Clinical trial NCT06529926: Investigation of The Effect of "Instrument-Assisted Soft Tissue Mobilization" in Individuals With Lumbar Disc Herniation
Official title: Investigation of The Effect of "Instrument-Assisted Soft Tissue Mobilization" in Individuals With Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Instrument-assisted Soft Tissue Mobilization
Treatment
Exercise
Pain
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Evaluation of Pain
timeFrame: Pre-treatment assessment.
measure: Evaluation of Pain
timeFrame: After 4 weeks of treatment (Post-treatment assessment).
measure: Evaluation of Pain
timeFrame: 2nd month post-treatment assessment.
measure: Evaluation of Functional Status (Straight leg raise test)
timeFrame: Pre-treatment assessment.
measure: Evaluation of Functional Status (Straight leg raise test)
timeFrame: After 4 weeks of treatment (Post-treatment assessment).
measure: Evaluation of Functional Status (Straight leg raise test)
timeFrame: 2nd month post-treatment assessment.
measure: Evaluation of Functional Status (Slump test)
timeFrame: Pre-treatment assessment.
measure: Evaluation of Functional Status (Slump test)
timeFrame: After 4 weeks of treatment (Post-treatment assessment).
measure: Evaluation of Functional Status (Slump test)
timeFrame: 2nd month post-treatment assessment.
measure: Evaluation of Functional Status (5-min walking test)
timeFrame: Pre-treatment assessment.
measure: Evaluation of Functional Status (5-min walking test)
timeFrame: After 4 weeks of treatment (Post-treatment assessment).
measure: Evaluation of Functional Status (5-min walking test)
timeFrame: 2nd month post-treatment assessment.
measure: Evaluation of Normal Joint ROM
timeFrame: Pre-treatment assessment.
measure: Evaluation of Normal Joint ROM
timeFrame: After 4 weeks of treatment (Post-treatment assessment).
measure: Evaluation of Normal Joint ROM
timeFrame: 2nd month post-treatment assessment.
measure: Evaluation of Quality of Life
timeFrame: Pre-treatment assessment.
measure: Evaluation of Quality of Life
timeFrame: After 4 weeks of treatment (Post-treatment assessment).
measure: Evaluation of Quality of Life
timeFrame: 2nd month post-treatment assessment.
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Muhammed Üsame TAŞ, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: