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

NCT ID: NCT06529926

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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.

Group Type: OTHER

Observational

Intervention Type: OTHER

Only classical physiotherapy application for 4 weeks.

IASTM Treatment Group

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).

Group Type: EXPERIMENTAL

IASTM Technique Application

Intervention Type: OTHER

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

Interventions

Observational

Only classical physiotherapy application for 4 weeks.

Intervention Type: OTHER

IASTM Technique Application

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Individuals have been diagnosed with LDH,

2. Their pain is 3 and above according to the Visual Analog Scale (VAS),

3. They are between the ages of 20-60,

4. Their clinical status is stable,

5. They are fully cooperative,

6. They do not have cognitive, cognitive and mental problems and they can express themselves,

7. They voluntarily agree to participate in the study.

Exclusion Criteria

1. Individuals have psychological disorders, mental disorders, cancer and severe depression,

2. Primary or metastatic spinal malignancy,

3. Have been diagnosed with advanced osteoporosis,

4. Have recently undergone surgical intervention or acute infection,

5. Cannot or do not want to perform tests or treatment exercises,

6. Want to leave voluntarily.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Usame TAS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammed Üsame TAŞ, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Inonu University

Locations

Inonu University

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ÜSAME TAŞ-004

Identifier Type: -

Identifier Source: org_study_id