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This study evaluates whether strain counterstrain therapy affects pain, fatigue, psychological status, and quality of life in women diagnosed with fibromyalgia. Participants are assigned to one of three groups: a control group, a conservative treatment group, or a conservative treatment plus strain counterstrain therapy group. Treatment sessions are conducted five days per week for three weeks. Outcomes are assessed before and after the intervention using validated measurement scales. The purpose is to compare changes among groups and determine the effects of adding strain counterstrain therapy to conservative treatment.
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, and functional limitations that may negatively affect psychological well-being and quality of life. Nonpharmacological approaches are commonly used in management and may support symptom control and functional improvement. Manual therapy techniques are among the interventions applied to address musculoskeletal symptoms.
This study is designed to investigate the effects of strain counterstrain therapy in individuals diagnosed with fibromyalgia. Participants are assigned to different intervention groups receiving either standard care alone or standard care combined with a manual therapy approach. The intervention is administered according to a structured treatment protocol over a defined study period. Outcome measures evaluate changes in pain, fatigue, psychological status, and quality of life using validated assessment instruments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participants in this group do not receive any therapeutic intervention during the study period and continue their usual daily activities. Outcome assessments are performed at baseline and after the study period for comparison with the intervention groups. | |
| Conservative Treatment Group | Active Comparator | Participants in this group receive conservative treatment consisting of standard physiotherapy modalities administered five days per week for three weeks according to a structured treatment protocol. No strain counterstrain therapy is applied in this group. |
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| Conservative Treatment Plus Strain Counterstrain Group | Experimental | Participants in this group receive conservative treatment consisting of standard physiotherapy modalities administered five days per week for three weeks, together with strain counterstrain therapy applied according to a structured manual therapy protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative Physiotherapy Program | Other | The conservative physiotherapy program consists of standard physical therapy modalities applied according to a structured treatment protocol. Sessions are conducted five days per week for three weeks and include routinely used physiotherapy approaches intended to support symptom management and functional improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity (Visual Analog Scale) | Pain intensity is assessed using the Visual Analog Scale (VAS), a validated measure consisting of a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants indicate their pain level on the scale, and change is calculated as the difference between pre-intervention and post-intervention scores. | Baseline and immediately after completion of the 3-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue Severity Score (Fatigue Severity Scale) | Fatigue is assessed using the Fatigue Severity Scale (FSS), a validated self-report questionnaire used to evaluate the impact of fatigue on daily functioning. Scores are calculated according to the instrument instructions, with higher scores indicating greater fatigue severity. Change is calculated as the difference between pre-intervention and post-intervention scores. |
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Inclusion Criteria:
Exclusion Criteria:
Only individuals who identify as female are eligible to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Ilker DEMÄ°R, PhD | Inonu University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inonu University Turgut Ozal Medical Center | Malatya | 4400 | Turkey (Türkiye) |
It is currently undecided whether individual participant data will be shared. Data sharing plans will be determined after study completion in accordance with institutional policies, ethical approvals, and participant consent.
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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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Participants are assigned to one of three parallel groups: a control group, a conservative treatment group, or a conservative treatment plus strain counterstrain therapy group. All groups are followed over the same study period, and outcomes are assessed before and after the intervention to compare changes among groups.
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| Strain Counterstrain Therapy | Procedure | Strain counterstrain therapy is a manual therapy technique applied by a trained therapist using passive positioning methods intended to reduce musculoskeletal tenderness and improve comfort. The intervention is administered according to a structured treatment protocol during scheduled sessions over the study period. |
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| Baseline and immediately after completion of the 3-week intervention period |
| Change in Depression Score (Beck Depression Inventory) | Depression is assessed using the Beck Depression Inventory, a validated self-report questionnaire used to measure the severity of depressive symptoms. Scores are calculated according to the instrument guidelines, with higher scores indicating greater depression severity. Change is calculated as the difference between pre-intervention and post-intervention scores. | Baseline and immediately after completion of the 3-week intervention period |
| Change in Anxiety Score (Beck Anxiety Inventory) | Anxiety is assessed using the Beck Anxiety Inventory, a validated self-report questionnaire used to measure the severity of anxiety symptoms. Scores are calculated according to the instrument guidelines, with higher scores indicating greater anxiety severity. Change is calculated as the difference between pre-intervention and post-intervention scores. | Baseline and immediately after completion of the 3-week intervention period |
| Change in Fibromyalgia Impact Score (Fibromyalgia Impact Questionnaire) | Fibromyalgia impact is assessed using the Fibromyalgia Impact Questionnaire, a validated instrument used to evaluate symptom severity, functional status, and overall impact of fibromyalgia on daily life. Scores are calculated according to the questionnaire instructions, with higher scores indicating greater disease impact. Change is calculated as the difference between pre-intervention and post-intervention scores. | Baseline and immediately after completion of the 3-week intervention period |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |