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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home based exercises | Other | given exercises to the participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Algometry | pain pressure threshold | 4 weeks |
| Spinal mouse for spinal mobility | spinal range of motion | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | used to assess anxiety and depressive symptoms in clinical populations | 4 weeks |
| Pittsburgh Sleep Quality Index (PSQI) | Quality of Sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahi Evran University | Kırşehir | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35949976 | Result | 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. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| 4 weeks |
| Short form-12 (SF-12) | Quality of Life | 4 weeks |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |