Clinical trial NCT07017647: Comparison of the Effectiveness of Conventional Treatment and Patient Education in Addition to Conventional Treatment in Individuals With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
Official title: Comparison of the Effectiveness of Conventional Treatment and Patient Education in Addition to Conventional Treatment in Individuals With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Patient education
Conventional treatment
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trials
Primary purpose: TREATMENT

Brief summary: Patient education is another treatment method that has recently begun to be used in patients with chronic back pain. In chronic lower back pain, factors such as the cause of the pain, negative factors that may contribute to the discomfort and exacerbate the symptoms, how to manage lower back pain, ways to prevent pain, exercises and proper postures to reduce pain, and harmful movements and positions to avoid in daily life can be included in patient education for chronic lower back pain. It has been reported that patient education in patients with chronic lower back pain can have positive effects on treatment outcomes by reducing pain, disability, and fear of movement.

Detailed description: Low back pain is a common musculoskeletal disorder that affects approximately 80% of adults. Low back pain causes disability and functional impairment and places a significant burden on national health expenditures. Factors such as trauma, high body mass index, heavy working conditions, and weak abdominal and back muscles can cause low back pain. The most common cause of lower back pain is regional mechanical dysfunction. Rather than a single acute trauma, repetitive, cumulative traumas over time play a significant role. Risk factors such as heavy living and working conditions, poor static and dynamic posture, improper use of body mechanics, decreased strength and flexibility of abdominal and back muscles, reduced cardiovascular endurance, smoking, and vibration are known to contribute to back pain. Therefore, it is crucial to educate individuals with back pain and those at risk of developing it about these preparatory and symptom-aggravating factors. Back pain negatively affects many activities of individuals, including social life, lifting weights, carrying objects, walking, bending, standing, travelling, and dressing, thereby reducing their quality of life. Therefore, it is crucial to treat lower back pain using the effective methods recommended in the literature. If lower back pain persists for more than six months, it is classified as chronic lower back pain.

The treatment of chronic low back pain includes surgical approaches and conservative treatment. The aim of conservative treatment is to bring the patient's current condition to the best possible level. To this end, functional restoration is important in terms of both the rehabilitation of the primary damaged area and the dysfunctional secondary areas in order to accelerate the return to activity and reduce the chance of recurrence of low back pain. A treatment and rehabilitation programme is necessary to maintain the patient's optimal physiological and biomechanical fitness and to reduce the frequency of recurrent episodes of back pain. The goals of treatment in patients with chronic back pain are to reduce pain, prevent loss of condition that may develop as a result of prolonged immobilisation, prevent recurrence, resolve psychosocial problems within a multidisciplinary approach, reduce the rate of degeneration, and ensure early return to normal activities and work. In patients with chronic low back pain, pain, spasm, decreased muscle strength, and impaired posture reduce physical endurance and negatively affect the patient's functional capacity and quality of life. Conventional treatment for chronic low back pain includes conservative treatment methods. These conservative treatment methods include electrophysical agents, massage, traction, manual treatment methods, and exercise. Effective results have been reported in patients with chronic low back pain using these conservative treatment methods.

Patient education is another treatment method that has recently begun to be used in patients with chronic back pain. In chronic lower back pain, factors such as the cause of the pain, negative factors that may contribute to the discomfort and exacerbate the symptoms, how to manage lower back pain, ways to prevent pain, exercises and proper postures to reduce pain, and harmful movements and positions to avoid in daily life can be included in patient education for chronic lower back pain. It has been reported that patient education in patients with chronic lower back pain can have positive effects on treatment outcomes by reducing pain, disability, and fear of movement.

The literature highlights the limited number of studies investigating the effectiveness of patient education as an adjunct to conventional treatment in patients with chronic low back pain, suggesting that further studies in this area could make important contributions to the literature. In light of this, the aim of this study is to compare the effects of conventional treatment and patient education administered in addition to conventional treatment on pain intensity, disability status, and quality of life in patients with chronic low back pain, and to share the findings with the literature.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chronic low back pain by a specialist physician
* Patients who have had low back pain for more than six months
* Patients aged 18 years or older and between 18 and 65 years of age
* Patients who are not currently receiving any treatment for low back pain
* Patients with chronic non-specific low back pain

Exclusion Criteria:

* Patients with a history of surgery or trauma involving the lumbar or thoracic region,
* Patients who have received treatment for back pain in the past year,
* Patients with disc pathology, spinal fracture or dislocation, infection, malignancy, previous surgery, metabolic or inflammatory back pain, and neurological loss
* Patients who refuse to participate in the study or who do not sign the informed consent form

Primary outcomes:
measure: Pain Severity
timeFrame: 6 week
Secondary outcomes:
measure: Disability
timeFrame: 6 week
measure: Assessment of Quality of Life
timeFrame: 6 week
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kırşehir Ahi Evran University
state: Kırşehir
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: Mehmet CANLI, PhD.
role: STUDY_DIRECTOR
References: