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

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

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.

Study Overview

• Status: Completed
• Conditions: Whiplash Injuries
• Intervention / Treatment: Behavioral: Exercise and education 3 times/week for 6 weeks; Other: Manual therapy 3 times/week for 6 weeks; Behavioral: Exercise and education twice/week for 6 weeks; Other: Manual therapy twice/week for 6 weeks; Behavioral: Exercise and education once/week for 6 weeks; Other: Manual therapy once/week for 6 weeks; Other: Manual therapy 3 times/week for 3 weeks; Other: Manual therapy twice/week for 3 weeks; Other: Manual therapy once/week for 3 weeks

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1C7
      • McMaster Univervisty
    • Hamilton, Ontario, Canada, L8S 4P9
      • Lifemark Health, Hamilton
    • London, Ontario, Canada, N6A 4L6
      • Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duration 6 weeks, frequency 3/week; 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 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 6 weeks Manual therapy twice/week for 6 weeks	Behavioral: Exercise and education twice/week for 6 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 6 weeks Manual therapy once/week for first 6 weeks	Behavioral: Exercise and education once/week for 6 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 6 weeks Manual therapy 3 times/week for first 3 weeks	Behavioral: Exercise and education 3 times/week for 6 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 6 weeks Manual therapy twice/week for first 3 weeks	Behavioral: Exercise and education twice/week for 6 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 6 weeks Manual therapy once/week for first 3 weeks	Behavioral: Exercise and education once/week for 6 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 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 6 weeks No manual therapy	Behavioral: Exercise and education 3 times/week for 6 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 6 weeks. No manual therapy	Behavioral: Exercise and education twice/week for 6 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 6 weeks No manual therapy	Behavioral: Exercise and education once/week for 6 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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)	12 weeks (end of treatment)
Psychophysical measures	Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)	12 weeks (end of treatment)
Motor coordination	Neck Walk Index (NWI)	12 weeks (end of treatment)
Health Status	Measured by SF-36	12 weeks (end of study) and 6- and 12- month follow-ups
Global perceived effect	Global perceived effect will be measured on a 7 point scale (-3 to +3)	12 weeks (end of treatment) and 6- and 12-month follow-ups
Upper extremity function	As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH).	12 weeks (end of treatment) and 6- and 12-month follow-ups

Collaborators and Investigators

• Sponsor: Jordan Miller, Graduate Student
• Collaborators: Physiotherapy Foundation of Canada
• Investigators: Principal Investigator: Joy C MacDermid, PhD, McMaster University; Principal Investigator: Jordan D Miller, MSc, McMaster University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 29, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: exercise; neck pain; manual therapy; whiplash; dosage
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Neck Injuries; Neck Pain; Whiplash Injuries
• Other Study ID Numbers: 13-569