Clinical trial NCT04334122: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Instrument-assisted Soft Tissue Mobilization
Keywords: pain
instrument-assisted soft tissue mobilization
depression
functionality
lumbar disc herniation
quality of life
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Demographic information
timeFrame: 4 week
measure: Assessment of pain (VAS)
timeFrame: 4 week
measure: Evaluation of normal joint motion (NEH)
timeFrame: 4 week
measure: Evaluation of the quality of life
timeFrame: 4 week
measure: Evaluation of depression
timeFrame: 4 week
measure: Functional evaluation for low back pain
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References: