CClinicalTrials.gg
CompletedNCT06898502Updated Jun 24, 2025

Investigation of Conservative Treatment Preferences of Patients With Chronic Low Back and Neck Pain

An interventional study of Electrotherapy ( TENS, hot pack, and therapeutic ultrasound ) in Chronic Low-back Pain (cLBP) and Chronic Neck Pain, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2024, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Low-back Pain (cLBP)
  • Chronic Neck Pain

Keywords

  • chronic low back pain
  • chronic neck pain
  • physiotherapy and Rehabilitation
  • patitent&#39;s preference
03

In context

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Electrotherapy

    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.

    Device: Electrotherapy ( TENS, hot pack, and therapeutic ultrasound )

Interventions

  • DeviceElectrotherapy ( TENS, hot pack, and therapeutic ultrasound )

    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.

    Also known as: Transcutaneous Electrical Nerve Stimulation, hot pack, therapeutic ultrasound, Electrotherapy

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    Time frame: Patients' treatment preferences will be assessed before starting the treatment.

07

Study locations

1 site
  • Istanbul University Cerrahpaşa
    Istanbul, Istanbul 34000, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06898502
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Sema Oztürk (master's student, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Mar 27, 2025
Start date
Sep 1, 2024
Primary completion
May 29, 2025
Completion
May 29, 2025
Last update
Jun 24, 2025

Study contacts

sema öztürk, Master's student
principal investigator · Istanbul University - Cerrahpasa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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