Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 4
- 主要终点
- Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test
研究概览
简要总结
Pain associated with fibromyalgia interferes with daily function, work, and social activities resulting in a decreased quality of life. People with fibromyalgia also have a significant amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of the main treatments for patients with fibromyalgia must focus on pain relief to allow the person to function more independently both at home and at work. Transcutaneous electrical nerve stimulation is used by health professionals to deliver electrical stimulation through the skin for pain control. Basic science studies, from the PI's laboratory show that TENS activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus the ideal patient population for the treatment of TENS would be one in which there is enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.
Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and that this decrease in pain and/or central excitability will reduce fatigue and fear of movement, thereby improving function and quality of life
详细描述
This is a phase II randomized, double-blind, placebo controlled multi-center clinical trial involving a device, Transcutaneous Electrical Nerve Stimulation (TENS). TENS is a non-pharmacological agent which delivers electrical stimulation by a battery operated device via electrodes placed on the skin. TENS is considered to be a safe, inexpensive and non-invasive modality used to treat a variety of acute and chronic pain conditions. The initial phase of the study will randomly allocate subjects to receive active TENS, placebo TENS or standard care (No TENS). After participating in the 1 month random assignment, all subjects will receive active TENS for 1 month. The subjects will make 4 visits to the clinic approximately 2 to 3 1/2 hours each visit. Visits will entail questionnaires, functional tasks, accelerometry, TENS, pain and fatigue assessments.
Study Aims:
Aim #1: The primary aim of the study is to test the effectiveness of repeated TENS use on movement-related pain in people with fibromyalgia with random assignment to three treatments: standard care, placebo TENS and active Aim #2: A secondary aim will test if pain reduction by TENs results in a concomitant decrease in fatigue and fear of movement, and an increase in function and quality of life. Outcome measures will include physical function by directly assessing daily activity with an accelerometer, as well as performing specific functional tasks
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants will be 18 to 70 years of age
- •Women may participate in the study, with the understanding that within the clinical population of fibromyalgia the there is a 7:1 ratio of female to male.
- •Diagnosis of Fibromyalgia by 1990 ACR criteria (11/18 tender points)
- •History of cervical or lumbar pain with fibromyalgia (this is expected in all patients since axial pain is required for diagnosis)
- •Current stable treatment regimen for the last 4 weeks and projected stable treatment regimen for the next 2 months.
- •English speaking
排除标准
- •Current or history of cardiovascular, pulmonary, neurological, endocrine, or renal disease that would preclude the involvement in the study.
- •TENS use in the last 5 years
- •Pacemaker
- •Uncontrolled blood pressure or diabetes
- •Neuropathic pain condition
- •Systemic autoimmune disorder (Lupus, PMR, RA, Psoriasis, Psoriatic arthritis)
- •Spinal fusion - cervical or lumbar
- •Metal implants in cervical or lumbar region
- •Severe skin allergy to adhesive
- •Allergy to nickel
- •Pain level less than 4
- •Pregnancy
- •Change in or new drug or treatment program within the last month or in the next 2months, i.e. must have a stable treatment plan
- •Unstable medical or psychiatric condition which in the opinion of the investigator could compromise the subject's welfare or confound the study results
研究组 & 干预措施
ActiveTENS
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
干预措施: TENS (Device)
Placebo TENS
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
干预措施: TENS (Device)
No TENS (Standard Care)
Participants will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
结局指标
主要结局
Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test
时间窗: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS
Numeric rating scale of 0-10 (low to high scale) for pain with movement during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test
时间窗: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
Numeric rating scale of 0-10 for pain with movement with five time sit to stand test. Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
次要结局
- Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale)(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Tampa Scale of Kinesiophobia (17 to 68 Low to High)(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Brief Pain Inventory - Interference (0-10 Low to High Scale)(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Brief Pain Inventory, Intensity (0-10 Low to High Scale)(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Six Minute Walk Test(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Five Time Sit to Stand Test Rate Per 10 Seconds(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Resting Pain (0-10 Low to High Scale)(Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS))
- Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Fibromyalgia Impact Questionnaire Revised(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Short Form Survey 36; Mental Component Score (T Score Mean of 50)(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Moderate Vigorous Physical Activity Minutes Per Day(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Resting Fatigue Rating (0-10 Low to High Scale)(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
- Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health(Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
研究者
Kathleen Sluka
Professor
University of Iowa