Disability in Patients With Non-specific Chronic Low Back Pain

NCT ID: NCT06271460

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-04

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Nonspecific Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Traditional physiotherapy

All participants will receive a 60-minute individual treatment program consisting of 16 sessions of routine physiotherapy aimed at reducing pain and improving function over four weeks. These treatments are already the patient's routine physiotherapy modalities. No changes will be made to the study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elif E Safran, asst. prof.

Role: PRINCIPAL_INVESTIGATOR

Acibadem University

Irmak I Çavuşoğlu, asst. prof.

Role: STUDY_CHAIR

Acibadem University

Nuray N Alaca, assoc. prof.

Role: STUDY_DIRECTOR

Acibadem University

Locations

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Acıbadem Health Group

Istanbul, None Selected, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Elif E Safran, asst. prof.

Role: CONTACT

500 4047 ext. 216

Nuray N Alaca, assoc. prof.

Role: CONTACT

500 4181 ext. 216

Facility Contacts

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Elif E Safran, asst. prof.

Role: primary

500 4047 ext. 216

Irmak Çavuşoğlu, asst. prof.

Role: backup

500 4184 ext. 216

Other Identifiers

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2023-21-728

Identifier Type: -

Identifier Source: org_study_id

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