Disability in Patients With Non-specific Chronic Low Back Pain

March 7, 2024 updated by: Acibadem University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • None Selected
      • Istanbul, None Selected, Turkey, 34752
        • Recruiting
        • Acıbadem Health Group
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elif E Safran, asst. prof.
        • Principal Investigator:
          • Irmak Çavuşoğlu, asst. prof.
        • Sub-Investigator:
          • Nuray Alaca, assoc. prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: baseline and through study completion, an average of 4 weeks
Visual Analog Scale (VAS) is a pain rating scale used in clinical and research settings to measure the intensity or frequency of various symptoms. In the current study, VAS will be used to record participants' pain intensity. VAS consists of a single 10 cm line; The left end is described as "No pain" and the right end is described as "The most severe pain ever experienced". Patients will be asked to mark the severity of their current pain on a 10 cm line. When calculating, the marked point will be measured in cm. An increase in the score means that the intensity of the pain increases.
baseline and through study completion, an average of 4 weeks
The Roland-Morris Disability Questionnaire
Time Frame: baseline and through study completion, an average of 4 weeks
The Roland-Morris Disability Questionnaire (RMDQ) is a tool used to assess the disability of individuals with low back pain. In the current study, the RMDQ will be used to evaluate how participants' low back pain affects functional activities. The survey, which focuses on physical functions related to low back pain, consists of 24 questions. The questionnaire is most sensitive for patients with mild to moderate disability due to acute, subacute, or chronic low back pain. It is sensitive to change over time and has been shown to provide reliable measurements in determining the level of disability. The higher the score (0-24), the higher the level of pain-related disability.
baseline and through study completion, an average of 4 weeks
The Quebec Back Pain Disability Scale
Time Frame: baseline and through study completion, an average of 4 weeks
The Quebec Back Pain Disability Scale (QBPDS) is a condition-specific questionnaire designed to measure the level of functional disability of patients with low back pain. In the current study, QBPDS will be used to evaluate the disability of patients with low back pain during functional skills. The QBPDS consists of 20 items regarding daily activities selected from six relevant subdomains of functional skills for patients with low back pain. The scale is scored on a Likert scale from 0 to 5; 0 means "not difficult at all" and 5 means "I can't do it". The total score can range from 0 to 100; a higher score indicates a more severe disability. The minimum detectable change (90% confidence) for QBPDS is 15 points.
baseline and through study completion, an average of 4 weeks
The Oswestry Disability Index
Time Frame: baseline and through study completion, an average of 4 weeks
The Oswestry Disability Index (ODI) is a self-completed questionnaire used to assess the level of disability in patients with low back pain. In the current study, the ODI will be used to evaluate the impact of low back pain on patients' daily lives.The survey consists of ten sections focusing on different aspects of daily life, such as pain severity, personal care, weight lifting, walking, sitting, standing, sleep, sexual function, social life, and travel. Each section contains six statements scored from 0 to 5; The first expression is zero, indicating no disability. The scores of all questions are summed and then multiplied by two to obtain an index ranging from 0 to 100. The higher the score, the greater the disability.
baseline and through study completion, an average of 4 weeks
The Perceived Global Impact
Time Frame: through study completion, an average of 4 weeks
The Perceived Global Impact Scale is a tool used to assess the impact of various factors on an individual's health and well-being. In the current study, the amount of improvement in symptoms perceived by participants will be assessed at the end of treatment with the Perceived Global Impact Scale. Participants were asked, "How would you describe your current situation compared to the beginning of treatment?" The question was asked. questions will be asked. They will be asked to rate on a seven-point Likert scale (1: no change or things have gotten worse; 7: much better, a significant improvement). A score of 6 or above will be chosen as the threshold for clinically significant improvement.
through study completion, an average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Elif E Safran, asst. prof., Acibadem University
  • Study Chair: Irmak I Çavuşoğlu, asst. prof., Acibadem University
  • Study Director: Nuray N Alaca, assoc. prof., Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-21-728

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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