Effects of SIS Therapy in Individuals With Chronic Nonspecific Low Back Pain

NCT07839169 | Not Yet Recruiting

• 1 other identifier: SIS-LBP-2026-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary - buraya yapıştırın Chronic nonspecific low back pain is a common condition that can cause pain, limitations in daily activities, and reduced quality of life. Exercise and conventional physiotherapy are commonly used to manage chronic low back pain. SIS Therapy is a physiotherapy approach intended to reduce pain and improve movement and function. The aim of this randomized controlled trial is to investigate the effects of SIS Therapy in individuals with chronic nonspecific low back pain and to compare these effects with conventional physiotherapy. Participants will be randomly assigned to one of two groups. The SIS Therapy group will receive SIS Therapy together with a standard exercise program consisting of lumbar stabilization and stretching exercises. The conventional physiotherapy group will receive a program consisting of heat application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and therapeutic exercise. Both groups will receive treatment twice a week for four weeks, for a total of eight sessions, and both groups will receive the same home exercise program. Participants will be evaluated before and after the four-week treatment period. The assessments will examine changes in pain intensity, lumbar mobility, and back extensor muscle endurance.

Conditions

Chronic Nonspecific Low Back Pain

Keywords

Exercise Therapy; Rehabilitation; Physiotherapy; Physical Therapy; Pain; Chronic Nonspecific Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)

  Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their current low back pain on a 10-cm horizontal scale ranging from 0 (no pain) to 10 (unbearable pain). Higher scores indicate greater pain intensity. Change in VAS score from baseline to the end of the 4-week intervention will be evaluated.

  Baseline and immediately after the 4-week intervention

• Change in Pressure Pain Threshold Assessed by Pressure Algometry

  Pressure pain threshold (PPT) will be assessed using a pressure algometer at standardized measurement sites in the lumbar paraspinal region. Pressure will be gradually increased until the participant first reports that the pressure sensation has become painful. The pressure value at this point will be recorded as the PPT. Higher PPT values indicate lower mechanical pain sensitivity.

  Pressure pain threshold (PPT) will be assessed using a pressure algometer at standardized measurement sites in the lumbar paraspinal region. Pressure will be gradually increased until the participant first reports that the pressure sensation has become p

Secondary Outcomes (3)

• Change in Functional Disability Assessed by the Oswestry Disability Index (ODI)

  Baseline and immediately after the 4-week intervention

• Change in Lumbar Flexion Mobility Assessed by the Modified Modified Schober Test (MMST)

  Baseline and immediately after the 4-week intervention

• Change in Back Extensor Muscle Endurance Assessed by the Sorensen Test

  Baseline and immediately after the 4-week intervention

Study Arms (2)

SIS Therapy Group

EXPERIMENTAL

Participants in this group will receive SIS Therapy in addition to a standard exercise program consisting of lumbar stabilization and stretching exercises. The intervention will be administered twice weekly for four weeks, for a total of eight treatment sessions. Participants will also receive a home exercise program.

Other: SIS Therapy

Conventional Physiotherapy Group

ACTIVE COMPARATOR

Participants in this group will receive conventional physiotherapy consisting of heat application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and therapeutic exercise. The intervention will be administered twice weekly for four weeks, for a total of eight treatment sessions. Participants will also receive the same home exercise program provided to the SIS Therapy group.

Other: Conventional Physiotherapy

Interventions

SIS Therapy OTHER

Participants assigned to the experimental group will receive SIS Therapy in addition to a standard exercise program consisting of lumbar stabilization and stretching exercises. Treatment will be administered twice weekly for four weeks, for a total of eight treatment sessions. Participants will also receive a home exercise program.

SIS Therapy Group

Conventional Physiotherapy OTHER

Participants assigned to the active comparator group will receive conventional physiotherapy consisting of heat application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and therapeutic exercise. Treatment will be administered twice weekly for four weeks, for a total of eight treatment sessions. Participants will also receive the same home exercise program provided to the experimental group.

Conventional Physiotherapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 65 years Having chronic nonspecific low back pain for at least 3 months Having a pain intensity of 4 or higher on the Visual Analog Scale (VAS) Being able to walk independently Volunteering to participate in the study and providing written informed consent

You may not qualify if:

• History of lumbar spine surgery Severe neurological deficit or radiculopathy associated with disc herniation Presence of vertebral fracture, tumor, infection, or inflammatory rheumatic disease Pregnancy History of malignancy Having received physiotherapy for the lumbar region within the previous 3 months Cognitive or communication problems that may prevent compliance with the assessments

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Aydın Şehir Hastanesi

Aydin, Aydın, 09100, Turkey (Türkiye)

Location

Related Publications (2)

• George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.

  PMID: 34719942 BACKGROUND

• Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

  PMID: 29573870 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

aysenur yılmaz, Assistant Professor, PT,PhD

CONTACT

05432833819; aysenuryilmaz@mehmetakif.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: the SIS Therapy group or the conventional physiotherapy group. Both groups will receive treatment twice weekly for four weeks, for a total of eight treatment sessions.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)