An interventional study of Hybrid exercise group and Motor control exercise group in Chronic Nonspecific Neck Pain, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
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.
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
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
Exclusion Criteria
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:
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
Assessment of outcomes
Outcome assessments conducted at:
Participants also rate programme helpfulness (1-10 scale) at completion and provide qualitative feedback on adherence facilitators/barriers.
Outcome Measures
Primary Outcomes:
Secondary Outcomes:
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.
Exclusion Criteria:
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)
Other: Hybrid exercise group
Deep cervical flexor motor control exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group)
Other: Motor control exercise group
Upper trapezius endurance exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group)
Other: Endurance exercise group
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.
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.
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.
Pain intensity
Pain intensity of the neck region measured by the Numeric Pain Raing Scale 0-10
Time frame: 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
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)
Time frame: 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).
General health status
Short-Form 12 is used to assess the self-reported general health status of the participants.
Time frame: 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-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).
Time frame: 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
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.
Time frame: At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
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%.
Time frame: 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)
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).
Time frame: At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
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/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:
Time frame: 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)
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).
Time frame: At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
Craniocervical flexion test performance
Deep cervcal flexor activation and endurance will be assessed using the craniocervical flexion test (Jull et al., 2004 and 2019).
Time frame: At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
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).
Time frame: At two time points 1) Baseline (T1: pre-exercise programme) and 2) 5 weeks (T2: immediately post-exercise programme.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
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The Hong Kong Polytechnic University