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Comparison of the Effects of Instrument Assisted Soft Tissue Mobilization Techniques Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Instrument Assisted Soft Tissue Mobilization Group While Lying Prone
Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring IASTM, chronic pain, flexibility, disability, mobility, muscular endurance

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being diagnosed with non-specific low back pain by a specialist physician 18-45 years old Having 3 or more pains on VAS for the last 3 months. Those who do not use analgesic drugs Not taking physiotherapy for the last 6 months. Exclusion Criteria: Those with orthopedic, neurological, psychiatric and systemic diseases (such as fracture, osteoporosis, scoliosis, kyphosis, stenosis, cauda equina, myositis ossificans, severe nerve compressions, rheumatoid arthritis, cancer) Those with a history of spinal surgery Pregnant and lactating Open wound, infection, serious kidney disease Those who have limited hip joint movements

Sites / Locations

  • Süleyman Güzelşemme

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Instrument Assisted Soft Tissue Mobilization (IASTM) Group While Lying Prone

Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement

Arm Description

The application will take a total of 6 sessions, with two sessions per week for 3 weeks. While individuals are lying in the prone position, the IASTM protocol will be applied bilaterally on the erector spinae and then on the hamstrings. The application will take approximately 17 minutes.

While standing in the "extended child pose (utthita balasana)" stance, the "IASTM" protocol will be applied bilaterally on the lumbar erector spines, with the hands on them and moving back to the old position. Then, the "IASTM" protocol will be applied bilaterally on the hamstrings by making consecutive knee flexion-extension up to 90 degrees while the individuals are lying prone. The application will take approximately 17 minutes.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
Individuals' pain levels will be measured using the Visual Analogue Scale (VAS) both at rest and during activity. It will be requested to mark any point on a horizontal line of 10 cm length such that 0 no pain, 10 unbearably severe pain.

Secondary Outcome Measures

Mobility (Modified Schober Test)
Individuals' spinal mobility will be assessed using the Modified Schober Test. While the patient is standing, the midpoint between the spina iliaca posterior superior is marked. This point is considered the L4-L5 level. Two more points are marked 10 cm above and 5 cm below this point. This distance will be measured both while standing and by asking them to bend forward without bending the knees, with the hands touching the feet.
Flexibility (Sit and Reach Test)
A measuring bench with a length of 55 cm in the upper part, 35 cm in the lower part, 32 cm in height and 45 cm in width will be used. The soles of both lower extremities will be fully touching the bench with bare feet and the patient will be asked to lie on the bench with knees extended straight and hands on top of each other. The level of the feet will be the 0 point on the table at the top. It will be recorded in such a way that it extends forward +, lagging behind -. The test will be calculated by taking the best value of the measurements after 3 consecutive repetitions.
Flexibility (Maximal Hip Flexion Active Knee Extension (MHFAKE))
Hamstring flexibility will be measured using the Active Knee Extension Test with Maximal Hip Flexion (MHFAKE). It has been reported to be the best measure of hamstring flexibility compared to traditional straight leg raises or other tests. While the individual is lying in the supine position, he will be asked to take the hip of the tested extremity to its maximal flexion and lock it with his hands, then actively bring the knee to the extension position until it reaches the maximal tension it can reach. The contralateral limb will be extended straight on the bed. To prevent variations, the contralateral extremity will be fixed to the bed from the distal thigh with a belt. Knee angle will be measured with a goniometer.
Disability (Oswestry Disability İndex)
The Turkish version of the Oswestry Low Back Pain Disability Questionnaire consisting of 10 questions will be used in order to measure the loss of function caused by low back pain. These questions are; It consists of questions compatible with daily life activities such as pain intensity, personal care, lifting/carrying, walking, sitting, standing, sleep, travel, social life, and degree of pain change. Higher scores mean more disability.
Trunk Extensors Muscle Endurance (Biering-Sorenson Test)
The trunk extensors muscle endurance of individuals will be evaluated with the Biering Sorenson test. Individuals will be asked to lie face down on the bed and extend their torso out of the bed from the anterior superior iliac spine (SIAS). A rolled towel will be placed in front of the ankle and their legs will be supported by the physiotherapist. Individuals will be asked to stand with their hands crossed in the pectoral region and keep their torso parallel to the ground against gravity. The time will be recorded in seconds.

Full Information

First Posted
November 14, 2022
Last Updated
February 14, 2023
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT05623735
Brief Title
Comparison of the Effects of Instrument Assisted Soft Tissue Mobilization Techniques Low Back Pain
Official Title
Comparison of the Effects of Two Different Instrument Assisted Soft Tissue Mobilization Techniques in Individuals With Chronic Non-Specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Mediterranean 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
The aim of this study is to determine whether the effectiveness of instrument-assisted soft tissue mobilization technique is different from passive prone lying when performed with a functional exercise in individuals with chronic nonspecific low back pain.
Detailed Description
Individuals participating in the study will first be divided into two groups by randomization. While IASTM (Instrument Assisted Soft Tissue Mobilization Techniques) will be applied to one group in the prone position, IASTM will be applied to the other group with functional exercise. The pain, mobility, flexibility, disability and endurance parameters of the individuals assigned to the groups after randomization will be determined just before the application, immediately after the 1st application and immediately after the 6th application. The study will last for a total of 6 sessions, with two sessions per week for 3 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
IASTM, chronic pain, flexibility, disability, mobility, muscular endurance

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Instrument Assisted Soft Tissue Mobilization (IASTM) Group While Lying Prone
Arm Type
Experimental
Arm Description
The application will take a total of 6 sessions, with two sessions per week for 3 weeks. While individuals are lying in the prone position, the IASTM protocol will be applied bilaterally on the erector spinae and then on the hamstrings. The application will take approximately 17 minutes.
Arm Title
Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement
Arm Type
Experimental
Arm Description
While standing in the "extended child pose (utthita balasana)" stance, the "IASTM" protocol will be applied bilaterally on the lumbar erector spines, with the hands on them and moving back to the old position. Then, the "IASTM" protocol will be applied bilaterally on the hamstrings by making consecutive knee flexion-extension up to 90 degrees while the individuals are lying prone. The application will take approximately 17 minutes.
Intervention Type
Other
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization Group While Lying Prone
Intervention Description
Sliding movements in all directions at 30 - 60 degree angles will be made in the form of mobilizations of 45 seconds with instruments. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. Starting with an angle of 60 degrees on the area to be treated, the movement of shifting towards an angle of 30 degrees will be made in all directions for 30 seconds. The tissue will be mobilized for 30 consecutive seconds, starting from just caudal to your waist and drawing the letter J towards the cranial. Sliding movements in all directions at 30 - 60 degree angles will be made with instruments in the form of mobilizations for 45 seconds. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 30 - 60 degree swipe movement shorter brushing style small movements will be done for 30 seconds.
Intervention Type
Other
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement
Intervention Description
Sliding movements in all directions at 30 - 60 degree angles will be made in the form of mobilizations of 45 seconds with instruments. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. Starting with an angle of 60 degrees on the area to be treated, the movement of shifting towards an angle of 30 degrees will be made in all directions for 30 seconds. The tissue will be mobilized for 30 consecutive seconds, starting from just caudal to your waist and drawing the letter J towards the cranial. Sliding movements in all directions at 30 - 60 degree angles will be made with instruments in the form of mobilizations for 45 seconds. Mobilizations of 45 seconds will be made with instruments along the quarter circle line in all directions at 30 - 60 degree angles. 30 - 60 degree swipe movement shorter brushing style small movements will be done for 30 seconds.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
Individuals' pain levels will be measured using the Visual Analogue Scale (VAS) both at rest and during activity. It will be requested to mark any point on a horizontal line of 10 cm length such that 0 no pain, 10 unbearably severe pain.
Time Frame
3 Weeks
Secondary Outcome Measure Information:
Title
Mobility (Modified Schober Test)
Description
Individuals' spinal mobility will be assessed using the Modified Schober Test. While the patient is standing, the midpoint between the spina iliaca posterior superior is marked. This point is considered the L4-L5 level. Two more points are marked 10 cm above and 5 cm below this point. This distance will be measured both while standing and by asking them to bend forward without bending the knees, with the hands touching the feet.
Time Frame
3 Weeks
Title
Flexibility (Sit and Reach Test)
Description
A measuring bench with a length of 55 cm in the upper part, 35 cm in the lower part, 32 cm in height and 45 cm in width will be used. The soles of both lower extremities will be fully touching the bench with bare feet and the patient will be asked to lie on the bench with knees extended straight and hands on top of each other. The level of the feet will be the 0 point on the table at the top. It will be recorded in such a way that it extends forward +, lagging behind -. The test will be calculated by taking the best value of the measurements after 3 consecutive repetitions.
Time Frame
3 Weeks
Title
Flexibility (Maximal Hip Flexion Active Knee Extension (MHFAKE))
Description
Hamstring flexibility will be measured using the Active Knee Extension Test with Maximal Hip Flexion (MHFAKE). It has been reported to be the best measure of hamstring flexibility compared to traditional straight leg raises or other tests. While the individual is lying in the supine position, he will be asked to take the hip of the tested extremity to its maximal flexion and lock it with his hands, then actively bring the knee to the extension position until it reaches the maximal tension it can reach. The contralateral limb will be extended straight on the bed. To prevent variations, the contralateral extremity will be fixed to the bed from the distal thigh with a belt. Knee angle will be measured with a goniometer.
Time Frame
3 Weeks
Title
Disability (Oswestry Disability İndex)
Description
The Turkish version of the Oswestry Low Back Pain Disability Questionnaire consisting of 10 questions will be used in order to measure the loss of function caused by low back pain. These questions are; It consists of questions compatible with daily life activities such as pain intensity, personal care, lifting/carrying, walking, sitting, standing, sleep, travel, social life, and degree of pain change. Higher scores mean more disability.
Time Frame
3 Weeks
Title
Trunk Extensors Muscle Endurance (Biering-Sorenson Test)
Description
The trunk extensors muscle endurance of individuals will be evaluated with the Biering Sorenson test. Individuals will be asked to lie face down on the bed and extend their torso out of the bed from the anterior superior iliac spine (SIAS). A rolled towel will be placed in front of the ankle and their legs will be supported by the physiotherapist. Individuals will be asked to stand with their hands crossed in the pectoral region and keep their torso parallel to the ground against gravity. The time will be recorded in seconds.
Time Frame
3 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being diagnosed with non-specific low back pain by a specialist physician 18-45 years old Having 3 or more pains on VAS for the last 3 months. Those who do not use analgesic drugs Not taking physiotherapy for the last 6 months. Exclusion Criteria: Those with orthopedic, neurological, psychiatric and systemic diseases (such as fracture, osteoporosis, scoliosis, kyphosis, stenosis, cauda equina, myositis ossificans, severe nerve compressions, rheumatoid arthritis, cancer) Those with a history of spinal surgery Pregnant and lactating Open wound, infection, serious kidney disease Those who have limited hip joint movements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Süleyman Güzelşemme, Res. Asst.
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sevim Öksüz, Asst. Prof.
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Study Director
Facility Information:
Facility Name
Süleyman Güzelşemme
City
Famagusta
ZIP/Postal Code
99628
Country
Cyprus

12. IPD Sharing Statement

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Comparison of the Effects of Instrument Assisted Soft Tissue Mobilization Techniques Low Back Pain

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