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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2022
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Myofascial release technique
Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles
Simulated Myofascial Release technique
Superficial hands contact on the lumbar area

Locations

Country Name City State
Canada Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

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
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