NCT01957033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

September 29, 2013

Last Update Submit

September 12, 2016

Conditions

Whiplash Injuries

Keywords

whiplashneck painmanual therapyexercisedosage

Outcome Measures

Primary Outcomes (3)

  • 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.

    1 year

  • Pain

    Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.

    12 weeks (end of treatment) and 6- and 12- month follow-ups

  • Function

    Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.

    12 weeks (end of treatment) and 6- and 12- month follow-up

Secondary Outcomes (7)

  • Fidelity

    1 year

  • Psychological measures

    12 weeks (end of treatment)

  • Psychophysical measures

    12 weeks (end of treatment)

  • Motor coordination

    12 weeks (end of treatment)

  • Health Status

    12 weeks (end of study) and 6- and 12- month follow-ups

  • +2 more secondary outcomes

Study Arms (9)

Duration 6 weeks, frequency 3/week

EXPERIMENTAL

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

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

Duration 6 weeks, Frequency twice/week

EXPERIMENTAL

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

Behavioral: Exercise and education twice/week for 6 weeksOther: Manual therapy twice/week for 6 weeks

Duration 6 weeks, Frequency once/week

EXPERIMENTAL

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

Behavioral: Exercise and education once/week for 6 weeksOther: Manual therapy once/week for 6 weeks

Duration 3 weeks, Frequency 3 times/week

EXPERIMENTAL

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

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

Duration 3 weeks, Frequency twice/week

EXPERIMENTAL

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

Behavioral: Exercise and education twice/week for 6 weeksOther: Manual therapy twice/week for 3 weeks

Duration 3 weeks, frequency once/week

EXPERIMENTAL

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

Behavioral: Exercise and education once/week for 6 weeksOther: Manual therapy once/week for 3 weeks

Duration 0 weeks, Frequency 3 times/week

EXPERIMENTAL

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

Behavioral: Exercise and education 3 times/week for 6 weeks

Duration 0 weeks, Frequency twice/week

EXPERIMENTAL

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

Behavioral: Exercise and education twice/week for 6 weeks

Duration 0 weeks, Frequency once/week

EXPERIMENTAL

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

Behavioral: Exercise and education once/week for 6 weeks

Interventions

Exercise and education once/week for 6 weeksBEHAVIORAL

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

Duration 0 weeks, Frequency once/weekDuration 3 weeks, frequency once/weekDuration 6 weeks, Frequency once/week
Exercise and education twice/week for 6 weeksBEHAVIORAL

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.

Duration 0 weeks, Frequency twice/weekDuration 3 weeks, Frequency twice/weekDuration 6 weeks, Frequency twice/week
Exercise and education 3 times/week for 6 weeksBEHAVIORAL

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.

Duration 0 weeks, Frequency 3 times/weekDuration 3 weeks, Frequency 3 times/weekDuration 6 weeks, frequency 3/week
Manual therapy once/week for 3 weeksOTHER

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Duration 3 weeks, frequency once/week
Manual therapy twice/week for 3 weeksOTHER

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Duration 3 weeks, Frequency twice/week
Manual therapy 3 times/week for 3 weeksOTHER

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Duration 3 weeks, Frequency 3 times/week
Manual therapy once/week for 6 weeksOTHER

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Duration 6 weeks, Frequency once/week
Manual therapy twice/week for 6 weeksOTHER

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Duration 6 weeks, Frequency twice/week
Manual therapy 3 times/week for 6 weeksOTHER

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Duration 6 weeks, frequency 3/week

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McMaster Univervisty

Hamilton, Ontario, L8S 1C7, Canada

Location

Lifemark Health, Hamilton

Hamilton, Ontario, L8S 4P9, Canada

Location

Western University

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Whiplash InjuriesNeck PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jordan D Miller, MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Joy C MacDermid, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate student, School of Rehabilitation Science

Study Record Dates

First Submitted

September 29, 2013

First Posted

October 8, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2015

Study Completion

September 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

CA(3)