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

• Conditions: Low Back Pain
• Interventions: Other: Case control study

• Registration Number: NCT05079893
• Lead Sponsor: Gulf Medical University

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.

Study Timeline

• Study First Submitted: 2021-09-23
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-04
• Last Update Submitted: 2021-10-04
• Study Start: 2021-10-15
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Primary Completion: 2022-01
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Case control study	The controls will be the patients matched for age, sex, handedness who had no complaints of lower back pain
Cases	Case control study	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.

Primary Outcome Measures

Name	Time	Method
Measuring Kinesiophobia.	5 MONTHS	Fear of movement/injury or reinjury will be assessed using the Tampa Scale for Kinesiophobia (TSK), a 17 self-reporting items with scores ranging from 17 (absence of fear) to 68 (highest fear). Tampa Scale for Kinesiophobia has been reported to have good reliability in patients with CLBP.
Measuring Lumbar repositioning tests	5 MONTHS	Lumbar repositioning tests will be measured with dual inclinometer
Measuring Lumbar extensor endurance.	5 MONTHS	The subjects will be tested during a 1-hour session and will be asked to undergo a body weight dependent isometric back extension (Sorensen) test on a horizontal table

Secondary Outcome Measures

Name	Time	Method
Measuring Pain	5 MONTHS	measured with Visual analog scale (VAS). The visual analogue scale consists of a 10-cm line, with the left extremity representing (absence of pain) and the right extremity indicating (great pain). Participants were asked to indicate in the scale their current level of pain, higher values being related to more intense pain.
Measuring Functional ability	5 MONTHS	Functional ability will be measured using Patient-specific Functional Scale. Patients are asked to rate (on an 11-point scale) the current level of difficulty associated with each activity, where "0" represents "unable to perform" and "10" represents "able to perform at prior level