Clinical trial NCT04381000: Quarantine and Telerehabilitation in Chronic Pain Patients During COVID-19 Pandemic.
Official title: The Impact of Quarantine and the Effectiveness of Telerehabilitation in Patients With Chronic Pain During COVID-19 Pandemic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: COVID-19
Quarantine
Musculoskeletal
Telerehabilitation
Psychosocial
Sleep
Exercise
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The quarantine during COVID-19 pandemic has changed daily routine. Staying at home for prolonged periods of time can pose a significant challenge for patients with chronic pain. The purpose of the current study is to investigate how the quarantine effects of psychosocial factors, quality of life, sleep, nutrition and physical activity in patients with chronic musculoskeletal pain. Another purpose is to examine whether a telerehabilitation exercise program is effective during the lockdown period.

Detailed description: Participants, both male and female, with chronic musculoskeletal pain for at least 3 months will be included in the study. They will complete some questions about anxiety, depression, sleep, nutrition, quality of life, pain behavior and characteristics, illness perceptions, functioning and daily routine. Questionnaires will be completed twice (first and last week of quarantine, 40 days of duration). A group of patients will follow an exercise program during this time. It will be evaluated the link between the question of physical and psychological factors in the experience of pain in quarantine situation and, also, it will examine whether a telerehabilitation exercise program is effective during the lockdown period.

Eligibility criteria: Inclusion Criteria:

* Patient with chronic musculoskeletal pain (Chronic pain will be defined as pain lasting for 3 or more months. Also, pain intensity will be at least 3 on a 0-10 numerical pain rating scale on most days of the last 3 months).
* Patient with sufficient understanding of the Greek language

Exclusion Criteria:

* Patients without being at quarantine
* Systemic diseases such as rheumatoid arthritis, fibromyalgia and/or polymyalgia rheumatic
* Osteoporosis, haemophilia and/or cancer
* Recent surgery or trauma
* Being pregnant or given birth in the preceding year
* Cognitive impairment
* Inability to provide informed consent and/or complete written questionnaires

Primary outcomes:
measure: Anxiety and Depression
timeFrame: Change From Baseline in HADS at 40 days
measure: Quality of Life and overall health
timeFrame: Change From Baseline in EQ-5D-3L at 40 days
measure: Pain Intensity
timeFrame: Change From Baseline in NPRS Scores at 40 days
Secondary outcomes:
measure: Quality and patterns of sleep
timeFrame: Change From Baseline in PSQI Scores at 40 days
measure: Patients' illness perceptions
timeFrame: Change From Baseline in BIPQ Scores at 40 days
measure: Disability
timeFrame: Change From Baseline in ODI Scores at 40 days
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: Clinical Exercise Physiology and Rehabilitation Laboratory
state: Sterea Ellada
Study officials:
affiliation: Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly
name: Eleni V Kapreli, MSc,PhD
role: STUDY_CHAIR
affiliation: TherapyLab
name: Georgios Tsatsakos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hawryluck L, Gold WL, Robinson S, Pogorski S, Galea S, Styra R. SARS control and psychological effects of quarantine, Toronto, Canada. Emerg Infect Dis. 2004 Jul;10(7):1206-12. doi: 10.3201/eid1007.030703.
citation: Chatterjee K, Chauhan VS. Epidemics, quarantine and mental health. Med J Armed Forces India. 2020 Apr;76(2):125-127. doi: 10.1016/j.mjafi.2020.03.017. Epub 2020 Apr 22. No abstract available.
citation: Torales J, O'Higgins M, Castaldelli-Maia JM, Ventriglio A. The outbreak of COVID-19 coronavirus and its impact on global mental health. Int J Soc Psychiatry. 2020 Jun;66(4):317-320. doi: 10.1177/0020764020915212. Epub 2020 Mar 31.