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Influence of Kinesiophobia on the Outcome of Chronic Low Back Pain Condition

G

Gulf Medical University

Status

Unknown

Conditions

Low Back Pain

Treatments

Other: Case control study

Study type

Observational

Funder types

Other

Identifiers

NCT05079893
IRB/COHS/FAC/03/May-2021

Details and patient eligibility

About

Though large body of evidence reported association between pain and kinesiophobia, there are paucity of studies in associating kinesiophobia to muscle endurance and position sense in patients with Chronic lower back pain [CLBP]. To the best of Investigator's knowledge, till date there is no studies assessing the relationship between kinesiophobia and endurance and position sense in subjects with CLBP. Therefore, the current study aims to compare the impact of kinesiophobia on lumbar extensor endurance, position sense in patient with CLBP and asymptomatic individuals.

Full description

Background:

Patients with chronic low back pain (CLBP) frequently present with kinesiophobia. Recent high quality studies reported a moderate to strong evidence of associations between a greater degree of kinesiophobia and greater levels of pain, greater levels of disability and poorer quality of life. However, there are paucity of studies in associating kinesiophobia to muscle endurance and position sense in patients with CLBP.

Objective:

The primary aim of the study is to compare the impact of kinesiophobia on lumbar extensor endurance, position sense in patient with CLBP and asymptomatic individuals. Secondarily, to examine the association between kinesiophobia and lumbar extensor endurance, position sense, pain intensity and functional ability in patients with CLBP. Thirdly to assess the degree of association with various factors on CLBP, lumbar endurance and position sense.

Material and Methods:

This case-control study will have 200 patients with CLBP and 400 controls. Kinesiophobia will be assessed with Tampa Scale for Kinesiophobia. Lumbar endurance will be assessed with Soren's lumbar extensor test and lumbar position sense with neutral and target lumbar re-positioning tests. Secondarily, the pain intensity will be assessed with visual analog scale, functional ability with patient-specific Functional Scale in patients with CLBP. Kinesiophobia, lumbar endurance, and joint position sense will be compared between patients and controls. Kinesiophobia scores will be correlated with lumbar extensor endurance and proprioception joint position errors, pain intensity, and functional ability. Simple and multiple binary logistic regression will be used to determine crude and adjusted Odd's Ratio for kinesiophobia, lumbar position sense and kinesiophobia, lumbar endurance.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for CLBP subjects:

  • Adults aged between 18 and 50 years.
  • Suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician.
  • Enough physical autonomy to participate in the physical activities required by the study.

Exclusion Criteria CLBP subjects:

  • Low back pain patients with radiculopathy, post fractures, stenosis and history of tumors, cauda equina syndrome and infection.
  • Patient under antidepressive medication Inclusion Criteria for Asymptomatic subjects Age 18 years and above, Either gender.

Exclusion Criteria for Asymptomatic subjects

  • H/o previous lower back injury.
  • H/o lower limb or trunk pathology.
  • Presence of deformity, or condition that may alter motor control.
  • History of inflammatory, infectious disease and malignancy in the spine
  • Patient under anti depressive medication

Trial design

600 participants in 2 patient groups

Cases
Description:
The cases will be the patients suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician.
Treatment:
Other: Case control study
Controls
Description:
The controls will be the patients matched for age, sex, handedness who had no complaints of lower back pain
Treatment:
Other: Case control study

Trial contacts and locations

0

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Central trial contact

Dr. Praveen Kumar Kandakurthi, PhD

Data sourced from clinicaltrials.gov

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