Manual Therapy Dosage Factorial Study

This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology.

Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. The dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect.

All patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. All patient participants will receive supervised exercise and advice for the full 12 weeks. All patients will be provided with an instructional CD and exercise brochure to reinforce the whole program.

Follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).

Hypothesis: During recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.

Study Overview

• Status: Withdrawn
• Conditions: Whiplash Injuries
• Intervention / Treatment: Procedure: Mobilization

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1C7
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days)
• pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache
• pain intensity must be at or above 30 mm on a 100 mm visual analogue scale
• must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months.

Exclusion Criteria:

• arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
• conditions that make the provision of neck exercise unsafe

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A; Zero treatment/3 weeks
Active Comparator: B; Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Active Comparator: C; Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Active Comparator: D; Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Active Comparator: F; Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Active Comparator: G; Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Active Comparator: H; Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Active Comparator: J; Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Active Comparator: K; Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Active Comparator: L; Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks	Procedure: Mobilization; Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
No Intervention: E; Zero treatment/6 weeks
No Intervention: I; Zero treatment/12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantitative Sensory Testing (QST)	Within 24 weeks
Current Perception Threshold (CPT)	Within 24 weeks
Neck Walk Index (NWI)	Within 24 weeks
Cyclical Reach and Grasp Test (CRGT)	Within 24 weeks
Muscle Biology (cytokine analyses)	Within 24 weeks
Central Breathing Control Test	Within 24 weeks
Neck Disability Index	Within 24 weeks
Pain Intensity - Visual Analogue Scale (VAS)	Within 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Global Perceived Effect (GPE)	Within 24 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH)	Within 24 weeks
Pain Threshold and Pain Tolerance Algometry	Within 24 weeks
Head Flexion Endurance	Within 24 weeks
Range of Motion	Within 24 weeks
Quality of Life (SF-36v2)	within 24 weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); National Institutes of Health (NIH); University of Western Ontario, Canada
• Investigators: Principal Investigator: Joy C MacDermid, PhD, McMaster University

Study record dates

Study Registration Dates

• First Submitted: November 19, 2007
• First Submitted That Met QC Criteria: November 19, 2007
• First Posted (Estimate): November 20, 2007

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: neck pain; dosage; mobilization; WAD II; WAD III; acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days
• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries; Whiplash Injuries
• Other Study ID Numbers: 1 R21 AT004263