Investıgatıon Of The Effect Of The Pandemıc Process In Indıvıduals Wıth Chronıc Low Back And Neck Paın
1 other identifier
observational
84
1 country
1
Brief Summary
There are a limited number of studies examining the difficulty of reaching treatment related to the pandemic process and the general effects of the process in patients with chronic low back and neck pain. However, no study has been found that compares the effects of individuals actively carrying and not carrying the Covid-19 virus. For this reason, the aim of the study is to examine the effects of the pandemic process on the cognitive level, pain catastrophization, physical activity level and quality of life in individuals with chronic low back and neck pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2021
CompletedStudy Start
First participant enrolled
November 22, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedNovember 21, 2023
August 1, 2022
11 months
October 8, 2021
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Pain Severity Assessment- Visual Analog Sacle
VAS indicates the level of pain that the person is currently experiencing with a vertical line on a plane. The pain felt by the person is marked as "0: I do not feel any pain", "10: I feel very severe pain". Scoring is based on measuring the vertical marking of the participant for pain marked on the plane with a ruler. The validity and reliability study of the scale was done by Price et al. made by
through study completion, an average of 1 year
Secondary Outcomes (4)
Assessment of Cognitive Level: Montreal Cognitive Assessment Scale (MOCA)
5 minutes, through study completion, an average of 1 year
Evaluation of Pain Catastrophization Level: Pain Catastrophization Scale
5 minutes, through study completion, an average of 1 year
Assessment of Physical Activity Level: International Physical Activity Questionnaire (UFAA)-Short Form
5 minutes, through study completion, an average of 1 year
Quality of Life Assessment: SF-36
5 minutes, through study completion, an average of 1 year
Study Arms (2)
Low back and neck pain group with experience of Covid-19
Low back and neck pain group without experience of Covid-19
Interventions
assessment of cognitive level, pain catastrophe, physical activity level and quality of life
Eligibility Criteria
Patients with chronic low back and neck pain
You may qualify if:
- Those between the ages of 18-60,
- Having low back or neck pain lasting longer than 3 months,
- Having a history of Covid-19 (At least 6 weeks-post acute),
- Individuals with chronic low back and neck pain without a history of Covid-19 will be included.
You may not qualify if:
- Those with an active diagnosis of Covid-19
- Having a rheumatological disease,
- Broken etc. severe deformity that may lead to nerve injury,
- Having a history of spinal surgery,
- Having neurological disease in addition to spinal pathology,
- Having problems such as cancer, diabetes, dementia, organic brain dysfunction,
- Illiterate individuals will not be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, 06200, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Physiotherapist
Study Record Dates
First Submitted
October 8, 2021
First Posted
January 28, 2022
Study Start
November 22, 2021
Primary Completion
October 15, 2022
Study Completion
December 15, 2022
Last Updated
November 21, 2023
Record last verified: 2022-08