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Clinical Trials/NCT04381000
NCT04381000
Completed
Not Applicable

The Impact of Quarantine and the Effectiveness of Telerehabilitation in Patients With Chronic Pain During COVID-19 Pandemic.

University of Thessaly1 site in 1 country170 target enrollmentApril 1, 2020
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Thessaly
Enrollment
170
Locations
1
Primary Endpoint
Anxiety and Depression
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
June 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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)

Study Sites (1)

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