Manual Therapy Dosage Factorial Study

NCT00560807 | Withdrawn Phase 2

• 1 other identifier: 1 R21 AT004263
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Injuries

Keywords

WAD II; WAD III; mobilization; dosage; acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days; neck pain

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• 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

Study Arms (12)

A

NO INTERVENTION

Zero treatment/3 weeks

B

ACTIVE COMPARATOR

Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks

Procedure: Mobilization

C

ACTIVE COMPARATOR

Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks

Procedure: Mobilization

D

ACTIVE COMPARATOR

Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks

Procedure: Mobilization

F

ACTIVE COMPARATOR

Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks

Procedure: Mobilization

G

ACTIVE COMPARATOR

Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks

Procedure: Mobilization

H

ACTIVE COMPARATOR

Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks

Procedure: Mobilization

J

ACTIVE COMPARATOR

Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks

Procedure: Mobilization

K

ACTIVE COMPARATOR

Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks

Procedure: Mobilization

L

ACTIVE COMPARATOR

Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks

Procedure: Mobilization

E

NO INTERVENTION

Zero treatment/6 weeks

I

NO INTERVENTION

Zero treatment/12 weeks

Interventions

Mobilization PROCEDURE

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.

B; C; D; F; G; H; J; K; L

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• National Institutes of Health (NIH): collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

MeSH Terms

Conditions

Whiplash Injuries; Weyers acrofacial dysostosis; Neck Pain

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joy C MacDermid, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

CA (1)