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

Chronic Low-back Pain Clinical Trial

Official title:

Comparison of the Effects of Two Different Instrument Assisted Soft Tissue Mobilization Techniques in Individuals With Chronic Non-Specific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05623735
• Other study ID #: ETK00-2022-0173
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: February 2, 2023

Study information

• Verified date: February 2023
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Instrument Assisted Soft Tissue Mobilization Group While Lying Prone
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.
• Instrument Assisted Soft Tissue Mobilization Group Combined with Functional Movement
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.

Locations

Country	Name	City	State
Cyprus	Süleyman Güzelsemme	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 Weeks
Secondary	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.	3 Weeks
Secondary	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.	3 Weeks
Secondary	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.	3 Weeks
Secondary	Disability (Oswestry Disability Index)	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.	3 Weeks
Secondary	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.	3 Weeks