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

NCT ID: NCT04334122

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2020-06-20

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.

Conditions

Lumbar Disc Herniation; Instrument-assisted Soft Tissue Mobilization

Study Design

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

Study Groups

Control group

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).

Group Type: EXPERIMENTAL

Traditional physiotherapy

Intervention Type: OTHER

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.

Experiment group

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.

Group Type: EXPERIMENTAL

Instrument-assisted soft tisue mobilization

Intervention Type: OTHER

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 physiotherapy

Intervention Type: OTHER

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.

Interventions

Instrument-assisted soft tisue mobilization

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

Traditional physiotherapy

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Ali Yıldırım

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

bvuayildirim

Identifier Type: -

Identifier Source: org_study_id