Electrical Stimulation for Hemiplegic Shoulder Pain
2017年12月26日 更新者：John Chae, MD、MetroHealth Medical Center
Post-stroke shoulder pain is a major rehabilitation problem affecting moderate to severely impaired stroke survivors.
Surface electrical stimulation (ES) of muscles surrounding the hemiparetic shoulder has been demonstrated to be beneficial, but despite the evidence for therapeutic benefit, the clinical implementation of surface ES for poststroke shoulder pain has been difficult.
In order to address the limitations of surface ES, the investigative team pioneered the development of percutaneous intramuscular (IM) ES for the treatment of post-stroke shoulder pain.
However, prior to acceptance by the clinical community, additional gaps in the scientific and clinical knowledge need to be addressed.
This study begins to do so.
The primary objective is to estimate the relative pain reduction associated with IM ES vs. "usual care."
We hypothesize that the IM ES group will exhibit a larger effect size with respect to pain reduction compared to "usual care".
A secondary objective is to estimate the effect on health related QOL of IM ES vs. "usual care."
Demonstration of improvement in QOL will validate the clinical relevance of the intervention.
We hypothesize that the IM ES group will exhibit greater improvement in health related QOL compared to "usual care".
調査の概要
研究の種類
介入
入学 (実際)
25
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Cleveland、Ohio、アメリカ、44109
- MetroHealth Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- shoulder pain localized to the glenohumeral joint, subacromial area or deltoid insertion associated with any of the following conditions: a) rest; b) passive abduction or external rotation ROM; c) active abduction or external rotation ROM; or d) manual palpation
- weakness of shoulder abductors (≤4/5 on MRC if isolated movement is present)
- age ≥21-yrs
- time from stroke ≥ 3-mo
- shoulder pain onset after the most recent stroke
- duration of shoulder pain ≥ 3-mo
- severity of shoulder pain on BPI-SF 3 ≥4
- cognitive ability to fulfill study requirements [a) exhibit 3 object immediate and 30 minute recall; b) ability to use a numeric rating scale (using a 0-10 numeric rating scale) by correctly ranking the tightness they feel on the unaffected arm of 3 low-pressure inflations with a standard sphygmomanometer cuff which follow a predetermined sequence (20, 40 and 0 mm Hg); and c) ability to follow 3-stage commands]
- availability of a reliable adult who can check the skin and assist the participant with the treatment protocol
- willing and able to report severity of shoulder pain throughout the study period
- willing to make all scheduled study visits post-implantation.
Exclusion Criteria:
- evidence of joint or overlying skin infection
- insensate skin
- >1 opioid or nonopioid analgesics daily for shoulder pain
- daily intake of pain medications for any other chronic pain
- intra-articular or subacromial steroid injections to the shoulder in the previous 12-wks
- botulinum toxin injection to the trapezius, pectoralis or subscapularis muscle in the previous 12-wks
- receiving physical or occupational therapies for shoulder pain
- physician-diagnosed shoulder pathology symptomatic within the 5 yrs prior to CVA
- bleeding disorder
- INR>3.0 for those on warfarin [INR>3.0]
- poorly controlled diabetes [HbA1c>7.0]
- medical instability
- pregnancy
- uncontrolled seizures (>1/mo for 6-mo)
- uncompensated hemi-neglect
- severely impaired communication
- moderate to severe depression
- other confounding conditions such as ipsilateral upper limb lower motorneuron lesion, Parkinson's Disease, spinal cord injury, traumatic brain injury or multiple sclerosis
- other medical issues such as complex regional pain syndrome, bicipital tendonitis, myofacial pain syndrome, etc.
- the following cardiac conditions: a) history of arrhythmia with hemodynamic instability, such as ventricular tachycardia, supraventricular tachycardia and rapid ventricular response atrial fibrillation; b) any implantable stimulator such as demand pacemakers or defibrillators; and c) valvular heart disease including artificial valves (due to risk of infection and endocarditis)
- likely non-compliance factors such as distance from the center, inadequate social support, or psychiatric/psychologic factors
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：IM Electrical Stimulation (IM ES)
The IM ES Group will receive electrical stimulation treatment for three weeks (6 hrs daily) with an Intramuscular Electrical Stimulator following a one week electrode stabilization period.
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A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable.
The exit site and electrode are covered by a bandage, but the cable extends out.
After a one week stabilization period, the cable is connected to a stimulator.
A self-adhesive surface electrode serves as the indifferent electrode.
Stimulation intensity is set by the investigator.
The prescription for daily stimulation treatment will be 6 hrs.
The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate.
The treatment period will be 3 weeks, after which the electrode will be removed.
Total time of electrode implantation is no more than 29 days.
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アクティブコンパレータ：Usual Care (UC)
The Usual Care Group will receive outpatient therapy for four weeks, coupled with prescribed daily home exercises.
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Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises.
The therapist will implement an individualized treatment plan consistent with the needs of the participant.
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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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Brief Pain Inventory Short Form
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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The BPI is a pain questionnaire, which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities.
Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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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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ShoulderQ VGRS Scale
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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The ShoulderQ Visual Graphics Rating Scale (VGRS) T is a structured questionnaire designed to assess severity of HSP at rest during the day, on movement, and at night on a 0-30 scale where higher numbers indicate greater pain.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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SF-36 Bodily Pain Component
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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The SF-36v2 is a population-norm based health related quality of life measure, presented in T-scores where population average equals a score of 50 with a standard deviation of 10.
Maximum is 100, with higher score indicating greater health realated quality of life.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Pain-free External ROM, Degrees
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Passive pain-free Externa ROM is a motor recovery measure.
The subject was supine with the shoulder adducted with hand resting on the abdomen, elbow flexed, and with the humerus supported by the mat.
The axis of a universal goniometer was centered on the olecranon process of the ulna projecting through the humeral shaft toward the humeral head.
The subject's shoulder was externally rotated passively to the pain threshold, defined as the start of any pain.
Pain at rest was recorded as 0 degrees.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Fugl-Myer Motor Assessment (FMA) - Upper Extremity
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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The Fugl-Myer Motor Assessment (FMA) is a motor recovery measure.
Volitional movement of the upper limb (shoulder, elbow, forearm, wrist, and hand) is examined in and out of synergies.
Each item was graded on a 3-point ordinal scale and summed to provide a maximum score of 66, with higher scores indicating lower impairment.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Pain Interference Questionnaire
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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BPI-9 from Brief Pain Inventory, Short Form.
Pain interference is on a 0 - 10 scale, with 0 being no interference, and 10 being complete interference.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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A measure of isometric strength in response to audio cue.
Isometric shoulder abduction moment was measured with a Biodex Biomechanical Measurement System (Biodex Medical Systems, Shirley, NY).
The average moment during the last second of the audible tone was calculated for each trial and those values were averaged over the three trials.
Subjects underwent testing of both shoulders, non-paretic side first, and the results are presented as the ratio of the paretic shoulder to the non-paretic shoulder to decrease the influence of intra-subject variability between measurements.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Delay in Initiation of Shoulder Abduction EMG Activity
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Electromyographic activity from the deltoid was also measured during the isometric abduction moment trials.
Surface EMG recording electrodes (2 cm x 2 cm) were placed over the deltoid muscle and spaced approximately 4 cm apart.
The EMG amplifier gain was adjusted to record as high-fidelity an EMG signal as possible during shoulder abduction.
Delay of initiation (DOI) was defined as the duration between onset of the audibe tone and the onset of EMG signal.
Raw EMG signals were analyzed visually to determine the earliest rise in EMG activity relative to steady state for delay of initiation.
The mean DOI of the three trials were calculated, and the ratio of the paretic to non-paretic shoulder DOI were used as summary metrics.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Delay in Termination of Shoulder Abduction EMG Activity
時間枠：Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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Electromyographic activity from the deltoid was also measured during the isometric abduction moment trials.
Surface EMG recording electrodes (2 cm x 2 cm) were placed over the deltoid muscle and spaced approximately 4 cm apart.
The EMG amplifier gain was adjusted to record as high-fidelity an EMG signal as possible during shoulder abduction.
Delay of termination (DOT) was defined as the duration between cessation of the audible tone and return of the EMG signal to baseline.
Raw EMG signals were analyzed visually to determine the earliest rise in EMG activity relative to steady state for delay of initiation, and return to steady for delay of termination.
The mean DOT of the three trials were calculated, and the ratio of the paretic to non-paretic shoulder DOT were used as summary metrics.
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Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：John Chae, MD、MetroHealth Medical Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Yu DT, Chae J, Walker ME, Fang ZP. Percutaneous intramuscular neuromuscular electric stimulation for the treatment of shoulder subluxation and pain in patients with chronic hemiplegia: a pilot study. Arch Phys Med Rehabil. 2001 Jan;82(1):20-5. doi: 10.1053/apmr.2001.18666.
- Yu DT, Chae J, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Feldstein M, Fang ZP. Intramuscular neuromuscular electric stimulation for poststroke shoulder pain: a multicenter randomized clinical trial. Arch Phys Med Rehabil. 2004 May;85(5):695-704. doi: 10.1016/j.apmr.2003.07.015.
- Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP. Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. Am J Phys Med Rehabil. 2005 Nov;84(11):832-42. doi: 10.1097/01.phm.0000184154.01880.72.
- Chae J, Ng A, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Intramuscular electrical stimulation for shoulder pain in hemiplegia: does time from stroke onset predict treatment success? Neurorehabil Neural Repair. 2007 Nov-Dec;21(6):561-7. doi: 10.1177/1545968306298412. Epub 2007 Mar 16.
- Wilson RD, Gunzler DD, Bennett ME, Chae J. Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial. Am J Phys Med Rehabil. 2014 Jan;93(1):17-28. doi: 10.1097/PHM.0000000000000011. Erratum In: Am J Phys Med Rehabil. 2016 Feb;95(2):e29.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年1月1日
一次修了 (実際)
2013年2月1日
研究の完了 (実際)
2013年2月1日
試験登録日
最初に提出
2010年5月12日
QC基準を満たした最初の提出物
2010年5月12日
最初の投稿 (見積もり)
2010年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2018年1月23日
QC基準を満たした最後の更新が送信されました
2017年12月26日
最終確認日
2017年12月1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。
Intramuscular Electrical Stimulatorの臨床試験
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First Affiliated Hospital of Zhejiang UniversityMaastricht University; Zhejiang Mingzhou Brain Rehabilitation Hospital完了
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Beijing Pins Medical Co., LtdBeijing Tiantan Hospitalわからない
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Saluda Medical Americas, Inc.完了
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Seoul National University Hospitalわからない