Answerability and Minimal Clinical Significance of the Pain Questionnaires

NCT ID: NCT06271447

Last Updated: 2024-08-14

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

2025-02-28

Brief Summary

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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.

Detailed Description

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Nonspecific chronic low back pain is a common condition that can have a significant impact on patient's daily lives and beliefs. Patients often believe that there is a strong relationship between structural changes in the lower back, pain, and activities of daily living. Patients with nonspecific low back pain may have lower expectations for recovery because they tend to believe that their condition is chronic and unlikely to improve significantly. Patients' beliefs and perceptions of their condition can influence the clinical management of low back pain. Tampa Scale for Kinesiophobia (TSK), Fear-Avoidance Beliefs Questionnaire (FABQ), and The Pain Catastrophizing Scale (PCS) are commonly used in patients with non-specific chronic low back pain. The common feature of these scales is that they evaluate issues such as pain perception, pain-related beliefs, and pain coping strategies. The use of these scales can provide important information to better respond to individuals' needs in pain management and rehabilitation processes. However, the minimal clinical relevance and answerability of the surveys were not explicitly discussed in the search results. Further research is needed to investigate the clinical consequences of fear-avoidance beliefs and their potential impact on treatment outcomes for patients with chronic low back pain.

Conditions

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Chronic Low-back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Traditional therapy

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.

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 previously received any exercise therapy and/or training in pain neuroscience.
* 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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Elif Esma Safran

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

Nuray N Alaca, assoc. prof.

Role: backup

500 4184 ext. Safran

Other Identifiers

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2023-21-705

Identifier Type: -

Identifier Source: org_study_id

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