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Comparative Effectiveness Randomised Controlled Trial of Hybrid Muscle Conditioning

2026年9月17日 更新者:The Hong Kong Polytechnic University

Powering Exercise-induced Hypoalgesia and Functional Recovery in Chronic Nonspecific Neck Pain by Hybrid Muscle Conditioning: a Comparative Effectiveness Randomised Controlled Trial With Mechanistic Analysis

Chronic nonspecific neck pain is a prevalent and recurrent condition frequently characterised by persistent impairments in cervical-scapular neuromuscular function. Deep cervical flexor motor-control deficits and reduced upper trapezius endurance represent two clinically relevant but distinct manifestations of neuromuscular dysfunction. Deep cervical flexor motor-control exercise targets cervical segmental control and movement coordination, while upper trapezius endurance exercise targets at the mechanical capacity of the cervical-scapular system. Although both exercise approaches have demonstrated clinical benefit when used independently, it remains unknown whether combining these two exercises as compared to single-exercise approach would provide additional or synergistic effects on the clinical recovery for individuals with chronic nonspecific neck pain.

This three-arm comparative randomised controlled trial will investigate a 5-week hybrid programme combining deep cervical flexor motor-control and upper trapezius endurance exercise as compared to their single-exercise comparator programme (i.e., deep cervical flexor motor-control exercise alone or upper trapezius endurance exercise alone) in managing the clinical recovery of adults with chronic nonspecific neck pain. Two hundred and ten participants will be randomly allocated to one of the three groups (70 participants per group) upon the completion of the baseline evaluation of the study outcomes. All programmes will use standardised exercise procedures, individualised progression, supervised instruction, and structured home exercise format. Study outcomes will be assessed at baseline, immediately after the 5-week intervention, and 6 months after programme completion in order to enable the evaluation of the exercise programme effectiveness at immediate and longer-term.

The primary objective is to determine the effectiveness of hybrid exercise programme as compared to the two single-component exercise programmes on the primary outcomes namely neck pain intensity, neck-related disability and upper-extremity physical function, and general health status (as secondary outcome) at immediate (change between pre- and post-programme of the 5-week programme) and longer-term reassessments (change between pre-programme and 6-month after the 5-week programme).

The secondary objective aims to study the mechanisms underpinning the observed effectiveness produced by the exercise programmes by evaluating the changes in neuromuscular and muscle-mechanical function, including deep cervical flexor performance, upper trapezius endurance, joint position error, muscle mechanical properties and vascularity, together with changes in pain sensitivity, exercise-induced hypoalgesia, and pain-related and exercise-specific self-efficacy, at both the immediate and longer-term reassessments.

Findings this trial will provide evidence if differential effectiveness on clinical outcomes present when rehabilitating adults with chronic nonspecific neck pain using combined and single-component exercise approaches. Furthermore, findings of the mechanism-mediation analysis will provide a scientific basis for more targeted, mechanism-informed exercise prescription for chronic nonspecific neck pain. Overall, results to be obtained from this trial will help refine the therapeutic exercise prescription and promote the outcome recovery for conservative management of this highly prevalent spinal condition.

調査の概要

詳細な説明

Study Summary This randomised controlled trial evaluates whether a 5-week hybrid exercise programme combining deep cervical flexor (DCF) motor-control training and upper trapezius (UT) endurance training yields greater improvements in neck pain, disability, and upper-extremity function than either single-exercise programme alone (Objective 1). Two hundred and ten adults with chronic non-specific neck pain will be randomised into three groups and followed for 6 months. Mechanistic domains (pain sensitivity, exercise-induced hypoalgesia, muscle mechanical properties, neuromuscular performance, joint position error, and self-efficacy) will be examined as potential mediators of clinical change (Objective 2).

Study Design

  • Type: Interventional, randomised controlled trial
  • Design: Three-arm parallel-group comparative effectiveness trial
  • Intervention Duration: 5 weeks
  • Follow-up: 6 months
  • Masking: Outcome assessors blinded
  • Allocation: Computer-generated minimisation for intervention randomisation
  • Primary Purpose: Treatment
  • Study Site: Musculoskeletal Physiotherapy Classroom (Room GH014), The Hong Kong Polytechnic University

Participants

Target Population and Recruitment Adults aged 18-50 years with unilateral chronic non-specific neck pain (CNSNP) lasting >3 months. Convenience sampling from the local community and from Prince of Wales Hospital. Eligibility screening conducted by physiotherapists with ≥5 years of musculoskeletal experience.

Eligibility Criteria of participants

Inclusion Criteria

  • Mechanical neck pain provoked by posture or movement
  • NPRS ≥3/10
  • NDI ≤25/50
  • DASH ≤60/100
  • Impaired DCF performance (CCFT activation <26 mmHg)
  • Positive scapular reposition test
  • Ability to perform required exercise movements

Exclusion Criteria

  • Trauma-related or specific cervical pathology (radiculopathy, disc herniation, stenosis)
  • Neurological deficits or congenital deformity
  • Prior cervical/thoracic/shoulder surgery
  • Marked cervical mobility restriction
  • BMI ≥25 kg/m²
  • Orthopaedic, neurological, or systemic comorbidities
  • High fear-avoidance (TSK ≥37)
  • Psychological distress (SF-12 MCS ≤40)
  • Regular analgesic/muscle relaxant/vasoactive medication use
  • Vestibular symptoms
  • Contraindications to electrical stimulation

Sample Size N = 210 participants (70 participants/intervention group), based on the sample size estimation of the objectives 1 and 2.

Randomisation and Allocation

Participants will be allocated using computer-generated minimisation (MinimPy), balancing:

  • Age
  • Sex
  • Hand dominance
  • Side of neck pain
  • BMI
  • Weekly screen-time hours
  • Baseline Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and Disability of Arm, Shoulder and Hand Questionnaire (DASH)

Allocation is performed by an independent researcher not involved in intervention delivery or assessment. Outcome assessors remain blinded.

Study Groups (Interventions)

Hybrid Group Combined DCF motor-control training combined with upper trapezius endurance training. Each component follows the same technique, dosage, and progression as its corresponding single-exercise comparator.

Motor-Control Group Low-load craniocervical flexion training targeting selective activation and endurance of the deep cervical flexors. Training progresses based on CCFT performance.

Endurance Group Low-load overhead shrug training using elastic resistance bands to improve upper trapezius endurance. Resistance is prescribed to achieve moderate exertion and progressed while maintaining movement quality.

Intervention implementation

  • Weeks 1-2: Two individual supervised 30-min sessions (once per week), followed by Home exercise 3×/day, 3 non-consecutive days/week during Weeks 3-5
  • Standardised manuals and instructional videos provided
  • Weekly reminders through message sent to the participants' mobilie
  • Exercise diaries used to record adherence, symptoms, and adverse events
  • Physiotherapists document responses during supervised sessions
  • Medication changes, reinjury, and additional treatments monitored throughout

Assessment of outcomes

Outcome assessments conducted at:

  • T1: Baseline
  • T2: Immediately post-intervention
  • T3: 6-month follow-up

Participants also rate programme helpfulness (1-10 scale) at completion and provide qualitative feedback on adherence facilitators/barriers.

Outcome Measures

Primary Outcomes:

  • Neck pain intensity (Numeric Pain Rating Sscale 0-10)
  • Neck-related disability (Neck Disabiilty Index)
  • Upper-extremity function (Disabiity of Arm, Shoulder and Hand Questionnaire)

Secondary Outcomes:

  • General health (Short Form-12)
  • Mechanistic domains:
  • Pain sensitivity
  • Exercise-induced hypoalgesia
  • Muscle mechanical properties
  • Neuromuscular performance
  • Cervical and scapular joint position error
  • Pain-related and exercise-specific self-efficacy

Details of outcome measures are provided in the respective section of this application.

Data Analysis Analyses follow the intention-to-treat principle. Primary outcomes will be evaluated using repeated-measures multivariate models comparing changes across groups over time. Prespecified mediation analyses will examine whether mechanistic changes statistically mediate clinical outcomes at post-intervention and 6-month follow-up.

Ethics has been approved by the institutional ethics committee. Written informed consent obtained from all participants.

研究の種類

介入

入学 (推定)

210

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。

研究連絡先

研究連絡先のバックアップ

研究場所

      • Hong Kong、香港
        • The Hong Kong Polytechnic University
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Sharon MH Tsang, 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

18年~50年 (大人)

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:

  • adults aged 18-50 years
  • unilateral CNSNP of more than 3 months' duration with mechanical nature (neck pain provoked or aggravated by cervical posture or movement)
  • baseline neck pain ≥3/10 on Numerical Pain Rating Scale (NPRS)
  • baseline functional disability ≤25/50 on Neck Disability Index (NDI)
  • baseline funcctional diability ≤60/100 on Disabilities of the Arm, Shoulder and Hand (DASH)
  • impaired deep cervical flexor performance verified by <26 mmHg on craniocervical flexion test (CCFT) activation score (Jull et al., 2004)
  • positive scapular reposition test verified by an immediate reduction in pain or improvement in cervical range of motion during manual scapular repositioning (Van Dillen et al., 2007; Wannaprom et al., 2021)

Exclusion Criteria:

  • neck pain caused by trauma or with a specific diagnosis (including radiculopathy, disc herniation, or spinal stenosis, or if neurological deficits or congenital cervical deformity)
  • history of previous surgery of the cervical or thoracic spine or shoulder
  • marked restriction of cervical mobility verified by extension <30° or rotation <60° (Cleland et al., 2010; Wainner et al., 2003)
  • inability to achieve full shoulder elevation required for the prescribed exercise
  • BMI ≥25 kg/m²
  • comoborities orthopaedic, neurological, or systemic conditions
  • high fear-avoidance beliefs verified by Tampa Scale for Kinesiophobia score ≥37 (Vlaeyen and Linton, 2000); psychological distress (SF-12 Mental Component Summary score ≤40) (Yu et al., 2015)
  • regular use of analgesics, muscle relaxants, or vasoactive medications
  • dizziness or vertigo suggestive of vestibular dysfunction or vertebrobasilar insufficiency
  • any contraindications to electrical stimulation for muscle endurance index measurement (any mental or neural implant, seizure)

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:Hybrid exercise group

Deep cervical flexor motor control exercise combined with upper trapezius endurance exercise (named as Hybrid group and serves as the experimental group for comparison of its effectiveness to the two single-exercise comparator groups)

Hybrid exercise programme included 1) deep cervical flexor motor-control and 2) upper trapezius endurance exercise for five consecutive weeks. The low-load craniocervical flexion exercise (for facilitation of the activation of longus capitis and longus colli) will be performed in supine crook lying position with the participants' head and neck in a neutral position. Training commences at the participant's baseline craniocervical flexion test endurance score (20mmHg to 30mmHg) for 10 repetiation of 10-second hold time using the pressure biofeedback unit, under the supervision by a physiotherapist, who is independent from study outcome assessment. Upper trapezius endurance exercise will be performed through overhead shrugging with an elastic band while maintaining the neutral head and neck in sitting. Three set of 15 repeitations with 1-min rest between sets, at the exercise level standardised to a perceived exertion of 7/10 on the Borg Category Ratio 10 scale.

アクティブコンパレータ:Motor control exercise group

Deep cervical flexor motor control exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group)

Deep cervical flexor motor-control will be performed by participants who are allocated to this exercise group. The same low-load craniocervical flexion exercise (for facilitation of the activation of longus capitis and longus colli) will be performed in supine crook lying position with the participants' head and neck in a neutral position. Training commences at the participant's baseline craniocervical flexion test endurance score (20mmHg to 30mmHg) for 10 repetiation of 10-second hold time using the pressure biofeedback unit, under the supervision by a physiotherapist, who is independent from study outcome assessment.

アクティブコンパレータ:Endurance exercise group

Upper trapezius endurance exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group)

Upper trapezius endurance exercise (the same exercise component described in hybrid exercise programme) will be performed through overhead shrugging with an elastic band while maintaining the neutral head and neck in sitting. Three set of 15 repeitations with 1-min rest between sets, at the exercise level standardised to a perceived exertion of 7/10 on the Borg Category Ratio 10 scale.

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
時間枠:At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).

Pain intensity of the neck region measured by the Numeric Pain Raing Scale 0-10

At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).
Functional disability
時間枠:At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).

Functional disabilty related to chronic nonspecific neck pain will be measured by 1. Neck Disabilty Index (NDI) and 2. Disability of Arm, Shoulder and Hand Qestionnaire (DASH)

At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).

二次結果の測定

結果測定
メジャーの説明
時間枠
General health status
時間枠:At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).

Short-Form 12 is used to assess the self-reported general health status of the participants.

At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).

その他の成果指標

結果測定
メジャーの説明
時間枠
Self-Efficacy
時間枠:At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).

Self-reported 1. Pain Self-Efficacy (measured by the Pain Self-Efficacy Questionnaire) (Lim et al., 2007) and 2. Exercise Self-Efficacy (measured by the Self-Efficacy for Exercise Scale (Wong et al., 2018).

At three time points 1) Baseline (T1: pre-exercise programme), 2) 5 weeks (T2: immediately post-exercise programme, and 3) 30 weeks (T3: 6-month after the 5-week exercise programme).
Pain sensitivity
時間枠:At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.

Measures of pain senstivity assessed by pressure pain threshold and pincprick-induced temporal summation of pain, over the cervical extensors and upper trapezius muscles. Pressure pain threshold indexes pressure pain sensitivity, whereas temporal summation of pain quantifies the facilitation of pain responses to repeated noxious stimulation.

At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
Exercise-induced hypoalgesia index
時間枠:At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.

EIH is assessed immediately before and after the assigned exercise intervention within the same assessment session using the NPRS and PPT procedures described above. The magnitude of EIH is quantified using an EIH index based on the pre-to-post change in NPRS and PPT, calculated as pre-exercise NPRS - post-exercise NPRS and post-exercise PPT - pre-exercise PPT, respectively. Positive values indicate a hypoalgesic response (van Leer et al., 2017). Relative changes are additionally calculated as the corresponding change divided by the pre-exercise value × 100%.

At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
Mechanical properties of the muscles (cervical extensors and upper trapezius)
時間枠:At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.

Mechanical properties of the cervical extensors and upper trapeizus will be assessed using the myotonPRO device (for muscle tone, stiffness and elasticity) and the shearwave elastography (for stiffness).

At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
Endurance Index
時間枠:At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.

Endurance index of upper trapezius will be assessed using a 5-min electrically evoked muscle-fatigue protocol based on the method described by Liss et al. (2020). Two surface electrodes are positioned over the upper trapezius , with a tri-axial accelerometer (Xsens DOT; Xsens Technologies B.V., Enschede, Netherlands) secured between the electrodes using double-sided tape and reinforced with micropore tape. Electrical stimulation is delivered using a 200-μs/50-μs pulse interval, with intensity individually adjusted between 15 and 25 mA to elicit vigorous but tolerable involuntary UT contractions. Acceleration is recorded simultaneously along three orthogonal axes (x, y, and z), and resultant acceleration is calculated using the formula reported. The endurance index is expressed as the percentage ratio of evoked twitch amplitude at the end of the 5-min stimulation period to that at baseline:

At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
Muscle vascularity (cervical extensors and upper trapezius)
時間枠:At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.

Vascularity (measured in terms of peak systolic velocity, end diastolic velocity, and resistance index) of cervical extensors (expressed in the deep cervical artery) and upper trapezius (expresssed in the trasverse cervical artery) and will be assessed using doppler ultrasonography (Adigozali et al., 2017).

At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
Craniocervical flexion test performance
時間枠:At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.

Deep cervcal flexor activation and endurance will be assessed using the craniocervical flexion test (Jull et al., 2004 and 2019).

At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
Joint position error
時間枠:At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.

Joint position error of the neck and shoulder blade (scapula) will be assessed using the published testing protocols (AlDahas et al., 2025, de Vries et al., 2015, Scibek and Carcia, 2012, Kim et al., 2024).

At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.

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

  • 主任研究者:Sharon Man Ha Tsang, PhD、Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

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

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 (推定)

2026年10月5日

一次修了 (推定)

2029年12月31日

研究の完了 (推定)

2030年6月30日

試験登録日

最初に提出

2026年9月14日

QC基準を満たした最初の提出物

2026年9月17日

最初の投稿 (実際)

2026年9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17日

最終確認日

2026年9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

The de-identified individual participant data will be shared, which include the de-identified baseline characteristics, primary and secondary outcome data, and adherence information. No identifiable data will be released.

IPD 共有時間枠

Data available beginning 12 months after publication of primary results and for at least 5 years thereafter.

IPD 共有アクセス基準

Data will be shared with qualified researchers for scientifically sound proposals. Requests must include a brief research plan, ethics approval, and a data-use agreement, and to be sent to the corresponding author of the publication.

Data will be provided through a secure, password-protected repository managed by the study team.

Restrictions apply: No re-identification, redistribution, or commercial use permitted.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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