Investıgatıon Of The Effect Of The Pandemıc Process In Indıvıduals Wıth Chronıc Low Back And Neck Paın

November 20, 2023 updated by: Ozlem Ulger, Hacettepe University

Investıgatıon Of The Effect Of The Pandemıc Process On Cognıtıve Level, Paın Catastrophızatıon, Physıcal Actıvıty Level And Qualıty Of Lıfe In Indıvıduals Wıth Chronıc Low Back And Neck Paın

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06200
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic low back and neck pain

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low back and neck pain group with experience of Covid-19
Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life
assessment of cognitive level, pain catastrophe, physical activity level and quality of life
Low back and neck pain group without experience of Covid-19
Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life
assessment of cognitive level, pain catastrophe, physical activity level and quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity Assessment- Visual Analog Sacle
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Cognitive Level: Montreal Cognitive Assessment Scale (MOCA)
Time Frame: 5 minutes, through study completion, an average of 1 year
The scale consists of 11 questions in total. The score range is 0-30. Below 21 points is interpreted as cognitive disability for the Turkish population. Turkish validity and reliability study was conducted by Selekler et al. made by
5 minutes, through study completion, an average of 1 year
Evaluation of Pain Catastrophization Level: Pain Catastrophization Scale
Time Frame: 5 minutes, through study completion, an average of 1 year
There are 13 questions in total on this scale. The questions are aimed at questioning the feelings and thoughts of individuals during pain. Each question scores between 0 and 4. A score of 30 and above indicates the presence of pain catastrophization. The validity and reliability study of the Turkish version of the scale was conducted by Süren et al. made by.
5 minutes, through study completion, an average of 1 year
Assessment of Physical Activity Level: International Physical Activity Questionnaire (UFAA)-Short Form
Time Frame: 5 minutes, through study completion, an average of 1 year
It was developed by Craig, Marshall, Sjostrom, Bauman, and Booth (2003) by conducting validity and reliability studies of individuals in 12 different countries. The questionnaire is a valid tool developed to determine the physical activity levels of individuals between the ages of 18-65. There are eight versions of the questionnaire, which was adapted into Turkish by Öztürk (2005). It has been developed as four short and four long forms. The short form "last 7 days" was used in this study. The short form (7 questions) provides information about time spent walking, moderate-to-vigorous and vigorous activities. The time spent sitting is considered as a separate question. It is classified as low, medium and high level by calculating the activity level of the person in terms of METs according to the duration, frequency and intensity level of the movement.
5 minutes, through study completion, an average of 1 year
Quality of Life Assessment: SF-36
Time Frame: 5 minutes, through study completion, an average of 1 year
SF-36 is a 36-item scale that evaluates the health status of a person with 8 sub-items (physical function, role limitations, social function, mental health, vitality, pain, general health). Each sub-item is scored separately between 0-100. As the score approaches 100, it indicates good health. Turkish validity and reliability study, Koçyiğit et al. (1999).
5 minutes, through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16969557-1040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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