Chronic Low-back Pain (cLBP)NCT06898502
Investigation of Conservative Treatment Preferences of Patients With Chronic Low Back and Neck Pain
A study testing Electrotherapy ( TENS, hot pack, and therapeutic ultrasound ) in people with Chronic Low-back Pain (cLBP) and Chronic Neck Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study is to determine the preferences of individuals with chronic low back and neck pain regarding physiotherapy treatment methods and to examine the factors influencing these preferences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain (cLBP), Chronic Neck Pain
- What is being tested?
- Electrotherapy ( TENS, hot pack, and therapeutic ultrasound )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 29 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who presented to the Physical Therapy Clinic of Istanbul Training and Research Hospital within the last 3 months with self-reported low back or neck pain intensity of at least 3 out of 10 on the NPRS (Numeric Pain Rating Scale),
- Patients aged 18 years or older,
- Patients who volunteered to participate in the study,
- Patients who have the ability to understand the assessment scales,
- Patients who do not have any contraindications to being included in the treatment program, These patients were included in the study.
Who cannot join
- Having undergone a physiotherapy program for low back or neck pain within the last 3 months,
- Having pain persisting for less than 3 months,
- Presence of radiculopathy or nerve root compression findings, inflammatory disease, serious metabolic, endocrine, cardiovascular, pulmonary, genitourinary, gastrointestinal, progressive/non-progressive central or peripheral neurological disease, or a history of malignancy,
- Pregnant or breastfeeding individuals, and those with serious musculoskeletal disorders other than low back or neck pain,
- Patients whose self-reported low back or neck pain intensity in the last 3 months was less than 3 out of 10 on the NPRS (Numeric Pain Rating Scale) were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpaşa
Istanbul, Istanbul, 34000
About this study
Objective: The aim of this study is to determine the preferences of individuals with chronic low back and neck pain regarding physiotherapy treatment methods and to examine the factors influencing these preferences. Additionally, the study aims to compare patient satisfaction, pain intensity, and disability levels between individuals who receive their preferred treatment and those who do not. Moreover, the relationships between patients' demographic characteristics, pain levels, pain beliefs, disability status, and depression severity with their preferred treatment methods will be investigated.
Materials and Methods: The study will include 50 patients with chronic low back and 50 patients with neck pain. In this study, four videos introducing commonly used physiotherapy and rehabilitation methods for the treatment of low back and neck pain (electrotherapy applications -TENS, ultrasound, hot pack-, manual therapy, kinesiotaping-dry needling, education, and exercise) will be prepared and shown to the participants. Pain intensity will be assessed using the "Numeric Pain Scale," pain beliefs with the "Pain Beliefs Scale," depression severity with the "Patient Health Questionnaire," and disability level with the "Oswestry Disability Index" for low back pain and the "Neck Disability Index" for neck pain. Participants will rank the treatment methods they watched and explain their reasons for preference. Each participant will receive electrotherapy treatment three times a week for four weeks. Each treatment session will consist of 20 minutes of TENS, 20 minutes of hot pack, and 6 minutes of ultrasound therapy. Twelve weeks after the treatment, participants will be contacted by phone and asked about their improvement using the "Global Rating of Change Scale (GRC)." Pain intensity and disability level will be reassessed through phone interviews using the "Numeric Pain Scale," the "Oswestry Disability Index" for low back pain, and the "Neck Disability Index" for neck pain at the 12th week. Thus, it will be evaluated whether there is any difference in patient satisfaction, pain intensity, and disability at the 12th week between participants who selected electrotherapy as the most effective method and those who chose other treatments. Statistical analysis of the data will be conducted using the SPSS program, and the analysis results will be presented with mean, standard deviation, frequency (%), number of patients (n), and confidence interval values. Treatment preferences and the factors influencing these preferences will be statistically examined, with a significance level of p<0.05 considered statistically significant.
- Conditions
- Chronic Low-back Pain (cLBP), Chronic Neck Pain
- Being tested
- Electrotherapy ( TENS, hot pack, and therapeutic ultrasound )
- Keywords
- chronic low back pain, chronic neck pain, physiotherapy and Rehabilitation, patitent's preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrotherapy ( TENS, hot pack, and therapeutic ultrasound )Device
Also called Transcutaneous Electrical Nerve Stimulation, hot pack, therapeutic ultrasound, Electrotherapy
Each participant will receive electrotherapy treatment three times a week for four weeks. Each treatment session will consist of 20 minutes of TENS, 20 minutes of hot pack, and 6 minutes of ultrasound therapy. Twelve weeks after the treatment, participants will be contacted by phone and asked about their improvement using the "Global Rating of Change Scale (GRC)." Pain intensity and disability level will be reassessed through phone interviews using the "Numeric Pain Scale," the "Oswestry Disability Index" for low back pain, and the "Neck Disability Index" for neck pain at the 12th week. Thus, it will be evaluated whether there is any difference in patient satisfaction, pain intensity, and disability at the 12th week between participants who selected electrotherapy as the most effective method and those who chose other treatments.
| Study group | Role | What they receive |
|---|---|---|
| Electrotherapy | Experimental | All 50 patients with chronic low back pain and 50 patients with chronic neck pain will receive electrotherapy treatment, which includes TENS, hot pack, and therapeutic ultrasound methods. Receives: Device: Electrotherapy ( TENS, hot pack, and therapeutic ultrasound ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale
Patients' pain intensity will be assessed using the 10 cm Numeric Pain Scale (NPS), ranging from "0" (no pain) to "10" (unbearable pain). Patients will be asked the question, "How would you rate your current pain?" and will be requested to rate their pain on the scale.
Measured: The pain intensity of all participants will be assessed using the Numeric Pain Scale (NPS) before starting the treatment and 12 weeks after the treatment.
Disability
The functional disability level of patients will be determined using the Oswestry Disability Index, which evaluates daily living activities from 10 different aspects. A higher score indicates greater functional disability. The impact of neck pain on an individual's daily life will be assessed using the Neck Disability Index (NDI). The NDI consists of 10 sections that assess neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreational activities.
Measured: The disability level will be assessed using the Oswestry Disability Index for low back pain and the Neck Disability Index for neck pain before starting the treatment and 12 weeks after the treatment.
Determination of patients' treatment preferences
In this study, To evaluate participants' perceptions regarding treatment preferences, four informative videos introducing commonly used physiotherapy and rehabilitation methods for the treatment of low back and neck pain (electrotherapy applications [TENS, ultrasound, hot pack], manual therapy, kinesiotaping and dry needling, exercise and education) will be prepared and shown to the participants. After watching the videos, participants will be asked to rank the treatment methods from the most effective to the least effective based on their perceived effectiveness, using a scale from 1 to 4 (1 = most effective, 4 = least effective).
This ranking will be based on participants' personal evaluations and will be conducted without the use of any standardized psychometric scale. In addition, participants will be asked to explain the reasons for their preferences through open-ended questions.
Measured: Patients' treatment preferences will be assessed before starting the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Sep 2024
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Oztürk, Istanbul University - Cerrahpasa
- Investigators
- sema öztürk, Master's student, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898502
- Sponsor's protocol ID
- İUCOztürk001
- Status last verified
- Jun 2025
- First submitted
- 20 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Conservative Treatment Preferences of Patients With Chronic Low Back and Neck Pain
- ClinicalTrials.gov ID
- NCT06898502
- Acronym / sponsor ID
- İUCOztürk001
- Conditions
- Chronic Low-back Pain (cLBP), Chronic Neck Pain
- Keywords
- chronic low back pain, chronic neck pain, physiotherapy and Rehabilitation, patitent's preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 27 Mar 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.
Objective: The aim of this study is to determine the preferences of individuals with chronic low back and neck pain regarding physiotherapy treatment methods and to examine the factors influencing these preferences. Additionally, the study aims to compare patient satisfaction, pain intensity, and disability levels between individuals who receive their preferred treatment and those who do not. Moreover, the relationships between patients' demographic characteristics, pain levels, pain beliefs, disability status, and depression severity with their preferred treatment methods will be investigated.
Materials and Methods: The study will include 50 patients with chronic low back and 50 patients with neck pain. In this study, four videos introducing commonly used physiotherapy and rehabilitation methods for the treatment of low back and neck pain (electrotherapy applications -TENS, ultrasound, hot pack-, manual therapy, kinesiotaping-dry needling, education, and exercise) will be prepared and shown to the participants. Pain intensity will be assessed using the "Numeric Pain Scale," pain beliefs with the "Pain Beliefs Scale," depression severity with the "Patient Health Questionnaire," and disability level with the "Oswestry Disability Index" for low back pain and the "Neck Disability Index" for neck pain. Participants will rank the treatment methods they watched and explain their reasons for preference. Each participant will receive electrotherapy treatment three times a week for four weeks. Each treatment session will consist of 20 minutes of TENS, 20 minutes of hot pack, and 6 minutes of ultrasound therapy. Twelve weeks after the treatment, participants will be contacted by phone and asked about their improvement using the "Global Rating of Change Scale (GRC)." Pain intensity and disability level will be reassessed through phone interviews using the "Numeric Pain Scale," the "Oswestry Disability Index" for low back pain, and the "Neck Disability Index" for neck pain at the 12th week. Thus, it will be evaluated whether there is any difference in patient satisfaction, pain intensity, and disability at the 12th week between participants who selected electrotherapy as the most effective method and those who chose other treatments. Statistical analysis of the data will be conducted using the SPSS program, and the analysis results will be presented with mean, standard deviation, frequency (%), number of patients (n), and confidence interval values. Treatment preferences and the factors influencing these preferences will be statistically examined, with a significance level of p<0.05 considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrotherapy | Experimental | Device: Electrotherapy ( TENS, hot pack, and therapeutic ultrasound )All 50 patients with chronic low back pain and 50 patients with chronic neck pain will receive electrotherapy treatment, which includes TENS, hot pack, and therapeutic ultrasound methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who presented to the Physical Therapy Clinic of Istanbul Training and Research Hospital within the last 3 months with self-reported low back or neck pain intensity of at least 3 out of 10 on the NPRS (Numeric Pain Rating Scale),
- Patients aged 18 years or older,
- Patients who volunteered to participate in the study,
- Patients who have the ability to understand the assessment scales,
- Patients who do not have any contraindications to being included in the treatment program, These patients were included in the study.
Key exclusion criteria (5 listed)
- Having undergone a physiotherapy program for low back or neck pain within the last 3 months,
- Having pain persisting for less than 3 months,
- Presence of radiculopathy or nerve root compression findings, inflammatory disease, serious metabolic, endocrine, cardiovascular, pulmonary, genitourinary, gastrointestinal, progressive/non-progressive central or peripheral neurological disease, or a history of malignancy,
- Pregnant or breastfeeding individuals, and those with serious musculoskeletal disorders other than low back or neck pain,
- Patients whose self-reported low back or neck pain intensity in the last 3 months was less than 3 out of 10 on the NPRS (Numeric Pain Rating Scale) were excluded from the study.
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 |
|---|---|---|
| Electrotherapy ( TENS, hot pack, and therapeutic ultrasound )Also: Transcutaneous Electrical Nerve Stimulation, hot pack, therapeutic ultrasound, ElectrotherapyEach participant will receive electrotherapy treatment three times a week for four weeks. Each treatment session will consist of 20 minutes of TENS, 20 minutes of hot pack, and 6 minutes of ultrasound therapy. Twelve weeks after the treatment, participants will be contacted by phone and asked about their improvement using the "Global Rating of Change Scale (GRC)." Pain intensity and disability level will be reassessed through phone interviews using the "Numeric Pain Scale," the "Oswestry Disability Index" for low back pain, and the "Neck Disability Index" for neck pain at the 12th week. Thus, it will be evaluated whether there is any difference in patient satisfaction, pain intensity, and disability at the 12th week between participants who selected electrotherapy as the most effective method and those who chose other treatments. | Device | Electrotherapy |
Primary outcome
Numeric Pain Scale
Time frame: The pain intensity of all participants will be assessed using the Numeric Pain Scale (NPS) before starting the treatment and 12 weeks after the treatment.
Patients' pain intensity will be assessed using the 10 cm Numeric Pain Scale (NPS), ranging from "0" (no pain) to "10" (unbearable pain). Patients will be asked the question, "How would you rate your current pain?" and will be requested to rate their pain on the scale.
Disability
Time frame: The disability level will be assessed using the Oswestry Disability Index for low back pain and the Neck Disability Index for neck pain before starting the treatment and 12 weeks after the treatment.
The functional disability level of patients will be determined using the Oswestry Disability Index, which evaluates daily living activities from 10 different aspects. A higher score indicates greater functional disability. The impact of neck pain on an individual's daily life will be assessed using the Neck Disability Index (NDI). The NDI consists of 10 sections that assess neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreational activities.
Determination of patients' treatment preferences
Time frame: Patients' treatment preferences will be assessed before starting the treatment.
In this study, To evaluate participants' perceptions regarding treatment preferences, four informative videos introducing commonly used physiotherapy and rehabilitation methods for the treatment of low back and neck pain (electrotherapy applications [TENS, ultrasound, hot pack], manual therapy, kinesiotaping and dry needling, exercise and education) will be prepared and shown to the participants. After watching the videos, participants will be asked to rank the treatment methods from the most effective to the least effective based on their perceived effectiveness, using a scale from 1 to 4 (1 = most effective, 4 = least effective). This ranking will be based on participants' personal evaluations and will be conducted without the use of any standardized psychometric scale. In addition, participants will be asked to explain the reasons for their preferences through open-ended questions.
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 24 Jun 2025.
Related trials for Chronic Low-back Pain (cLBP)
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Recruiting
SENECA - Smart Therapies for Chronic Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)
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.
sema öztürk, Master's student principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrotherapy ( TENS, hot pack, and therapeutic ultrasound ) in people with Chronic Low-back Pain (cLBP) and Chronic Neck Pain, run by Istanbul University - Cerrahpasa 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 5 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 24 Jun 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?
Numeric Pain Scale (time frame: The pain intensity of all participants will be assessed using the Numeric Pain Scale (NPS) before starting the treatment and 12 weeks after the treatment.). The study lists 3 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 24 Jun 2025.