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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05079893
• Other study ID #: IRB/COHS/FAC/03/May-2021
• Status: Not yet recruiting
• Start date: October 15, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: October 2021
• Source: Gulf Medical University
• Contact: Dr. Praveen Kumar Kandakurthi, PhD
• Phone: +971 6 7431333
• Email: dean.coahs[@]gmu.ac.ae
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: January 31, 2022
• Est. primary completion date: January 2022
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Case control study
Observational case control study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gulf Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Measuring Lumbar repositioning tests	Lumbar repositioning tests will be measured with dual inclinometer	5 MONTHS
Secondary	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
Secondary	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

External Links

•   Related Info