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

NCT06835270 | Completed

• 1 other identifier: 15/18
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Yoga; electrotherapy; kinesiology taping; chronic nonspecific low back pain; elderly

Outcome Measures

Primary Outcomes (2)

• Pain Assesment

  The Visual Analog Scale (VAS) is a commonly used tool in clinical settings to measure subjective characteristics or feelings that cannot be directly measured, such as pain intensity, fatigue, or mood. It typically consists of a straight line, often 10 cm in length, with two endpoints representing extreme levels of the phenomenon being measured. Ends of the scale: The left end (0) usually represents the absence of the characteristic (e.g., "No pain"), and the right end (10) represents the maximum intensity or severity of that characteristic (e.g., "Worst possible pain"). Patient's response: The patient marks a point on the line that represents their perception of the current intensity. The position of the mark is then measured in millimeters or centimeters.Pain: The VAS might be used to assess pain, with one end of the line representing "No pain" and the other representing "Worst pain imaginable."

  4 weeks

• Disability Assessment

  The Oswestry Disability Index (ODI) is a widely used clinical tool designed to measure the degree of disability in patients with low back pain. It assesses the impact of back pain on a person's daily activities, quality of life, and ability to function. The ODI is often used in both clinical practice and research to track changes in disability over time, particularly in individuals with chronic or acute low back pain.The ODI consists of 10 questions, each with 6 possible responses. Each question is related to a specific activity or aspect of life that could be impacted by low back pain. The responses are scored on a scale from 0 (no disability) to 5 (maximum disability), and each section is then given a score that reflects the severity of the disability.

  4 weeks

Secondary Outcomes (2)

• Sleep Quality Assesment

  4 weeks

• Quality of life assessment

  4 weeks

Study Arms (4)

The group that received standard physiotherapy approaches

OTHER

therapeutic ultrasound, hotpack and TENS (5x5 cm electrodes, applied to the thoracic 12 and sacral 1 regions).

Device: Standard physiotherapy approaches

The group that received yoga interventions

EXPERIMENTAL

Yoga Group practiced Iyengar yoga asanas, pranayama, and mental focusing components in a group exercise format for 45 minutes.

Other: Yoga Exercises

Kinesiology taping group

EXPERIMENTAL

In the kinesiology taping technique, tape was applied in an I-shape parallel to the m. quadratus lumborum muscle.

Other: Kinesiology taping

The group that received educational sessions on low back pain

OTHER

The educational training was based on the WHO's guidelines for back pain.

Behavioral: Awareness training for low back pain

Interventions

Yoga Exercises OTHER

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.

The group that received yoga interventions

Standard physiotherapy approaches DEVICE

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

The group that received standard physiotherapy approaches

Kinesiology taping OTHER

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

Kinesiology taping group

Awareness training for low back pain BEHAVIORAL

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

The group that received educational sessions on low back pain

Eligibility Criteria

• Age: 65 Years - 86 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Be able to understand verbal and visual communications
• Be literate
• To volunteer for the study
• Be 65 years of age or older
• Have Chronic Non-Specific Low Back Pain (CNSLBP)

You may not qualify if:

• Individuals who wish to withdraw from the study
• Those with spinal infections, radiculopathy, myelopathy, autoimmune diseases, spondylolysis, spondylolisthesis, spinal fractures
• Cardiovascular or pulmonary diseases that may contraindicate participation."

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

İzmir Private Rehabilitation Centre

Izmir, İzmir, 35000, Turkey (Türkiye)

Location

Study Officials

• Kevser Gursan, Dr.

  Uşak University

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 19, 2025
• Study Start: July 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)