Chronic Nonspecific Neck PainNCT07837414
Comparative Effectiveness Randomised Controlled Trial of Hybrid Muscle Conditioning
A study testing Hybrid exercise group and Endurance exercise group in people with Chronic Nonspecific Neck Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Nonspecific Neck Pain
- What is being tested?
- Hybrid exercise group and Endurance exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Oct 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Hong Kong Polytechnic University
Hong Kong
Sharon MH Tsang, PhD, 852-27664332 ext. 4332, Sharon.Tsang@polyu.edu.hk
Vangie CY Chung, Master, 852-27664329 ext. 4329, vangie.chung@polyu.edu.hk
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Nonspecific Neck Pain
- Being tested
- Hybrid exercise group, Motor control exercise group, Endurance exercise group
- Keywords
- chronic nonspecific neck pain, exercise-induced hypoalgesia, deep cervical flexor motor control exercise, upper trapezius endurance exercise, comparative effectiveness randomised controlled trial, mediation analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid exercise groupOther
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.
Motor control exercise groupOther
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.
Endurance exercise groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Hybrid exercise group |
| 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) Receives: Other: Motor control exercise group |
| Endurance exercise group | Active comparator | Upper trapezius endurance exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group) Receives: Other: Endurance exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity of the neck region measured by the Numeric Pain Raing Scale 0-10
Measured: 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)
Measured: 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).
Secondary outcomes (1)
General health status
Short-Form 12 is used to assess the self-reported general health status of the participants.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start5 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonspecific Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Sharon Man Ha Tsang, PhD, Principal investigator, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837414
- Sponsor's protocol ID
- IRB20260115006
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Wannaprom N, Treleaven J, Jull G, Uthaikhup S. Response rate and comparison of clinical features associated with positive or negative responses to a scapular positioning test in patients with neck pain and altered scapular alignment: a cross-sectional study. BMJ Open. 2021;11(12):e057459.
Kim T-G, Kim J-S, Zhang H, Kim S-Y. Reliability of scapular position and periscapular muscle strength tests in healthy subjects with forward neck and rounded shoulder posture. Isokinetics and Exercise Science. 2024;32(3):265-72.
Scibek JS, Carcia CR. Assessment of scapulohumeral rhythm for scapular plane shoulder elevation using a modified digital inclinometer. World J Orthop. 2012 Jun 18;3(6):87-94. doi: 10.5312/wjo.v3.i6.87.
PubMed 22720268de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2.
PubMed 25983238AlDahas A, Devecchi V, Deane JA, Falla D. Responsiveness of the cervical joint position error test to detect changes in neck proprioception following four weeks of home-based proprioceptive training. PLoS One. 2024 May 10;19(5):e0303066. doi: 10.1371/journal.pone.0303066. eCollection 2024.
PubMed 38728251Liss CM, Sanni AA, McCully KK. Endurance of the Dorsal and Ventral Muscles in the Neck. J Funct Morphol Kinesiol. 2020 Jul 8;5(3):47. doi: 10.3390/jfmk5030047.
PubMed 33467263Adigozali H, Shadmehr A, Ebrahimi E, Rezasoltani A, Naderi F. Reliability of assessment of upper trapezius morphology, its mechanical properties and blood flow in female patients with myofascial pain syndrome using ultrasonography. J Bodyw Mov Ther. 2017 Jan;21(1):35-40. doi: 10.1016/j.jbmt.2016.04.010. Epub 2016 Apr 7.
PubMed 28167187van Leer E, van Mersbergen M. Using the Borg CR10 Physical Exertion Scale to Measure Patient-perceived Vocal Effort Pre and Post Treatment. J Voice. 2017 May;31(3):389.e19-389.e25. doi: 10.1016/j.jvoice.2016.09.023. Epub 2016 Nov 22.
PubMed 27887811Yu DS, Yan EC, Chow CK. Interpreting SF-12 mental component score: an investigation of its convergent validity with CESD-10. Qual Life Res. 2015 Sep;24(9):2209-17. doi: 10.1007/s11136-015-0959-x. Epub 2015 Mar 19.
PubMed 25786886Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Allison S. Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine (Phila Pa 1976). 2003 Jan 1;28(1):52-62. doi: 10.1097/00007632-200301010-00014.
PubMed 12544957Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
PubMed 20634268Van Dillen LR, McDonnell MK, Susco TM, Sahrmann SA. The immediate effect of passive scapular elevation on symptoms with active neck rotation in patients with neck pain. Clin J Pain. 2007 Oct;23(8):641-7. doi: 10.1097/AJP.0b013e318125c5b6.
PubMed 17885341Jull G, Kristjansson E, Dall'Alba P. Impairment in the cervical flexors: a comparison of whiplash and insidious onset neck pain patients. Man Ther. 2004 May;9(2):89-94. doi: 10.1016/S1356-689X(03)00086-9.
PubMed 15040968Jull GA, Falla D, Treleaven J, O'Leary S, Lewis JS. Management of neck pain disorders : a research-informed approach. Edinburgh: Elsevier; 2019.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07837414
- Acronym / sponsor ID
- IRB20260115006
- Conditions
- Chronic Nonspecific Neck Pain
- Keywords
- chronic nonspecific neck pain, exercise-induced hypoalgesia, deep cervical flexor motor control exercise, upper trapezius endurance exercise, comparative effectiveness randomised controlled trial, mediation analysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- University of Birmingham, Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hybrid exercise group | Experimental | Other: Hybrid exercise groupDeep 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) |
| Motor control exercise group | Active comparator | Other: Motor control exercise groupDeep cervical flexor motor control exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group) |
| Endurance exercise group | Active comparator | Other: Endurance exercise groupUpper trapezius endurance exercise (serves as the single exercise comparator to the experimental group i.e., hybrid group) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid exercise groupHybrid 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. | Other | Hybrid exercise group |
| Motor control exercise groupDeep 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. | Other | Motor control exercise group |
| Endurance exercise groupUpper 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. | Other | Endurance exercise group |
Primary outcome
Pain intensity
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 intensity of the neck region measured by the Numeric Pain Raing Scale 0-10
Functional disability
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 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)
1 secondary outcome
General health status
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- BackgroundWannaprom N, Treleaven J, Jull G, Uthaikhup S. Response rate and comparison of clinical features associated with positive or negative responses to a scapular positioning test in patients with neck pain and altered scapular alignment: a cross-sectional study. BMJ Open. 2021;11(12):e057459.
- BackgroundKim T-G, Kim J-S, Zhang H, Kim S-Y. Reliability of scapular position and periscapular muscle strength tests in healthy subjects with forward neck and rounded shoulder posture. Isokinetics and Exercise Science. 2024;32(3):265-72.
- Background: PubMed 22720268Scibek JS, Carcia CR. Assessment of scapulohumeral rhythm for scapular plane shoulder elevation using a modified digital inclinometer. World J Orthop. 2012 Jun 18;3(6):87-94. doi: 10.5312/wjo.v3.i6.87.
- Background: PubMed 25983238de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2.
- Background: PubMed 38728251AlDahas A, Devecchi V, Deane JA, Falla D. Responsiveness of the cervical joint position error test to detect changes in neck proprioception following four weeks of home-based proprioceptive training. PLoS One. 2024 May 10;19(5):e0303066. doi: 10.1371/journal.pone.0303066. eCollection 2024.
- Background: PubMed 33467263Liss CM, Sanni AA, McCully KK. Endurance of the Dorsal and Ventral Muscles in the Neck. J Funct Morphol Kinesiol. 2020 Jul 8;5(3):47. doi: 10.3390/jfmk5030047.
- Background: PubMed 28167187Adigozali H, Shadmehr A, Ebrahimi E, Rezasoltani A, Naderi F. Reliability of assessment of upper trapezius morphology, its mechanical properties and blood flow in female patients with myofascial pain syndrome using ultrasonography. J Bodyw Mov Ther. 2017 Jan;21(1):35-40. doi: 10.1016/j.jbmt.2016.04.010. Epub 2016 Apr 7.
- Background: PubMed 27887811van Leer E, van Mersbergen M. Using the Borg CR10 Physical Exertion Scale to Measure Patient-perceived Vocal Effort Pre and Post Treatment. J Voice. 2017 May;31(3):389.e19-389.e25. doi: 10.1016/j.jvoice.2016.09.023. Epub 2016 Nov 22.
- Background: PubMed 25786886Yu DS, Yan EC, Chow CK. Interpreting SF-12 mental component score: an investigation of its convergent validity with CESD-10. Qual Life Res. 2015 Sep;24(9):2209-17. doi: 10.1007/s11136-015-0959-x. Epub 2015 Mar 19.
- Background: PubMed 12544957Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Allison S. Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine (Phila Pa 1976). 2003 Jan 1;28(1):52-62. doi: 10.1097/00007632-200301010-00014.
- Background: PubMed 20634268Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
- Background: PubMed 17885341Van Dillen LR, McDonnell MK, Susco TM, Sahrmann SA. The immediate effect of passive scapular elevation on symptoms with active neck rotation in patients with neck pain. Clin J Pain. 2007 Oct;23(8):641-7. doi: 10.1097/AJP.0b013e318125c5b6.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharon Man Ha Tsang, PhD principal investigator
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid exercise group and Endurance exercise group in people with Chronic Nonspecific Neck Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon MH Tsang, PhD (852-27664332 ext. 4332, Sharon.Tsang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07837414, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.