The Enso Study for Chronic Low Back Pain (EPS)
A Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain
調査の概要
詳細な説明
Fifty subjects will be selected based on the inclusion criteria and then randomized to either the intervention group or the sham control group. Each subject will be randomly fitted with an Enso or a sham device and will be instructed to self-administer treatment daily for one hour or more per day for four weeks in both cohorts. Throughout the duration of the study, data will be recorded via a smartphone application regarding treatment usage and intensity, pain levels, the subject's impression of any changes in their functionality, and their opioid and non-opioid medication intake. Medication usage will also be tracked through the use of CURES 2.0 information and pill counts at specified study visits. Additional functional testing will be conducted at each study visit.
At the 4 week visit, the study blind will be broken, and subjects who were randomized to the sham group will be given the opportunity to cross over for an additional week in the study, using the active device.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94143
- 募集
- University of California Medical Center
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コンタクト：
- Bobby Tay, MD
- 電話番号：415-353-2739
- メール：TayB@ucsf.edu
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コンタクト：
- Krishn Khanna, MD
- 電話番号：719-510-9613
- メール：Krishn.Khanna@ucsf.edu
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Mechanical (myofascial), axial back pain (focused around the spine)
- 6/10 or greater level of pain
- Functionally debilitated by their pain (e.g., difficulty walking)
- Minimal radicular symptoms with no effect on functionality, medication, quality of life
- Expressed desire to stop taking pain medications
- Expressed desire to improve disability
- 80% or greater of disability is due to pain in the low back (as opposed to other body areas)
- Experiencing chronic pain for at least 6 months
- Interested in being active, improving their functionality
- Comfortable with using technology in daily life
- Subject able to understand and grant informed consent
- Documented adherence with clinic follow up visits per medical records
- Has an email account
- Above 18 years old
Exclusion Criteria:
- Patients that do not own or have access to a smartphone
- Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
- Primary symptoms due to spinal stenosis
- Source of back pain related to an acute nerve impingement
- Diagnosis of cancer/malignant tumors in the last 5 years
- Source of back pain is an infection
- Source of pain is a prior spinal fusion surgery
- Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
- Has radicular pain symptoms that affect functionality, quality of life or medication intake
- Has undergone surgery to solve pain related to the study indication in the past 6 months
- Patients with history of opioid, alcohol or drug abuse in the last 5 years, per investigator discretion
- Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in the judgement of the investigator
- Inability to complete subjective data as required; e.g. on mobile application and questionnaires
- Pregnant women (as determined by self-report)
- Have severe epilepsy
- Have severe form of cardiovascular disease
- Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Active or Enso Group
Active Enso device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
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An active Enso device that delivers neuromodulation therapy.
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介入なし：Sham Group
Sham device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Six Minute Walk Test
時間枠：Once a week for 4 weeks
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Compare the change in patient's 6 Minute Walk Test (6MWT) between the Enso intervention group and the sham group using the validated 6MWT procedure.
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Once a week for 4 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional back pain assessment
時間枠：Once a week for 4 weeks
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Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.
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Once a week for 4 weeks
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協力者と研究者
捜査官
- 主任研究者：Bobby Tay, MD、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Enso deviceの臨床試験
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Thimble Bioelectronics, Inc.University of California, San Francisco引きこもった
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Ohio State UniversityMedical University of South Carolina; Northwestern University終了しました
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University of Kansas Medical Center招待による登録
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Karolinska Institutet完了