Effects of COVID-19 in Chronic Pain

Covid19 Clinical Trial

Official title:

EVALUATION OF THE EFFECTS OF THE COVID-19 PANDEMIC ON PAIN, STRESS, SLEEP AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC MUSCULOSKELETAL PAIN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878900
• Other study ID #: 2020-3-16
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2021
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the effects of the COVID-19 pandemic on pain, stress, sleep and quality of life in patients with chronic musculoskeletal pain and the relationships between them. In this cross-sectional study, 100 volunteer patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain were included. Age, gender, body-mass index (BMI) and systemic diseases of the participants were recorded as demographic data. Data were collected regarding the area of the body where pain is most dominant in the musculoskeletal system and how long the pain has been in these area, whether there is routine use of analgesics before and after the pandemic and the amount if any, whether the person or the person's relatives have a history of COVID-19, whether exercising regularly before and after the pandemic. Afterwards, the participants were asked to evaluate their general pain severity and global well-being assesment with the visual analog scale (VAS) in the pre-pandemic period and in the last month. For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad. The distance between the point marked by the patient and the starting point was measured. The higher the measured value meant the greater the severity of the patient's pain and the worse the patient's global assessment [11]. Subsequently, the patients were asked to answer questions on the Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI) and Nottingham Health Profile (NHP) scales.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain

Exclusion Criteria:

• Having a history of trauma and surgical intervention in the last 3 months,

• Having a history of known inflammatory rheumatic disease,

• Having a history of chronic severe systemic or neurological disease,

• Having a moderate or severe impairment of cognitive status determined by the minimental test.

Related Conditions & MeSH terms

• Chronic Pain
• Covid19

Intervention

Other:
• Survey
Survey

Locations

Country	Name	City	State
Turkey	Ufuk University	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General pain severity and global well-being assesment with the visual analog scale (VAS).	For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad.	2 months
Primary	Perceived Stress Scale (PSS)	It is a scale to evaluate how stressful some situations in life are perceived by the individual. The long form of the scale consists of 14 items in total. The situations given in each item are evaluated with a 5-point Likert-type scale (0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often). The scale has two short forms consisting of 10 and 4 items. The total score ranges from 0-56 for PSS-14, 0-40 for PSS-10, and 0-16 for PSS-4. The higher the scores, the greater the person's perception of stress.	2 months
Primary	Pittsburgh Sleep Quality Index (PSQI)	It is a scale to evaluate sleep quality and disorders. It consists of 24 questions in total. 19 questions are self-assessment questions, 5 questions are assessment questions made by their spouse or roommate. 18 question items are used in scoring. The scale consists of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. While some of the components consist of a single question item, some are formed by grouping several items. Each component is scored between 0 and 3 points, and the total score of the components gives the total score of the scale. The higher the total score the worse the sleep quality.	2 months
Primary	Nottingham Health Profile (NHP)	It is a general health status scale that evaluates perceived problems in physical, emotional and social areas and how these problems affect daily activities. The questions in the first part of the scale are about the health status of the people, and the questions in the second part are about the effects of their health status on daily life. The first part consists of 38 items in which each item is answered as yes or no. This section has a total of 6 sub-dimensions: pain, emotional reactions, sleep, social isolation and physical mobility and energy. The higher the score, the worse the perception of quality of life regarding health status. The second part consists of 7 items that question whether there are problems in the daily life areas that are most likely to be affected by the health condition of the person, such as work life, housework, social life, interpersonal relationships, sexual life, hobbies and holidays, each item being answered as yes or no.	2 months