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

Whiplash Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957033
• Other study ID #: 13-569
• Status: Completed
• Phase: N/A
• First received: September 29, 2013
• Last updated: September 12, 2016
• Start date: October 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain
• Whiplash Injuries

Intervention

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
• 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.
• 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 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Lifemark Health, Hamilton	Hamilton	Ontario
Canada	McMaster Univervisty	Hamilton	Ontario
Canada	Western University	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Jordan Miller, Graduate Student	Physiotherapy Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	Psychophysical measures	Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)	12 weeks (end of treatment)	No
Secondary	Motor coordination	Neck Walk Index (NWI)	12 weeks (end of treatment)	No
Secondary	Health Status	Measured by SF-36	12 weeks (end of study) and 6- and 12- month follow-ups	No
Secondary	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	No
Secondary	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	No