Clinical trial NCT06898502: Investigation of Conservative Treatment Preferences of Patients With Chronic Low Back and Neck Pain
Official title: Investigation of Conservative Treatment Preferences of Patients With Chronic Low Back and Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain (cLBP)
Chronic Neck Pain
Keywords: chronic low back pain
chronic neck pain
physiotherapy and Rehabilitation
patitent&#39;s preference
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Numeric Pain Scale
timeFrame: 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.
measure: Disability
timeFrame: 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.
measure: Determination of patients' treatment preferences
timeFrame: Patients' treatment preferences will be assessed before starting the treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University Cerrahpaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: sema öztürk, Master's student
role: PRINCIPAL_INVESTIGATOR
References: