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Quarantine and Telerehabilitation in Chronic Pain Patients During COVID-19 Pandemic.

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Exercise Group
Sponsored by
Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring COVID-19, Quarantine, Musculoskeletal, Telerehabilitation, Psychosocial, Sleep, Exercise

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Exercise Physiology and Rehabilitation Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention

Arm Description

The control group will not participate in any exercise program.

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.

Outcomes

Primary Outcome Measures

Anxiety and Depression
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
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
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 Outcome Measures

Quality and patterns of sleep
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in the older adult. PSQI will be used to assess quality and patterns of sleep in the current study. PSQI differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The client self-rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5" or greater indicates a "poor" sleeper. Although there are several questions that request the evaluation of the client's bed mate or roommate, these are not scored, nor reflected in the attached instrument. An update to the scoring: if 5 is not complete or the value is missing, it now counts as a "0".
Patients' illness perceptions
Patients' illness perceptions will be measured based on the Brief Illness Perception Questionnaire (BIPQ). The patient has to rate 8 statements on a 10-point scale (1-10). The higher the score, the greater is the extent to which the patient's illness perceptions are threatening him or her.
Disability
Disability will be assessed using Oswestry Disability Index (ODI) that present ten sections cover Pain, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, and Traveling. Each section has six statements reflecting an increasing level of disability. Respondents choose the statement that most applies to them in each section. The first statement is scored 0; the second is scored 1 and so on to 5 for the last statement. The sum of the section scores is divided by 50 if all sections are completed and multiplied by 100 for the final percentage score.

Full Information

First Posted
May 7, 2020
Last Updated
June 30, 2020
Sponsor
Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
Collaborators
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT04381000
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 29, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
Collaborators
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
COVID-19, Quarantine, Musculoskeletal, Telerehabilitation, Psychosocial, Sleep, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will not participate in any exercise program.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Exercise Group
Intervention Description
The group follows warm up exercise (maximum 10 minutes). This consisted of combined, breathing techniques, low-impact aerobic exercises, free range of motion exercises of upper and lower limbs and spine, and coordination-based exercises of hands and feet. Breathing techniques take regular activities such as sitting, walking, and lying down. At the end of this phase, active stretching exercises of major muscles of arm, leg and trunk were performed.
Primary Outcome Measure Information:
Title
Anxiety and Depression
Description
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.
Time Frame
Change From Baseline in HADS at 40 days
Title
Quality of Life and overall health
Description
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.
Time Frame
Change From Baseline in EQ-5D-3L at 40 days
Title
Pain Intensity
Description
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.
Time Frame
Change From Baseline in NPRS Scores at 40 days
Secondary Outcome Measure Information:
Title
Quality and patterns of sleep
Description
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in the older adult. PSQI will be used to assess quality and patterns of sleep in the current study. PSQI differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The client self-rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5" or greater indicates a "poor" sleeper. Although there are several questions that request the evaluation of the client's bed mate or roommate, these are not scored, nor reflected in the attached instrument. An update to the scoring: if 5 is not complete or the value is missing, it now counts as a "0".
Time Frame
Change From Baseline in PSQI Scores at 40 days
Title
Patients' illness perceptions
Description
Patients' illness perceptions will be measured based on the Brief Illness Perception Questionnaire (BIPQ). The patient has to rate 8 statements on a 10-point scale (1-10). The higher the score, the greater is the extent to which the patient's illness perceptions are threatening him or her.
Time Frame
Change From Baseline in BIPQ Scores at 40 days
Title
Disability
Description
Disability will be assessed using Oswestry Disability Index (ODI) that present ten sections cover Pain, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, and Traveling. Each section has six statements reflecting an increasing level of disability. Respondents choose the statement that most applies to them in each section. The first statement is scored 0; the second is scored 1 and so on to 5 for the last statement. The sum of the section scores is divided by 50 if all sections are completed and multiplied by 100 for the final percentage score.
Time Frame
Change From Baseline in ODI Scores at 40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleni V Kapreli, MSc,PhD
Organizational Affiliation
Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Georgios Tsatsakos, PhD
Organizational Affiliation
TherapyLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Exercise Physiology and Rehabilitation Laboratory
City
Lamia
State/Province
Sterea Ellada
ZIP/Postal Code
35100
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
15324539
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.
Results Reference
background
PubMed Identifier
32327877
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.
Results Reference
background
PubMed Identifier
32233719
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.
Results Reference
background

Learn more about this trial

Quarantine and Telerehabilitation in Chronic Pain Patients During COVID-19 Pandemic.

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