Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study
- Conditions
- Whiplash Injuries
- Interventions
- Behavioral: Exercise and education twice/week for 6 weeksBehavioral: Exercise and education 3 times/week for 6 weeksBehavioral: Exercise and education once/week for 6 weeksOther: Manual therapy 3 times/week for 6 weeksOther: Manual therapy twice/week for 3 weeksOther: Manual therapy once/week for 6 weeksOther: Manual therapy 3 times/week for 3 weeksOther: Manual therapy twice/week for 6 weeksOther: Manual therapy once/week for 3 weeks
- Registration Number
- NCT01957033
- Lead Sponsor
- Jordan Miller, Graduate Student
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Duration 6 weeks, frequency 3/week Manual therapy 3 times/week for 6 weeks Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for 6 weeks Duration 3 weeks, Frequency twice/week Manual therapy twice/week for 3 weeks Exercise and education twice/week for 6 weeks Manual therapy twice/week for first 3 weeks Duration 0 weeks, Frequency twice/week Exercise and education twice/week for 6 weeks Exercise and education twice/week for 6 weeks. No manual therapy Duration 6 weeks, Frequency twice/week Exercise and education twice/week for 6 weeks Exercise and education twice/week for 6 weeks Manual therapy twice/week for 6 weeks Duration 6 weeks, frequency 3/week Exercise and education 3 times/week for 6 weeks Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for 6 weeks Duration 6 weeks, Frequency once/week Manual therapy once/week for 6 weeks Exercise and education once/week for 6 weeks Manual therapy once/week for first 6 weeks Duration 3 weeks, Frequency 3 times/week Exercise and education 3 times/week for 6 weeks Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for first 3 weeks Duration 0 weeks, Frequency 3 times/week Exercise and education 3 times/week for 6 weeks Exercise and education 3 times/week for 6 weeks No manual therapy Duration 3 weeks, Frequency 3 times/week Manual therapy 3 times/week for 3 weeks Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for first 3 weeks Duration 3 weeks, Frequency twice/week Exercise and education twice/week for 6 weeks Exercise and education twice/week for 6 weeks Manual therapy twice/week for first 3 weeks Duration 0 weeks, Frequency once/week Exercise and education once/week for 6 weeks Exercise and education once/week for 6 weeks No manual therapy Duration 6 weeks, Frequency twice/week Manual therapy twice/week for 6 weeks Exercise and education twice/week for 6 weeks Manual therapy twice/week for 6 weeks Duration 6 weeks, Frequency once/week Exercise and education once/week for 6 weeks Exercise and education once/week for 6 weeks Manual therapy once/week for first 6 weeks Duration 3 weeks, frequency once/week Exercise and education once/week for 6 weeks Exercise and education once/week for 6 weeks Manual therapy once/week for first 3 weeks Duration 3 weeks, frequency once/week Manual therapy once/week for 3 weeks Exercise and education once/week for 6 weeks Manual therapy once/week for first 3 weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
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).
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)
Trial Locations
- Locations (3)
McMaster Univervisty
🇨🇦Hamilton, Ontario, Canada
Lifemark Health, Hamilton
🇨🇦Hamilton, Ontario, Canada
Western University
🇨🇦London, Ontario, Canada