- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05279794
Efficacy of Two Types of Non-invasive Erector Spinae Muscle Taut Band Therapy in University Students With Low Back Pain
May 19, 2022 updated by: Juan Martínez Fuentes, Universidad Católica San Antonio de Murcia
Efficacy of Two Types of Non-invasive Erector Spinae Muscle Taut Band Therapy in University Students With Low Back Pain: A Randomized Clinical Trial
Non-specific low back pain can be caused by the presence of active trigger points in the muscles of the lumbopelvic region.
Trigger points are defined as hypersensitive points within a taut band of a musculoskeletal system that cause pain during contraction, stretching, or stimulation of said muscle.
If these points are active, they can trigger referred pain, local tenderness, and vegetative responses.
There is scientific evidence of the improvement of the treatment of these points through non-invasive manual techniques.
The objective of this study will be to determine the effect of Strain Counterstrain and Myofascial Induction techniques in subjects with low back pain secondary to the presence of active trigger points in the lumbopelvic region.
Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes.
The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy.
Based on these factors, the objective of the study is to determine the effect of the combined therapy of the Strain Counterstrain technique and Myofascial Induction in participants with the presence of an active trigger point in the erector spinae muscle.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 2 experimental groups and a placebo group, of no-pain positioning.
In addition to basic indices and scales of low back pain and disability caused by low back pain, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when representing reliable results in differences between techniques.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
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
-
-
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Murcia, Spain, 30107
- Universidad Católica de Murcia
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-
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
19 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Presence of low back pain
- Presence of active trigger point in the erector spinae as described by Lawrence H. Jones
Exclusion Criteria:
- Participants who present dizziness, vertigo;
- Previous or scheduled surgeries in the lumbar spine and/or lower extremities;
- Suspicion of serious fractures or pathologies (tumor, inflammation, infection, rheumatological disorder, systemic disease, presence of fever);
- Diagnosis of radiculopathy or neuropathy;
- Structural deformity in the spine; spondyloarthropathy, disabling pain and physical disability;
- Use of pain relievers or anti-inflammatory drugs in the last 48 hours;
- Neurological or psychiatric disorder;
- Presence or suspicion of pregnancy
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Jones Group (Strain Counterstrain)
Jones Group consist in 90 seconds in a ralease positioning of no pain in muscle acortation
|
No pain positioning technique with diaphragmatic breathing
|
Active Comparator: Myofascial Induction Group
Myofascial Induction Group consist in 15 minutes of superficial and deep lumbar fascia maneuvers
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Myofascial Induction technique on the lumbar fascia
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Placebo Comparator: Placebo Group
Placebo Group only have to mantain no pain positioning for 3 minutes
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No pain positioning of participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 20 minutes
|
Measured with Numeric Rating Scale wich consist in measure pain intensity with a score of 0-10
|
20 minutes
|
Pression algometer
Time Frame: 20 minutes
|
Measures pressure pain thresholds
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spinal test
Time Frame: 20 minutes
|
Measured with Baiobit Software.
The range of movement will be measured in grades as per: flexion/extension; right/left rotation; and right/left inclination
|
20 minutes
|
Countermovement jump test
Time Frame: 20 minutes
|
Measured with Baiobit software counter movement jump test wich consist a velocity, height and accuracy evaluation of a vertical jump
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
March 21, 2022
Primary Completion (Actual)
March 23, 2022
Study Completion (Actual)
May 19, 2022
Study Registration Dates
First Submitted
February 7, 2022
First Submitted That Met QC Criteria
March 14, 2022
First Posted (Actual)
March 15, 2022
Study Record Updates
Last Update Posted (Actual)
May 20, 2022
Last Update Submitted That Met QC Criteria
May 19, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE012207
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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