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

Influence of Kinesiophobia on Pain Intensity, Disability, Muscle Endurance and Position Sense in Subjects With Chronic Low Back Pain- A Case Control Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Case control study

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Dr. Praveen Kumar Kandakurthi, PhD; Phone Number: 1386 +971 6 7431333; Email: dean.coahs@gmu.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; 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.	Other: Case control study; Observational case control study
Controls; The controls will be the patients matched for age, sex, handedness who had no complaints of lower back pain	Other: Case control study; Observational case control study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring Kinesiophobia.	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.	5 MONTHS
Measuring Lumbar extensor endurance.	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	5 MONTHS
Measuring Lumbar repositioning tests	Lumbar repositioning tests will be measured with dual inclinometer	5 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring Pain	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.	5 MONTHS
Measuring Functional ability	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	5 MONTHS

Collaborators and Investigators

• Sponsor: Gulf Medical University
• Investigators: Study Chair: Dr. Praveen Kumar Kandakurthi, PhD, College of Health Sciences, Gulf Medical University; Principal Investigator: Dr. Watson Arulsingh Daniel Ragland, PhD, College of Health Sciences, Gulf Medical University; Principal Investigator: Sharad Patil, MPT, Thumbay Physical Therapy and Rehabilitation Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Low back pain; Kinesiophobia; Endurance; position sense
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB/COHS/FAC/03/May-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No