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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPamukkale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • SIS Therapy

    Other intervention

    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.

  • Conventional Physiotherapy

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SIS Therapy GroupExperimental treatment 1 intervention
Group B: Conventional Physiotherapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and immediately after the 4-week intervention
2

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.

Time frame
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

1

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

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

Time frame
Baseline and immediately after the 4-week intervention
2

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

Lumbar flexion mobility will be assessed using the Modified Modified Schober Test (MMST). The change in distance between standardized anatomical landmarks during maximal forward trunk flexion will be recorded in centimeters. A greater increase in distance indicates greater lumbar flexion mobility.

Time frame
Baseline and immediately after the 4-week intervention
3

Change in Back Extensor Muscle Endurance Assessed by the Sorensen Test

Back extensor muscle endurance will be assessed using the Sorensen Back Extensor Endurance Test. The duration for which the participant can maintain the standardized horizontal trunk position will be recorded in seconds. Longer durations indicate greater back extensor muscle endurance.

Time frame
Baseline and immediately after the 4-week intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pamukkale University

Lead sponsor

Burdur Mehmet Akif Ersoy University

Sponsor institution

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