Investigation of The Effect of "Instrument-Assisted Soft Tissue Mobilization" in Individuals With Lumbar Disc Herniation

NCT06529926 | Completed

• 1 other identifier: ÜSAME TAŞ-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Instrument-assisted soft tissue mobilization is an instrument-assisted soft tissue mobilization technique. It consists of stainless steel instrument designed to adapt to various tissues/shapes/curves of the body. The instruments were developed as an alternative to transverse friction massage. Stainless steel acts a bit like a diaposon when it comes into contact with fibrotic tissue. A resonance or reverberation in the instrument is created upon contact and transmitted through the instrument to the hands of the clinician. The application of heavy pressure (compared to light or medium pressure) using instruments has been proven to promote a greater fibroblastic response. Instrument-assisted soft tissue mobilization is not used without insulation. It is imperative to use movement and strengthening in combination with soft tissue mobilization to promote tissue adaptation and remodeling. Mechanical loading has been shown to affect chondrocyte alignment and fibroblast activity with increased proteoglycan and collagen synthesis. The aim of this study was to investigate the effects of the IASTM technique on individuals of different ages diagnosed with LDH.

Conditions

Instrument-assisted Soft Tissue Mobilization; Treatment; Exercise; Pain

Outcome Measures

Primary Outcomes (18)

• Evaluation of Pain

  Visual analog scale was used to evaluate the pain of the patients.

  Pre-treatment assessment.

• Evaluation of Pain

  Visual analog scale was used to evaluate the pain of the patients.

  After 4 weeks of treatment (Post-treatment assessment).

• Evaluation of Pain

  Visual analog scale was used to evaluate the pain of the patients.

  2nd month post-treatment assessment.

• Evaluation of Functional Status (Straight leg raise test)

  Straight leg raise test was used to evaluate the functional status of the patients.

  Pre-treatment assessment.

• Evaluation of Functional Status (Straight leg raise test)

  Straight leg raise test was used to evaluate the functional status of the patients.

  After 4 weeks of treatment (Post-treatment assessment).

• Evaluation of Functional Status (Straight leg raise test)

  Straight leg raise test was used to evaluate the functional status of the patients.

  2nd month post-treatment assessment.

• Evaluation of Functional Status (Slump test)

  Slump test was used to evaluate the functional status of the patients.

  Pre-treatment assessment.

• Evaluation of Functional Status (Slump test)

  Slump test was used to evaluate the functional status of the patients.

  After 4 weeks of treatment (Post-treatment assessment).

• Evaluation of Functional Status (Slump test)

  Slump test was used to evaluate the functional status of the patients.

  2nd month post-treatment assessment.

• Evaluation of Functional Status (5-min walking test)

  5-min walking test was used to evaluate the functional status of the patients.

  Pre-treatment assessment.

• Evaluation of Functional Status (5-min walking test)

  5-min walking test was used to evaluate the functional status of the patients.

  After 4 weeks of treatment (Post-treatment assessment).

• Evaluation of Functional Status (5-min walking test)

  5-min walking test was used to evaluate the functional status of the patients.

  2nd month post-treatment assessment.

• Evaluation of Normal Joint ROM

  Goniometer was used to evaluate the normal joint ROM of the patients.

  Pre-treatment assessment.

• Evaluation of Normal Joint ROM

  Goniometer was used to evaluate the normal joint ROM of the patients.

  After 4 weeks of treatment (Post-treatment assessment).

• Evaluation of Normal Joint ROM

  Goniometer was used to evaluate the normal joint ROM of the patients.

  2nd month post-treatment assessment.

• Evaluation of Quality of Life

  Short Form-36 was used to evaluate the quality of life of the patients.

  Pre-treatment assessment.

• Evaluation of Quality of Life

  Short Form-36 was used to evaluate the quality of life of the patients.

  After 4 weeks of treatment (Post-treatment assessment).

• Evaluation of Quality of Life

  Short Form-36 was used to evaluate the quality of life of the patients.

  2nd month post-treatment assessment.

Study Arms (2)

Control Group

OTHER

Treated with classical physiotherapy (Hotpack+TENS+Ultrasound) program. A 20-minute hotpack was applied to the lumbar area. TENS and ultrasound were applied as electrotherapy agents. The TENS application was made with the Chattanooga Intelect Advanced Combo device. Conventional tens was applied at a frequency of 100 Hz for 20 min with a current of 100 μs. The ultrasound application was made with the Chattanooga Intelect Advanced Combo device. Lumbar area was administered at a dose of 1 MHz, 1.5 W/cm² using a 5 cm diameter cap for 6 min. In the first session, the physiotherapist had the patient explain the exercises (posterior pelvic tilt exercise, hip flexors stretching exercise, lumbar extensors stretching exercise, abdominal muscle strengthening exercise, SLR exercise, pelvic elevation exercise, cat-camel exercise and lumbar extensor strengthening exercise). Afterwards, patients were advised to rest for 1 minute between exercises, 1 time a day and for 4 weeks, 5 days a week.

Other: Observational

IASTM Treatment Group

EXPERIMENTAL

IASTM application was applied at an angle of 45° in a direction parallel to the muscle fibers for about 20 seconds. Immediately afterwards, a total of 40 seconds of treatment time was applied by treating the muscle fibers at a 45° angle with the instrument for an additional 20 seconds in a direction perpendicular to them. In other words, for each area (paraspinal muscles, gluteus maximus and gluteus medius muscles, hamstrings), a total of 2 minutes was applied to the right and left sides separately for 40x3 seconds. Paraspinal muscles were treated from caudal to cranium, gluteal muscles from proximal to distal and hamstring muscles from popliteal fossa to gluteal line. Stretching was provided by exercises applied to the control group. After the cold application, IASTM application was made, the cold-pack was applied to each area for 5 minutes. (The application was performed by a trained and experienced physiotherapist and with a stainless steel gua sha device).

Other: IASTM Technique Application

Interventions

Observational OTHER

Only classical physiotherapy application for 4 weeks.

Control Group

IASTM Technique Application OTHER

IASTM application for 2 sessions per week with classical physiotherapy for 4 weeks.

IASTM Treatment Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals have been diagnosed with LDH,
• Their pain is 3 and above according to the Visual Analog Scale (VAS),
• They are between the ages of 20-60,
• Their clinical status is stable,
• They are fully cooperative,
• They do not have cognitive, cognitive and mental problems and they can express themselves,
• They voluntarily agree to participate in the study.

You may not qualify if:

• Individuals have psychological disorders, mental disorders, cancer and severe depression,
• Primary or metastatic spinal malignancy,
• Have been diagnosed with advanced osteoporosis,
• Have recently undergone surgical intervention or acute infection,
• Cannot or do not want to perform tests or treatment exercises,
• Want to leave voluntarily.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Pain

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Muhammed Üsame TAŞ, Lecturer

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 31, 2024
• Study Start: November 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2018
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)