NCT05079893

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

September 23, 2021

Last Update Submit

October 4, 2021

Conditions

Keywords

Low back painKinesiophobiaposition senseEndurance

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Measuring Pain

    5 MONTHS

  • Measuring Functional ability

    5 MONTHS

Study Arms (2)

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

Controls

The controls will be the patients matched for age, sex, handedness who had no complaints of lower back pain

Other: Case control study

Interventions

Observational case control study

CasesControls

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Suffering from low back pain for at least three months and referred by an orthopedic doctor or general physician.

You may qualify if:

  • 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.

You may not qualify if:

  • Low back pain patients with radiculopathy, post fractures, stenosis and history of tumors, cauda equina syndrome and infection.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kandakurti PK, de Sa Ferreira A, Calazans Nogueira LA, Arulsingh Daniel Ragland W, Patil SS. Influence of kinesiophobia on lumbar position sense in patients with chronic low back pain-a case-control study. J Back Musculoskelet Rehabil. 2025 Sep;38(5):1158-1164. doi: 10.1177/10538127251326152. Epub 2025 Mar 20.

  • 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.

Related Links

MeSH Terms

Conditions

Low Back PainKinesiophobia

Interventions

Case-Control Studies

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dr. Praveen Kumar Kandakurthi, PhD

    College of Health Sciences, Gulf Medical University

    STUDY CHAIR
  • Dr. Watson Arulsingh Daniel Ragland, PhD

    College of Health Sciences, Gulf Medical University

    PRINCIPAL INVESTIGATOR
  • Sharad Patil, MPT

    Thumbay Physical Therapy and Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Praveen Kumar Kandakurthi, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 15, 2021

Study Start

October 15, 2021

Primary Completion

January 1, 2022

Study Completion

January 31, 2022

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share