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NCT Number: NCT05212870

Investıgatıon Of The Effect Of The Pandemıc Process 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.

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Key information

Conditions

Neck Pain Back Pain COVID-19 COVID-19 Pandemic Cognitive Level Coronaviridae Infections Coronavirus Infections Infections Low Back Pain Lung Diseases Neurologic Manifestations Nidovirales Infections Pain Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

assessment of cognitive level, pain catastrophe, physical activity level and quality of life

Other

assessment of cognitive level, pain catastrophe, physical activity level and quality of life

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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