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Effectiveness of Stimulation on the Sciatic Nerve in ACLR

2026年5月4日 更新者:Javier Reina Abellan; PhD、Universidad de Murcia

"Effectiveness of Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve in Patients Undergoing Surgical Reconstruction of the Anterior Cruciate Ligament. A Randomized Clinical Trial".

After randomization, the control group will receive conventional physiotherapy, including manual therapy and therapeutic exercise for ACL rehabilitation. The first experimental group will undergo percutaneous electrical nerve stimulation of the sciatic nerve, while the second experimental group will receive a placebo stimulation. Both interventions aim to improve isometric strength, muscle activation, joint range of motion, and thigh circumference, as well as reduce pain and intra-articular effusion. The procedure involves needle insertion into the sciatic nerve epineurium, placement of a surface electrode on the hamstrings, and connection to an electrostimulator.

調査の概要

詳細な説明

After randomization, participants in the control group will undergo only the conventional physiotherapy program, which consists of manual therapy and therapeutic exercise for the rehabilitation of the anterior cruciate ligament. The first experimental group will receive a percutaneous electrical nerve stimulation protocol applied to the sciatic nerve, consisting of 10 cycles of 10 seconds of electrical current followed by 10 seconds of rest, with the intensity adjusted to the patient's tolerance threshold. The second experimental group will follow the same procedure but with a placebo stimulation. The interventions aim to improve isometric strength, muscle activation, joint range of motion, and thigh circumference, while also reducing pain and intra-articular effusion. The experimental procedure involves inserting a needle into the epineurium of the sciatic nerve after disinfecting the area and placing a surface electrode on the hamstring muscles, followed by connecting the needle to an electrostimulator.

研究の種類

介入

入学 (推定)

62

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

    • Madrid
      • Madrid、Madrid、スペイン、28049
        • 募集
        • Clinica CEMTRO, Montecarmelo, Madrid
        • コンタクト:
        • コンタクト:
          • Javier Reina Abellán, PhD
          • 電話番号:+34 656887703
          • メールjreina@ucam.edu
        • 主任研究者:
          • Adrián Cases Sebastià, Physiotherapist
        • 副調査官:
          • Luis Blanco López, Physiotherapist
        • 副調査官:
          • Javier Reina Abellán, PhD
        • 副調査官:
          • Pedro Guillén García, PhD
        • 副調査官:
          • Iván Nacher Moltó, PhD

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Use of the Semitendinous and Gracilis tendons for ACL Reconstruction
  • Joint Range of Motion greater than or equal to 90
  • Primary ACL injury in the leg to be treated

Exclusion Criteria:

  • Chronic or rheumatic joint disease
  • Central nervous system disorder
  • Heart disease (pacemaker)
  • Neoplasms
  • Epilepsy
  • Coagulopathies (use of anticoagulants)
  • History of spinal surgery or lumbar disease
  • History of neurological disorders
  • Prosthesis or osteosynthesis in the operated leg
  • Structural discrepancy in lower-limb length
  • Belonephobia (overwhelming fear of needles)
  • Neuropathic pain or bilateral symptoms
  • Use of analgesics
  • Quadriceps tendon graft harvest
  • Body mass index <20 or >30 kg/m²
  • Acute muscle injuries
  • Knee joint instability
  • Acute joint inflammation

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:実験グループ
Percutaneous Electrical Nerve Stimulation on the Sciatic Nerve
介入なし:対照群

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
Maximal Isometric Strength of the Hamstring Musculature
時間枠:5 weeks after surgery

Maximal Isometric Strength of the Hamstring Musculature

This was recorded with the patient in a prone position, with the knee flexed at 90 degrees and the ankle in plantar flexion.

The patient was instructed to perform an isometric knee flexion against a Lafayette hand-held dynamometer, positioned at the level of the Achilles tendon.

Three repetitions were recorded and measured in Newtons, with a 60-second rest interval between repetitions.

5 weeks after surgery

二次結果の測定

結果測定
メジャーの説明
時間枠
Surface Electromyography of the Hamstring Musculature
時間枠:5 weeks after surgery

This variable was assessed in three different positions. The first position involved the patient lying prone with the knee flexed at 90 degrees and the ankle in plantar flexion.

In the second position, the patient was seated at the edge of the examination table with the trunk upright, the hip flexed at 90 degrees, and the knee flexed at 90 degrees, with the ankle in plantar flexion.

In the third position, the patient stood in front of the examination table with the injured leg supported on it. The leg was positioned with 90 degrees of hip flexion, 30 degrees of knee flexion, and the ankle in dorsiflexion.

The percentage of activation of the biceps femoris and semitendinosus muscles was recorded, as well as the mean activation ratio of these muscles and the peak activation of both. The latter two variables were measured in microvolts.

Three repetitions of 5 seconds of activation were performed, with a 60-second rest interval between each repetition.

5 weeks after surgery
Postsurgery Pain
時間枠:5 weeks after surgery
NRS scale: 0 = no pain and 10 = the worst pain
5 weeks after surgery
Thigh Circumference Measurement
時間枠:5 weeks after surgery

Thigh circumference was measured using a measuring tape, a validated tool with high inter- and intra-rater reliability in patients with anterior cruciate ligament (ACL) reconstruction.

The patient was positioned in a seated posture with the legs hanging off the examination table. The evaluator stood on the ipsilateral side of the operated limb to ensure unobstructed access.

The operated knee was maintained in maximal extension, and the patient was instructed to remain relaxed and avoid any contraction of the thigh musculature that could bias the measurement.

The evaluator then used the measuring tape to encircle the thigh at a point 10 cm above the superior pole of the patella and recorded the circumference.

5 weeks after surgery
Intra-Articular Effusion
時間枠:5 weeks after surgery

Intra-articular effusion was assessed with the patient in a supine position and the knee in extension. The patient was required to remain relaxed to allow accurate assessment of post-surgical joint effusion using the "Stroke test." During this test, the evaluator performed sweeping strokes with the hands from medial to lateral and vice versa, observing the behavior of the effusion and whether it returned to the medial side.

This test is graded on a 0-3 scale: 0 indicates no detectable effusion; 1 indicates a measurable fluid wave with a single maneuver; 2 indicates visible fluid with slight pressure; and 3 indicates a large effusion without the need for pressure.

This method is validated by the IKDC 2000 (International Knee Documentation Committee) and is widely used in research studies.

5 weeks after surgery
Knee Range of Motion
時間枠:5 weeks after surgery

Active and passive knee range of motion was measured using a universal manual goniometer, a highly validated tool commonly used in clinical physiotherapy practice.

The patient was positioned supine for accurate measurement. The greater trochanter was identified, and the patient was asked to actively flex the knee by sliding the heel along the table without using the hands.

The evaluator stabilized the operated limb with the caudal hand and placed the axis of the goniometer over the lateral femoral condyle. The proximal arm was aligned with the midline of the thigh toward the greater trochanter, and the distal arm with the midline of the leg toward the lateral malleolus.

For knee extension, the patient remained in a supine position with the heel, gastrocnemius, and hamstring musculature supported on the table. The patient was then asked to perform active extension, and the goniometer was positioned using the same anatomical landmarks to determine both passive and active extension.

5 weeks after surgery

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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12月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2025年12月2日

QC基準を満たした最初の提出物

2026年5月4日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月6日

QC基準を満たした最後の更新が送信されました

2026年5月4日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CE102505

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