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NCT Number: NCT04334122

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

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.

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Key information

Conditions

Lumbar Disc Herniation Behavior Behavioral Symptoms Bone Diseases Depression Hernia Instrument-Assisted Soft Tissue Mobilization Intervertebral Disc Displacement Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Instrument-assisted soft tisue mobilization

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2020
Registry last updated
Jul 8, 2020

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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