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Comparative Effectiveness Randomised Controlled Trial of Hybrid Muscle Conditioning

17 września 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

210

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

      • Hong Kong, Hongkong
        • The Hong Kong Polytechnic University
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Sharon MH Tsang, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 50 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Aktywny komparator: 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.

Aktywny komparator: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pain intensity
Ramy czasowe: 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
Ramy czasowe: 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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
General health status
Ramy czasowe: 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).

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Self-Efficacy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Sharon Man Ha Tsang, PhD, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

5 października 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2029

Ukończenie studiów (Szacowany)

30 czerwca 2030

Daty rejestracji na studia

Pierwszy przesłany

14 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 września 2026

Pierwszy wysłany (Rzeczywisty)

23 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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