Disability in Patients With Non-specific Chronic Low Back Pain

Recruiting

• Conditions: Chronic Nonspecific Low Back Pain

• Registration Number: NCT06271460
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-21
• Status Verified: 2024-03
• Study Start: 2024-03-04
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-08
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	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.
The Roland-Morris Disability Questionnaire	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.
The Quebec Back Pain Disability Scale	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.
The Oswestry Disability Index	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.
The Perceived Global Impact	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.

Trial Locations

Locations (1)

Acıbadem Health Group; 🇹🇷 Istanbul, None Selected, Turkey