Is Central Sensitization a Prognostic Indicator in Chronic Nonspecific Low Back Pain?

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMardin Artuklu University

About this trial

This observational study will examine whether signs of increased sensitivity in the nervous system at the beginning of the study are associated with short-term clinical outcomes in adults with chronic nonspecific low back pain. Approximately 180 participants will complete questionnaires about central sensitization, disability, pain, anxiety, and depression at the beginning of the study.

After 6 weeks, disability, pain, and the participant's overall perception of change will be assessed again. The researchers will evaluate whether the initial level of central sensitization is associated with meaningful improvement in disability and perceived treatment benefit. Participants will not be assigned to a treatment as part of this study and will continue to receive routine clinical care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 65 years

Diagnosis of chronic nonspecific low back pain lasting for at least 3 months

Willingness to participate in the study

Ability to provide written informed consent

Disqualifiers

Progressive neurological deficit

Inflammatory rheumatic disease

Active malignancy

History of serious spinal trauma or spinal surgery

Trial population

Adults aged 18-65 years with chronic nonspecific low back pain lasting for at least 3 months will be recruited from the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital. Participants will receive routine clinical care and will be evaluated at baseline and after 6 weeks. No healthy control group will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 1 trial group
Group A: Chronic Nonspecific Low Back Pain Cohort

Trial outcomes

Primary outcomes

1

Clinically Meaningful Improvement in the Oswestry Disability Index

The proportion of participants who achieve a reduction of at least 30% in the Oswestry Disability Index (ODI) score from baseline. The ODI ranges from 0 to 100, with higher scores indicating greater disability.

Time frame
Baseline to 6 weeks

Secondary outcomes

1

Change in the Oswestry Disability Index Score

Change in the Oswestry Disability Index (ODI) score from baseline to 6 weeks. The ODI ranges from 0 to 100, with higher scores indicating greater disability. A greater reduction indicates greater improvement in disability.

Time frame
Baseline to 6 weeks
2

Change in Pain Intensity

Change in pain intensity measured using a 0-10 Visual Analog Scale from baseline to 6 weeks. A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain. A greater reduction indicates greater improvement in pain.

Time frame
Baseline to 6 weeks
3

Patient-Perceived Improvement

Patient-perceived change in overall clinical status will be assessed using the Global Rating of Change scale at 6 weeks. Participants will report whether their condition has improved, remained unchanged, or worsened compared with baseline. The responses will be classified as perceived treatment benefit or no perceived treatment benefit according to the prespecified study criteria.

Time frame
At 6 weeks

Other outcomes

Sponsors and contacts

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Mardin Artuklu University

Lead sponsor

Mardin Training and Research Hospital

Collaborator