Chronic Low Back Pain Clinical Trial
Official title:
Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Paraspinal Muscle and Thoracolumbar Fascia in Chronic Low Back Pain Adults Assessed by Elastography, Ultrasonography and Myometry
NCT number | NCT04830566 |
Other study ID # | 2021-3572 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 19, 2021 |
Est. completion date | July 15, 2022 |
Verified date | October 2022 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. As it is richly endowed with pain receptors, the thoracolumbar fascia could therefore be a key contributor to this chronic pain condition. Myofascial techniques (MFTs) are commonly used in manual therapy by practitioners of various backgrounds to address fascia biomechanical properties, but there is a paucity of objective evidence on their effects on tissue state. Musculoskeletal ultrasonography, sonoelastography and myometry are emerging imaging techniques that can quantify the biomechanical properties of fascia and underlying muscle. These innovative techniques could in turn contribute to a better understanding of MFTs effects on fascial properties. The main objective of this study is to evaluate the immediate effect of a standardized MFT on the elastography features of the lumbar paraspinal muscle and fascia (i.e. myofascial unit). The secondary objectives are to evaluate the immediate effects of a MFT on: i) ultrasonography features of the myofascial unit; ii) myometry features of the myofascial unit; ii) pain intensity.
Status | Completed |
Enrollment | 49 |
Est. completion date | July 15, 2022 |
Est. primary completion date | July 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adults over 18 years of age, - lumbar pain and/or referred pain above or below the gluteal fold , with intensity > 3/10, persisting for > 6 months and presenting during the day > 50% of the time. Exclusion Criteria: - history of serious spinal or lower extremity injury or surgery in the last year - identifiable back pain or known pathology - known rheumatological condition - oral or injectable corticosteroids in the lumbar spine within the last 3 months - psychiatric disorder - pregnancy - manual treatment of the lumbo-sacral region 1 month prior to the experimentation and during the week of the study |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in elastography features of the myofascial unit | Evaluated with a shear wave sonoelastography device. | Baseline (before treatment), post-treatment (immediately after treatment) | |
Secondary | Changes in ultrasonography features of the myofascial unit | Evaluated with a B-mode ultrasound imaging device | Baseline (before treatment) post-treatment (immediately after treatment) | |
Secondary | Changes in myometry features of the myofascial unit | Evaluated with a myotonometer | Baseline (before treatment) post-treatment (immediately after treatment) | |
Secondary | Changes in pain intensity | Numeric rating Scale (0 to 10; minimum = 0; maximum = 10; higher score means worst outcome) | Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03243084 -
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
|
N/A | |
Suspended |
NCT04735185 -
Stem Cells vs. Steroids for Discogenic Back Pain
|
N/A | |
Completed |
NCT03162952 -
RAND Center of Excellence for the Study of Appropriateness of Care in CAM
|
||
Completed |
NCT03240146 -
Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain
|
N/A | |
Completed |
NCT05282589 -
Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients
|
N/A | |
Completed |
NCT03637998 -
Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT02289170 -
Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
|
N/A | |
Active, not recruiting |
NCT01944163 -
The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain
|
N/A | |
Completed |
NCT02231554 -
Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT02063503 -
Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients
|
N/A | |
Terminated |
NCT01620775 -
MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
|
N/A | |
Completed |
NCT01704677 -
Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up
|
N/A | |
Completed |
NCT01177241 -
Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids
|
N/A | |
Completed |
NCT01177254 -
Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions
|
N/A | |
Completed |
NCT01177280 -
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes
|
N/A | |
Completed |
NCT01490905 -
A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain
|
Phase 4 | |
Completed |
NCT00984815 -
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
|
Phase 3 | |
Completed |
NCT00767806 -
A Study for Patient With Chronic Low Back Pain
|
Phase 3 | |
Completed |
NCT00763321 -
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
|
Phase 3 | |
Completed |
NCT00761150 -
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
|
Phase 3 |