Trapezius MyalgiaNCT05856006
Effects of Upper Trapezius Stretching With and Without Mid Lower Trapezius Strengthening in Trapezius Myalgia
A study testing upper trapezius stretching plus neck isometrics and upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics in people with Trapezius Myalgia, run by Riphah International University at 1 site in Pakistan.
Trial summary
A Randomized controlled trial will be conducted. Non-probability convnience sampling will be used to collect the data. Sample size of 42 subjects with age group between 18 to 40 years will be taken. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Trapezius Myalgia
- What is being tested?
- upper trapezius stretching plus neck isometrics and upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Females between the age range of 18-40 years
- Examination-Symptoms provoked by neck movement and palpation of Trapezius musculature.
- Positive Trapezius Strength Test
Who cannot join
- Participants who present with dizziness and vertigo
- Infection or febrile state at the time of performing the test;
- Anxiety or extreme emotional tension;
- pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)
- Disc lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Upper Trapezius Stretching With and Without Mid Lower Trapezius Strenghthening Exercises on Pain, Disability and Quality of Life in Female Desk Workers With Trapezius Myalgia
A Randomized controlled trial will be conducted. Non-probability convnience sampling will be used to collect the data. Sample size of 42 subjects with age group between 18 to 40 years will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain, Neck Disability Index (NDI) for disability and SF-36 for Quality of life. An informed consent will be taken. A total of 20 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both groups will come thrice per week for a total of 4 weeks.
Read the detailed description
Trapezius myalgiais the complaint of pain, stiffness, and tightness of the upper trapezius muscle. It is characterised by acute or persistent neck-shoulder pain. In today's society, due to the increased use of computers, where the neck and shoulders are maintained in static abnormal postures to look at the computer screens and become vulnerable to cause neck pain. The aim of the study is to determine effects of upper trapezius stretching with and without mid lower trapezius strengthening exercises on pain, disability and quality of life in females with work related trapezius myalgia.
A Randomized controlled trial will be conducted in physiotherapy outpatient department of Bahria International Hospital Lahore. Non-probability convnience sampling will be used to collect the data. Sample size of 42 subjects with age group between 18 to 40 years will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain, Neck Disability Index (NDI) for disability and SF-36 for Quality of life. An informed consent will be taken. A total of 20 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both groups will come thrice per week for a total of 4 weeks. The data will be analysed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Trapezius Myalgia
- Being tested
- upper trapezius stretching plus neck isometrics, upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper trapezius stretching plus neck isometricsOther
upper trapezius stretching plus neck isometrics
upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometricsOther
Mid-Lower Trapezius strengthening exercise includes:
- Latissimus pull down
- Prone V- raise
- Modified Prone Cobra
| Study group | Role | What they receive |
|---|---|---|
| Stretching Group | Active comparator | upper trapezius stretching plus neck isometrics Receives: Other: upper trapezius stretching plus neck isometrics |
| Stretching plus strengthening Group | Experimental | upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics Receives: Other: upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rate Scale (NPRS)
Patient level of pain will be assessed using this scale. This scale ranges from 0to10."0"indicates "no pain" and "10" indicates "worst pain".
Measured: up to 4 weeks
Neck Disability Index
NDI is a 10-item questionnaire that measures a patient's self-reported neck pain related disability
Measured: up to 4 weeks
SF-36 for Quality of life
The SF-36 is a 36-item scale constructed to survey health status and quality. The SF-36 assesses eight health concepts: limitations in Quality of lifephysical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The standard form of the instruments asks for participants to reply to questions according to how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 pointsmotions
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Apr 2023
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Trapezius MyalgiaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Azam, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856006
- Sponsor's protocol ID
- REC/RCR & AHS/23/0527
- Status last verified
- Mar 2024
- First submitted
- 4 May 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang YZ, Wang AN, Gao XS, Du Y, Li L, Zhao JJ. [Effect of the small needle knife through the Zusanli(ST 36) on behavior and hippocampal expression of NLRP3 and IL-1beta in myalgia comorbid depressed rats]. Zhongguo Gu Shang. 2019 Dec 25;32(12):1151-1155. doi: 10.3969/j.issn.1003-0034.2019.12.017. Chinese.
PubMed 31870077Kamper SJ, Henschke N, Hestbaek L, Dunn KM, Williams CM. Musculoskeletal pain in children and adolescents. Braz J Phys Ther. 2016 Feb 16;20(3):275-84. doi: 10.1590/bjpt-rbf.2014.0149.
PubMed 27437719Lee KW, Kim WH. Effect of thoracic manipulation and deep craniocervical flexor training on pain, mobility, strength, and disability of the neck of patients with chronic nonspecific neck pain: a randomized clinical trial. J Phys Ther Sci. 2016 Jan;28(1):175-80. doi: 10.1589/jpts.28.175. Epub 2016 Jan 30.
PubMed 26957752Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
PubMed 34900443Cote P, Cassidy JD, Carroll L. The Saskatchewan Health and Back Pain Survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976). 1998 Aug 1;23(15):1689-98. doi: 10.1097/00007632-199808010-00015.
PubMed 9704377Suvarnnato T, Puntumetakul R, Kaber D, Boucaut R, Boonphakob Y, Arayawichanon P, Chatchawan U. The effects of thoracic manipulation versus mobilization for chronic neck pain: a randomized controlled trial pilot study. J Phys Ther Sci. 2013 Jul;25(7):865-71. doi: 10.1589/jpts.25.865. Epub 2013 Aug 20.
PubMed 24259872Chansirinukor W, Wilson D, Grimmer K, Dansie B. Effects of backpacks on students: measurement of cervical and shoulder posture. Aust J Physiother. 2001;47(2):110-6. doi: 10.1016/s0004-9514(14)60302-0.
PubMed 11552866Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.
PubMed 28356648
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Trapezius Stretching With and Without Mid Lower Trapezius Strenghthening Exercises on Pain, Disability and Quality of Life in Female Desk Workers With Trapezius Myalgia
- ClinicalTrials.gov ID
- NCT05856006
- Acronym / sponsor ID
- REC/RCR & AHS/23/0527
- Conditions
- Trapezius Myalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 12 May 2023 (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.
A Randomized controlled trial will be conducted. Non-probability convnience sampling will be used to collect the data. Sample size of 42 subjects with age group between 18 to 40 years will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain, Neck Disability Index (NDI) for disability and SF-36 for Quality of life. An informed consent will be taken. A total of 20 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both groups will come thrice per week for a total of 4 weeks.
Detailed description
Trapezius myalgiais the complaint of pain, stiffness, and tightness of the upper trapezius muscle. It is characterised by acute or persistent neck-shoulder pain. In today's society, due to the increased use of computers, where the neck and shoulders are maintained in static abnormal postures to look at the computer screens and become vulnerable to cause neck pain. The aim of the study is to determine effects of upper trapezius stretching with and without mid lower trapezius strengthening exercises on pain, disability and quality of life in females with work related trapezius myalgia.
A Randomized controlled trial will be conducted in physiotherapy outpatient department of Bahria International Hospital Lahore. Non-probability convnience sampling will be used to collect the data. Sample size of 42 subjects with age group between 18 to 40 years will be taken. Data will be collected by using tools Numeric Pain Rate Scale (NPRS) for pain, Neck Disability Index (NDI) for disability and SF-36 for Quality of life. An informed consent will be taken. A total of 20 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both groups will come thrice per week for a total of 4 weeks. The data will be analysed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching Group | Active comparator | Other: upper trapezius stretching plus neck isometricsupper trapezius stretching plus neck isometrics |
| Stretching plus strengthening Group | Experimental | Other: upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometricsupper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Females between the age range of 18-40 years
Key exclusion criteria (5 listed)
- Participants who present with dizziness and vertigo
- Infection or febrile state at the time of performing the test;
- Anxiety or extreme emotional tension;
- pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)
- Disc lesions
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 |
|---|---|---|
| upper trapezius stretching plus neck isometricsupper trapezius stretching plus neck isometrics | Other | Stretching Group |
| upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometricsMid-Lower Trapezius strengthening exercise includes: 1. Latissimus pull down 2. Prone V- raise 3. Modified Prone Cobra | Other | Stretching plus strengthening Group |
Primary outcome
Numeric Pain Rate Scale (NPRS)
Time frame: up to 4 weeks
Patient level of pain will be assessed using this scale. This scale ranges from 0to10."0"indicates "no pain" and "10" indicates "worst pain".
Neck Disability Index
Time frame: up to 4 weeks
NDI is a 10-item questionnaire that measures a patient's self-reported neck pain related disability
SF-36 for Quality of life
Time frame: up to 4 weeks
The SF-36 is a 36-item scale constructed to survey health status and quality. The SF-36 assesses eight health concepts: limitations in Quality of lifephysical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The standard form of the instruments asks for participants to reply to questions according to how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 pointsmotions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 31870077Wang YZ, Wang AN, Gao XS, Du Y, Li L, Zhao JJ. [Effect of the small needle knife through the Zusanli(ST 36) on behavior and hippocampal expression of NLRP3 and IL-1beta in myalgia comorbid depressed rats]. Zhongguo Gu Shang. 2019 Dec 25;32(12):1151-1155. doi: 10.3969/j.issn.1003-0034.2019.12.017. Chinese.
- Background: PubMed 27437719Kamper SJ, Henschke N, Hestbaek L, Dunn KM, Williams CM. Musculoskeletal pain in children and adolescents. Braz J Phys Ther. 2016 Feb 16;20(3):275-84. doi: 10.1590/bjpt-rbf.2014.0149.
- Background: PubMed 26957752Lee KW, Kim WH. Effect of thoracic manipulation and deep craniocervical flexor training on pain, mobility, strength, and disability of the neck of patients with chronic nonspecific neck pain: a randomized clinical trial. J Phys Ther Sci. 2016 Jan;28(1):175-80. doi: 10.1589/jpts.28.175. Epub 2016 Jan 30.
- Background: PubMed 34900443Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
- Background: PubMed 9704377Cote P, Cassidy JD, Carroll L. The Saskatchewan Health and Back Pain Survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976). 1998 Aug 1;23(15):1689-98. doi: 10.1097/00007632-199808010-00015.
- Background: PubMed 24259872Suvarnnato T, Puntumetakul R, Kaber D, Boucaut R, Boonphakob Y, Arayawichanon P, Chatchawan U. The effects of thoracic manipulation versus mobilization for chronic neck pain: a randomized controlled trial pilot study. J Phys Ther Sci. 2013 Jul;25(7):865-71. doi: 10.1589/jpts.25.865. Epub 2013 Aug 20.
- Background: PubMed 11552866Chansirinukor W, Wilson D, Grimmer K, Dansie B. Effects of backpacks on students: measurement of cervical and shoulder posture. Aust J Physiother. 2001;47(2):110-6. doi: 10.1016/s0004-9514(14)60302-0.
- Background: PubMed 28356648Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maryam Azam, MS* principal investigator
Riphah International 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 upper trapezius stretching plus neck isometrics and upper trapezius stretching with mid-lower trapezius strengthening exercises plus neck isometrics in people with Trapezius Myalgia, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 5 Mar 2024. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rate Scale (NPRS) (time frame: up to 4 weeks). The study lists 3 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 NCT05856006, which also lists 8 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 5 Mar 2024.