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NCT Number: NCT06796881

Instrument Assisted Soft Tissue Mobilization Versus Myofascial Release in Patients With Chronic Non¬Specific Low Back Pain

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.

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Key information

Conditions

Myofascial Release Chronic Low-back Pain Instrument Assisted Soft Tissue Mobilization

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Outpatient Clinic of the Police Authority Hospital

Cairo, Egypt

Location status: Recruiting

Location contact

Dalia Salah Ahmed Elshatoury, physical therapist

CONTACT

[email protected]

+201550677823

About this study

Low back pain affects 20% of the workforce annually, leading to increased work absenteeism. Chronic non specific low back pain restricts functional and occupational activities, impacting society and the economy. Treatment is often unsatisfactory, and there is no consensus on the optimal approach. Further scientific research is needed to understand the effects of facial tissue manipulation on Chronic non specific low back pain patients. The literature has not addressed the distinctions between myofascial force transmission instrumental assisted soft tissue mobilization and myofascial release on Chronic non specific low back pain patients, which could help physical therapists find effective treatments. This study is the first to include pain, Pressure pain threshold, back function, and range of motion as outcome measures and compare instrumental assisted soft tissue mobilization and myofascial release in Chronic non specific low back pain patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic non-specific low back pain for more than 3 months.
  • Age between 25-45 years.

Exclusion criteria

  • 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 .
  • Lower limb injuries.
  • Body mass index (BMI) greater than 25.

Treatment and study plan

Instrument assisted soft tissue mobilization

Other

The 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

The 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

Patients 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.

Primary outcomes

  1. Assessing the change of pain intensity using visual analogue scale

    Time frame: at baseline and after 6 weeks

    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.

Secondary outcomes

  1. Assessing the change of pressure pain threshold using the pressure algometer

    Time frame: at baseline and after 6 weeks

    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.

  2. Assessing the change of flexion range of motion of the lumbar spine using the back range of motion device

    Time frame: at baseline and after 6 weeks

    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.

  3. Assessing the change of extension range of motion of the lumbar spine using the back range of motion device

    Time frame: at baseline and after 6 weeks

    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

  4. Assessing the change of lateral flexion range of motion of the lumbar spine using the back range of motion device

    Time frame: at baseline and after 6 weeks

    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.

  5. Assessing the change of rotation range of motion of the lumbar spine using the back range of motion device

    Time frame: at baseline and after 6 weeks

    The therapist will place the back range of motion unit, so the unit's feet are in line with T12. The therapist will hold the center of the unit firmly against the patient's back and zero the compass. The therapist will have the patient slowly turn the shoulders to either side, making sure they go to full range and record the reading

  6. Assessing the change of back function using the 5) The Arabic version of Oswestry Disability Index

    Time frame: at baseline and after 6 weeks

    The Oswestry Disability Index is a self-reported questionnaire with 10 questions assessing daily living activities in patients with low back pain. The questions range from pain intensity to personal care and are scored on a 6-item Likert scale. The Arabic version of the oswestry disability index has good intra-observer reliability and good construct validity, with strong correlations with the visual analogue scale pain scale, Roland-Morris Low Back Pain Disability, and Quebec Back Pain Disability Scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia salah Ahmed Elshatoury, physical therapist

CONTACT

[email protected]

+201550677823

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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