Manual Therapy Dosage Factorial Study

Sponsor

McMaster University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00560807

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), National Institutes of Health (NIH) (NIH), University of Western Ontario, Canada (Other)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Whiplash Injuries	Procedure: Mobilization	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Manual Therapy Dosage Factorial Study

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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