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

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05212870
Collaborator
(none)
46
1
12.7
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: assessment of cognitive level, pain catastrophe, physical activity level and quality of life

Study Design

Study Type:
Observational
Anticipated Enrollment :
46 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
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
Actual Study Start Date :
Nov 22, 2021
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Pain Severity Assessment- Visual Analog Sacle [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

Secondary Outcome Measures

  1. Assessment of Cognitive Level: Montreal Cognitive Assessment Scale (MOCA) [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

  2. Evaluation of Pain Catastrophization Level: Pain Catastrophization Scale [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.

  3. Assessment of Physical Activity Level: International Physical Activity Questionnaire (UFAA)-Short Form [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.

  4. Quality of Life Assessment: SF-36 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Turkey 06200

Sponsors and Collaborators

  • Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozlem Ulger, Professor, Physiotherapist, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05212870
Other Study ID Numbers:
  • 16969557-1040
First Posted:
Jan 28, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2022