Clinical trial NCT06271460: Disability in Patients With Non-specific Chronic Low Back Pain
Official title: Answerability and Minimal Clinical Significance of the Turkish Versions of the Roland-Morris Disability Questionnaire, Quebec Low Back Pain Disability Scale, and Oswestry Disability Index in Patients With Non-specific Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Nonspecific Low Back Pain
Keywords: chronic low back pain
disability
minimal clinically significant difference
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients diagnosed with chronic nonspecific low back pain (documented history of low back pain lasting more than twelve weeks without a recognizable, specific pathoanatomical cause of the pain) who applied to the Physical Therapy and Rehabilitation Polyclinic of the hospitals in the Acıbadem Health Group and the Physiotherapy and Rehabilitation Department of Avicenna Ataşehir Hospital will be included in the study. Diagnoses will be made by Health Physical Medicine and Rehabilitation Doctors with at least 20 years of experience.

Brief summary: To investigate the reliability and sensitivity of the Turkish versions of the Roland-Morris Disability Questionnaire, The Quebec Back Pain Disability Scale, and the Oswestry Disability Index in patients with chronic non-specific low back pain and to increase confidence in their use in clinical practice and research by determining the most appropriate minimal clinically significant difference values for this patient population.

Detailed description: The minimum clinically important difference (MCID) for nonspecific chronic low back pain and disability scales varies depending on the questionnaire used and the method used to assess the MCID. Different surveys have been proposed in the areas of pain intensity, disability-specific to low back pain, patient satisfaction with treatment results, and work disability. Validated and widely used questionnaires for disability assessment include the Roland-Morris Disability Questionnaire (RMDQ) the Quebec Back Pain Disability Scale (QBPDS) and the Oswestry Disability Index (ODI). These scales are valuable tools for assessing the level of disability and functional limitations in individuals with nonspecific chronic low back pain and play a crucial role in monitoring patients' progress and comparing the effectiveness of different interventions.

Eligibility criteria: Inclusion Criteria:

* Getting diagnosed with chronic non-specific low back pain
* Being able to read and speak Turkish
* Being between the ages of 18 and 65
* Agreeing to participate in the research and signing the voluntary consent form

Exclusion Criteria:

* Presence of systemic disease
* Cognitive impairment status (Mini-Mental State Examination \<24),
* Recent (\<12 weeks) history of myocardial infarction, cerebrovascular accident
* Presence of radiculopathy, infection, tumor, osteoporosis, vertebral fracture, trauma and surgery in the lumbar region
* Having received any exercise therapy before
* Refusal of treatment or failure to comply with treatment

Primary outcomes:
measure: Visual Analog Scale
timeFrame: baseline and through study completion, an average of 4 weeks
measure: The Roland-Morris Disability Questionnaire
timeFrame: baseline and through study completion, an average of 4 weeks
measure: The Quebec Back Pain Disability Scale
timeFrame: baseline and through study completion, an average of 4 weeks
measure: The Oswestry Disability Index
timeFrame: baseline and through study completion, an average of 4 weeks
measure: The Perceived Global Impact
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Health Group
state: None Selected
Study officials:
affiliation: Acibadem University
name: Elif E Safran, asst. prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Acibadem University
name: Irmak I Çavuşoğlu, asst. prof.
role: STUDY_CHAIR
affiliation: Acibadem University
name: Nuray N Alaca, assoc. prof.
role: STUDY_DIRECTOR
References: