Effect of Adding Neuromodulation Technique to Cognitive Behavior Therapy on Fibromyalgia in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of the pain distribution
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of adding transcutaneous electrical nerve stimulation to cognitive behavior therapy on fibromyalgia in postmenopausal women.
The study aims to answer whether there would be an effect of adding TENS to cognitive behavior therapy (CBT) and medicines on pain, symptoms, HRV, and QOL in postmenopausal women with fibromyalgia
The primary hypothesis is that there would be no effect of adding TENS to CBT and medicines on pain, symptoms, Heart rate variability (HRV), and quality of life (QOL) in postmenopausal women with fibromyalgia.
Sixty postmenopausal women with mild to moderate fibromyalgia were allocated to 3 groups: Group A received medical treatment, Group B received medical treatment and CBT, and Group C received the same as B and low TENS.
Pain was assessed using the widespread pain index (WPI) and pain pressure threshold (PPT). Fibromyalgia symptoms were evaluated using the symptoms severity index (SSI). Heart rate variability (HRV) and quality of life were assessed using the Fibromyalgia Impact Questionnaire (FIQ).
详细描述
It is a three-armed, single-blind, parallel group randomized controlled trial. All patients who met the study's inclusion criteria were randomly allocated using a computerized randomization procedure to one of three groups with a 1:1:1 ratio. A blind researcher to the patient assignment evaluated the patient before and after the treatment procedures.
Sixty postmenopausal women with mild to moderate fibromyalgia were recruited from the rheumatology clinic at Al Kasr Al Ainy Hospital and the faculty of physical therapy outpatient clinic.
Patients were randomly allocated to three different groups: Group A received medical treatment in the form of pain relievers such as acetaminophen and antidepressants such as Duloxetine (Cymbalta) and milnacipran. Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks. Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks. There were no patient withdrawals throughout the study.
Pain was assessed using the widespread pain index (WPI) and pain pressure threshold (PPT). Fibromyalgia symptoms were evaluated using the symptoms severity index (SSI). Heart rate variability (HRV) and quality of life were assessed using the Fibromyalgia Impact Questionnaire (FIQ).
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
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients aged 50-60 years old
- •body mass index (BMI) between 25 and 29.9 kg/m2
- •patients meeting the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia syndrome, including a widespread pain index (WPI) score of 7 or more, a symptom severity (SS) score of 5 or more, or a WPI score of 4 to 6 and an SS score of 9 or more.
- •Symptoms were present at a similar level for a minimum of 3 months.
- •No other condition accounts for the patient's pain
排除标准
- •had other rheumatologic, musculoskeletal, or neurological disorders or any diseases that cause cognitive abnormality or
- •had any contraindications to TENS.
研究组 & 干预措施
Group (B)
Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks.
干预措施: Cognitive behavior therapy (Behavioral)
Group (A)
Group (A) received medical treatment in the form of pain relievers such as acetaminophen and antidepressants such as Duloxetine (Cymbalta) and milnacipran.
干预措施: medical treatment (Drug)
Group (B)
Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks.
干预措施: medical treatment (Drug)
Group (C)
Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks.
干预措施: Cognitive behavior therapy (Behavioral)
Group (C)
Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks.
干预措施: medical treatment (Drug)
Group (C)
Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks.
干预措施: TENS (Device)
结局指标
主要结局
Assessment of the pain distribution
时间窗: 12 weeks
The Widespread Pain Index (WPI) is a self-report index measure that was used to assess bodily distribution of pain and to specifically quantify the degree of widespread body pain and assess for pain features (e.g., cognitive, emotional, and physical symptoms). The WPI assesses the presence of pain in 19 designated body locations over the past 7 days, such as the neck, right upper arm, left lower leg. Each location is equal to a score of 1.
次要结局
- Symptom Severity Scale (SSI)(Baseline and after 12 weeks)
- Assessment of pain threshold(Baseline and after 12 weeks)
- Assessment of heart rate variability (HRV)(Baseline and after 12 weeks)
- Assessment of fibromyalgia symptoms(Baseline and after 12 weeks)
研究者
Gehad Mohamed Mohamdeen Ali Mohamed
lecturer
Cairo University