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

Sponsor

Jordan Miller, Graduate Student (Other)

Overall Status

Completed

CT.gov ID

NCT01957033

Collaborator

Physiotherapy Foundation of Canada (Other)

Enrollment

Locations

Arms

Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Whiplash Injuries	Behavioral: Exercise and education once/week for 6 weeks Behavioral: Exercise and education twice/week for 6 weeks Behavioral: Exercise and education 3 times/week for 6 weeks Other: 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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Feasibility [1 year]
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 [12 weeks (end of treatment) and 6- and 12- month follow-ups]
Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.
Function [12 weeks (end of treatment) and 6- and 12- month follow-up]
Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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).