Lumbar Disc HerniationNCT04334122
The Efficacy Of Instrument-Assisted Soft Tissue Mobilization At Lumbar Region Disc Herniations
A study testing Instrument-assisted soft tisue mobilization and Traditional physiotherapy in people with Lumbar Disc Herniation and Instrument-assisted Soft Tissue Mobilization, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Instrument-assisted Soft Tissue Mobilization
- What is being tested?
- Instrument-assisted soft tisue mobilization and Traditional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2020to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bulging and protruding disc presence
- Facet joint problem
- Mechanical low back pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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-
- 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.
- Being tested
- Instrument-assisted soft tisue mobilization, Traditional physiotherapy
- Keywords
- pain, instrument-assisted soft tissue mobilization, depression, functionality, lumbar disc herniation, quality of life
- Medical subject headings
- Intervertebral Disc Displacement, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument-assisted soft tisue mobilizationOther
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.
Traditional physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | 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). Receives: Other: Traditional physiotherapy |
| Experiment group | Experimental | 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. Receives: Other: Instrument-assisted soft tisue mobilization; Other: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 week
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.
Measured: 4 week
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.
Measured: 4 week
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.
Measured: 4 week
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.
Measured: 4 week
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)
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start16 Apr 2020
- Primary completion16 May 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yıldırım, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334122
- Sponsor's protocol ID
- bvuayildirim
- Status last verified
- Jul 2020
- First submitted
- 2 Apr 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yildirim A, Ozyilmaz S, Aksoy A, Hosbay Z. The effect of instrument-assisted soft tissue mobilization in lumbar disc herniation: A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:424-429. doi: 10.1016/j.jbmt.2024.04.046. Epub 2024 Apr 25.
PubMed 39593620
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Of Instrument-Assisted Soft Tissue Mobilization At Lumbar Region Disc Herniations
- ClinicalTrials.gov ID
- NCT04334122
- Acronym / sponsor ID
- bvuayildirim
- Keywords
- pain, instrument-assisted soft tissue mobilization, depression, functionality, lumbar disc herniation, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 16 May 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: Traditional physiotherapyAll 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). |
| Experiment group | Experimental | Other: Instrument-assisted soft tisue mobilization, Other: Traditional physiotherapyIn 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bulging and protruding disc presence
- Facet joint problem
- Mechanical low back pain
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrument-assisted soft tisue mobilizationAll 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. | Other | Experiment group |
| Traditional physiotherapyAll 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. | Other | Control group, Experiment group |
Primary outcome
Demographic information
Time frame: 4 week
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)
Time frame: 4 week
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)
Time frame: 4 week
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
Time frame: 4 week
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
Time frame: 4 week
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
Time frame: 4 week
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 39593620Yildirim A, Ozyilmaz S, Aksoy A, Hosbay Z. The effect of instrument-assisted soft tissue mobilization in lumbar disc herniation: A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:424-429. doi: 10.1016/j.jbmt.2024.04.046. Epub 2024 Apr 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument-assisted soft tisue mobilization and Traditional physiotherapy in people with Lumbar Disc Herniation and Instrument-assisted Soft Tissue Mobilization, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic information (time frame: 4 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04334122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.