Clinical trial NCT05079893: Influence of Kinesiophobia on the Outcome of Chronic Low Back Pain Condition
Official title: Influence of Kinesiophobia on Pain Intensity, Disability, Muscle Endurance and Position Sense in Subjects With Chronic Low Back Pain- A Case Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Keywords: Low back pain
Kinesiophobia
position sense
Endurance
Lead sponsor: Gulf Medical University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician.

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Measuring Kinesiophobia.
timeFrame: 5 MONTHS
measure: Measuring Lumbar extensor endurance.
timeFrame: 5 MONTHS
measure: Measuring Lumbar repositioning tests
timeFrame: 5 MONTHS
Secondary outcomes:
measure: Measuring Pain
timeFrame: 5 MONTHS
measure: Measuring Functional ability
timeFrame: 5 MONTHS
Other outcomes:
Locations:
Study officials:
affiliation: College of Health Sciences, Gulf Medical University
name: Dr. Praveen Kumar Kandakurthi, PhD
role: STUDY_CHAIR
affiliation: College of Health Sciences, Gulf Medical University
name: Dr. Watson Arulsingh Daniel Ragland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thumbay Physical Therapy and Rehabilitation Hospital
name: Sharad Patil, MPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kandakurti PK, Arulsingh W, S Patil S. Influence of kinesiophobia on pain intensity, disability, muscle endurance, and position sense in patients with chronic low back pain-a case-control study. Trials. 2022 Jun 6;23(1):469. doi: 10.1186/s13063-022-06406-6.