Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635759
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
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 a Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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 a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Our 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 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
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 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
Detailed Description:
1 Introduction
Neck-shoulder pain also known as the proxy for neck or shoulder pain in research of global burden of diseases is one of the leading causes of disability and is a common work-related musculoskeletal disorder in workers performing static or repetitive work leading to huge socio-economic burdens worldwide Wu et al 2024 It was revealed that about 203 million people suffered from neck-shoulder pain globally Wu et al 2024 Owing to factors such as aging population and increasing prevalence of sedentary lifestyle the related burden of neck-shoulder pain on the individuals and health care system is expected to be increasing Wu et al 2024 Therefore effective intervention particularly the active and self-care approach is needed to address this issue
Exercise therapy is one of the widely used interventions for chronic neck-shoulder pain because exercise is relatively safe with temporary and benign side effects Gross et al 2015 Examples of active exercises for neck-shoulder pain include but are not limited to specific neck and shoulder stretching strengthening and endurance training cervico-scapulothoracic stabilization exercises neuromuscular exercises with eye-neck coordination and proprioceptive training and mindfulness exercises Gross et al 2016 Evidence has shown that strengthening exercises when combined with either endurance or stretching exercise has been shown to be beneficial for neck-shoulder pain Gross et al 2015 Nevertheless when either stretching or endurance exercise is incorporated as the only intervention it appears to have minimal effect on pain and function Gross et al 2015 Due to the lack of high quality evidence there is still uncertainty concerning the effectiveness of these specified types of exercise for management of neck-shoulder pain
Muscle stiffness refers to the tissue resistance during passive stretching and it would depend on the type of external force applied and the deformation of the structure caused Baumgart 2000 Thus muscles can be stretched without tearing for flexibility and joint range of motion demonstrating extensibility and they can return to their original form after being stretched or contracted demonstrating elasticity Rothwell and Rothwell 1994 These mechanical properties allow muscles to function effectively for generating movement stabilizing joints and maintaining postures Some evidence has shown that neck-shoulder pain is related to increased stiffness of the upper trapezius muscle Leong Hug and Fu 2016 Recent studies have also demonstrated the association between the myofascial stiffness elasticity and chronic neck-shoulder pain Seidel Brandl Egner and Schleip 2023 Opara and Kozinc 2023 However the precise association between upper trapezius tightness and neck-shoulder pain remains unclear A possible explanation is that altered tissue morphology of the myofascia leads to altered muscle imbalance between prevertebral and spinal extensor muscles On the contrary another possible mechanism is that increased muscle tone in upper trapezius is a protective strategy to limit painful neck movements which mimics the phenomenon that increased stiffness in trunk extensor muscles among low back pain patients Koppenhaver et al 2020
If muscle stiffness of upper trapezius is associated with neck-shoulder pain it is expected that lengthening or releasing its muscle tone should induce long-term improvement in terms of pain Yet neck muscle stretching and acupuncture addressing the myofascial stiffness and trigger point has been associated with short-term relief from neck-shoulder pain only Wilke et al 2014 Accordingly active trigger points appear in the upper trapezius among 40 of mechanical neck-shoulder pain Muñoz-Muñoz et al 2012 Hence stretching exercise might alleviate short-term pain only by targeting trigger points rather than addressing muscle stiffness by inhibiting dorsal horn of nociception As a result neck-shoulder pain will still be present in the long term due to the nociceptive input resulting in the formation of new trigger points
At microscopic level Meulemeester et al 2018 realized that office workers with trapezius myalgia have more type II fibers fast twitch and less type I fiber slow twitch when compared to healthy workers The authors have proposed that insufficiency of blood supply and overloading of type I fibers cause metabolic stress The reliance on increased anaerobic metabolism and low-load prolonged activity of upper trapezius in working leads to development of trapezius myalgia eventually It is reasonable to deduce that increasing aerobic capacity from a higher proportion of slow oxidative type I fibers may be able to cope with the prolonged low-level activity of upper trapezius Knutson 2000 indicated that pain and inflammation might activate type III and IV sensory endings This could stimulate gamma-motor neurons and potentially alter muscle spindle excitability leading to increased muscle tone Kisilewicz et al 2020 and Heredia-Rizo et al 2020 demonstrated that eccentric training can increase the pressure pain threshold and decrease muscle stiffness of upper trapezius muscle in chronic neck-shoulder pain patients It is possible that increased fatigue threshold might alleviate the increased resting tone and thus muscle stiffness Therefore we hypothesize that a low-load endurance training of upper trapezius compared to stretching exercise might yield better improvement in neck-shoulder pain and muscle stiffness
To the extent of our comprehension there is no randomized controlled trial RCT comparing the effect of endurance training with stretching exercise of upper trapezius on neck-shoulder pain Therefore the objective of our study is 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 Our 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
2 Study Design
This study is a two-arm parallel assessor-blinded randomized controlled trial A two-group pretest-posttest design is implemented This study will be conducted between November 2024 and March 2025 in accordance with the Consolidated Standards of Reporting Trials CONSORT guidelines
3 Stratification and Randomization
Participants will be recruited through flyer or email in The Hong Kong Polytechnic University and social media After the initial screening for eligibility randomization will be stratified using the Minimize software to ensure an almost even distribution of key parameters across each group Stratification factors will include age gender male or female hand dominance left or right symptomatic side of unilateral neck-shoulder pain left or right body mass index kgm square working hours smaller or equal to 40 hoursweek or larger than 40 hoursweek and Neck Disability Index NDI Score 0-24 with no to moderate disability 25-34 with severe disability 35-50 with complete disability Randomization will be conducted prior to baseline measurements with eligible participants assigned to one of the two groups endurance exercise EE group or stretching exercise SE group for the affected side of neck-shoulder region
4 Study Groups
Exercises will be instructed by two physiotherapists who have 3 years of experience in musculoskeletal physiotherapy Video demonstrations will be provided to participants to facilitate the exercise compliance All participants with neck-shoulder pain will complete a 5-week home-based intervention according to their group allocation Message reminders will be sent to participants through a mobile communication application to ensure compliance with the assigned exercises A video call will be made through the mobile communication application every week to monitor each participants rehabilitation progression and pain level
41 Experimental Group Upper trapezius low-load endurance exercise EE group The upper trapezius low-load endurance exercise namely the overhead shrug exercise will be prescribed and practiced by the participants allocated to the EE group Overhead shrug movement is chosen instead of shoulder shrug in neutral position for its more specific and precise activation of upper trapezius with minimal activation of levator scapulae for which overactivity of levator scapulae is commonly found in individuals with neck-shoulder pain Castelein et al 2016 Participants in the EE group will perform the overhead shrug exercise for the affected side using a green Thera-Band Elastic Band
42 Comparison Group Upper trapezius stretching exercise SE group Participants in the SE group will perform static upper trapezius stretching exercise for the affected side
Load management principles will be taught to all participants to avoid excessive loading and adverse events Participants should report to the two physiotherapists through the mobile communication application immediately in case of adverse conditions such as neck-shoulder soreness or pain lasting for more than 2 days after exercise an increase in neck-shoulder pain by equal to or more than 2 out of 10 cm on the VAS score during or after the practice of the exercise or the appearance of neurological symptoms such as numbness or pins and needles These conditions will be reassessed by the physiotherapists in order to determine whether modification of the exercise dosage is required or termination of the exercise programme is needed
5 Data Collection Procedure
After obtaining written informed consent from the participants two principal investigators physiotherapists who are blinded to group allocation and are responsible to conduct all the outcome assessments will then carry out the initial screening of the recruited participants The participants will be assessed at two different time points for all outcome measures 1 baseline assessment before treatment 2 after the end of treatment week 5
6 Demographic Primary and Secondary Outcome Variables
Prior to randomization demographic data will be recorded for each participant including age gender body mass index hand dominance symptomatic side of unilateral neck-shoulder pain duration of neck-shoulder pain occupation and duration of DSE usage per week working hours The intervention group allocation will then be completed by an independent research personnel
Primary outcomes include pain assessed by VAS scale muscle stiffness of upper trapezius assessed by MyotonPRO pressure pain theraband assessed by electronic pressure algometer over upper trapezius and upper trapezius endurance measured by 5-minute electrical stimulation protocol
Secondary outcomes include two questionnaires which include Neck Disability Index NDI and Disabilities of Shoulder Arm and Hand DASH Questionnaire
7 Data Analysis
All statistical analyses will be conducted using IBM SPSS software IBM Armonk NY USA with a 5 significance level two-sided For validation the data will be entered twice Outcome measures will be analyzed based on the intention-to-treat principle Baseline characteristics and demographic data between the two study groups will be compared using one-way ANOVA chi-square test or Fishers exact test as appropriate Two-way repeated measures ANOVA will be adopted to compare changes in primary and secondary outcomes at the two time points between the study groups
8 Clinical Significance and Implications
This RCT will provide high-quality evidence to verify the efficacy of the specific exercise therapy on management for neck-shoulder pain This research is the first RCT comparing the effect of upper trapezius endurance training with traditionally used stretching exercise on neck-shoulder pain If endurance training is found to be more effective in decreasing pain pressure pain and muscle stiffness it could inform the clinical management by refining the exercise prescription for promoting the clinical outcome for individuals suffering from neck-shoulder pain In addition it could also inform us of 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
Low-load endurance training may also enhance self-management of neck-shoulder pain Endurance training of the upper trapezius is a non-invasive and easily accessible exercise with minimal equipment required It is one of the practical choices of exercise that can be performed both in clinical and home settings which may improve patients adherence to exercise In addition it is a cost-effective intervention due to the simplicity and low cost of implementing this training This is particularly important and beneficial in our healthcare system with limited resources
In conclusion our study has the potential to improve our understanding of effective treatments for neck-shoulder pain By providing evidence on the benefits of low-load endurance training of the upper trapezius it could influence clinical practice and improve the quality of care for patients suffering from this chronic musculoskeletal condition of the spine
Neck-shoulder pain also known as the proxy for neck or shoulder pain in research of global burden of diseases is one of the leading causes of disability and is a common work-related musculoskeletal disorder in workers performing static or repetitive work leading to huge socio-economic burdens worldwide Wu et al 2024 It was revealed that about 203 million people suffered from neck-shoulder pain globally Wu et al 2024 Owing to factors such as aging population and increasing prevalence of sedentary lifestyle the related burden of neck-shoulder pain on the individuals and health care system is expected to be increasing Wu et al 2024 Therefore effective intervention particularly the active and self-care approach is needed to address this issue
Exercise therapy is one of the widely used interventions for chronic neck-shoulder pain because exercise is relatively safe with temporary and benign side effects Gross et al 2015 Examples of active exercises for neck-shoulder pain include but are not limited to specific neck and shoulder stretching strengthening and endurance training cervico-scapulothoracic stabilization exercises neuromuscular exercises with eye-neck coordination and proprioceptive training and mindfulness exercises Gross et al 2016 Evidence has shown that strengthening exercises when combined with either endurance or stretching exercise has been shown to be beneficial for neck-shoulder pain Gross et al 2015 Nevertheless when either stretching or endurance exercise is incorporated as the only intervention it appears to have minimal effect on pain and function Gross et al 2015 Due to the lack of high quality evidence there is still uncertainty concerning the effectiveness of these specified types of exercise for management of neck-shoulder pain
Muscle stiffness refers to the tissue resistance during passive stretching and it would depend on the type of external force applied and the deformation of the structure caused Baumgart 2000 Thus muscles can be stretched without tearing for flexibility and joint range of motion demonstrating extensibility and they can return to their original form after being stretched or contracted demonstrating elasticity Rothwell and Rothwell 1994 These mechanical properties allow muscles to function effectively for generating movement stabilizing joints and maintaining postures Some evidence has shown that neck-shoulder pain is related to increased stiffness of the upper trapezius muscle Leong Hug and Fu 2016 Recent studies have also demonstrated the association between the myofascial stiffness elasticity and chronic neck-shoulder pain Seidel Brandl Egner and Schleip 2023 Opara and Kozinc 2023 However the precise association between upper trapezius tightness and neck-shoulder pain remains unclear A possible explanation is that altered tissue morphology of the myofascia leads to altered muscle imbalance between prevertebral and spinal extensor muscles On the contrary another possible mechanism is that increased muscle tone in upper trapezius is a protective strategy to limit painful neck movements which mimics the phenomenon that increased stiffness in trunk extensor muscles among low back pain patients Koppenhaver et al 2020
If muscle stiffness of upper trapezius is associated with neck-shoulder pain it is expected that lengthening or releasing its muscle tone should induce long-term improvement in terms of pain Yet neck muscle stretching and acupuncture addressing the myofascial stiffness and trigger point has been associated with short-term relief from neck-shoulder pain only Wilke et al 2014 Accordingly active trigger points appear in the upper trapezius among 40 of mechanical neck-shoulder pain Muñoz-Muñoz et al 2012 Hence stretching exercise might alleviate short-term pain only by targeting trigger points rather than addressing muscle stiffness by inhibiting dorsal horn of nociception As a result neck-shoulder pain will still be present in the long term due to the nociceptive input resulting in the formation of new trigger points
At microscopic level Meulemeester et al 2018 realized that office workers with trapezius myalgia have more type II fibers fast twitch and less type I fiber slow twitch when compared to healthy workers The authors have proposed that insufficiency of blood supply and overloading of type I fibers cause metabolic stress The reliance on increased anaerobic metabolism and low-load prolonged activity of upper trapezius in working leads to development of trapezius myalgia eventually It is reasonable to deduce that increasing aerobic capacity from a higher proportion of slow oxidative type I fibers may be able to cope with the prolonged low-level activity of upper trapezius Knutson 2000 indicated that pain and inflammation might activate type III and IV sensory endings This could stimulate gamma-motor neurons and potentially alter muscle spindle excitability leading to increased muscle tone Kisilewicz et al 2020 and Heredia-Rizo et al 2020 demonstrated that eccentric training can increase the pressure pain threshold and decrease muscle stiffness of upper trapezius muscle in chronic neck-shoulder pain patients It is possible that increased fatigue threshold might alleviate the increased resting tone and thus muscle stiffness Therefore we hypothesize that a low-load endurance training of upper trapezius compared to stretching exercise might yield better improvement in neck-shoulder pain and muscle stiffness
To the extent of our comprehension there is no randomized controlled trial RCT comparing the effect of endurance training with stretching exercise of upper trapezius on neck-shoulder pain Therefore the objective of our study is 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 Our 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
2 Study Design
This study is a two-arm parallel assessor-blinded randomized controlled trial A two-group pretest-posttest design is implemented This study will be conducted between November 2024 and March 2025 in accordance with the Consolidated Standards of Reporting Trials CONSORT guidelines
3 Stratification and Randomization
Participants will be recruited through flyer or email in The Hong Kong Polytechnic University and social media After the initial screening for eligibility randomization will be stratified using the Minimize software to ensure an almost even distribution of key parameters across each group Stratification factors will include age gender male or female hand dominance left or right symptomatic side of unilateral neck-shoulder pain left or right body mass index kgm square working hours smaller or equal to 40 hoursweek or larger than 40 hoursweek and Neck Disability Index NDI Score 0-24 with no to moderate disability 25-34 with severe disability 35-50 with complete disability Randomization will be conducted prior to baseline measurements with eligible participants assigned to one of the two groups endurance exercise EE group or stretching exercise SE group for the affected side of neck-shoulder region
4 Study Groups
Exercises will be instructed by two physiotherapists who have 3 years of experience in musculoskeletal physiotherapy Video demonstrations will be provided to participants to facilitate the exercise compliance All participants with neck-shoulder pain will complete a 5-week home-based intervention according to their group allocation Message reminders will be sent to participants through a mobile communication application to ensure compliance with the assigned exercises A video call will be made through the mobile communication application every week to monitor each participants rehabilitation progression and pain level
41 Experimental Group Upper trapezius low-load endurance exercise EE group The upper trapezius low-load endurance exercise namely the overhead shrug exercise will be prescribed and practiced by the participants allocated to the EE group Overhead shrug movement is chosen instead of shoulder shrug in neutral position for its more specific and precise activation of upper trapezius with minimal activation of levator scapulae for which overactivity of levator scapulae is commonly found in individuals with neck-shoulder pain Castelein et al 2016 Participants in the EE group will perform the overhead shrug exercise for the affected side using a green Thera-Band Elastic Band
42 Comparison Group Upper trapezius stretching exercise SE group Participants in the SE group will perform static upper trapezius stretching exercise for the affected side
Load management principles will be taught to all participants to avoid excessive loading and adverse events Participants should report to the two physiotherapists through the mobile communication application immediately in case of adverse conditions such as neck-shoulder soreness or pain lasting for more than 2 days after exercise an increase in neck-shoulder pain by equal to or more than 2 out of 10 cm on the VAS score during or after the practice of the exercise or the appearance of neurological symptoms such as numbness or pins and needles These conditions will be reassessed by the physiotherapists in order to determine whether modification of the exercise dosage is required or termination of the exercise programme is needed
5 Data Collection Procedure
After obtaining written informed consent from the participants two principal investigators physiotherapists who are blinded to group allocation and are responsible to conduct all the outcome assessments will then carry out the initial screening of the recruited participants The participants will be assessed at two different time points for all outcome measures 1 baseline assessment before treatment 2 after the end of treatment week 5
6 Demographic Primary and Secondary Outcome Variables
Prior to randomization demographic data will be recorded for each participant including age gender body mass index hand dominance symptomatic side of unilateral neck-shoulder pain duration of neck-shoulder pain occupation and duration of DSE usage per week working hours The intervention group allocation will then be completed by an independent research personnel
Primary outcomes include pain assessed by VAS scale muscle stiffness of upper trapezius assessed by MyotonPRO pressure pain theraband assessed by electronic pressure algometer over upper trapezius and upper trapezius endurance measured by 5-minute electrical stimulation protocol
Secondary outcomes include two questionnaires which include Neck Disability Index NDI and Disabilities of Shoulder Arm and Hand DASH Questionnaire
7 Data Analysis
All statistical analyses will be conducted using IBM SPSS software IBM Armonk NY USA with a 5 significance level two-sided For validation the data will be entered twice Outcome measures will be analyzed based on the intention-to-treat principle Baseline characteristics and demographic data between the two study groups will be compared using one-way ANOVA chi-square test or Fishers exact test as appropriate Two-way repeated measures ANOVA will be adopted to compare changes in primary and secondary outcomes at the two time points between the study groups
8 Clinical Significance and Implications
This RCT will provide high-quality evidence to verify the efficacy of the specific exercise therapy on management for neck-shoulder pain This research is the first RCT comparing the effect of upper trapezius endurance training with traditionally used stretching exercise on neck-shoulder pain If endurance training is found to be more effective in decreasing pain pressure pain and muscle stiffness it could inform the clinical management by refining the exercise prescription for promoting the clinical outcome for individuals suffering from neck-shoulder pain In addition it could also inform us of 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
Low-load endurance training may also enhance self-management of neck-shoulder pain Endurance training of the upper trapezius is a non-invasive and easily accessible exercise with minimal equipment required It is one of the practical choices of exercise that can be performed both in clinical and home settings which may improve patients adherence to exercise In addition it is a cost-effective intervention due to the simplicity and low cost of implementing this training This is particularly important and beneficial in our healthcare system with limited resources
In conclusion our study has the potential to improve our understanding of effective treatments for neck-shoulder pain By providing evidence on the benefits of low-load endurance training of the upper trapezius it could influence clinical practice and improve the quality of care for patients suffering from this chronic musculoskeletal condition of the spine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None