The Impact of Quarantine and the Effectiveness of Telerehabilitation in Patients With Chronic Pain During COVID-19 Pandemic.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Thessaly
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Anxiety and Depression
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control Group
The control group will not participate in any exercise program.
Intervention
The intervention group will participate in an exercise program for 6 weeks/ 2 sessions per week, for a total of 12 sessions of 30-45 minutes each.
Intervention: Exercise Group (Other)
Outcomes
Primary Outcomes
Anxiety and Depression
Time Frame: Change From Baseline in HADS at 40 days
To measure the levels of anxiety and depression Hospital Anxiety and Depression Scale (HADS), will be used. Patients have to score 14 opinions. Seven of the items relate to anxiety and seven relate to depression. A cut-off point of 8/21 for anxiety or depression has been recommended.
Quality of Life and overall health
Time Frame: Change From Baseline in EQ-5D-3L at 40 days
To measure quality of life, EQ-5D-3L will be used. The EQ-5D-3L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Pain Intensity
Time Frame: Change From Baseline in NPRS Scores at 40 days
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults and it will be used in the current study. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").The NPRS is a valid and reliable scale to measure pain intensity. In this study, will rate current pain intensity and mean pain intensity during the past 7 days.
Secondary Outcomes
- Patients' illness perceptions(Change From Baseline in BIPQ Scores at 40 days)
- Quality and patterns of sleep(Change From Baseline in PSQI Scores at 40 days)
- Disability(Change From Baseline in ODI Scores at 40 days)