Manual Therapy Dosage Factorial Study

Whiplash Injuries Clinical Trial

Official title:

Manual Therapy Dosage Factorial Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00560807
• Other study ID #: 1 R21 AT004263
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: November 19, 2007
• Last updated: September 22, 2015

Study information

• Verified date: September 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Whiplash Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), National Institutes of Health (NIH), University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Sensory Testing (QST)		Within 24 weeks	No
Primary	Current Perception Threshold (CPT)		Within 24 weeks	No
Primary	Neck Walk Index (NWI)		Within 24 weeks	No
Primary	Cyclical Reach and Grasp Test (CRGT)		Within 24 weeks	No
Primary	Muscle Biology (cytokine analyses)		Within 24 weeks	No
Primary	Central Breathing Control Test		Within 24 weeks	No
Primary	Neck Disability Index		Within 24 weeks	No
Primary	Pain Intensity - Visual Analogue Scale (VAS)		Within 24 weeks	No
Secondary	Global Perceived Effect (GPE)		Within 24 weeks	No
Secondary	Disabilities of the Arm, Shoulder, and Hand (DASH)		Within 24 weeks	No
Secondary	Pain Threshold and Pain Tolerance Algometry		Within 24 weeks	No
Secondary	Head Flexion Endurance		Within 24 weeks	No
Secondary	Range of Motion		Within 24 weeks	No
Secondary	Quality of Life (SF-36v2)		within 24 weeks	No