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

NCT ID: NCT01957033

Last Updated: 2016-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Whiplash Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Duration 6 weeks, frequency 3/week

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

Group Type EXPERIMENTAL

Exercise and education 3 times/week for 6 weeks

Intervention Type BEHAVIORAL

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.

Manual therapy 3 times/week for 6 weeks

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Exercise and education twice/week for 6 weeks

Intervention Type BEHAVIORAL

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.

Manual therapy twice/week for 6 weeks

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Exercise and education once/week for 6 weeks

Intervention Type BEHAVIORAL

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

Manual therapy once/week for 6 weeks

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Exercise and education 3 times/week for 6 weeks

Intervention Type BEHAVIORAL

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.

Manual therapy 3 times/week for 3 weeks

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Exercise and education twice/week for 6 weeks

Intervention Type BEHAVIORAL

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.

Manual therapy twice/week for 3 weeks

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Exercise and education once/week for 6 weeks

Intervention Type BEHAVIORAL

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

Manual therapy once/week for 3 weeks

Intervention Type OTHER

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

Duration 0 weeks, Frequency 3 times/week

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

Group Type EXPERIMENTAL

Exercise and education 3 times/week for 6 weeks

Intervention Type BEHAVIORAL

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/week

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

Group Type EXPERIMENTAL

Exercise and education twice/week for 6 weeks

Intervention Type BEHAVIORAL

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 once/week

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

Group Type EXPERIMENTAL

Exercise and education once/week for 6 weeks

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Physiotherapy Foundation of Canada

UNKNOWN

Sponsor Role collaborator

Jordan Miller, Graduate Student

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jordan Miller, Graduate Student

Graduate student, School of Rehabilitation Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jordan D Miller, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Joy C MacDermid, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McMaster Univervisty

Hamilton, Ontario, Canada

Site Status

Lifemark Health, Hamilton

Hamilton, Ontario, Canada

Site Status

Western University

London, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-569

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rehabilitation for Whiplash Associated Disorders
NCT05319808 ACTIVE_NOT_RECRUITING NA