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ERGON Therapy and Muscle Energy Technique for Mechanical Neck Pain (ERGOMET)

Comparison of ERGON Therapy With and Without Muscle Energy Technique in Patients With Mechanical Neck Pain: A Randomized Clinical Trial

This randomized clinical trial will compare the effectiveness of ERGON Therapy combined with Muscle Energy Technique (MET) versus ERGON Therapy alone in patients with mechanical neck pain. Participants will be randomly assigned to one of two intervention groups. Both groups will receive conventional physiotherapy consisting of Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises. The study will evaluate changes in pain intensity, cervical range of motion, and functional disability. The findings are expected to provide evidence regarding the added benefit of MET when combined with ERGON Therapy in the management of mechanical neck pain.

調査の概要

詳細な説明

Mechanical neck pain is a common musculoskeletal condition that can adversely affect daily activities, work productivity, and quality of life. Various manual therapy approaches have been used to manage neck pain, including Instrument-Assisted Soft Tissue Mobilization (IASTM) techniques such as ERGON Therapy and Muscle Energy Technique (MET). However, limited evidence exists regarding the comparative effectiveness of ERGON Therapy with and without MET in individuals with mechanical neck pain.

This randomized clinical trial will recruit 42 participants diagnosed with mechanical neck pain. Eligible participants will be randomly allocated into two groups. Group A will receive ERGON Therapy in combination with Muscle Energy Technique, while Group B will receive ERGON Therapy alone. In addition, both groups will receive a standardized conventional physiotherapy program consisting of TENS, hot pack application, and cervical stretching exercises.

The intervention period will be conducted according to a predefined treatment protocol. Outcome measures will include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), cervical range of motion measured using appropriate clinical tools, and functional disability assessed using the Neck Disability Index (NDI). Assessments will be performed at baseline and after completion of the intervention period.

The primary objective of the study will be to determine whether the addition of Muscle Energy Technique to ERGON Therapy provides superior improvements in pain reduction, cervical mobility, and functional disability compared with ERGON Therapy alone. The results of this trial are expected to contribute to evidence-based rehabilitation strategies for the management of mechanical neck pain.

研究の種類

介入

入学 (実際)

42

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

Individuals clinically diagnosed with mechanical neck pain Duration of neck pain of at least 2 weeks Willingness to participate and provide written informed consent

Exclusion Criteria:

History of cervical spine surgery within the past 12 months History of trauma or infection in the cervical region Presence of neurological deficits or cervical radiculopathy Presence of systemic disorders affecting musculoskeletal function Any other musculoskeletal deformity or significant disability affecting the neck region

-

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:Experimental Group
ERGON Therapy combined with Muscle Energy Technique plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
Participants in the experimental group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique combined with Muscle Energy Technique. ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain. Muscle Energy Technique will be used to facilitate joint mobility and reduce muscular tightness. In addition, participants will receive conventional physiotherapy including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.
他の名前:
  • TENS, Hot Pack, Cervical Stretching
アクティブコンパレータ:Comparator Group
ERGON Therapy alone plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
Participants in the comparator group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique alone. ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain. In addition, participants will receive the same conventional physiotherapy protocol including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.
他の名前:
  • TENS, Hot Pack, Cervical Stretching

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
Pain Intensity (NPRS)
時間枠:Baseline and after completion of 6 treatment sessions (2 weeks)
Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
Baseline and after completion of 6 treatment sessions (2 weeks)
Cervical Range of Motion (CROM)
時間枠:Baseline and after completion of 6 treatment sessions over 2 weeks
Cervical range of motion refers to the measurement of movement of the cervical spine in different planes, including flexion, extension, lateral flexion, and rotation. It reflects neck mobility and functional joint movement and will be assessed using standard clinical methods at baseline and post-intervention.
Baseline and after completion of 6 treatment sessions over 2 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional Disability (Neck Disability Index - NDI)
時間枠:Baseline and after completion of 6 treatment sessions over 2 weeks
Functional disability related to mechanical neck pain will be assessed using the Neck Disability Index (NDI). The questionnaire measures the impact of neck pain on activities of daily living, including personal care, lifting, reading, work, and concentration. Higher scores indicate greater disability.
Baseline and after completion of 6 treatment sessions over 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。

捜査官

  • スタディチェア:DANYAL AHMAD、University of Management and Technology Sialkot Pakistan

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7月15日

研究の完了 (推定)

2026年7月30日

試験登録日

最初に提出

2026年6月22日

QC基準を満たした最初の提出物

2026年6月22日

最初の投稿 (実際)

2026年6月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26日

QC基準を満たした最後の更新が送信されました

2026年6月22日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

De-identified individual participant data including baseline characteristics (age, gender), pain scores (Numeric Pain Rating Scale), cervical range of motion measurements, and Neck Disability Index scores will be shared. No personal identifiers such as names, contact details, or hospital record numbers will be included.

IPD 共有時間枠

IPD will be available beginning 6 months after study completion and will remain available for 5 years after study completion.

IPD 共有アクセス基準

De-identified individual participant data including baseline characteristics (age, gender), pain scores (Numeric Pain Rating Scale), cervical range of motion measurements, and Neck Disability Index scores will be shared. No personally identifiable information such as names, contact numbers, or hospital identification numbers will be included.

Supporting study documents such as study protocol and data collection forms may also be made available.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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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