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Perineural Injection Treatment for Shoulder Pain

2026年4月24日 更新者:Rizki Darmawan

Effect of Perineural Injection Treatment on Pain Intensity and Functional Outcomes in Patients With Shoulder Pain: A Randomized Controlled Trial

Shoulder pain is a common musculoskeletal condition that can lead to significant functional limitation and reduced quality of life. Conventional treatments often provide limited or temporary relief, highlighting the need for alternative approaches targeting peripheral pain mechanisms.

This study aims to evaluate the effectiveness of Perineural Injection Treatment (PIT) compared to Transcutaneous Electrical Nerve Stimulation (TENS) in reducing pain and improving functional outcomes in patients with subacute or chronic shoulder pain.

In this randomized controlled trial, participants are assigned to receive either PIT or TENS, in addition to a standardized exercise program. The intervention is delivered over two sessions within a two-week period. Pain intensity is assessed using the Numeric Rating Scale (NRS), and functional outcomes are measured using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

The results of this study are expected to provide evidence on the comparative effectiveness of PIT and TENS, and to support clinical decision-making in the management of shoulder pain.

調査の概要

詳細な説明

Shoulder pain is one of the most prevalent musculoskeletal disorders and is associated with substantial disability and reduced quality of life. The etiology is multifactorial, involving structures such as the rotator cuff, glenohumeral joint, and surrounding soft tissues. In addition to nociceptive mechanisms, neuropathic and nociplastic components may contribute to persistent pain, making management challenging.

Conventional treatments, including pharmacological therapy, physical therapy, and injection-based interventions, have shown variable effectiveness and may provide only short-term relief. Therefore, there is increasing interest in minimally invasive interventions that target peripheral sensitization.

Perineural Injection Treatment (PIT) is a therapeutic approach involving subcutaneous injection of low-concentration dextrose solution along peripheral nerve pathways. It is proposed to reduce neurogenic inflammation and modulate nociceptor activity, potentially leading to improved pain and function. However, evidence regarding its effectiveness in shoulder pain remains limited.

This study is designed as a single-blind randomized controlled trial comparing PIT with Transcutaneous Electrical Nerve Stimulation (TENS) in patients with subacute or chronic shoulder pain. A total of 32 participants are randomly assigned to either the PIT group or the TENS group. Both groups receive a standardized exercise program, including active range of motion, stretching, and strengthening exercises.

The intervention consists of two treatment sessions administered over a two-week period. PIT is performed using subcutaneous injections of 5% dextrose along painful peripheral nerve areas. TENS is applied using conventional parameters with frequency 75-100 Hz and pulse width less than 200 microseconds.

Outcome measures include pain intensity assessed using the Numeric Rating Scale (NRS) and functional status evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Assessments are conducted at baseline, immediately after intervention, and at the end of the intervention period.

The primary objective of this study is to evaluate the effectiveness of PIT in reducing pain intensity compared to TENS. Secondary objectives include assessing functional improvement and immediate analgesic effects following intervention.

The findings of this study are expected to contribute to evidence-based management of shoulder pain and support the use of mechanism-based interventions targeting peripheral nociceptive pathways.

研究の種類

介入

入学 (実際)

32

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

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Adults aged 18-65 years
  • Patients with subacute or chronic shoulder pain
  • Pain intensity ≥ 3 on the Numeric Rating Scale (NRS)
  • Diagnosed with shoulder conditions such as adhesive capsulitis, rotator cuff tendinopathy or tear, glenohumeral osteoarthritis, acromioclavicular joint sprain, or biceps tendinopathy
  • Able to provide informed consent

Exclusion Criteria:

  • History of injection therapy or use of analgesic medications within one week prior to intervention
  • Presence of neurological or systemic diseases affecting upper limb function
  • Pregnancy
  • Contraindications to injection therapy (e.g., infection at injection site, needle phobia, allergy to dextrose)
  • Refusal to participate or inability to complete the study protocol

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
実験的:Perineural Injection Treatment (PIT)
Participants receive perineural injection treatment using 5% dextrose administered subcutaneously along painful peripheral nerve areas. The intervention is delivered in two sessions over a two-week period. All participants also receive a standardized exercise program.
A 5% dextrose solution is administered via subcutaneous perineural injection targeting painful peripheral nerve areas using a fine needle.
A standardized exercise program including active range of motion, stretching, and strengthening exercises using elastic resistance bands.
アクティブコンパレータ:Transcutaneous Electrical Nerve Stimulation (TENS)
Participants receive transcutaneous electrical nerve stimulation (TENS) using conventional parameters, along with a standardized exercise program. The intervention is delivered in two sessions over a two-week period.
A standardized exercise program including active range of motion, stretching, and strengthening exercises using elastic resistance bands.
TENS is applied using conventional mode with a frequency of 75-100 Hz and pulse width less than 200 microseconds, delivered for approximately 20 minutes per session.

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 Intensity Measured by Numeric Rating Scale (NRS)
時間枠:Baseline to 2 weeks
Pain intensity is assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The outcome is defined as the change in NRS score from baseline to the end of the intervention period.
Baseline to 2 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Functional Status Measured by Disabilities of the Arm, Shoulder and Hand (DASH)
時間枠:Baseline to 2 weeks
Functional status is assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, with scores ranging from 0 to 100, where lower scores indicate better function. The outcome is defined as the change in DASH score from baseline to the end of the 2-week intervention period.
Baseline to 2 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

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)

2025年10月1日

一次修了 (実際)

2026年1月31日

研究の完了 (実際)

2026年1月31日

試験登録日

最初に提出

2026年4月24日

QC基準を満たした最初の提出物

2026年4月24日

最初の投稿 (実際)

2026年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年4月30日

QC基準を満たした最後の更新が送信されました

2026年4月24日

最終確認日

2026年4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。

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