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

January 20, 2026 updated by: Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread musculoskeletal pain, altered pain processing, fatigue, and functional limitations. In addition to pain-related symptoms, individuals with FM frequently present with postural alterations, reduced spinal mobility, and impaired segmental control of the spine, which may contribute to functional disability and reduced quality of life. However, objective assessment of spinal posture and segmental mobility in FM remains limited.

This study aims to comprehensively evaluate spinal posture and sagittal plane mobility in patients with fibromyalgia using the Spinal Mouse®, a validated, non-invasive, computer-assisted device that measures spinal curvature and segmental inclination without radiation exposure. The Spinal Mouse allows for reliable assessment of thoracic and lumbar spinal alignment as well as dynamic movement patterns during functional tasks.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duloxetin+home based therapy
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
given exercises to the participants
No Intervention: Duloxetin only
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algometry
Time Frame: 4 weeks
pain pressure threshold
4 weeks
Spinal mouse for spinal mobility
Time Frame: 4 weeks
spinal range of motion
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 4 weeks
used to assess anxiety and depressive symptoms in clinical populations
4 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4 weeks
Quality of Sleep
4 weeks
Short form-12 (SF-12)
Time Frame: 4 weeks
Quality of Life
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirsehir Ahi Evran Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2025

Primary Completion (Actual)

December 25, 2025

Study Completion (Actual)

December 28, 2025

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEU-FTR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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