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Chronic PainNCT04381000

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

A study testing Exercise Group in people with Chronic Pain, run by University of Thessaly at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Pain
What is being tested?
Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteGreece
Study dates
1 Apr 2020to 10 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Clinical Exercise Physiology and Rehabilitation Laboratory

    Lamia, Central Greece, 35100

Other trials in Greece

About this study

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

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.

Read the 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.

Conditions
Chronic Pain
Being tested
Exercise Group
Keywords
COVID-19, Quarantine, Musculoskeletal, Telerehabilitation, Psychosocial, Sleep, Exercise
Medical subject headings
Chronic Pain, COVID-19, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise GroupOther

    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.

Study groups in NCT04381000
Study groupRoleWhat they receive
Control GroupNo interventionThe control group will not participate in any exercise program.
InterventionExperimentalThe 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.
Receives: Other: Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change From Baseline in HADS at 40 days

  2. 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.

    Measured: Change From Baseline in EQ-5D-3L at 40 days

  3. 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.

    Measured: Change From Baseline in NPRS Scores at 40 days

Secondary outcomes (3)

  1. 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".

    Measured: Change From Baseline in PSQI Scores at 40 days

  2. 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.

    Measured: Change From Baseline in BIPQ Scores at 40 days

  3. 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.

    Measured: Change From Baseline in ODI Scores at 40 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start1 Apr 2020
  3. Primary completion29 May 2020
  4. Study completion10 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381000
Sponsor's protocol ID
3
Status last verified
Jun 2020
First submitted
7 May 2020
Last updated
1 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 15324539

  • 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.

    PubMed 32327877

  • 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.

    PubMed 32233719

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Group in people with Chronic Pain, run by University of Thessaly at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety and Depression (time frame: Change From Baseline in HADS at 40 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04381000, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.

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