Low Back PainNCT07017647
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 study testing Conservative treatment and Patient Education in people with Low Back Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Conservative treatment and Patient Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2025to 10 Nov 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University
Kırşehir, Kırşehir, 40100
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Conservative treatment, Patient Education
- Keywords
- Low back pain, Patient education, Conventional treatment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentOther
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.
Patient EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Conservative treatment; Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 week
Secondary outcomes (2)
Disability
Participants' disability level will be assessed using the Oswestry Disability Index. The Oswestry Disability Index helps to assess how low back pain affects daily living activities such as pain intensity, personal care, lifting weights, walking, sitting, standing, sleeping, sexual life, social life, and travel. Each item is scored on a scale of 0-5, with higher scores representing greater disability.
Measured: 6 week
Assessment of Quality of Life
In assessing quality of life, the Turkish version of the SF-36 Quality of Life Assessment Scale, whose validity and reliability have been previously confirmed, will be used. The SF-36 Quality of Life Assessment Scale was developed to assess quality of life. The scale consists of a total of 36 items. A high total score on the scale indicates a high quality of life.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start10 Jul 2025
- Primary completion6 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trials
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet CANLI, Kirsehir Ahi Evran Universitesi
- Investigators
- Mehmet CANLI, PhD., Study director, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017647
- Sponsor's protocol ID
- 43834581758.
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07017647
- Acronym / sponsor ID
- 43834581758.
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Patient education, Conventional treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 12 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trials
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Conservative treatmentConventional 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 |
| Patient Education Group | Experimental | Other: Conservative treatment, Other: Patient EducationPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Conservative treatmentConventional 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. | Other | Control Group, Patient Education Group |
| Patient EducationPatient 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. | Other | Patient Education Group |
Primary outcome
Pain Severity
Time frame: 6 week
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.
2 secondary outcomes
Disability
Time frame: 6 week
Assessment of Quality of Life
Time frame: 6 week
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 17 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Mehmet CANLI, PhD. study director
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment and Patient Education in people with Low Back Pain, run by Kirsehir Ahi Evran Universitesi 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 4 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 17 Nov 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?
Pain Severity (time frame: 6 week). 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 17 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.