Effect of the Strain Counterstrain Technique in Women With Fibromyalgia Syndrome: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (Visual Analog Scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged within the predefined study age range
- •Diagnosis of fibromyalgia according to established clinical criteria
- •Ability to participate in treatment sessions and assessments
- •Willingness to participate and provide informed consent
排除标准
- •Those in menopause or postmenstrual period,
- •Those with psychiatric, neurological and/or chronic progressive systemic disease,
- •Those with immunodeficiency,
- •Those with heart, kidney, or liver failure,
- •Those receiving any pharmacological treatment,
- •Those with health issues preventing participation in the treatment programmes,
- •Pregnant patients were excluded from the study.
研究组 & 干预措施
Control Group
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
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.
干预措施: Conservative Physiotherapy Program (Other)
Conservative Treatment Plus Strain Counterstrain Group
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.
干预措施: Strain Counterstrain Therapy (Procedure)
结局指标
主要结局
Change in Pain Intensity (Visual Analog Scale)
时间窗: Baseline and immediately after completion of the 3-week intervention period
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.
次要结局
- Change in Fatigue Severity Score (Fatigue Severity Scale)(Baseline and immediately after completion of the 3-week intervention period)
- Change in Depression Score (Beck Depression Inventory)(Baseline and immediately after completion of the 3-week intervention period)
- Change in Anxiety Score (Beck Anxiety Inventory)(Baseline and immediately after completion of the 3-week intervention period)
- Change in Fibromyalgia Impact Score (Fibromyalgia Impact Questionnaire)(Baseline and immediately after completion of the 3-week intervention period)
研究者
İlker DEMİR
Principal Investigator
Inonu University