Clinical trial NCT06835270: Investigation of Different Treatment Approaches in Elderly Individuals With Chronic Low Back Pain
Official title: Investigation of Different Treatment Approaches in Elderly Individuals With Chronic Nonspecific Low Back Pain: A Comparative Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Elderly (People Aged 65 or More)
Keywords: Yoga
electrotherapy
kinesiology taping
chronic nonspecific low back pain
elderly
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Maximum age (years): 86
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: With the rapid advancements in technology and medicine, life expectancy worldwide is steadily increasing, leading to a growing proportion of the elderly population. It is estimated that in the coming years, one in six individuals will be aged 60 or older. This demographic shift necessitates a more focused examination of health issues prevalent among older adults and the development of effective interventions.

The aging process is characterized by a progressive decline in cellular functions, resulting in adverse effects on physical health. One of the most prominent consequences of aging is musculoskeletal disorders. In particular, low back pain (LBP) is among the most prevalent conditions affecting elderly individuals and is directly associated with disability and a decline in quality of life. Notably, a substantial proportion of LBP cases occur without an identifiable underlying pathology and often become chronic, significantly impairing daily activities.

In the coming years, the prevalence of LBP is expected to rise considerably due to the aging population. This condition not only contributes to physical discomfort but also restricts mobility, increases dependency in daily activities, and negatively impacts sleep quality. The coexistence of chronic pain and sleep disturbances further exacerbates the decline in overall well-being among older adults. Consequently, identifying effective treatment strategies specifically targeting elderly individuals has become increasingly critical.

A variety of pharmacological and non-pharmacological approaches are available for managing LBP. However, pharmacological treatments may not always be the optimal solution, as they can pose risks of adverse effects, particularly in older adults. Non-pharmacological interventions, including yoga, electrotherapy, kinesiology taping, educational programs, and home-based exercise regimens, have been explored as alternative treatment modalities. Nevertheless, the existing body of research on these approaches remains limited, and further evidence is required, particularly concerning their efficacy in elderly populations.

This study aims to evaluate the effectiveness of different treatment modalities for elderly individuals suffering from chronic LBP. Various interventions, including standard physical therapy, electrotherapy, yoga, kinesiology taping, home exercise programs, and educational sessions, were compared to determine their effects on pain relief, mobility, sleep quality, and overall quality of life.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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."

Primary outcomes:
measure: Pain Assesment
timeFrame: 4 weeks
measure: Disability Assessment
timeFrame: 4 weeks
Secondary outcomes:
measure: Sleep Quality Assesment
timeFrame: 4 weeks
measure: Quality of life assessment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: İzmir Private Rehabilitation Centre
Study officials:
affiliation: Uşak University
name: Kevser Gursan, Dr.
role: PRINCIPAL_INVESTIGATOR
References: