[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657258":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":57,"studyPopulation":51,"armGroups":58,"interventions":76,"overallOfficials":86,"centralContacts":91,"locations":103,"responsibleParty":118,"collaborators":120,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":51,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":51,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":153,"whyStopped":51,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Pain intensity","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).",{"measure":14,"description":15,"timeFrame":12},"Functional disability","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)",[17],{"measure":18,"description":19,"timeFrame":12},"General health status","Short-Form 12 is used to assess the self-reported general health status of the participants.",[21,24,28,31,34,37,40,43],{"measure":22,"description":23,"timeFrame":12},"Self-Efficacy","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).",{"measure":25,"description":26,"timeFrame":27},"Pain sensitivity","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.",{"measure":29,"description":30,"timeFrame":27},"Exercise-induced hypoalgesia index","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%.",{"measure":32,"description":33,"timeFrame":27},"Mechanical properties of the muscles (cervical extensors and upper trapezius)","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).",{"measure":35,"description":36,"timeFrame":27},"Endurance Index","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\u002F50-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:",{"measure":38,"description":39,"timeFrame":27},"Muscle vascularity (cervical extensors and upper trapezius)","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).",{"measure":41,"description":42,"timeFrame":27},"Craniocervical flexion test performance","Deep cervcal flexor activation and endurance will be assessed using the craniocervical flexion test (Jull et al., 2004 and 2019).",{"measure":44,"description":45,"timeFrame":27},"Joint position error","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).",{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":51,"timePerspective":51,"maskingInfo":52},"RANDOMIZED","PARALLEL","This is a three-arm comparative effectiveness randomised controlled trial aimed to investigate the a 5-week hybrid programme combining deep cervical flexor motor-control and upper trapezius endurance exercise programme (hybrid 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. Mediation analysis of the list of putative mediators emcompassing the mechanical properties of the neck muscles and physiological mechanisms underpinning the effectiveness of the exercise programmes on the primary outcomes (neck pain intensity and functional disability) will also be conducted to offering the understanding of the possible mechanisms involved in the observed changes of the primary outcomes contributed by the respective exercise programmes.","TREATMENT",null,{"masking":53,"maskingDescription":54,"whoMasked":55},"SINGLE","No.",[56],"OUTCOMES_ASSESSOR","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).\n\nStudy Design\n\n* Type: Interventional, randomised controlled trial\n* Design: Three-arm parallel-group comparative effectiveness trial\n* Intervention Duration: 5 weeks\n* Follow-up: 6 months\n* Masking: Outcome assessors blinded\n* Allocation: Computer-generated minimisation for intervention randomisation\n* Primary Purpose: Treatment\n* Study Site: Musculoskeletal Physiotherapy Classroom (Room GH014), The Hong Kong Polytechnic University\n\nParticipants\n\nTarget 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.\n\nEligibility Criteria of participants\n\nInclusion Criteria\n\n* Mechanical neck pain provoked by posture or movement\n* NPRS ≥3\u002F10\n* NDI ≤25\u002F50\n* DASH ≤60\u002F100\n* Impaired DCF performance (CCFT activation \\\u003C26 mmHg)\n* Positive scapular reposition test\n* Ability to perform required exercise movements\n\nExclusion Criteria\n\n* Trauma-related or specific cervical pathology (radiculopathy, disc herniation, stenosis)\n* Neurological deficits or congenital deformity\n* Prior cervical\u002Fthoracic\u002Fshoulder surgery\n* Marked cervical mobility restriction\n* BMI ≥25 kg\u002Fm²\n* Orthopaedic, neurological, or systemic comorbidities\n* High fear-avoidance (TSK ≥37)\n* Psychological distress (SF-12 MCS ≤40)\n* Regular analgesic\u002Fmuscle relaxant\u002Fvasoactive medication use\n* Vestibular symptoms\n* Contraindications to electrical stimulation\n\nSample Size N = 210 participants (70 participants\u002Fintervention group), based on the sample size estimation of the objectives 1 and 2.\n\nRandomisation and Allocation\n\nParticipants will be allocated using computer-generated minimisation (MinimPy), balancing:\n\n* Age\n* Sex\n* Hand dominance\n* Side of neck pain\n* BMI\n* Weekly screen-time hours\n* Baseline Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and Disability of Arm, Shoulder and Hand Questionnaire (DASH)\n\nAllocation is performed by an independent researcher not involved in intervention delivery or assessment. Outcome assessors remain blinded.\n\nStudy Groups (Interventions)\n\nHybrid 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.\n\nMotor-Control Group Low-load craniocervical flexion training targeting selective activation and endurance of the deep cervical flexors. Training progresses based on CCFT performance.\n\nEndurance 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.\n\nIntervention implementation\n\n* Weeks 1-2: Two individual supervised 30-min sessions (once per week), followed by Home exercise 3×\u002Fday, 3 non-consecutive days\u002Fweek during Weeks 3-5\n* Standardised manuals and instructional videos provided\n* Weekly reminders through message sent to the participants' mobilie\n* Exercise diaries used to record adherence, symptoms, and adverse events\n* Physiotherapists document responses during supervised sessions\n* Medication changes, reinjury, and additional treatments monitored throughout\n\nAssessment of outcomes\n\nOutcome assessments conducted at:\n\n* T1: Baseline\n* T2: Immediately post-intervention\n* T3: 6-month follow-up\n\nParticipants also rate programme helpfulness (1-10 scale) at completion and provide qualitative feedback on adherence facilitators\u002Fbarriers.\n\nOutcome Measures\n\nPrimary Outcomes:\n\n* Neck pain intensity (Numeric Pain Rating Sscale 0-10)\n* Neck-related disability (Neck Disabiilty Index)\n* Upper-extremity function (Disabiity of Arm, Shoulder and Hand Questionnaire)\n\nSecondary Outcomes:\n\n* General health (Short Form-12)\n* Mechanistic domains:\n* Pain sensitivity\n* Exercise-induced hypoalgesia\n* Muscle mechanical properties\n* Neuromuscular performance\n* Cervical and scapular joint position error\n* Pain-related and exercise-specific self-efficacy\n\nDetails of outcome measures are provided in the respective section of this application.\n\nData 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.\n\nEthics has been approved by the institutional ethics committee. Written informed consent obtained from all participants.",[59,65,71],{"label":60,"type":61,"description":62,"interventionNames":63},"Hybrid exercise group","EXPERIMENTAL","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)",[64],"Other: Hybrid exercise group",{"label":66,"type":67,"description":68,"interventionNames":69},"Motor control exercise group","ACTIVE_COMPARATOR","Deep cervical flexor motor control exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group)",[70],"Other: Motor control exercise group",{"label":72,"type":67,"description":73,"interventionNames":74},"Endurance exercise group","Upper trapezius endurance exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group)",[75],"Other: Endurance exercise group",[77,80,83],{"type":6,"name":60,"description":78,"armGroupLabels":79,"otherNames":51},"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\u002F10 on the Borg Category Ratio 10 scale.",[60],{"type":6,"name":66,"description":81,"armGroupLabels":82,"otherNames":51},"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.",[66],{"type":6,"name":72,"description":84,"armGroupLabels":85,"otherNames":51},"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\u002F10 on the Borg Category Ratio 10 scale.",[72],[87],{"name":88,"affiliation":89,"role":90},"Sharon Man Ha Tsang, PhD","Department of Rehabilitation Sciences, The Hong Kong Polytechnic University","PRINCIPAL_INVESTIGATOR",[92,98],{"name":93,"role":94,"phone":95,"phoneExt":96,"email":97},"Sharon MH Tsang, PhD","CONTACT","852-27664332","4332","Sharon.Tsang@polyu.edu.hk",{"name":99,"role":94,"phone":100,"phoneExt":101,"email":102},"Vangie CY Chung, Master Degree","852-27664329","4329","vangie.chung@polyu.edu.hk",[104],{"facility":5,"status":51,"city":105,"state":51,"zip":51,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Hong Kong","HK",{"type":108,"coordinates":109},"Point",[110,111],114.17469,22.27832,{"lat":111,"lon":110},[114,115,117],{"name":93,"role":94,"phone":95,"phoneExt":96,"email":97},{"name":116,"role":94,"phone":100,"phoneExt":101,"email":102},"Vangie CY Chung, Master",{"name":93,"role":90,"phone":51,"phoneExt":51,"email":51},{"type":119,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR",[121,123,125],{"name":122,"class":6},"University of Birmingham",{"name":124,"class":6},"Prince of Wales Hospital, Shatin, Hong Kong",{"name":126,"class":6},"Chinese University of Hong Kong","100657258","comparative-effectiveness-randomised-controlled-trial-of-hybrid-muscle-conditioning-100657258",false,"NCT07837414","Comparative Effectiveness Randomised Controlled Trial of Hybrid Muscle Conditioning","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","Inclusion Criteria:\n\n* adults aged 18-50 years\n* unilateral CNSNP of more than 3 months' duration with mechanical nature (neck pain provoked or aggravated by cervical posture or movement)\n* baseline neck pain ≥3\u002F10 on Numerical Pain Rating Scale (NPRS)\n* baseline functional disability ≤25\u002F50 on Neck Disability Index (NDI)\n* baseline funcctional diability ≤60\u002F100 on Disabilities of the Arm, Shoulder and Hand (DASH)\n* impaired deep cervical flexor performance verified by \\\u003C26 mmHg on craniocervical flexion test (CCFT) activation score (Jull et al., 2004)\n* 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)\n\nExclusion Criteria:\n\n* 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)\n* history of previous surgery of the cervical or thoracic spine or shoulder\n* marked restriction of cervical mobility verified by extension \\\u003C30° or rotation \\\u003C60° (Cleland et al., 2010; Wainner et al., 2003)\n* inability to achieve full shoulder elevation required for the prescribed exercise\n* BMI ≥25 kg\u002Fm²\n* comoborities orthopaedic, neurological, or systemic conditions\n* 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)\n* regular use of analgesics, muscle relaxants, or vasoactive medications\n* dizziness or vertigo suggestive of vestibular dysfunction or vertebrobasilar insufficiency\n* any contraindications to electrical stimulation for muscle endurance index measurement (any mental or neural implant, seizure)","ALL","18 Years","50 Years",{"count":138,"type":139},210,"ESTIMATED","INTERVENTIONAL",[142],"NA","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.\n\nThis 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.\n\nThe 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).\n\nThe 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.\n\nFindings 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.",[145],"Chronic Nonspecific Neck Pain",[147,148,149,150,151,152],"chronic nonspecific neck pain","exercise-induced hypoalgesia","deep cervical flexor motor control exercise","upper trapezius endurance exercise","comparative effectiveness randomised controlled trial","mediation analysis","NOT_YET_RECRUITING","2026-09-17",{"date":156,"type":157},"2026-09-23","ACTUAL",{"date":159,"type":139},"2026-10-05",{"date":161,"type":139},"2030-06-30",{"name":5,"class":6},1]