Efficacy of Home-Based Posture Exercises as an Addition to Pharmacological Treatment in Fibromyalgia

NCT06738472 | Completed

• 1 other identifier: AEU-FTR1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This interventional study aimed to evaluate the effects of home exercise in addition to pharmacological treatment on pain threshold and spinal mobility in fibromyalgia patients.

Conditions

Fibromyalgia

Keywords

fibromyalgia; home-based therapy; pain; quality of life

Outcome Measures

Primary Outcomes (2)

• Algometry

  pain pressure threshold

  4 weeks

• Spinal mouse for spinal mobility

  spinal range of motion

  4 weeks

Secondary Outcomes (3)

• Hospital Anxiety and Depression Scale (HADS)

  4 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  4 weeks

• Short form-12 (SF-12)

  4 weeks

Study Arms (2)

Duloxetin+home based therapy

EXPERIMENTAL

Participants in this arm will receive standard pharmacological treatment for fibromyalgia as prescribed by a physician, in addition to a structured home exercise program. The home exercise program will include stretching and strengthening exercises targeting the spinal and trunk muscles and will be performed according to the study protocol. Clinical outcomes and spinal posture and mobility will be assessed using the Spinal Mouse® device in upright standing, maximum trunk flexion, and maximum trunk extension positions at baseline and follow-up.

Other: home based exercises

Duloxetin only

NO INTERVENTION

Participants in this arm will receive standard pharmacological treatment for fibromyalgia as prescribed by a physician, without any additional exercise intervention. Clinical outcomes and spinal posture and mobility will be assessed using the Spinal Mouse® device in upright standing, maximum trunk flexion, and maximum trunk extension positions at baseline and follow-up.

Interventions

home based exercises OTHER

given exercises to the participants

Duloxetin+home based therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were between the ages of 18 and 65,
• No diagnosis of rheumatic disease,
• No diagnosis of chronic comorbid disease,
• Participants diagnosed with fibromyalgia syndrome according to the European League Against Rheumatism (EULAR) criteria will be included as volunteers.

You may not qualify if:

• Patients under 18, over 65 years of age
• Those diagnosed with chronic comorbid diseases
• Those with a history of rheumatic disease

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ahi Evran University

Kırşehir, Turkey (Türkiye)

Location

Related Publications (1)

• Ozcelep OF, Ustun I, Algun ZC. Effect of task-oriented training on pain, functionality, and quality of life in rheumatoid arthritis. Turk J Phys Med Rehabil. 2022 Mar 1;68(1):76-83. doi: 10.5606/tftrd.2022.6666. eCollection 2022 Mar.

  PMID: 35949976 RESULT

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 17, 2024
• Study Start: January 25, 2025
• Primary Completion: December 25, 2025
• Study Completion: December 28, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)