Chronic Nonspecific Low Back PainNCT06835270
Investigation of Different Treatment Approaches in Elderly Individuals With Chronic Low Back Pain
A study testing Yoga Exercises, Standard physiotherapy approaches and Kinesiology taping in people with Chronic Nonspecific Low Back Pain and Elderly (People Aged 65 or More), run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Nonspecific Low Back Pain, Elderly (People Aged 65 or More)
- What is being tested?
- Yoga Exercises, Standard physiotherapy approaches and Kinesiology taping
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 86 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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."
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Private Rehabilitation Centre
Izmir, İzmir, 35000
About this study
Official title: Investigation of Different Treatment Approaches in Elderly Individuals With Chronic Nonspecific Low Back Pain: A Comparative Randomized Study
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).
Read more
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.
Read the 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.
- Being tested
- Yoga Exercises, Standard physiotherapy approaches, Kinesiology taping, Awareness training for low back pain
- Keywords
- Yoga, electrotherapy, kinesiology taping, chronic nonspecific low back pain, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ExercisesOther
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.
Standard physiotherapy approachesDevice
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
Kinesiology tapingOther
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
Awareness training for low back painBehavioural
The educational training was based on the WHO's guidelines for back pain. This group was additionally recommended to perform home exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Awareness training for low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
Sleep Quality Assesment
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-reported questionnaire that assesses the quality and patterns of sleep over a 1-month period. It is designed to measure various aspects of sleep, including sleep duration, sleep disturbances, and overall sleep quality. The PSQI is useful for identifying sleep disorders and monitoring changes in sleep quality over time, especially in clinical and research settings.The PSQI consists of 19 questions that are grouped into 7 components. Each component is scored individually, and the sum of the scores determines the overall sleep quality. The seven components assess different aspects of sleep and its impact on daily life.
Measured: 4 weeks
Quality of life assessment
The SF-36 (Short Form 36) is a widely used health survey tool designed to assess an individual's overall health status and quality of life. It is a generic, multidimensional measure of health that evaluates physical and mental well-being, and is often used in clinical practice, research, and health policy settings. The SF-36 is particularly useful for comparing the impact of different diseases, treatments, or interventions on individuals' health.
The SF-36 consists of 36 items organized into 8 scales that measure various dimensions of health. These scales cover both physical and mental aspects of health, with questions on general health perceptions, functional status, and emotional well-being.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jul 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonspecific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Gürsan, Uşak University
- Investigators
- Kevser Gursan, Dr., Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835270
- Sponsor's protocol ID
- 15/18
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Different Treatment Approaches in Elderly Individuals With Chronic Nonspecific Low Back Pain: A Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT06835270
- Acronym / sponsor ID
- 15/18
- Keywords
- Yoga, electrotherapy, kinesiology taping, chronic nonspecific low back pain, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The group that received standard physiotherapy approaches | Other | Device: Standard physiotherapy approachestherapeutic ultrasound, hotpack and TENS (5x5 cm electrodes, applied to the thoracic 12 and sacral 1 regions). |
| The group that received yoga interventions | Experimental | Other: Yoga ExercisesYoga Group practiced Iyengar yoga asanas, pranayama, and mental focusing components in a group exercise format for 45 minutes. |
| Kinesiology taping group | Experimental | Other: Kinesiology tapingIn the kinesiology taping technique, tape was applied in an I-shape parallel to the m. quadratus lumborum muscle. |
| The group that received educational sessions on low back pain | Other | Behavioral: Awareness training for low back painThe educational training was based on the WHO's guidelines for back pain. |
Who may qualify
- Ages
- 65 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga ExercisesYoga 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. | Other | The group that received yoga interventions |
| Standard physiotherapy approachesStandard 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 | Device | The group that received standard physiotherapy approaches |
| Kinesiology tapingIn 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 | Other | Kinesiology taping group |
| Awareness training for low back painThe educational training was based on the WHO's guidelines for back pain. This group was additionally recommended to perform home exercises. | Behavioural | The group that received educational sessions on low back pain |
Primary outcome
Pain Assesment
Time frame: 4 weeks
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."
Disability Assessment
Time frame: 4 weeks
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.
2 secondary outcomes
Sleep Quality Assesment
Time frame: 4 weeks
Quality of life assessment
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevser Gursan, Dr. principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Exercises, Standard physiotherapy approaches and Kinesiology taping in people with Chronic Nonspecific Low Back Pain and Elderly (People Aged 65 or More), run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assesment (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.