot study, the secondary outcome of interest is treatment fidelity. We will measure this through ability of health care providers to provide treatment at the dosage described in the protocol.
Psychological measures
Catastrophic thinking measured by Pain Catastrophizing Scale (PCS) Anxiety and Depression measured by Hospital Anxiety and Depression Scale (HADS) Psychological distress measured by Trauma Anxiety and Distress Scale (TADS)
Psychophysical measures
Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)
Motor coordination
Neck Walk Index (NWI)
Health Status
Measured by SF-36
Global perceived effect
Global perceived effect will be measured on a 7 point scale (-3 to +3)
Upper extremity function
As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH).

Full Information

First Posted
September 29, 2013
Last Updated
September 12, 2016
Sponsor
Jordan Miller, Graduate Student
Collaborators
Physiotherapy Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01957033
Brief Title
Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study
Official Title
Clinical and Biological Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jordan Miller, Graduate Student
Collaborators
Physiotherapy Foundation of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. Also, this study will help us determine the best way to measure the effect of treatment. Finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. In order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. This study will help us determine if the study protocol can be carried out as planned. This includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. This will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries
Keywords
whiplash, neck pain, manual therapy, exercise, dosage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duration 6 weeks, frequency 3/week
Arm Type
Experimental
Arm Description
Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for 6 weeks
Arm Title
Duration 6 weeks, Frequency twice/week
Arm Type
Experimental
Arm Description
Exercise and education twice/week for 6 weeks Manual therapy twice/week for 6 weeks
Arm Title
Duration 6 weeks, Frequency once/week
Arm Type
Experimental
Arm Description
Exercise and education once/week for 6 weeks Manual therapy once/week for first 6 weeks
Arm Title
Duration 3 weeks, Frequency 3 times/week
Arm Type
Experimental
Arm Description
Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for first 3 weeks
Arm Title
Duration 3 weeks, Frequency twice/week
Arm Type
Experimental
Arm Description
Exercise and education twice/week for 6 weeks Manual therapy twice/week for first 3 weeks
Arm Title
Duration 3 weeks, frequency once/week
Arm Type
Experimental
Arm Description
Exercise and education once/week for 6 weeks Manual therapy once/week for first 3 weeks
Arm Title
Duration 0 weeks, Frequency 3 times/week
Arm Type
Experimental
Arm Description
Exercise and education 3 times/week for 6 weeks No manual therapy
Arm Title
Duration 0 weeks, Frequency twice/week
Arm Type
Experimental
Arm Description
Exercise and education twice/week for 6 weeks. No manual therapy
Arm Title
Duration 0 weeks, Frequency once/week
Arm Type
Experimental
Arm Description
Exercise and education once/week for 6 weeks No manual therapy
Intervention Type
Behavioral
Intervention Name(s)
Exercise and education once/week for 6 weeks
Intervention Description
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book
Intervention Type
Behavioral
Intervention Name(s)
Exercise and education twice/week for 6 weeks
Intervention Description
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.
Intervention Type
Behavioral
Intervention Name(s)
Exercise and education 3 times/week for 6 weeks
Intervention Description
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.
Intervention Type
Other
Intervention Name(s)
Manual therapy once/week for 3 weeks
Intervention Description
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Intervention Type
Other
Intervention Name(s)
Manual therapy twice/week for 3 weeks
Intervention Description
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Intervention Type
Other
Intervention Name(s)
Manual therapy 3 times/week for 3 weeks
Intervention Description
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Intervention Type
Other
Intervention Name(s)
Manual therapy once/week for 6 weeks
Intervention Description
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Intervention Type
Other
Intervention Name(s)
Manual therapy twice/week for 6 weeks
Intervention Description
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Intervention Type
Other
Intervention Name(s)
Manual therapy 3 times/week for 6 weeks
Intervention Description
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Primary Outcome Measure Information:
Title
Feasibility
Description
As a pilot study, the main outcome of interest is feasibility. This includes: ability to train assessors and health care providers, time it takes to complete all assessments, ability to recruit 12 patients within 1 year, and completeness of data collected.
Time Frame
1 year
Title
Pain
Description
Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.
Time Frame
12 weeks (end of treatment) and 6- and 12- month follow-ups
Title
Function
Description
Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.
Time Frame
12 weeks (end of treatment) and 6- and 12- month follow-up
Secondary Outcome Measure Information:
Title
Fidelity
Description
As a pilot study, the secondary outcome of interest is treatment fidelity. We will measure this through ability of health care providers to provide treatment at the dosage described in the protocol.
Time Frame
1 year
Title
Psychological measures
Description
Catastrophic thinking measured by Pain Catastrophizing Scale (PCS) Anxiety and Depression measured by Hospital Anxiety and Depression Scale (HADS) Psychological distress measured by Trauma Anxiety and Distress Scale (TADS)
Time Frame
12 weeks (end of treatment)
Title
Psychophysical measures
Description
Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)
Time Frame
12 weeks (end of treatment)
Title
Motor coordination
Description
Neck Walk Index (NWI)
Time Frame
12 weeks (end of treatment)
Title
Health Status
Description
Measured by SF-36
Time Frame
12 weeks (end of study) and 6- and 12- month follow-ups
Title
Global perceived effect
Description
Global perceived effect will be measured on a 7 point scale (-3 to +3)
Time Frame
12 weeks (end of treatment) and 6- and 12-month follow-ups
Title
Upper extremity function
Description
As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH).
Time Frame
12 weeks (end of treatment) and 6- and 12-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults ≥ 21 years main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache. pain intensity must be ≥ 12/40 on the 4-item pain scale (P4). Exclusion Criteria: non-mechanical sources of neck pain or over-riding comorbidity listed below: rheumatoid arthritis neurological diseases fractures dislocation rheumatoid arthritis upper motor neuron dysfunction or malignancy pregnant women closed head injury on steroid-based medications within the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan D Miller, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
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 Univervisty
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1C7
Country
Canada
Facility Name
Lifemark Health, Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4P9
Country
Canada
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

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Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

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