A Multi-Center, Double-Blind, Sham-Controlled, Randomized Trial of Dual Field PEMF Therapy [Provant® Therapy System] in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy (DSPN) (The RELIEF Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 36
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
Part A of this trial is a multi-center, prospective, double-blinded, sham-controlled, randomized clinical trial. Part A will evaluate PEMF treatment compared to sham treatment in patients with painful diabetic distal symmetric peripheral neuropathy (DSPN) when treatment is administered 30 minutes twice daily through a 120-day period (4 months). Part B is a 8-month open-label active treatment extension period designed to collect longer-term data on pain, medication use, quality of life and safety (Part B).Part B of this trial is a an extension period upon completion of Part A.
详细描述
Eligible subjects will be entered into a 14-day ePRO diary run-in period to collect average baseline pain scores related to their diabetic neuropathy in the lower extremities, diary compliance, and analgesic consumption (maintenance and prn prescribed peripheral neuropathic pain medication pill counts). Subjects will collect electronic patient-reported outcome (ePRO) data each morning around the same time during the run-in period.
Subjects will return to the clinic at Baseline (Day 0) for review of eligibility, diary compliance, average baseline diabetic neuropathic pain score of ≥4 and <9, and review of stable analgesic pain consumption profile during the 14-day run-in period. Qualified subjects based on diary compliance and average pain score will be randomized 1:1 (active: sham) and will be instructed to self-treat twice daily for 120 days. Subjects will record electronic patient-reported outcome (ePRO) data following each morning treatment for 120 days. Subjects consenting to distal thigh and distal leg skin biopsies during the Screening visit will have biopsies collected and sent to the central laboratory for assessment. All subjects will have baseline assessments conducted.
Subjects will receive a telephone call at Day 7 to ensure compliance to treatment and diary completion, provide follow-up information on the biopsy sites (if applicable), complete a blinding assessment as well as be assessed for safety and concomitant medication changes.
At Month 1 subjects will return to the clinic for evaluation of safety, concomitant medication changes, review device usage and ePRO diary completion, and Patient Global Impression (PGI). Treatment satisfaction will also be assessed.
At Month 2 subjects will return to the clinic for evaluation of safety, concomitant medication changes, treatment satisfaction, review of device usage (reports will be supplied to the site) and ePRO diary completion, quality of life outcomes (WPAIQ and NeuroQoL), Patient Global Impression (PGI), and interim visit measurements of SPP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active and sham devices will look identical. Participants and site staff will be blind to the randomization.
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or Type 2 diabetes
- •Pain attributed to symmetrical lower extremity diabetic peripheral neuropathy for at least 6 months
- •DPN pain over the preceding 24 hours is ≥4 and <9 based on the 11-point NPRS (0-10)
- •22 to 80 years of age
- •On stable diabetes treatment
- •HbA1c less than or equal to 10%
- •No recent changes to analgesic prescriptions
- •ABI of ≥0.8 to ≤1.3
- •Walks independently
- •Willing and able to give consent
- •If female, must be post-menopausal, surgically sterile, abstinent or practicing an effective method of birth control
- •Can access an internet browser or smart phone
- •To be randomized after the 14-day run-in period, average pain (NPRS) must be ≥ 4 and < 9 over preceding 7 days and subject must be 70% compliant with ePRO assessments (electronic diary)
排除标准
- •Active, open ulcer on either extremity
- •Significant peripheral vascular disease
- •Venous insufficiency
- •History of solid organ transplant or severe renal disease
- •Diagnosed with a non-diabetic cause of chronic neuropathy
- •Previous or current history of primary or tertiary hyperparathyroidism, hypercalcemia, psychiatric disorder, alcohol dependency, Hepatitis B or C, or HIV infection
- •Significant cardiovascular disease
- •Uncontrolled medical illness
- •Requires or anticipates the need for surgery during the study
- •Total foot depth of >8 cm
- •Has received any investigational drug or device within 30 days
- •Has used systemic corticosteroids within 3 months
- •History of malignancy within 5 years in treatment area
- •A psychiatric disorder of sufficient severity
- •Receiving prn narcotic medications
- •History of drug or alcohol abuse within 1 year
- •Implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s0
- •Pregnant or planning to become pregnant
- •Previous treatment with Provant Therapy
- •Unwilling to follow instructions or comply with study instructions
- •Pain from any other source that could confuse DPN pain assessment
- •Clinically significant foot deformity
- •Skin condition that could alter peripheral sensations
- •Previous surgery to the spine or lower extremity with residual symptoms of pain or difficulty with movement.
- •Clinically significant arthropathy
结局指标
主要结局
Change in Pain Intensity
时间窗: Baseline through 4 months
Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain).
次要结局
- Patients With 2 Point or 30% Reduction in Pain at 4 Months(Baseline to 4 months)
- Time to 30% or 2-point Reduction in NPRS, Whichever Comes First, Through 4 Months(Through 4 months)
- Patient Global Impression at 4 Months(Baseline through 4 months.)
- Change in Neuropathy Related Quality of Life (NeuroQoL) Between Baseline and End of Treatment at 4 Months.(Baseline to 4 months)
- Changes in Quantitative Sensory Testing (QST) Between Baseline and End of Treatment at 4 Months.(Baseline to 4 months)
- Change is Skin Perfusion Pressure (SPP) for Baseline to End of Treatment at 4 Months(Baseline to 4 months)
- Changes in Nerve Conduction Studies of Velocity Between Baseline and End of Treatment at 4 Months.(Baseline to 4 Months)
- Changes in Nerve Conduction Studies of Amplitude Between Baseline and End of Treatment at 4 Months.(Baseline to 4 Months)