Investigation of Different Treatment Approaches in Elderly Individuals With Chronic Low Back Pain

NCT06835270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-02-19

No results posted yet for this study

Summary

Chronic nonspecific low back pain (CNSLBP) is a common issue among the elderly, affecting their physical health, daily activities, sleep quality, and overall quality of life. This study aimed to compare the effects of various interventions, including standard therapy (ST), transcutaneous electrical nerve stimulation (TENS), yoga, kinesiology taping (KT), awareness education, and home exercises on pain, disability, sleep quality, and quality of life in elderly with CNSLBP. In line with the objectives of this randomized controlled trial, the following hypotheses have been formulated:

Hypothesis 1: Standard treatment and transcutaneous electrical nerve stimulation (TENS) have an effect on pain, disability status, sleep, and quality of life in elderly individuals with chronic non-specific low back pain (CNSLBP).

Hypothesis 2: Yoga has an effect on pain, disability status, sleep, and quality of life in elderly individuals with CNSLBP.

Hypothesis 3: Educational sessions and home exercise programs have an effect on pain, disability status, sleep, and quality of life in elderly individuals with CNSLBP.

Hypothesis 4: Kinesiology taping and home exercise programs have an effect on pain, disability status, sleep, and quality of life in elderly individuals with CNSLBP.

The study was conducted at a private physical therapy and rehabilitation center in the Aegean region between July 2024 and November 2024.

Patients were randomly assigned to four different groups. Group 1 (G1): Participants received standard physiotherapy approaches, including therapeutic ultrasound and hot packs, in addition to transcutaneous electrical nerve stimulation (TENS). TENS was applied using two channels with 5x5 cm electrodes placed over the thoracic 12 and sacral 1 regions. Four electrodes were used for 20 minutes with a pulse width of 50-100 µs and a frequency of 60-120 Hz.

Group 2 (G2): Participants engaged in Iyengar yoga sessions that included asanas, pranayama, and mental focus exercises. The sessions lasted 45 minutes and were conducted as group exercises tailored for elderly individuals. Additionally, participants were encouraged to continue yoga exercises on non-session days.

Group 3 (G3): Participants received educational sessions and home exercise programs targeting low back pain. The educational sessions were based on the World Health Organization (WHO) guidelines for low back pain management.

Group 4 (G4): Participants received kinesiology taping and home exercise programs. Kinesiology taping was applied in an I-shaped parallel manner to the quadratus lumborum muscle.

All interventions were administered three times per week for four weeks, totaling 12 sessions.

Conditions

  • Chronic Nonspecific Low Back Pain
  • Elderly (People Aged 65 or More)

Interventions

OTHER

Yoga Exercises

Yoga group practiced Iyengar yoga asanas, pranayama, and mental focusing components in a group exercise format for 45 minutes.The yoga group was advised to practice yoga exercises at home following their yoga sessions.

DEVICE

Standard physiotherapy approaches

Standard physiotherapy approaches group ( standard physiotherapy approaches (therapeutic ultrasound, hotpack) and TENS (5x5 cm electrodes, applied to the thoracic 12 and sacral 1 regions). Four electrodes were applied for 20 minutes with a pulse width of 50-100 µs and a frequency of 60-120 Hz. This group was additionally recommended to perform home exercises

OTHER

Kinesiology taping

In the kinesiology taping technique, tape was applied in an I-shape parallel to the m. quadratus lumborum muscle. Interventions were conducted three times a week for four weeks, totaling 12 sessions.This group was additionally recommended to perform home exercises

BEHAVIORAL

Awareness training for low back pain

The educational training was based on the WHO's guidelines for back pain. This group was additionally recommended to perform home exercises.

Sponsors & Collaborators

  • Uşak University

    lead OTHER

Principal Investigators

  • Kevser Gursan, Dr. · Uşak University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
86 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835270 on ClinicalTrials.gov