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Completed

NCT Number: NCT06529926

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

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.

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Key information

Conditions

Instrument-Assisted Soft Tissue Mobilization Behavior Exercise Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Treatment

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 44280, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Observational

Other

Only classical physiotherapy application for 4 weeks.

IASTM Technique Application

Other

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

Primary outcomes

  1. Evaluation of Pain

    Time frame: Pre-treatment assessment.

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

  2. Evaluation of Pain

    Time frame: After 4 weeks of treatment (Post-treatment assessment).

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

  3. Evaluation of Pain

    Time frame: 2nd month post-treatment assessment.

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

  4. Evaluation of Functional Status (Straight leg raise test)

    Time frame: Pre-treatment assessment.

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

  5. Evaluation of Functional Status (Straight leg raise test)

    Time frame: After 4 weeks of treatment (Post-treatment assessment).

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

  6. Evaluation of Functional Status (Straight leg raise test)

    Time frame: 2nd month post-treatment assessment.

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

  7. Evaluation of Functional Status (Slump test)

    Time frame: Pre-treatment assessment.

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

  8. Evaluation of Functional Status (Slump test)

    Time frame: After 4 weeks of treatment (Post-treatment assessment).

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

  9. Evaluation of Functional Status (Slump test)

    Time frame: 2nd month post-treatment assessment.

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

  10. Evaluation of Functional Status (5-min walking test)

    Time frame: Pre-treatment assessment.

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

  11. Evaluation of Functional Status (5-min walking test)

    Time frame: After 4 weeks of treatment (Post-treatment assessment).

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

  12. Evaluation of Functional Status (5-min walking test)

    Time frame: 2nd month post-treatment assessment.

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

  13. Evaluation of Normal Joint ROM

    Time frame: Pre-treatment assessment.

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

  14. Evaluation of Normal Joint ROM

    Time frame: After 4 weeks of treatment (Post-treatment assessment).

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

  15. Evaluation of Normal Joint ROM

    Time frame: 2nd month post-treatment assessment.

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

  16. Evaluation of Quality of Life

    Time frame: Pre-treatment assessment.

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

  17. Evaluation of Quality of Life

    Time frame: After 4 weeks of treatment (Post-treatment assessment).

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

  18. Evaluation of Quality of Life

    Time frame: 2nd month post-treatment assessment.

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

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

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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