Disability in Patients With Non-specific Chronic Low Back Pain

NCT06271460 | Recruiting

• 1 other identifier: 2023-21-728
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Nonspecific Low Back Pain

Keywords

chronic low back pain; disability; minimal clinically significant difference

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale

  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

  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

  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

  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

  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

Interventions

Traditional physiotherapy OTHER

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem Health Group

Istanbul, None Selected, 34752, Turkey (Türkiye)

RECRUITING

Study Officials

• Elif E Safran, asst. prof.

  Acibadem University

  PRINCIPAL INVESTIGATOR

• Irmak I Çavuşoğlu, asst. prof.

  Acibadem University

  STUDY CHAIR

• Nuray N Alaca, assoc. prof.

  Acibadem University

  STUDY DIRECTOR

Central Study Contacts

Elif E Safran, asst. prof.

CONTACT

500 4047; elif.bayraktar@acibadem.edu.tr

Nuray N Alaca, assoc. prof.

CONTACT

500 4181; nuray.alaca@acibadem.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: March 4, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

TU (1)