- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01413997
Connective Tissue Motion Measure (CTMM1)
August 9, 2011 updated by: Stromatec, Inc.
Feasibility Study of Connective Tissue Motion Measure - a Biomarker for Perimuscular Connective Tissue Pathology.
The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure (CTMM) -quantifying the functional behavior of perimuscular connective tissues.
Study Overview
Status
Completed
Conditions
Detailed Description
The differential motion between specific connective tissue strata will be measured during tissue displacement (linear oscillation) initiated by a computer-controlled needle stimulus tool (NST).
The CTMM will be suitable as an outcome measure for mechanistic and clinical studies of CAM interventions.
The CTMM also will potentially serve as a clinical diagnostic and treatment-monitoring tool for manual therapists, acupuncturists, and CAM clinicians interested in assessing the functional status of a patient's connective tissue.
Study Type
Observational
Enrollment (Actual)
39
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- Stromatec, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community Sample
Description
Inclusion criteria for LBP subjects:
- history of recurrent or chronic LBP for a minimum of 12 months
- ability to stand and walk without assistance
- ability to understand and read English
- ability to understand and sign a consent form
Inclusion criteria for No-LBP subjects:
- no history of low back pain or any other chronic pain that has limited activities of daily living or work
- a numerical current pain index of less than 0.5.
Exclusion Criteria for all subjects:
- previous severe back or low extremity injury or surgery
- major structural spinal deformity (scoliosis, kyphosis, stenosis)
- ankylosing spondylitis or rheumatoid arthritis
- neurological deficit (weakness and/or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica)
- neurological or major psychiatric disorder
- bleeding disorders
- corticosteroid or anticoagulant medication
- pregnancy
- worker's compensation or disability case
- in litigation for the LBP problem
- acute systemic infection
- BMI less than 21 or greater than 35
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Chronic Low Back Pain
|
No Low Back Pain
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
August 9, 2011
First Submitted That Met QC Criteria
August 9, 2011
First Posted (Estimate)
August 10, 2011
Study Record Updates
Last Update Posted (Estimate)
August 10, 2011
Last Update Submitted That Met QC Criteria
August 9, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ctmmp1-R43AT006085
- 1R43AT006085-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
-
Universidade Federal do PiauíFoundation for Research Support of the State of PiauíCompletedLow Back Pain, Recurrent | Chronic Low Back PainBrazil
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChronic Low Back Pain | Mechanical Low Back PainUnited States
-
University of ExtremaduraCompletedChronic Low Back Pain | Postural Low Back PainSpain
-
Université du Québec à Trois-RivièresCompletedChronic Low Back Pain | Mechanical Low Back PainCanada