NCT06125496

Brief Summary

The aim of this study was to examine the relationship between pain management, kinesiophobia, physical activity and disability level in patients with chronic low back pain (CLBP) in different genders. Eighty-two patients with CLBP (42 females, 42 males) between the ages of 20-60 participated in the study. Pain management strategies were determined by Pain Coping Questionnaire (PCQ). Tampa Scale for Kinesiophobia for perception of kinesiophobia, Oswestry Disability Index for disability due to pain and International Physical Activity Questionnaire-Short Form (IPAQ-SF) for the physical activity level were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

November 3, 2023

Last Update Submit

November 8, 2023

Conditions

Low Back Pain

Keywords

Pain managementKinesiophobiaPhysical activityDisability

Outcome Measures

Primary Outcomes (1)

  • Pain Coping Questionnaire (PCQ)

    The scale assesses how chronic pain patients cope with organic or psychogenic pain. The scale consists of four subdimensions that are self-coping, helplessness, conscious cognitive interventions, and seeking medical help, and 29 items. The self-report scale consists of a 4-point Likert scale (0: never, 3: often).

    From 25 December 2019 to 10 November 2021

Secondary Outcomes (4)

  • Visual Analogue Scale (VAS)

    From 25 December 2019 to 10 November 2021

  • Oswestry Disability Index (ODI)

    From 25 December 2019 to 10 November 2021

  • Tampa Scale of Kinesiophobia (TSK)

    From 25 December 2019 to 10 November 2021

  • International Physical Activity Questionnaire-Short Form (IPAQ -SF)

    From 25 December 2019 to 10 November 2021

Study Arms (2)

Female

Forty one females with CLBP between the ages of 20-60 participated in the study. Pain management strategies were determined by Pain Coping Questionnaire (PCQ). Tampa Scale for Kinesiophobia for perception of kinesiophobia, Oswestry Disability Index for disability due to pain and International Physical Activity Questionnaire-Short Form (IPAQ-SF) for the physical activity level were used.

Other: Pain management

Male

Forty one males with CLBP between the ages of 20-60 participated in the study. Pain management strategies were determined by Pain Coping Questionnaire (PCQ). Tampa Scale for Kinesiophobia for perception of kinesiophobia, Oswestry Disability Index for disability due to pain and International Physical Activity Questionnaire-Short Form (IPAQ-SF) for the physical activity level were used.

Other: Pain management

Interventions

Pain managementOTHER

Investigation of relationship between kinesiophobia, physical activity and disability level and pain management in patients with CLBP

FemaleMale

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

One hundred twenty-six subjects were invited to participate in the study. The study was completed with the participation of 84 subjects, 42 women and 42 men.

You may qualify if:

  • Individuals who are between 20 and 60 years old,
  • Experienced low back pain lasting longer than 3 months, and had no problems with reading, writing, and comprehension were included in the study.

You may not qualify if:

  • Individuals who underwent surgery for low back pain,
  • Had any diagnosed spinal problem,
  • Who were pregnant,
  • And who had communication problems were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainAgnosiaKinesiophobiaMotor Activity

Interventions

Pain Management

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesPhobic DisordersAnxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsDisease ManagementPatient Care ManagementHealth Services Administration

Study Officials

  • Ayşe Ünal, Assoc. Prof

    Alanya Alaaddin Keykubat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 9, 2023

Study Start

December 25, 2019

Primary Completion

November 20, 2021

Study Completion

December 28, 2021

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)