Comparative Effectiveness Randomised Controlled Trial of Hybrid Muscle Conditioning

NCT07837414 | Not Yet Recruiting DMC

• 1 other identifier: IRB20260115006
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

• 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)

  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

  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).

Other Outcomes (8)

• Self-Efficacy

  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

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

• Exercise-induced hypoalgesia index

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

Study Arms (3)

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)

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)

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)

Other: Endurance exercise group

Interventions

Hybrid exercise group OTHER

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.

Hybrid exercise group

Endurance exercise group OTHER

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.

Endurance exercise group

Motor control exercise group OTHER

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.

Motor control exercise group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• University of Birmingham: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (14)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22720268 BACKGROUND

• de 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.

  PMID: 25983238 BACKGROUND

• AlDahas 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.

  PMID: 38728251 BACKGROUND

• Liss 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.

  PMID: 33467263 BACKGROUND

• Adigozali 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.

  PMID: 28167187 BACKGROUND

• van 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.

  PMID: 27887811 BACKGROUND

• Yu 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.

  PMID: 25786886 BACKGROUND

• Wainner 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.

  PMID: 12544957 BACKGROUND

• Cleland 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.

  PMID: 20634268 BACKGROUND

• Van 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.

  PMID: 17885341 BACKGROUND

• Jull 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.

  PMID: 15040968 BACKGROUND

• Jull GA, Falla D, Treleaven J, O'Leary S, Lewis JS. Management of neck pain disorders : a research-informed approach. Edinburgh: Elsevier; 2019.

  BACKGROUND

Study Officials

• Sharon Man Ha Tsang, PhD

  Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon MH Tsang, PhD

CONTACT

852-27664332; Sharon.Tsang@polyu.edu.hk

Vangie CY Chung, Master Degree

CONTACT

852-27664329; vangie.chung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data available beginning 12 months after publication of primary results and for at least 5 years thereafter.
• Access Criteria: 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.

Locations

HK (1)