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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212870
• Other study ID #: 16969557-1040
• Status: Completed
• Start date: November 22, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: August 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Low Back Pain
• Neck Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of Cognitive Level: Montreal Cognitive Assessment Scale (MOCA)	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
Secondary	Evaluation of Pain Catastrophization Level: Pain Catastrophization Scale	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
Secondary	Assessment of Physical Activity Level: International Physical Activity Questionnaire (UFAA)-Short Form	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
Secondary	Quality of Life Assessment: SF-36	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, Koçyigit et al. (1999).	5 minutes, through study completion, an average of 1 year