Failed Back Surgery Syndromeback painNCT07488936
Effects of Low Back Pain Types on Pain Severity and Quality of Life in Patients With Failed Back Surgery Syndrome
An observational study of Failed Back Surgery Syndrome and Chronic Pain, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome. The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Chronic Pain
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.
Who may be able to join
- *Being over 18 years of age
- Being willing to participate in the study
- Having been diagnosed with failed back surgery syndrome
Who cannot join
- *Those under 18 years of age
- Those with major psychiatric illnesses
- Those with communication problems
- Other causes of back pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya Beyhekim Eğitim Araştırma Hastanesi
Konya, Selçuklu, 42060
Emrah Çetin, doctor, 05417606950, dremrahcetin4547@gmail.com
About this study
The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome.
The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.
Read more
Patients will be evaluated in a single session. The Visual Analog Scale (VAS), Pain Catastrophizing Scale (PCS) will be used to determine the patients' pain level and impact, the Roland-Morris Disability Questionnaire (RMDQ) will be used for functionality assessment, and the SF-36 score will be used for quality of life assessment.
To determine the type of pain:
Those with pain levels above the cutoff value on the DN4 (Douleur Neuropathique 4 Questions) pain scale will be diagnosed with neuropathic pain.
For nociplastic pain affecting the musculoskeletal system, a diagnosis of nociplastic pain will be made according to clinical criteria and grading scores.
Those who do not meet these criteria will be classified as having nociceptive pain.
Read the detailed description
The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome.
The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.
Patients will be evaluated in a single session. The Visual Analog Scale (VAS), Pain Catastrophizing Scale (PCS) will be used to determine the patients' pain level and impact, the Roland-Morris Disability Questionnaire (RMDQ) will be used for functionality assessment, and the SF-36 score will be used for quality of life assessment.
To determine the type of pain:
Those with pain levels above the cutoff value on the DN4 (Douleur Neuropathique 4 Questions) pain scale will be diagnosed with neuropathic pain.
For nociplastic pain affecting the musculoskeletal system, a diagnosis of nociplastic pain will be made according to clinical criteria and grading scores.
Those who do not meet these criteria will be classified as having nociceptive pain.
This study is designed as a prospective, hospital-based study. Twenty hundred patients with failed lumbar spine syndrome who presented to the physical therapy and rehabilitation (PHR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of low back pain lasting at least three months will be included in the study. A power analysis could not be performed due to the lack of similar studies in the literature review. Once 200 patients are reached, a PoSHOCK power analysis will be performed, and if an 80% power ratio is not achieved, patient recruitment will continue. Detailed histories and physical examinations will be conducted for all participants. Sociodemographic and clinical characteristics of the participants will be determined through questions regarding age, gender, height, weight, education level, employment status, and income level.
Inclusion Criteria *Being over 18 years of age
- Being willing to participate in the study
- Having been diagnosed with failed back surgery syndrome Exclusion Criteria
- Those under 18 years of age
- Those with major psychiatric illnesses
- Those with communication problems
- Other causes of back pain Once 200 patients are reached, a Poshoc power analysis will be performed, and if an 80% power ratio is not achieved, patient recruitment will continue.
- Conditions
- Failed Back Surgery Syndrome, Chronic Pain
- Keywords
- failed back surgery syndrome, back pain, types of pain
- Medical subject headings
- Failed Back Surgery Syndrome, Chronic Pain, Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of pain types on quality of life in patients with failed back surgery syndrome
Quality of life will be assessed using the SF-36 , Pain Catastrophizing Scale-PCS , The Roland-Morris Disability Questionnaire-RMDQ, DN4 (Douleur Neuropathique 4 Questions) Vizüel Analog Scale (VAS) scale and quality of life scores will be compared according to different pain types.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- savaş KARPUZ, ASSOCIATE PROFESSOR DOCTOR, Study director, KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİSAVAŞ KARPUZ, Study director, KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488936
- Sponsor's protocol ID
- KonyaBeyhekimTRH2023/360
- Acronym
- back pain
- Status last verified
- Jan 2026
- First submitted
- 12 Dec 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: failed spinal surgeon syndrome
Publications
Manchikanti L, Singh V. Failed back surgery: etiology and diagnostic evaluation. Spine J. 2004 Jul-Aug;4(4):486-8; author reply 488-9. doi: 10.1016/j.spinee.2004.03.007. No abstract available.
PubMed 15246312
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Back Pain Types on Pain Severity and Quality of Life in Patients With Failed Back Surgery Syndrome
- ClinicalTrials.gov ID
- NCT07488936
- Acronym / sponsor ID
- back pain / KonyaBeyhekimTRH2023/360
- Conditions
- Failed Back Surgery Syndrome, Chronic Pain
- Keywords
- failed back surgery syndrome, back pain, types of pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (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.
The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome.
The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.
Patients will be evaluated in a single session. The Visual Analog Scale (VAS), Pain Catastrophizing Scale (PCS) will be used to determine the patients' pain level and impact, the Roland-Morris Disability Questionnaire (RMDQ) will be used for functionality assessment, and the SF-36 score will be used for quality of life assessment.
To determine the type of pain:
Those with pain levels above the cutoff value on the DN4 (Douleur Neuropathique 4 Questions) pain scale will be diagnosed with neuropathic pain.
For nociplastic pain affecting the musculoskeletal system, a diagnosis of nociplastic pain will be made according to clinical criteria and grading scores.
Those who do not meet these criteria will be classified as having nociceptive pain.
Detailed description
The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome.
The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.
Patients will be evaluated in a single session. The Visual Analog Scale (VAS), Pain Catastrophizing Scale (PCS) will be used to determine the patients' pain level and impact, the Roland-Morris Disability Questionnaire (RMDQ) will be used for functionality assessment, and the SF-36 score will be used for quality of life assessment.
To determine the type of pain:
Those with pain levels above the cutoff value on the DN4 (Douleur Neuropathique 4 Questions) pain scale will be diagnosed with neuropathic pain.
For nociplastic pain affecting the musculoskeletal system, a diagnosis of nociplastic pain will be made according to clinical criteria and grading scores.
Those who do not meet these criteria will be classified as having nociceptive pain.
This study is designed as a prospective, hospital-based study. Twenty hundred patients with failed lumbar spine syndrome who presented to the physical therapy and rehabilitation (PHR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of low back pain lasting at least three months will be included in the study. A power analysis could not be performed due to the lack of similar studies in the literature review. Once 200 patients are reached, a PoSHOCK power analysis will be performed, and if an 80% power ratio is not achieved, patient recruitment will continue. Detailed histories and physical examinations will be conducted for all participants. Sociodemographic and clinical characteristics of the participants will be determined through questions regarding age, gender, height, weight, education level, employment status, and income level.
Inclusion Criteria *Being over 18 years of age
- Being willing to participate in the study
- Having been diagnosed with failed back surgery syndrome Exclusion Criteria
- Those under 18 years of age
- Those with major psychiatric illnesses
- Those with communication problems
- Other causes of back pain Once 200 patients are reached, a Poshoc power analysis will be performed, and if an 80% power ratio is not achieved, patient recruitment will continue.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.
Key inclusion criteria (3 listed)
- *Being over 18 years of age
Key exclusion criteria (4 listed)
- *Those under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of pain types on quality of life in patients with failed back surgery syndrome
Time frame: Baseline
Quality of life will be assessed using the SF-36 , Pain Catastrophizing Scale-PCS , The Roland-Morris Disability Questionnaire-RMDQ, DN4 (Douleur Neuropathique 4 Questions) Vizüel Analog Scale (VAS) scale and quality of life scores will be compared according to different pain types.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 15246312Manchikanti L, Singh V. Failed back surgery: etiology and diagnostic evaluation. Spine J. 2004 Jul-Aug;4(4):486-8; author reply 488-9. doi: 10.1016/j.spinee.2004.03.007. No abstract available.
- Manchikanti L, Singh V. Failedbacksurgery: etiology and diagnosticevaluation. Spine J. 2004;4(4):486-8.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. failed spinal surgeon syndrome
Related trials for Failed Back Surgery Syndrome
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Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
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Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
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Not yet recruitingObservational study
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
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Active, not recruiting
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Recruiting
Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
Failed Back Surgery Syndrome
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.
savaş KARPUZ, ASSOCIATE PROFESSOR DOCTOR study director
KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ
SAVAŞ KARPUZ study director
KONYA BEYHEKİM EĞİTİM ARAŞTIRMA HASTANESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed Back Surgery Syndrome and Chronic Pain, run by Konya Beyhekim Training and Research Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact emrah çetin, doctor (+905417606950, dremrahcetin4547@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of pain types on quality of life in patients with failed back surgery syndrome (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07488936, which also lists 1 linked publication.
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 23 Mar 2026.