Instrument Assisted Soft Tissue Mobilization Versus Myofascial Release in Patients With Chronic Non¬Specific Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-45
SponsorCairo University
About this trial
This study was done to compare the effect of instrumental-assisted soft tissue mobilization versus the effect of myofascial release on pain intensity, pressure pain threshold, back function, and back range of motion in patients with chronic nonspecific low back pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with chronic non-specific low back pain for more than 3 months.
Age between 25-45 years.
Disqualifiers
Patients who have serious spinal pathologies, such as fractures, tumors or inflammatory diseases (such as ankylosing spondylitis)
Patients who have nerve root compromise, disk herniation, spondylolisthesis with neurological involvement, or narrowing of spinal canal
Pregnant women
Cancer patients .
Trial design
Design model
Parallel
Treatments tested in this trial
Instrument assisted soft tissue mobilization
Other interventionThe group will undergo Instrument assisted soft tissue mobilization using M2Tblade, applying it for 40-120 seconds until hyperemia occurs. After treatment, ice packs will be applied for 5 minutes to reduce hyperemia. The therapist will ensure comfort through continuous communication and reporting any discomfort.
Myofascial release
Other interventionThe therapist will use a cross-hand release technique to release the lumbar spine, ensuring the patient is prone and suitable. They will lean into the patient to the tissue depth barrier, wait, and follow each release, avoiding force or slipping. The technique will be applied for 5 minutes on each side.
The conventional exercise program
Other interventionPatients will undergo a 12-session exercise program for 6 weeks, consisting of straight leg raising, bridging exercise, prone hip extension exercise, and abdominal curl exercise. The exercises will be done 3 sets, 10 repetitions each, with 1 minute rest between each set. The abdominal curl exercises involve supine or hook-lying positions with the lumbar spine neutral, with the patient performing a drawing in maneuver to stabilize the abdominal muscles. The progression involves lifting the shoulders, changing arm positions, and holding a weight or medicine ball. The patient's position is hook-lying, maintaining a neutral spinal position.
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Instrument assisted soft tissue mobilization groupExperimental treatment 2 interventions
Group B: Myofascial Release groupActive comparator 2 interventions
Group C: Exercise only groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assessing the change of pain intensity using visual analogue scale
The visual analogue scale is a reliable tool for assessing chronic musculoskeletal pain, including chronic low back pain, with high correlations with verbal descriptive and numeric rating scales. It is a 10-cm line marked with no pain and severe pain, with higher scores indicating greater pain intensity.
Time frame
at baseline and after 6 weeksSecondary outcomes
1
Assessing the change of pressure pain threshold using the pressure algometer
A 1-cm diameter disk with a calibrated dial gauge is used to measure soft tissue tenderness on myofascial trigger points. The force applied to the point gradually increases, and patients are instructed to stop the algometry when experiencing a painful sensation. The force in Pascal is then read from the display.
Time frame
at baseline and after 6 weeks2
Assessing the change of flexion range of motion of the lumbar spine using the back range of motion device
The back range of motion II uses two Universal Inclinometers to measure range of motion to the spine, eliminating errors associated with stand-alone inclinometers. The investigator uses these inclinometers for flexion measurements, with the patient in an upright position. The therapist palpates and marks S1 and T12 on bare skin, centers the inclinometers, zeros them, and records the readings after the patient flexes forward.
Time frame
at baseline and after 6 weeks3
Assessing the change of extension range of motion of the lumbar spine using the back range of motion device
The back range of motion II uses two Universal Inclinometers to measure range of motion to the spine, eliminating errors associated with stand-alone inclinometers. The investigator uses these inclinometers for extension measurements, with the patient in an upright position. The therapist will repeat flexion protocol for extension having the patient extends back for full extension and will record the value
Time frame
at baseline and after 6 weeks4
Assessing the change of lateral flexion range of motion of the lumbar spine using the back range of motion device
The therapist will position the patient against a wall to prevent bending during lateral flexion measurements. The back range of motion unit will be adjusted until the inclinometer reads zero. For right lateral flexion, the patient will slide their hand down their leg while keeping their legs straight.
Time frame
at baseline and after 6 weeksSponsors and contacts
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Source ClinicalTrials.gov