Multicomponent Therapy With Telerehabilitation

NCT05250531 | Unknown

• 1 other identifier: Istanbul University,Istanbul
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized study, our aim was to evaluate the comprehensive multicomponent treatment of fibromyalgia women with telerehabilitation, including "patient education, special psychotherapy/psychosocial intervention, and exercise including relaxation exercises". Does it differ in terms of reduction and functionality?

Conditions

Fibromyalgia

Keywords

telerehabilitation; multicomponent therapy; psychotherapy; pain; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• change in The Revised Fibromyalgia Impact Questionnaire (FIQR)

  The fibromyalgia impact questionnaire was developed from information gathered from patient reports, functional status tools, and clinical observations. This questionnaire measures physical function, work status (days off and work difficulty), depression, anxiety, morning fatigue, pain, stiffness, fatigue, and well-being in the past week.

  Baseline (before intervention), 1 month after intervention, 3 months after the intervention

Secondary Outcomes (9)

• change in Jenkins Sleep Evaluation Questionnaire (JSEQ)

  Baseline (before intervention), 1 month after intervention, 3 months after the intervention

• change in The Fatigue Severity Scale (FSS)

  Baseline (before intervention), 1 month after intervention, 3 months after the intervention

• change in Visual Analogue Scale (VAS)

  Baseline (before intervention), 1 month after intervention, 3 months after the intervention

• change in ICF Core Set for Chronic Widespread Pain

  Baseline (before intervention), 1 month after intervention, 3 months after the intervention

• change in The Central Sensitization (CSI) Inventory

  Baseline (before intervention), 1 month after intervention, 3 months after the intervention

Study Arms (2)

GROUP 1

EXPERIMENTAL

33 patients in the multicomponent treatment group selected to group 1 (G1) will be treated with telerehabilitation for a total of 6 sessions of two hours once a week for 3 weeks. After 1 month, one more session will be applied for a two-hour follow-up and sustainability.

Behavioral: multicomponent therapy

GROUP 2

ACTIVE COMPARATOR

As a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation.

Behavioral: multicomponent therapy

Interventions

multicomponent therapy BEHAVIORAL

patient education,Exercise training,Private Psychotherapy,relaxation

GROUP 1; GROUP 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: effect of gender difference on intervention outcomes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women
• Symptom persistence for more than 3 months
• Pervasive Network Scale Score \>7 and Symptom Severity Score \>5 according to 2016 ACR criteria
• Symptom Severity Score of \>9 and Diffuse Pain Scale Score between 4-6 according to 2016 ACR criteria
• Getting a high (11 and above) score on the Hospital Anxiety and Depression Scale
• Having the opportunity to participate in the applications online
• No change in the medical treatment he received for fibromyalgia syndrome during the study period
• Those between the ages of 18-55

You may not qualify if:

• Patients with endocrine, neuromuscular, infectious and inflammatory rheumatological diseases
• Patients with liver or kidney disease
• Patients with malignancy
• Patients with a history of severe trauma
• Patients with severe psychiatric illness
• Patients with serious physical comorbidities
• The illiterate
• Known central nervous system or peripheral nervous system disease, progressive neurological deficit
• Peripheral venous insufficiency, coagulopathies and anticoagulant drug use
• Serious cardiovascular pathologies
• Loss of sensation, loss of position sense, unhealed fracture or open surgical wound
• Pregnancy

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diren Ozer Ozbey, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diren Ozer Ozbey, MD

CONTACT

+902124142000; direnozer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 22, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)