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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by McMaster University
Sponsor:
Collaborator:
Physiotherapy Foundation of Canada
Information provided by (Responsible Party):
Jordan Miller, Graduate Student, McMaster University
ClinicalTrials.gov Identifier:
NCT01957033
First received: September 29, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Whiplash Injuries
Behavioral: Exercise and education once/week for 12 weeks
Behavioral: Exercise and education twice/week for 12 weeks
Behavioral: Exercise and education 3 times/week for 12 weeks
Procedure: Manual therapy once/week for 3 weeks
Other: Manual therapy twice/week for 3 weeks
Other: Manual therapy 3 times/week for 3 weeks
Other: Manual therapy once/week for 6 weeks
Other: Manual therapy twice/week for 6 weeks
Other: Manual therapy 3 times/week for 6 weeks
Other: Manual therapy once/week for 12 weeks
Other: Manual therapy twice/week for 12 weeks
Other: Manual therapy 3 times/week for 12 weeks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Biological Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks (end of treatment) and 6- and 12- month follow-ups ] [ Designated as safety issue: No ]
    Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.

  • Function [ Time Frame: 12 weeks (end of treatment) and 6- and 12- month follow-up ] [ Designated as safety issue: No ]
    Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.


Secondary Outcome Measures:
  • Fidelity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks (end of treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks (end of treatment) ] [ Designated as safety issue: No ]
    Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)

  • Motor coordination [ Time Frame: 12 weeks (end of treatment) ] [ Designated as safety issue: No ]
    Neck Walk Index (NWI)

  • Health Status [ Time Frame: 12 weeks (end of study) and 6- and 12- month follow-ups ] [ Designated as safety issue: No ]
    Measured by SF-36

  • Global perceived effect [ Time Frame: 12 weeks (end of treatment) and 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
    Global perceived effect will be measured on a 7 point scale (-3 to +3)

  • Upper extremity function [ Time Frame: 12 weeks (end of treatment) and 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
    As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH).


Estimated Enrollment: 12
Study Start Date: October 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duration 12 weeks, frequency 3/week
Exercise and education 3 times/week for 12 weeks Manual therapy 3 times/week for 12 weeks
Behavioral: Exercise and education 3 times/week for 12 weeks
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.
Other: Manual therapy 3 times/week for 12 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 12 weeks, Frequency twice/week
Exercise and education twice/week for 12 weeks Manual therapy twice/week for first 9 weeks
Behavioral: Exercise and education twice/week for 12 weeks
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.
Other: Manual therapy twice/week for 12 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 12 weeks, Frequency once/week
Exercise and education once/week for 12 weeks Manual therapy once/week for first 9 weeks
Behavioral: Exercise and education once/week for 12 weeks
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
Other: Manual therapy once/week for 12 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 6 weeks, Frequency 3 times/week
Exercise and education 3 times/week for 12 weeks Manual therapy 3 times/week for first 6 weeks
Behavioral: Exercise and education 3 times/week for 12 weeks
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.
Other: Manual therapy 3 times/week for 6 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 6 weeks, Frequency twice/week
Exercise and education twice/week for 12 weeks Manual therapy twice/week for first 6 weeks
Behavioral: Exercise and education twice/week for 12 weeks
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.
Other: Manual therapy twice/week for 6 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 6 weeks, frequency once/week
Exercise and education once/week for 12 weeks Manual therapy once/week for first 6 weeks
Behavioral: Exercise and education once/week for 12 weeks
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
Other: Manual therapy once/week for 6 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 3 weeks, Frequency 3 times/week
Exercise and education 3 times/week for 12 weeks Manual therapy 3 times/week for first 3 weeks
Behavioral: Exercise and education 3 times/week for 12 weeks
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.
Other: Manual therapy 3 times/week for 3 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 3 weeks, Frequency twice/week
Exercise and education twice/week for 12 weeks Manual therapy twice/week for first 3 weeks
Behavioral: Exercise and education twice/week for 12 weeks
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.
Other: Manual therapy twice/week for 3 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 3 weeks, Frequency once/week
Exercise and education once/week for 12 weeks Manual therapy once/week for first 3 weeks
Behavioral: Exercise and education once/week for 12 weeks
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
Procedure: Manual therapy once/week for 3 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Experimental: Duration 0 weeks, Frequency 3 times/week
Exercise and education 3 times/week for 12 weeks No manual therapy
Behavioral: Exercise and education 3 times/week for 12 weeks
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.
Experimental: Duration 0 weeks, Frequency twice/week
Exercise and education twice/week for 12 weeks. No manual therapy
Behavioral: Exercise and education twice/week for 12 weeks
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.
Experimental: Duration 0 weeks, Frequency once/week
Exercise and education once/week for 12 weeks No manual therapy
Behavioral: Exercise and education once/week for 12 weeks
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults ≥ 21 years
  • new episode of neck pain
  • whiplash mechanism of injury
  • symptom duration of ≤ 90 days.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957033

Contacts
Contact: Jordan Miller 905-872-9938 millerjd@mcmaster.ca
Contact: Margaret Lomotan 905-525-9140 ext 27328 lomotam@mcmaster.ca

Locations
Canada, Ontario
Lifemark Health, Hamilton Recruiting
Hamilton, Ontario, Canada, L8S 4P9
Contact: Anita Gross, MSc    905-577-0098    grossa@sympatico.ca   
Principal Investigator: Anita R Gross, MSc         
McMaster Univervisty Recruiting
Hamilton, Ontario, Canada, L8S 1C7
Contact: Jordan Miller    905-872-9938    millerjd@mcmaster.ca   
Contact: Margaret Lomotan    905-525-9140 ext 27328    lomotam@mcmaster.ca   
Principal Investigator: Jordan Miller         
Western University Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David Walton    519 661-2111 ext 80145    dwalton5@uwo.ca   
Principal Investigator: David Walton         
Sponsors and Collaborators
Jordan Miller, Graduate Student
Physiotherapy Foundation of Canada
Investigators
Principal Investigator: Jordan D Miller, MSc McMaster University
Principal Investigator: Joy C MacDermid, PhD McMaster University
  More Information

No publications provided

Responsible Party: Jordan Miller, Graduate Student, Graduate student, School of Rehabilitation Science, McMaster University
ClinicalTrials.gov Identifier: NCT01957033     History of Changes
Other Study ID Numbers: 13-569
Study First Received: September 29, 2013
Last Updated: April 16, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
whiplash
neck pain
manual therapy
exercise
dosage

Additional relevant MeSH terms:
Neck Pain
Whiplash Injuries
Neck Injuries
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014