NCT07017647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
Last Updated

November 17, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 4, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

Low back painPatient educationConventional treatment

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

    Visual Analogue Scale (VAS) was used to determine the presence and severity of low back pain in the study participants. VAS is a practical test with high validity and reliability in pain assessment. VAS is an assessment method numbered from 0 to 10, where '0' indicates no pain and '10' indicates the presence of the most severe pain. Participants were asked to mark the degree of pain they had on this scale and recorded.

    6 week

Secondary Outcomes (2)

  • Disability

    6 week

  • Assessment of Quality of Life

    6 week

Study Arms (2)

Control Group

EXPERIMENTAL

Conventional physiotherapy treatments will be administered to patients in the control group three days a week for six weeks. This programme will include the following treatments: electrotherapy modalities for pain relief (TENS current application), moist heat application, flexibility and strengthening exercises to stretch and strengthen the back and spinal muscles, and massage and manual therapy to relax the back muscles and reduce pain. First, TENS current will be applied for 15 minutes using an electrical stimulation device due to its pain-relieving properties. Then, moist heat application will be performed for 15 minutes. Following this, flexibility and strengthening exercises aimed at stretching and strengthening the lower back and back muscles will be performed under the supervision of a physical therapist for approximately 20 minutes. Patients will be guided to perform the exercises correctly. Thus, the total duration of the conventional physical therapy session will be 50 minut

Other: Conservative treatment

Patient Education Group

EXPERIMENTAL

Patients in the pain education group will receive conventional physiotherapy treatments three days a week for six weeks. In addition to conventional physiotherapy treatments, patients will receive comprehensive patient education for 6 weeks. This education will be provided immediately after each conventional physiotherapy session. Patients will be asked to pay attention to and comply with the recommendations/instructions provided in this education. Comprehensive patient education includes the following: the cause of chronic back pain, negative factors that may cause discomfort and exacerbate symptoms, how to cope with back pain, ways to prevent pain, exercises and proper postures to reduce pain, and harmful movements and positions to avoid in daily life.

Other: Conservative treatmentOther: Patient Education

Interventions

Conventional physiotherapy treatments will be administered to patients in both groups three days a week for six weeks. This programme will include the following treatments: electrotherapy modalities for pain relief (TENS current application), moist heat application, flexibility and strengthening exercises to stretch and strengthen the back and spinal muscles, and massage and manual therapy applications to relax the back muscles and reduce pain. First, TENS current will be applied for 15 minutes using an electrical stimulation device due to its pain-relieving properties. Then, moist heat application will be performed for 15 minutes. Following this, flexibility and strengthening exercises aimed at stretching and strengthening the lower back and back muscles will be performed under the supervision of a physical therapist for approximately 20 minutes.

Control GroupPatient Education Group

Patient education will be provided immediately after conventional physiotherapy applications in each session. Patients will be asked to pay attention to and comply with the recommendations/issues covered in this education. Comprehensive patient education includes the following: the cause of chronic back pain, negative factors that may cause discomfort and exacerbate symptoms, how to cope with back pain, ways to prevent pain, exercises and proper postures to reduce pain, and harmful movements and positions to avoid in daily life.

Patient Education Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Conservative TreatmentPatient Education as Topic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mehmet CANLI, PhD.

    Kirsehir Ahi Evran Universitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

July 10, 2025

Primary Completion

November 6, 2025

Study Completion

November 10, 2025

Last Updated

November 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations