Effects of Manipulative Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
Objective: Compare degree of improvement can reach patients diagnosed with fibromyalgia syndrome, by treatment with Manipulative and Massage Techniques versus an exercise program for lower thoracic and cervical spine.
Study Design: A single-blind randomized controlled trial was conducted on patients with fibromyalgia syndrome (FMS).
Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving manipulative and massage therapy, or to a control group for exercise program.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Fibromyalgia Syndrome.
- •Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
- •Agreement to attend evening therapy sessions.
- •Non-practice of regular physical activity.
排除标准
- •A history of surgery.
- •The presence of comorbid conditions (e.g., morbid obesity, inflammatory diseases, irritable bowel syndrome and interstitial cystitis).
- •A history of whiplash injury.
- •Severe physical disability.
- •Uncontrolled endocrine disorders (e.g., hyperthyroidism, diabetes).
- •Illness (e.g., schizophrenia or substance abuse).
- •The use of medication other than as-needed analgesics (excluding long-term narcotics).
- •Malignancy.
- •Psychiatric disorders.
- •A score of ≥ 9 points in the Beck depression inventory.
研究组 & 干预措施
Manipulative and Massage Therapy
Ten sessions (2/week):
- High speed and low amplitude technique to lower cervical spine (C3-C4).
- Dog technique flexion for high thoracic area (T1-T4).
- Dog technique flexion for mid-thoracic area (T5-T8).
- Dog technique flexed to low thoracic (T6-T12).
Classic Massage Therapy during 40 minutes (2 time / week):
干预措施: Manipulative and Massage Therapy (Other)
Exercise Program
Ten sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises.
干预措施: Exercise Program (Other)
结局指标
主要结局
Pain Intensity
时间窗: Changes from Baseline, and 5 weeks
A 10-point numerical scale (0 = no pain, 10: very severe pain)
次要结局
- Schöber Test(Changes from Baseline, and 5 weeks)
- Pittsburgh Quality of Life Questionnaire(Changes from Baseline, and 5 weeks)
- McGill Pain Questionnaire(Changes from Baseline, and 5 weeks)
- Quality of Life Questionnaire (SF-36)(Changes from Baseline, and 5 weeks)
- Fibromyalgia Impact Questionnaire (FIQ)(Changes from Baseline, and 5 weeks)
- Fatigue Impact Scale (FIS)(Changes from Baseline, and 5 weeks)
- Beck Depression Inventory(Changes from Baseline, and 5 weeks)
- Pressure Algometry(Changes from Baseline, and 5 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Changes from Baseline, and 5 weeks)
研究者
Adelaida María Castro-Sánchez
Professor
Universidad de Almeria