Answerability and Minimal Clinical Significance of the Pain Questionnaires

NCT06271447 | Recruiting

• 1 other identifier: 2023-21-705
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation.

Conditions

Chronic Low-back Pain

Keywords

Chronic Low Back Pain; pain management; rehabilitation; minimal clinical significance

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

• Fear-Avoidance Beliefs Questionnaire

  Fear-Avoidance Beliefs Questionnaire is a tool used to assess fear-avoidance beliefs in patients with low back pain. In the current study, the fear and avoidance behaviors of the participants will be evaluated with FABQ. In the survey, which consists of sixteen questions and two subscales (physical activity and work), each question is scored on a six-point Likert scale (0: strongly disagree; 5: strongly agree). A high score in the evaluation is considered to indicate an increase in fear-avoidance behavior.

  baseline and through study completion, an average of 4 weeks

• Tampa Scale for Kinesiophobia

  The Tampa Scale for Kinesiophobia (TSK) will be used to assess participants' fear of movement. TSK is a 17-item scale developed to describe the fear of movement or re-injury. Each question is scored on a four-point Likert scale (1: strongly disagree; 4: strongly agree). The scoring of four items was reversed (items 4, 8, 12, and 16). Higher scores represent an increased fear of movement.

  baseline and through study completion, an average of 4 weeks

• The Pain Catastrophizing Scale

  The Pain Catastrophizing Scale will be used to assess participants' pain-related thoughts and feelings. It is self-administered and consists of 13 items and 3 subscales (helplessness, magnification, and rumination). It is scored using a five-point Likert-type scale (0: never; 4: always). High scores indicate high levels of catastrophizing.

  baseline and through study completion, an average of 4 weeks

• The Perceived Global Impact

  The Global Perceived Impact Scale (GAES) is the usual gold standard for assessing minimal clinically significant change associated with pain in a patient's subjective perception of improvement (global perceived impact). In the current study, the amount of improvement in symptoms perceived by the participants will be evaluated at the end of treatment with GAES. Participants were asked "How would you describe your current condition compared to the beginning of treatment?" question 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 therapy 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. Since the questionnaires to be used in the study are related to fear of movement and pain, neuroscience education will be included in the treatment program of the patients. Patients will be informed about proper posture and movement regarding fear of movement and pain avoidance behaviors.

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 given by Health Physical Medicine and Rehabilitation Doctors with at least 20 years of experience. At the first meeting, eligible participants will be informed about the study, potential participants will be screened in terms of inclusion criteria, and verbal and written informed consent will be obtained from eligible participants by the Helsinki criteria.

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 previously received any exercise therapy and/or training in pain neuroscience.
• Refusal of treatment or failure to comply with treatment

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Elif Esma Safran

Istanbul, None Selected, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

TU (1)