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

NCT04381000 | Completed

• 1 other identifier: 3
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

COVID-19; Quarantine; Musculoskeletal; Telerehabilitation; Psychosocial; Sleep; Exercise

Outcome Measures

Primary Outcomes (3)

• 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.

  Change From Baseline in HADS at 40 days

• 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.

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

• 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.

  Change From Baseline in NPRS Scores at 40 days

Secondary Outcomes (3)

• Quality and patterns of sleep

  Change From Baseline in PSQI Scores at 40 days

• Patients' illness perceptions

  Change From Baseline in BIPQ Scores at 40 days

• Disability

  Change From Baseline in ODI Scores at 40 days

Study Arms (2)

Control Group

NO INTERVENTION

The control group will not participate in any exercise program.

Intervention

EXPERIMENTAL

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.

Other: Exercise Group

Interventions

Exercise Group OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Clinical Exercise Physiology and Rehabilitation Laboratory

Lamia, Central Greece, 35100, Greece

Location

Related Publications (3)

• 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.

  PMID: 15324539 BACKGROUND

• 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.

  PMID: 32327877 BACKGROUND

• 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.

  PMID: 32233719 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; COVID-19; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Eleni V Kapreli, MSc,PhD

  Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly

  STUDY CHAIR

• Georgios Tsatsakos, PhD

  TherapyLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: April 1, 2020
• Primary Completion: May 29, 2020
• Study Completion: June 10, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

GR (1)