Clinical trial NCT01957033: 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
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash Injuries
Keywords: whiplash
neck pain
manual therapy
exercise
dosage
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Physiotherapy Foundation of Canada
First posted: 2013-10-08
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Feasibility
timeFrame: 1 year
measure: Pain
timeFrame: 12 weeks (end of treatment) and 6- and 12- month follow-ups
measure: Function
timeFrame: 12 weeks (end of treatment) and 6- and 12- month follow-up
Secondary outcomes:
measure: Fidelity
timeFrame: 1 year
measure: Psychological measures
timeFrame: 12 weeks (end of treatment)
measure: Psychophysical measures
timeFrame: 12 weeks (end of treatment)
measure: Motor coordination
timeFrame: 12 weeks (end of treatment)
measure: Health Status
timeFrame: 12 weeks (end of study) and 6- and 12- month follow-ups
measure: Global perceived effect
timeFrame: 12 weeks (end of treatment) and 6- and 12-month follow-ups
measure: Upper extremity function
timeFrame: 12 weeks (end of treatment) and 6- and 12-month follow-ups
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Univervisty
state: Ontario
city: Hamilton
country: Canada
facility: Lifemark Health, Hamilton
state: Ontario
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: McMaster University
name: Jordan D Miller, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Joy C MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
References: