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Not yet recruiting NCT07296185

The Effect of Body Awareness on Pain, Disability, Sensorimotor Acuity, Psychosocial and Central Sensitization Levels in Individuals With Non-Specific Chronic Low Back Pain

— Observational Non-specific Chronic Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Non-specific Chronic Low Back Pain. Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study will be conducted to examine the levels of pain, pressure pain threshold, joint position sense, sensation, functionality, pain catastrophizing, central sensitization, and body awareness in individuals with non-specific chronic low back pain, and to compare these findings with those of healthy individuals. Additionally, the study will aim to objectively investigate the relationships between lumbar self-perception (FreBAQ) and tactile acuity (TPDT), pressure pain threshold (PPT), lumbar joint position sense (LJPS), as well as psychosocial (PCS) and central sensitization (CSI) indicators in individuals with non-specific chronic low back pain. Furthermore, the study will seek to evaluate the predictive effects of lumbar self-perception on pain (VAS) and disability (RMDQ), in conjunction with objectively assessed sensory and sensorimotor measures in individuals with non-specific chronic low back pain.

Detailed description

This study will be conducted to examine the levels of pain, pressure pain threshold, joint position sense, sensation, functionality, pain catastrophizing, central sensitization, and body awareness in individuals with non-specific chronic low back pain, and to compare these findings with those of healthy individuals. Additionally, the study will aim to objectively investigate the relationships between lumbar self-perception (FreBAQ) and tactile acuity (TPDT), pressure pain threshold (PPT), lumbar joint position sense (LJPS), as well as psychosocial (PCS) and central sensitization (CSI) indicators in individuals with non-specific chronic low back pain. Furthermore, the study will seek to evaluate the predictive effects of lumbar self-perception on pain (VAS) and disability (RMDQ), in conjunction with objectively assessed sensory and sensorimotor measures in individuals with non-specific chronic low back pain. A total of forty-one individuals with non-specific chronic low back pain will be included in the NCLBP group (n=41), and forty-one healthy individuals will be included in the healthy group (n=41). All participants will be between 25 and 65 years of age. Pain levels and catastrophization levels of all participants will be assessed using the Visual Analogue Scale (VAS) and Pain Catastrophizing Scale (PCS). Lumbar joint position sense will be evaluted using a with digital electrogoniometer, tactile acuity of the lumbar region will be assessed using Two-Point Discrimination Test (TPDT), Pressure Pain Threshold (PPT) will be measured using algometer, functionality will be assessed using Roland Morris Disability Questionnaire (RMDQ), body awareness levels with Fremantle Back Awareness Questionnaire (FreBAQ) and central sensitization levels with Central Sensitization Inventory (CSI).

Interventions

  • Other No intervention
    No intervention applied, observational study.

Primary outcome measures

  • Central sensitization levels [Time frame: Baseline.]
  • Body awareness levels [Time frame: Baseline.]
  • Tactile acuity of the lumbar region [Time frame: Baseline.]
  • Lumbar joint position sense [Time frame: Baseline.]
  • Pressure Pain Threshold (PPT) [Time frame: Baseline.]
  • Pain levels [Time frame: Baseline.]
  • Functionality [Time frame: Baseline.]
  • Catastrophization levels [Time frame: Baseline.]

Eligibility criteria

Inclusion criteria are as follows:

  • Eligible participants were defined according to the National Institute of Health Task Force for Research Standards for Chronic Pain (RTF). The RTF defines chronic pain as a pain problem that has persisted for at least 3 months and has been present on at least half of the days in the past 6 months. Following these guidelines, two questions will be used to determine chronicity:
  • "How long has the pain been an ongoing problem for you?"
  • "How often has pain been an ongoing problem for you over the past 6 months?" A response of "greater than 3 months" to question 1 and "at least half the days in the past 6 months" to question 2 indicated chronic pain.
  • Being 25 and 65 years of age and having no spinal fractures or acute disc herniation;
  • Non-specific chronic low back group for pain a current VAS pain rating ≥4/10; and scoring at least 4 points on the Roland-Morris Disability Questionnaire (RMDQ),
  • Having pain that does not correspond to specific anatomical structures and is widespread;
  • Having no current psychiatric disorders or cognitive impairments and cognitive level sufficient to complete the interview and questionnaires;
  • For the healthy group; Absence of low back pain during the past six months, no history of chronic pain lasting ≥3 months in any body region, having a Visual Analog Scale (VAS) score of VAS ≤1, which having a Roland Morris Disability Questionnaire (RMDQ) score of RMDQ ≤4;
  • Having no history of spinal surgery.

Exclusion criteria are as follows:

  • The current use of tranquilizers or opioids, any visual or motor impairments (including dyslexia) or presentation with any neurological disease or significant mental illness;
  • Potential subjects if they have nerve symptoms below the knee;
  • Diagnosed chronic fatigue syndrome, fibromyalgia, or other chronic widespread pain syndromes.
  • Severe comorbidities such as neurological disorders, cardiovascular diseases, or rheumatologic conditions.
  • Patients who had undergone spinal surgery, had any illness, or received any treatment that could cause harm were excluded;
  • Having a diagnosis of lumbar radiculopathy;
  • Tumors or infections;
  • Pain arising from metastasis, osteoporosis, inflammatory arthritis, or fractures;
  • Specific medical conditions (such as neck or back surgery within the last 3 years, osteoporotic vertebral fractures);
  • Receiving any other treatment for chronic non-specific low back pain during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medipol Unıversity — Istanbul

Identifiers

NCT: NCT07296185 · KBA-MED25-REK · E-10840098-202.3.02-624

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗