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肘部管症候群における姿勢矯正

2026年9月18日 更新者:Yale University

肘部管症候群(CuTS)の治療のための姿勢矯正

The primary objective of this study is to determine whether the UpRight Go posture trainer reduces the symptoms of cubital tunnel syndrome in patients who have not had corrective surgery, as determined by improvements in VAS scores for pain, numbness, and weakness.

調査の概要

状態

終了しました

詳細な説明

This is a randomized controlled, non-blinded trial. All patients who are eligible to participate and who consent to participate will be randomized to either receive standard of care treatment alone, or standard of care treatment with the additional intervention of posture training. The nature of the intervention prevents blinding. All patients will be followed for 6 weeks and evaluated for symptom improvement or resolution.

All patients aged 18 and older who present to clinic with cubital tunnel syndrome of any severity and who have not previously undergone surgical intervention for this condition will be eligible to participate in this study. All participants must be amenable to conservative management of CuTS, wearing a posture training device daily, completing the accompanying questionnaires throughout the study, and returning for follow-up.

研究の種類

介入

入学 (実際)

6

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

    • Connecticut
      • New Haven、Connecticut、アメリカ、06520
        • Yale New Haven Hospital

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

18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:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Adult patients, between 18 and 99 years old
  • Exhibiting signs and symptoms consistent with cubital tunnel syndrome including but not limited to pain, numbness, or paresthesia in an ulnar distribution, loss of grip strength, or loss of fine motor control of the fingers.
  • Nerve conduction study, electromyography, MRI or ultrasound results consistent with the diagnosis of cubital tunnel syndrome
  • Ability to wear a posture trainer daily and manage the associated smartphone application and questionnaire

Exclusion Criteria:

  • History of spinal surgery, hand surgery or hand/wrist fracture
  • History of cubital tunnel release surgery or carpal tunnel syndrome
  • Pregnancy or lactation
  • Known allergic reactions to silicon
  • Long-standing history of T2DM, documented neuropathic pain

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:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:normal conservative management + posture training

Participants will receive normal conservative management as well as posture training via the UpRight Go posture trainer. The device will be provided to participants with all supplies and instructions that come from the original manufacturer and will be walked through how to install and use the necessary smartphone application as well as wear the posture trainer. Participants will be asked to wear the device daily for six weeks with goals for the amount of time spent wearing the sensor each day provided by the smartphone app. Participants will return to clinic in six weeks to return the device and submit usage data, or will mail back the device. Devices will be cleaned with disinfectant wipes before use by future participants.

The UpRight Go posture trainer is a commercially available biofeedback sensor that externally attaches to the wearer via a necklace or silicon adhesive. It vibrates when it senses that the wearer is slouching and connects to a smartphone application which sets daily goals, tracks usage, and provides assistance and support. It complies with International Electrotechnical Commission (IEC) standards.

介入なし:normal conservative management only (standard of care)

Participants will receive conservative management.only: standard of care for initial treatment of cubital tunnel syndrome

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
Change in pain score for pain using a Visual Analogue Scale (VAS)
時間枠:Baseline and 6 weeks

Pain score assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

Baseline and 6 weeks
Change in pain score for numbness using a Visual Analogue Scale (VAS)
時間枠:Baseline and 6 weeks

Pain score for numbness assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

Baseline and 6 weeks
Change in pain score for weakness using a Visual Analogue Scale (VAS)
時間枠:Baseline and 6 weeks

Pain score for weakness assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

Baseline and 6 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
時間枠:Baseline and 6 weeks

The DASH questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Each item is scored on a 5 point Likert scale. Total score ranges from 0 (no disability) to 100 (most severe disability). Higher scores indicate a greater level of disability and severity.

Baseline and 6 weeks
Change in strength testing via pinch/grip test
時間枠:Baseline and 6 weeks

Pinch testing involves the patient pinching a pinchmeter, which measures the strength of the patient's pinch. Grip testing involves the patient gripping a dynamometer. The force that the patient is able to exert on the pinchmeter/dynamometer is measured in lbs/kgs, Newtons, or Pascals, and a higher reading indicates a greater strength. This provides valuable information about how a patient's strength is affected by cubital tunnel syndrome.

Baseline and 6 weeks
Change in Medical Research Council (MRC) Scale for Muscle Strength
時間枠:Baseline and 6 weeks

The MRC Scale is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). This score was defined as the sum of MRC scores from six muscles in the upper and lower limbs on both sides so that the score ranged from 60 (normal) to 0 (quadriplegic). The Criteria requires that each of the six muscle groups listed in the table are examined bilaterally.

Baseline and 6 weeks
Change in range of motion testing
時間枠:Baseline and 6 weeks

Patients will be asked to actively move their upper body through a series of movements and postures, testing for flexibility in the neck, shoulders, elbows, and wrists. Limitations in movement are recorded qualitatively, which indicates the potential presence of concomitant pathology in the upper extremities, which could affect a patient's response to treatment.

Baseline and 6 weeks
Change in two-point discrimination testing
時間枠:Baseline and 6 weeks

A caliper or two point discriminator is used to apply pressure to a patient's finger tips. The patient is then asked to determine if one or two points of pressure are present, with the distance between the two points changing. The lowest distance between two points that the patient can distinguish is recorded in millimeters. A smaller distance indicates better fine-touch sensation at the finger tips and can indicate the quality of sensory nerves at the distal upper extremity.

Baseline and 6 weeks
Change in Semmes-Weinstein monofilament testing.
時間枠:Baseline and 6 weeks

The Semmes-Weinstein monofilament (SWM) testing is one of the clinical tests that measures the response to a touching sensation of the monofilaments using a numerical quantity. The monofilament is a small strand of nylon attached to a plastic base at fixed spacing's from 2mm to 15mm. The provider uses this monofilament to check for loss of feeling on your foot.

Baseline and 6 weeks
Change in Boston Carpal Tunnel Syndrome (BCTS) questionnaire
時間枠:Baseline and 6 weeks

The BCTS is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult. A final score is calculated for each scale (the sum of the individual scores divided by the number of items) and ranges from 1 to 5, with a higher score indicating a more severe handicap.

Baseline and 6 weeks
Hours per day device was worn
時間枠:up to 6 weeks

The mean hours per day device was worn

up to 6 weeks
Time spent with good posture
時間枠:up to 6 weeks

The mean time spent with good posture while wearing the device

up to 6 weeks

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。

スポンサー

捜査官

  • 主任研究者:Elspeth Hill, MBChB, PhD, MRes, MRCS、Yale University

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 (実際)

2023年12月15日

一次修了 (実際)

2024年7月24日

研究の完了 (実際)

2024年7月24日

試験登録日

最初に提出

2023年10月16日

QC基準を満たした最初の提出物

2023年10月16日

最初の投稿 (実際)

2023年10月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月23日

QC基準を満たした最後の更新が送信されました

2026年9月18日

最終確認日

2026年9月1日

詳しくは

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