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Clinical Trials/NCT00560807
NCT00560807WithdrawnPhase 2

Manual Therapy Dosage Factorial Study

McMaster University1 site in 1 countryStarted: November 20, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Locations
1
Primary Endpoint
Quantitative Sensory Testing (QST)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

No Intervention

Zero treatment/3 weeks

B

Active Comparator

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

Intervention: Mobilization (Procedure)

C

Active Comparator

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

Intervention: Mobilization (Procedure)

D

Active Comparator

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

Intervention: Mobilization (Procedure)

F

Active Comparator

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

Intervention: Mobilization (Procedure)

G

Active Comparator

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

Intervention: Mobilization (Procedure)

H

Active Comparator

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

Intervention: Mobilization (Procedure)

J

Active Comparator

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

Intervention: Mobilization (Procedure)

K

Active Comparator

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

Intervention: Mobilization (Procedure)

L

Active Comparator

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

Intervention: Mobilization (Procedure)

E

No Intervention

Zero treatment/6 weeks

I

No Intervention

Zero treatment/12 weeks

Outcomes

Primary Outcomes

Quantitative Sensory Testing (QST)

Time Frame: Within 24 weeks

Neck Walk Index (NWI)

Time Frame: Within 24 weeks

Cyclical Reach and Grasp Test (CRGT)

Time Frame: Within 24 weeks

Muscle Biology (cytokine analyses)

Time Frame: Within 24 weeks

Central Breathing Control Test

Time Frame: Within 24 weeks

Neck Disability Index

Time Frame: Within 24 weeks

Pain Intensity - Visual Analogue Scale (VAS)

Time Frame: Within 24 weeks

Current Perception Threshold (CPT)

Time Frame: Within 24 weeks

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (1)

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