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The Efficacy Of Instrument-Assisted Soft Tissue Mobilization At Lumbar Region Disc Herniations

Primary Purpose

Lumbar Disc Herniation, Instrument-assisted Soft Tissue Mobilization

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Instrument-assisted soft tisue mobilization
Traditional physiotherapy
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring pain, instrument-assisted soft tissue mobilization, depression, functionality, lumbar disc herniation, quality of life

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Bulging and protruding disc presence
  2. Facet joint problem
  3. Mechanical low back pain

Exclusion Criteria:

  1. Extruded and sequestrated disc presence
  2. Previous operational status through the lumbar region
  3. Having inflammatory pain (osteoarthritis)
  4. Pain associated with malignancy (primary or metastatic tumors)
  5. Severe psychological discomfort
  6. Having communication problems

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control group

Experiment group

Arm Description

All patients in the control group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week. As a traditional treatment, patients received hot packs, conventional transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound and exercise. Hot packs used as superficial heat were wrapped in a towel and applied to the waist area for 20 minutes. Conventional TENS used as analgesic current were applied to the waist region for 20 minutes with 4 electrodes with 2 outputs, with a current time of 180 ms at a frequency of 80 Hz. It was applied with a dose of 1Mhz for 5 minutes with ultrasan (Chattanooga Intelect Mobile Combo model device) used to heat deep tissues. Waist exercises were asked to be done during the treatment, with 10 repetitions, each exercise twice a day (morning and evening).

In addition to the traditional physiotherapy program, tool-assisted soft tissue mobilization was performed 3 times a week (12 sessions with 1 day interval) in the experimental group. Instrument Assisted Soft Tissue Mobilization (IASTM) treatment was applied to ilicostalis lumborum, priformism, gluteus medius, erector spinas, quadratus lumborum muscles, superficial and deep fascia. Before applying the application, petroleum jelly was applied to the area and the tool was slipped. IASTM treatment was applied to the treated muscle fibers for 6 minutes, each technique (SWEEP-FAN-BRUSH-SWEEP techniques) with 8-10 repetitions. Sweep: Applied in all directions at 30 or 60 degree angle. Fan: It was applied by moving one side fixed arm at 30 degree angle. Brush: It was applied in straight steps at 30 degrees angle. Each stage of IASTM treatment was done by the physiotherapist.

Outcomes

Primary Outcome Measures

Demographic information
Personal information (name, surname, address, telephone, marital status, educational status, occupational and health security), demographic and clinical information (age (year), gender, height (cm), weight (kg), BMI of all patients participating in the study (calculated by the formula of the ratio of body weight to neck squared (kg / m²)), information about the disease, drugs used for lumbar disc hernia, other drugs used, presence of chronic disease, surgical history, smoking and alcohol use] by questioning '' Demographic Information Forms '' recorded.
Assessment of pain (VAS)
The pain intensities of the patients at rest, during the activity and at night were determined using the Visual Analogue Scale (VAS). VAS is an easy-to-apply scale, as values that cannot be measured numerically can be digitized and quickly understood. The patients were asked to mark their severity (rest, activity, night) on a 10 cm line. The starting point of the truth was '' 0 '' '' I have no pain '', the end point was '' 10 '' '' I have pain of unbearable severity ''. The point that the patient marked on the right was measured with a ruler and recorded in "cm". Localization of the pain, its frequency and the causes that increase and decrease pain were questioned and recorded. The Turkish validity and reliability study of the scale was performed.
Evaluation of normal joint motion (NEH)
The limitation of flexion, extension, lateral flexion and rotation movements of the lumbosacral joint was measured using a universal goniometer. All normal joint movements were repeated 3 times and the average of the obtained values was recorded in degrees.
Evaluation of the quality of life
Quality of life was assessed with the survey "SF-36 (Short form-36) quality of life". SF-36 is a generic scale that evaluates the overall health status. It consists of 36 questions that evaluate 2 main (physical and mental component) and 8 sub parameters (physical function, emotional function, physical role, social function, mental health, pain, general health and vitality). The score of each subgroup is evaluated between 0-100. A high score indicates that the quality of life is good. The Turkish validity and reliability study of the SF-36 questionnaire was conducted.
Evaluation of depression
Depression level of the patients was evaluated by Beck Depression questionnaire. The scale developed by Beck consists of 21 questions. 4-point Likert scoring is used in the scale. Each item gets points between 0-3. The total score ranges from 0-63. Points obtained from the survey; 0-10 points → no depression 11-17 points → mild depression 18-23 points → moderate depression 24 points above → interpreted as severe depression. The Turkish validity and reliability study of the scale was conducted.
Functional evaluation for low back pain
Oswestry Disability Index was used to evaluate the disability caused by low back pain. The scale evaluates how much back pain affects daily life activities. Pain severity consists of 10 questions evaluating personal care, weight lifting, walking, sitting, standing, sleep quality, social life, ability to travel and the degree of pain. Six-point likert scoring is used. A high total score indicates an increase in disability. The Turkish validity and reliability study of this scale was conducted. Points obtained from the survey; 0% - 20% → minimal disability 20% to 40% → mild disability 40% to 60% → severe disability 60% - 80% → complete limitation 80% - 100% → bed-dependent (or symptoms are exaggerated)

Secondary Outcome Measures

Full Information

First Posted
April 2, 2020
Last Updated
July 7, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT04334122
Brief Title
The Efficacy Of Instrument-Assisted Soft Tissue Mobilization At Lumbar Region Disc Herniations
Official Title
The Efficacy Of Instrument-Assisted Soft Tissue Mobilization At Lumbar Region Disc Herniations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
May 16, 2020 (Actual)
Study Completion Date
June 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was carried out to investigate the effect of instrument-assisted soft tissue mobilization in patients with lomber region disc herniation. 60 patients with lumbar disc herniation between the ages of 30-65 were included in the study. Following the evaluation, the patients were divided into two groups by closed envelope method; control group (n=30) and experimental group (n=30). In both groups, 4 weeks (20 sessions) hot pack (hotpack), conventional transcutaneous electrical nerve stimulation (TENS), therapeutic physical therapy program with therapeutic ultrasound applications were performed. In addition to this program, Instrumental Assisted Soft Tissue Mobilization (IASTM) was applied to the experimental group in 12 sessions of 3 times a week. This technique was performed by using stainless steel tools of different sizes and shapes. IASTM treatment was performed (including SWEEP-FAN-BRUSH-SWEEP technique, 45° angle with the skin, by 8-10 repetitions) for the ilicostalis lumborum, priformis, gluteus medius, erector spines, quadratus lumborum muscles, superficial and deep fascia. Depression levels of the patients were evaluated with Beck Depression Scale, before the treatment and after 4 weeks pain severity, VAS pain scale, functional status with Oswestry Scale, quality of life with Short Form-36 (SF- 36) and normal range of motion with goniometer. The results were analyzed by using SPSS v.20 program. In all analyzes, the significance ratio was accepted as p <0.05. At the end of the four-week treatment program, significant improvements were observed in VAS levels, normal joint movements (flexion, extension, right-left lateral flexion, rotation) in both groups (p <0.05). Oswestry and Beck Depression Scale scores showed significant improvement merely in the experimental group compared to the control group (p <0.05). There was no significant difference in VAS values, normal joint motion and Oswestry scale while there was no notable difference in SF-36 and Beck Depression Scale. As a result of the study, it was concluded that IASTM is a more effective method on normal range of motion and functionality in comparison with traditional physiotherapy program in patients with lumbar disc herniation and it can be used as an alternative method in patients during the physiotherapy and rehabilitation program if needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Instrument-assisted Soft Tissue Mobilization
Keywords
pain, instrument-assisted soft tissue mobilization, depression, functionality, lumbar disc herniation, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
All patients in the control group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week. As a traditional treatment, patients received hot packs, conventional transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound and exercise. Hot packs used as superficial heat were wrapped in a towel and applied to the waist area for 20 minutes. Conventional TENS used as analgesic current were applied to the waist region for 20 minutes with 4 electrodes with 2 outputs, with a current time of 180 ms at a frequency of 80 Hz. It was applied with a dose of 1Mhz for 5 minutes with ultrasan (Chattanooga Intelect Mobile Combo model device) used to heat deep tissues. Waist exercises were asked to be done during the treatment, with 10 repetitions, each exercise twice a day (morning and evening).
Arm Title
Experiment group
Arm Type
Experimental
Arm Description
In addition to the traditional physiotherapy program, tool-assisted soft tissue mobilization was performed 3 times a week (12 sessions with 1 day interval) in the experimental group. Instrument Assisted Soft Tissue Mobilization (IASTM) treatment was applied to ilicostalis lumborum, priformism, gluteus medius, erector spinas, quadratus lumborum muscles, superficial and deep fascia. Before applying the application, petroleum jelly was applied to the area and the tool was slipped. IASTM treatment was applied to the treated muscle fibers for 6 minutes, each technique (SWEEP-FAN-BRUSH-SWEEP techniques) with 8-10 repetitions. Sweep: Applied in all directions at 30 or 60 degree angle. Fan: It was applied by moving one side fixed arm at 30 degree angle. Brush: It was applied in straight steps at 30 degrees angle. Each stage of IASTM treatment was done by the physiotherapist.
Intervention Type
Other
Intervention Name(s)
Instrument-assisted soft tisue mobilization
Intervention Description
All patients in the experimental group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week. In addition to the traditional physiotherapy program, the patients in the experimental group were subjected to tool-assisted soft tissue mobilization 3 times a week (12 sessions with 1 day interval). All evaluations were repeated to all patients in the experimental and control groups after four weeks.
Intervention Type
Other
Intervention Name(s)
Traditional physiotherapy
Intervention Description
All patients in the control group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week.
Primary Outcome Measure Information:
Title
Demographic information
Description
Personal information (name, surname, address, telephone, marital status, educational status, occupational and health security), demographic and clinical information (age (year), gender, height (cm), weight (kg), BMI of all patients participating in the study (calculated by the formula of the ratio of body weight to neck squared (kg / m²)), information about the disease, drugs used for lumbar disc hernia, other drugs used, presence of chronic disease, surgical history, smoking and alcohol use] by questioning '' Demographic Information Forms '' recorded.
Time Frame
4 week
Title
Assessment of pain (VAS)
Description
The pain intensities of the patients at rest, during the activity and at night were determined using the Visual Analogue Scale (VAS). VAS is an easy-to-apply scale, as values that cannot be measured numerically can be digitized and quickly understood. The patients were asked to mark their severity (rest, activity, night) on a 10 cm line. The starting point of the truth was '' 0 '' '' I have no pain '', the end point was '' 10 '' '' I have pain of unbearable severity ''. The point that the patient marked on the right was measured with a ruler and recorded in "cm". Localization of the pain, its frequency and the causes that increase and decrease pain were questioned and recorded. The Turkish validity and reliability study of the scale was performed.
Time Frame
4 week
Title
Evaluation of normal joint motion (NEH)
Description
The limitation of flexion, extension, lateral flexion and rotation movements of the lumbosacral joint was measured using a universal goniometer. All normal joint movements were repeated 3 times and the average of the obtained values was recorded in degrees.
Time Frame
4 week
Title
Evaluation of the quality of life
Description
Quality of life was assessed with the survey "SF-36 (Short form-36) quality of life". SF-36 is a generic scale that evaluates the overall health status. It consists of 36 questions that evaluate 2 main (physical and mental component) and 8 sub parameters (physical function, emotional function, physical role, social function, mental health, pain, general health and vitality). The score of each subgroup is evaluated between 0-100. A high score indicates that the quality of life is good. The Turkish validity and reliability study of the SF-36 questionnaire was conducted.
Time Frame
4 week
Title
Evaluation of depression
Description
Depression level of the patients was evaluated by Beck Depression questionnaire. The scale developed by Beck consists of 21 questions. 4-point Likert scoring is used in the scale. Each item gets points between 0-3. The total score ranges from 0-63. Points obtained from the survey; 0-10 points → no depression 11-17 points → mild depression 18-23 points → moderate depression 24 points above → interpreted as severe depression. The Turkish validity and reliability study of the scale was conducted.
Time Frame
4 week
Title
Functional evaluation for low back pain
Description
Oswestry Disability Index was used to evaluate the disability caused by low back pain. The scale evaluates how much back pain affects daily life activities. Pain severity consists of 10 questions evaluating personal care, weight lifting, walking, sitting, standing, sleep quality, social life, ability to travel and the degree of pain. Six-point likert scoring is used. A high total score indicates an increase in disability. The Turkish validity and reliability study of this scale was conducted. Points obtained from the survey; 0% - 20% → minimal disability 20% to 40% → mild disability 40% to 60% → severe disability 60% - 80% → complete limitation 80% - 100% → bed-dependent (or symptoms are exaggerated)
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bulging and protruding disc presence Facet joint problem Mechanical low back pain Exclusion Criteria: Extruded and sequestrated disc presence Previous operational status through the lumbar region Having inflammatory pain (osteoarthritis) Pain associated with malignancy (primary or metastatic tumors) Severe psychological discomfort Having communication problems
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Efficacy Of Instrument-Assisted Soft Tissue Mobilization At Lumbar Region Disc Herniations

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