Extending Ultrasound Elastography to Manual Treatment Methods

NCT01221155 | Completed

• 1 other identifier: 72152
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Manual treatment offers benefit to some patients suffering from back pain but little is known about which of the many tissue layers are affected. This study will help identify which tissues may be stimulated sufficiently to be a source for the clinical effects of treatment and to prioritize future work to understand mechanisms of back pain and to improve care. Current soft-tissue ultrasound elastography techniques, under static condition, will be extended to quantify relative displacement and strains(active and passive)across the depth of tissue strata that arise from small amplitude motions during continuous passive motion clinical procedures and in weight bearing postures. Relative movement of the stratified layers of the back, from treatment and task-generated perturbations, will enable the elastography interrogation of the tissue.

Conditions

Back Pain

Keywords

Musculoskeletal

Outcome Measures

Primary Outcomes (3)

• The quantitative tissue displacement and strains.

  These parameters may be considered as total cumulative displacement and strain over the recording interval or smaller epochs sequentially over time. After analysis completion, power and effect sizes will be calculated for the various parameters being studied. In cases where statistical power is found to be insufficient, calculation for appropriate sample size estimates will be compiled to guide future work. Secondary analyses will explore linear vs non-linear representations of the data. The best fit of linear/nonlinear correlations will be used to describe all muscle relationships.

  baseline and 6 weeks

• Timing of change in the relative myoelectric activity.

  These parameters may be considered as total cumulative displacement and strain over the recording interval or smaller epochs sequentially over time. After analysis completion, power and effect sizes will be calculated for the various parameters being studied. In cases where statistical power is found to be insufficient, calculation for appropriate sample size estimates will be compiled to guide future work. Secondary analyses will explore linear vs non-linear representations of the data. The best fit of linear/nonlinear correlations will be used to describe all muscle relationships.

  baseline and 6 weeks

• Strain ratio in the context of a series of motions in upright/recumbent postures and in healthy/chronic low back pain volunteers.

  These parameters may be considered as total cumulative displacement and strain over the recording interval or smaller epochs sequentially over time. After analysis completion, power and effect sizes will be calculated for the various parameters being studied. In cases where statistical power is found to be insufficient, calculation for appropriate sample size estimates will be compiled to guide future work. Secondary analyses will explore linear vs non-linear representations of the data. The best fit of linear/nonlinear correlations will be used to describe all muscle relationships.

  baseline and 6 weeks

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Group 1: Fifteen healthy volunteers from Canadian Memorial Chiropractic College (CMCC) community. Group 2: 30 Subjects (15 healthy volunteers and 15 chronic low back pain)

You may qualify if:

• years old
• a clean history
• no episode of disabling back pain
• no episode of disabling leg pain
• no episode within the prior 90 days will be required Back Pain Subjects
• experiencing continuous episodes of low back pain within the prior 90 days
• experiencing recurring episodes of low back pain within the prior 90 days
• have pain at \>3.0 on Visual Analogue Scale

You may not qualify if:

• history of diabetes
• history of neuromuscular disease
• history of scoliosis apparent on inspection
• a bleeding disorder
• collagen vascular disease
• corticosteroid therapy
• extensive scarring or dermatological abnormalities, including adhesive tape sensitivity
• women who are pregnant or have active menstruation will be excluded to avoid positional discomfort.
• pain radiating below the knee or loss of motor, bowel or bladder control
• Volunteers taking anti-inflammatory or antihistamine medications will be asked to discontinue their use 3 days before testing.

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead

Study Sites (1)

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John J. Triano, DC, PhD

  Canadian Memorial Chiropractic College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: October 14, 2010
• Study Start: December 1, 2007
• Study Completion: December 1, 2011
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

CA (1)