FibromyalgiaNCT06738472
Efficacy of Home-Based Posture Exercises as an Addition to Pharmacological Treatment in Fibromyalgia
A study testing home based exercises in people with Fibromyalgia, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- home based exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2025to 28 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under 18, over 65 years of age
- Those diagnosed with chronic comorbid diseases
- Those with a history of rheumatic disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- home based exercises
- Keywords
- fibromyalgia, home-based therapy, pain, quality of life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home based exercisesOther
given exercises to the participants
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algometry
pain pressure threshold
Measured: 4 weeks
Spinal mouse for spinal mobility
spinal range of motion
Measured: 4 weeks
Secondary outcomes (3)
Hospital Anxiety and Depression Scale (HADS)
used to assess anxiety and depressive symptoms in clinical populations
Measured: 4 weeks
Pittsburgh Sleep Quality Index (PSQI)
Quality of Sleep
Measured: 4 weeks
Short form-12 (SF-12)
Quality of Life
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start25 Jan 2025
- Primary completion25 Dec 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk ÖZÇELEP, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738472
- Sponsor's protocol ID
- AEU-FTR1
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35949976
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Home-Based Posture Exercises as an Addition to Pharmacological Treatment in Fibromyalgia
- ClinicalTrials.gov ID
- NCT06738472
- Acronym / sponsor ID
- AEU-FTR1
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, home-based therapy, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetin+home based therapy | Experimental | Other: home based exercisesParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients under 18, over 65 years of age
- Those diagnosed with chronic comorbid diseases
- Those with a history of rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home based exercisesgiven exercises to the participants | Other | Duloxetin+home based therapy |
Primary outcome
Algometry
Time frame: 4 weeks
pain pressure threshold
Spinal mouse for spinal mobility
Time frame: 4 weeks
spinal range of motion
3 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 weeks
Short form-12 (SF-12)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Results publication: PubMed 35949976Ozcelep 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home based exercises in people with Fibromyalgia, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 22 Jan 2026. 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 Turkey (Türkiye). 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?
Algometry (time frame: 4 weeks). The study lists 2 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 NCT06738472, which also lists 1 linked publication.
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 22 Jan 2026.