The Effect of Low-load Endurance Training of Upper Trapezius on Pain, Pressure Pain and Muscle Stiffness in Chronic Neck-shoulder Pain Compared to Stretching Exercise

NCT06635759 | Not Yet Recruiting

• 1 other identifier: HSEARS20240925004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effectiveness of low-load endurance exercise as compared to stretching exercise on upper trapezius on pain, pressure pain and muscle stiffness in patients with chronic neck-shoulder pain. The hypothesis is that endurance exercise of the upper trapezius should result in significantly better improvement in terms of neck-shoulder pain, pressure pain threshold and muscle stiffness than stretching exercise. Participants with unilateral neck-shoulder pain will either perform low-load endurance exercise or stretching exercise of the upper trapezius muscle of the affected side in a 5-week period. Before and after the 5-week training, outcomes will be assessed by investigators in order to compare the effectiveness of two exercises on pain, pressure pain, muscle stiffness, and muscle endurance. Secondary outcomes include Neck Disability Index (NDI) to assess various aspects of daily living impacted by neck pain, and Disabilities of Shoulder, Arm and Hand (DASH) Questionnaire to evaluate the ability to perform various upper limb activities. Findings to be obtained from this study will help inform the clinical management in particular for self-care of this chronic neck pain group of participants, by refining the exercise prescription for promoting the clinical outcomes for individuals suffering from neck-shoulder pain. In addition, results of this study will also inform physiotherapists the possible mechanisms underlying the improvement of neck-shoulder pain by examination of the relationship between biomechanical properties of muscles, such as muscle endurance or muscle stiffness, and neck-shoulder pain.

Conditions

Chronic Neck Pain; Neck Pain Treatment; Neck Pain Chronic

Keywords

endurance exercise; endurance training; endurance; stretching; stretching exercise; neck pain; neck-shoulder pain; chronic neck pain; chronic neck-shoulder pain; pain; pressure pain; muscle stiffness

Outcome Measures

Primary Outcomes (4)

• Pain

  The average neck-shoulder pain will be indicated by a mark on a 10-cm VAS scale with the leftmost value representing 'no pain (0)' and rightmost value representing 'the worst pain (10)'. The VAS is the most commonly used method to assess neck-shoulder pain intensity, and its test-retest reliability for neck pain is very high, with an intraclass correlation coefficient (ICC) of 0.97.

  From enrollment to the end of treatment at 5 weeks

• Muscle stiffness of upper trapezius

  Muscle stiffness of the upper trapezius will be measured using a handheld myotonometer device, MyotonPRO. MyotonPRO is a non-invasive, portable device that uses superficial mechanical deformation to assess the biomechanical characteristics of soft tissues. The subject will be tested in a seated position in a chair with back support. The myotonometer will be positioned vertically on the 2 designated points of the upper trapezius. The probe will apply a compression force of 0.18 N, followed by a 5-time mechanical impulse (0.4 N for 15 ms). Stiffness (N/m) will be measured. The measurement will be done on each spot for 3 times in order to obtain an average stiffness (N/m). The stiffness of upper trapezius on both sides will be measured.

  From enrollment to the end of treatment at 5 weeks

• Pressure Pain Threshold (PPT)

  PPT, the minimum pressure force (kPa) required to evoke pain, will be assessed using a handheld electronic pressure algometer over the upper trapezius. Pressure algometry is a reliable tool for assessing chronic neck pain, with an ICC ranging from 0.78 to 0.93. After the myotonometry measurement is completed, the subject will lie prone on a plinth for the PPT measurement. The same 2 designated points used for the myotonometry measurement will be assessed. During the test, the algometer will be placed perpendicular to the skin and apply an increasing pressure at a constant rate. The subject will press a handheld button when the pressure exerted turns to pain. The measurement will be done on each spot for 3 times in order to obtain an average (N/cm square), and it will be performed on both sides.

  From enrollment to the end of treatment at 5 weeks

• Upper Trapezius Endurance

  The muscle endurance of upper trapezius will be measured objectively utilizing a 5-minute electrical stimulation protocol, which was adopted in a previous study. Two silicon electrodes will be placed at two points: one point just lateral to C7 spinous process and the other point medial to acromion, with ultrasound gel applied underneath the electrodes. A tri-axial accelerometer will be positioned between the two electrodes. The upper trapezius will be stimulated with a current level that produces a visually noticeable and comfortable contraction in the subject. Then, the intensity will be adjusted to achieve a vigorous contraction ranging from 25mA to 30mA, with a pulse duration of 200μs. The electrical stimulation will last for 5 minutes at a frequency of 5Hz. The endurance index (EI) will be calculated by dividing the peak twitches at the end of the acceleration by the peak twitches at the start, expressed as a percentage.

  From enrollment to the end of treatment at 5 weeks

Secondary Outcomes (2)

• Neck Disability Index (NDI)

  From enrollment to the end of treatment at 5 weeks

• Disabilities of Shoulder, Arm and Hand (DASH) Questionnaire

  From enrollment to the end of treatment at 5 weeks

Study Arms (2)

Experimental Group: Upper trapezius low-load endurance exercise (EE) group

EXPERIMENTAL

Participants in the EE group will perform the overhead shrug exercise for the affected side using a green Thera-Band Elastic Band. To perform this exercise, the subject will stand and place one arm of the affected side in an overhead position against the wall. The middle portion of the theraband will be placed on the floor, and the subject will stand on the middle portion of the theraband to fixate it in place with both feet shoulder-width apart. Then, the subject grasp both tails of the theraband and perform the shoulder shrug movement for the affected side with a 3-second elevation, hold at the end range for 5 seconds, and then return back to the starting position with a 3-second depression. The subject will perform this exercise for 20 repetitions per set, 3 sets a day with 1-minute rest between sets, 3 alternate days a week, for 5 weeks. They will be instructed to record all training sessions in a diary.

Other: Upper trapezius low-load endurance exercise

Comparison Group: Upper trapezius stretching exercise (SE) group

ACTIVE COMPARATOR

Participants in the SE group will perform static upper trapezius stretching exercise for the affected side. To perform the stretch, participants will be asked to sit upright on a chair and look straight ahead. To reduce scapular elevation and upward rotation, the ipsilateral hand should be placed below the buttock. The subject will then be asked to perform deep neck flexion, neck rotation towards the affected side, and contralateral side flexion using the opposite hand in a diagonal direction until the position of 'mild discomfort' is attained. They should maintain the deep neck flexion when performing the stretch. The stretch will be held for 30 seconds each set, 3 sets a day, daily for 5 weeks.

Other: Upper trapezius stretching exercise

Interventions

Upper trapezius low-load endurance exercise OTHER

Participants in the EE group will perform the overhead shrug exercise for the affected side using a green Thera-Band Elastic Band. To perform this exercise, the subject will stand and place one arm of the affected side in an overhead position against the wall. The middle portion of the theraband will be placed on the floor, and the subject will stand on the middle portion of the theraband to fixate it in place with both feet shoulder-width apart. Then, the subject grasp both tails of the theraband and perform the shoulder shrug movement for the affected side with a 3-second elevation, hold at the end range for 5 seconds, and then return back to the starting position with a 3-second depression. The subject will perform this exercise for 20 repetitions per set, 3 sets a day with 1-minute rest between sets, 3 alternate days a week, for 5 weeks. They will be instructed to record all training sessions in a diary.

Experimental Group: Upper trapezius low-load endurance exercise (EE) group

Upper trapezius stretching exercise OTHER

Participants in the SE group will perform static upper trapezius stretching exercise for the affected side. To perform the stretch, participants will be asked to sit upright on a chair and look straight ahead. To reduce scapular elevation and upward rotation, the ipsilateral hand should be placed below the buttock. The subject will then be asked to perform deep neck flexion, neck rotation towards the affected side, and contralateral side flexion using the opposite hand in a diagonal direction until the position of 'mild discomfort' is attained. They should maintain the deep neck flexion when performing the stretch. The stretch will be held for 30 seconds each set, 3 sets a day, daily for 5 weeks.

Comparison Group: Upper trapezius stretching exercise (SE) group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults who
• (1) are between 20 and 60 years of age;
• (2) have worked with Display Screen Equipment (DSE) for a minimum of 20 hours per week;
• (3) are presenting persistent, non-specific pain over unilateral neck-shoulder region for more than 3 months, with at least 30 days of pain during the last year;
• (4) have average pain rating of Visual Analogue Scale (VAS) larger than 3.4 centimeter out of 10 (moderate level of pain) during the week before data collection;
• (5) possess the range of motion of cervical rotation to the symptomatic side more than that of cervical rotation to the asymptomatic side with at least 10° difference as measured by placing a goniometric measurement sensor on the external occipital tuberosity (the lower edge of the upper sensor) and the spinous process of C7 vertebrae (the upper edge of the lower sensor), which may indicate "pseudo-tightness" of upper trapezius over the symptomatic side.

You may not qualify if:

• (1) have regular strength training of the neck and upper limbs during the year before the study;
• (2) have neck-shoulder pain with specific diagnosis or known cause, for instance cervical radiculopathy, prolapse of intervertebral disc or disc herniation, or with neurological deficits and symptoms;
• (3) have previous cervical spine or upper limb surgery;
• (4) have comorbidity which includes but is not limited to neurological disease such as stroke, Parkinson's disease or spinal cord injury, mental illness, heart disease, diagnosis of carpal tunnel syndrome or fibromyalgia; or
• (5) contraindicated for electrical stimulation which will be involved during assessment, such as impaired skin sensation and/or conditions, pregnancy, local malignancy or recently radiated tissue, electronic implant or metal implant, actively bleeding tissue.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Neck Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 24 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee (e.g., Institutional Review Board) to achieve aims in the approved proposal. Proposals should be directed to Dr. Sharon Tsang via email at Sharon.Tsang@polyu.edu.hk. To gain access, data requestors will need to sign a data access agreement. Data are available for 2 years at a third-party website (link to be included).

Locations

HK (1)