Neck PainNCT05392023
Effects of Scapular Stabilization Program in Patients Chronic Non-specific Neck Pain
A study testing Relaxation Exercises and Scapular Stabilization exercise program and Relaxation Exercises of cervico- scapular region in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to determine the effects of scapular stabilization program on pain, range of motion and disability in patients with chronic non- specific neck pain. This study will be a randomized controlled trial and 28 patients fulfilling the inclusion criteria will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Relaxation Exercises and Scapular Stabilization exercise program and Relaxation Exercises of cervico- scapular region
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2022to 30 Jan 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of age between 18-35 years
- NPRS value more than or equal to 4
- Chronic nonspecific neck pain for more than 3 months
- Shoulder flexion 130˚ or more
Who cannot join
- Structural abnormalities like fractures/spondylosis
- Any other musculoskeletal problem
- Neurological problems
- H/o cervical or thoracic surgery Psychological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Scapular Stabilization Program on Pain, Range of Motion and Disability in Patients With Chronic Non- Specific Neck Pain
The aim of this study is to determine the effects of scapular stabilization program on pain, range of motion and disability in patients with chronic non- specific neck pain. This study will be a randomized controlled trial and 28 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using non- probability purposive sampling technique. Experimental group will receive relaxation exercises for the cervico-scapular region combined with SSP(scapular stabilization program). The Control group will receive relaxation exercises only. Outcome measure: Numeric Pain Rating Scale, Goniometer, and Neck Disability Index will measure pain, range of motion, and disability. The experimental group will receive a total of 45 minutes sessions, thrice a week on alternate days for 3 weeks. The Control group will receive relaxation exercises in cervico-scapular region including neck stretches, stretches of scapular muscles, and myofascial release 3 times a week for 3 weeks on alternate days. Measurements will be taken at the baseline, at the end of 3rd week and for long term effects follow- up at 6 weeks. Data will be analyzed by SPSS version 20.
Read the detailed description
This study will provide evidence for management strategies of chronic NNP (nonspecific neck pain) solely focusing on a well-designed SSP (scapular stabilization program). The study will enable physiotherapists to induct this exercise program (Scapular stabilization program) in their treatment regimens to manage NNP. Some studies have used these exercises in combination to treat people with chronic neck pain. It is hypothesized that adding a scapular stabilization program will increase treatment efficacy. This study will enable us to solely evaluate the effects of SSP on NNP without adding other treatment strategies. This study aims to determine the effects of a scapular stabilization program on pain, range of motion and disability in patients with chronic non-specific neck pain. This study will be a randomized controlled trial and 28 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using the non-probability purposive sampling technique. The experimental group will receive relaxation exercises for the cervico-scapular region combined with SSP(scapular stabilization program). The Control group will receive relaxation exercises only. Outcome measure: Numeric Pain Rating Scale, Goniometer and Neck Disability Index will measure pain, range of motion, and disability. The experimental group will receive a total of 45 minutes sessions, thrice a week on alternate days for 3 weeks. The Control group will receive relaxation exercises in the cervico-scapular region including neck stretches, stretches of scapular muscles, and myofascial release 3 times a week for 3 weeks on alternate days. Measurements will be taken at the baseline, at the end of the 3rd week and for long-term effects follow up at the 6th week. Data will be analyzed by SPSS version 20.
- Conditions
- Neck Pain
- Being tested
- Relaxation Exercises and Scapular Stabilization exercise program, Relaxation Exercises of cervico- scapular region
- Keywords
- Neck pain, Scapular stabilization program, Neck Disability Index
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Exercises and Scapular Stabilization exercise programOther
Scapular Stabilization Program (3 sets of 10 reps each/day). This exercise program is for muscles affecting scapular alignment due to chronic neck pain. A specialized program of non-resistive scapular upward rotation, wall facing arm lift, backward rolling arm lift, overhead arm raise, shoulder abduction in scapular plane above 120˚, shoulder shrugs, levator scapulae and pectoralis minor stretching. Hot pack (10 min) and relaxation exercises including myofascial release and stretching of neck and scapular region muscles. A total of 45 minutes session three times a week on alternate days for 3 weeks. Assessment will be done at baseline, on the end of 3rd week and for long-term effects at the end of 6th week.
Relaxation Exercises of cervico- scapular regionOther
Relaxation exercises of the cervico-scapular region including neck stretches of scapular muscles and myofascial release will be given to patients three times a week on alternate days for 3 weeks. Assessment will be done at baseline, at the end of the 3rd week, and for long-term effects at the end of the 6th week.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Scapular Stabilization exercise program Receives: Other: Relaxation Exercises and Scapular Stabilization exercise program |
| Group B | Other | Relaxation Exercises of cervico- scapular region Receives: Other: Relaxation Exercises of cervico- scapular region |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
Measured: 3rd day
Goniometer
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Thoracic flexion and extension will be assessed through it.
Measured: 3rd day
NDI
It is a 10-item questionnaire that measures a patient's self-reported neck pain related disability.
Measured: 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 May 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil-ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392023
- Sponsor's protocol ID
- REC/RCR & AHS/22/0143 Moeen
- Status last verified
- Mar 2023
- First submitted
- 23 May 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Melo Castro Deligne L, Rocha MCB, Malta DC, Naghavi M, de Azeredo Passos VM. The burden of neck pain in Brazil: estimates from the global burden of disease study 2019. BMC Musculoskelet Disord. 2021 Sep 21;22(1):811. doi: 10.1186/s12891-021-04675-x.
PubMed 34548044Sadeghian F, Raei M, Amiri M. Persistent of Neck/Shoulder Pain among Computer Office Workers with Specific Attention to Pain Expectation, Somatization Tendency, and Beliefs. Int J Prev Med. 2014 Sep;5(9):1169-77.
PubMed 25317301Mahmud N, Bahari SF, Zainudin NF. Psychosocial and ergonomics risk factors related to neck, shoulder and back complaints among Malaysia office workers. International Journal of Social Science and Humanity. 2014;4(4):260-3.
Haldeman S, Carroll L, Cassidy JD. Findings from the bone and joint decade 2000 to 2010 task force on neck pain and its associated disorders. J Occup Environ Med. 2010 Apr;52(4):424-7. doi: 10.1097/JOM.0b013e3181d44f3b.
PubMed 20357682Helgadottir H, Kristjansson E, Mottram S, Karduna AR, Jonsson H Jr. Altered scapular orientation during arm elevation in patients with insidious onset neck pain and whiplash-associated disorder. J Orthop Sports Phys Ther. 2010 Dec;40(12):784-91. doi: 10.2519/jospt.2010.3405. Epub 2010 Oct 22.
PubMed 20972341Yildiz TI, Turgut E, Duzgun I. Neck and Scapula-Focused Exercise Training on Patients With Nonspecific Neck Pain: A Randomized Controlled Trial. J Sport Rehabil. 2018 Sep 1;27(5):403-412. doi: 10.1123/jsr.2017-0024. Epub 2018 Jul 25.
PubMed 28605288Cagnie B, Struyf F, Cools A, Castelein B, Danneels L, O'leary S. The relevance of scapular dysfunction in neck pain: a brief commentary. J Orthop Sports Phys Ther. 2014 Jun;44(6):435-9. doi: 10.2519/jospt.2014.5038. Epub 2014 May 10.
PubMed 24816504Sihawong R, Janwantanakul P, Sitthipornvorakul E, Pensri P. Exercise therapy for office workers with nonspecific neck pain: a systematic review. J Manipulative Physiol Ther. 2011 Jan;34(1):62-71. doi: 10.1016/j.jmpt.2010.11.005.
PubMed 21237409Andersen CH, Andersen LL, Zebis MK, Sjogaard G. Effect of scapular function training on chronic pain in the neck/shoulder region: a randomized controlled trial. J Occup Rehabil. 2014 Jun;24(2):316-24. doi: 10.1007/s10926-013-9441-1.
PubMed 23832167Kang JI, Choi HH, Jeong DK, Choi H, Moon YJ, Park JS. Effect of scapular stabilization exercise on neck alignment and muscle activity in patients with forward head posture. J Phys Ther Sci. 2018 Jun;30(6):804-808. doi: 10.1589/jpts.30.804. Epub 2018 Jun 12.
PubMed 29950768
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scapular Stabilization Program on Pain, Range of Motion and Disability in Patients With Chronic Non- Specific Neck Pain
- ClinicalTrials.gov ID
- NCT05392023
- Acronym / sponsor ID
- REC/RCR & AHS/22/0143 Moeen
- Conditions
- Neck Pain
- Keywords
- Neck pain, Scapular stabilization program, Neck Disability Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 26 May 2022 (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.
The aim of this study is to determine the effects of scapular stabilization program on pain, range of motion and disability in patients with chronic non- specific neck pain. This study will be a randomized controlled trial and 28 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using non- probability purposive sampling technique. Experimental group will receive relaxation exercises for the cervico-scapular region combined with SSP(scapular stabilization program). The Control group will receive relaxation exercises only. Outcome measure: Numeric Pain Rating Scale, Goniometer, and Neck Disability Index will measure pain, range of motion, and disability. The experimental group will receive a total of 45 minutes sessions, thrice a week on alternate days for 3 weeks. The Control group will receive relaxation exercises in cervico-scapular region including neck stretches, stretches of scapular muscles, and myofascial release 3 times a week for 3 weeks on alternate days. Measurements will be taken at the baseline, at the end of 3rd week and for long term effects follow- up at 6 weeks. Data will be analyzed by SPSS version 20.
Detailed description
This study will provide evidence for management strategies of chronic NNP (nonspecific neck pain) solely focusing on a well-designed SSP (scapular stabilization program). The study will enable physiotherapists to induct this exercise program (Scapular stabilization program) in their treatment regimens to manage NNP. Some studies have used these exercises in combination to treat people with chronic neck pain. It is hypothesized that adding a scapular stabilization program will increase treatment efficacy. This study will enable us to solely evaluate the effects of SSP on NNP without adding other treatment strategies. This study aims to determine the effects of a scapular stabilization program on pain, range of motion and disability in patients with chronic non-specific neck pain. This study will be a randomized controlled trial and 28 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using the non-probability purposive sampling technique. The experimental group will receive relaxation exercises for the cervico-scapular region combined with SSP(scapular stabilization program). The Control group will receive relaxation exercises only. Outcome measure: Numeric Pain Rating Scale, Goniometer and Neck Disability Index will measure pain, range of motion, and disability. The experimental group will receive a total of 45 minutes sessions, thrice a week on alternate days for 3 weeks. The Control group will receive relaxation exercises in the cervico-scapular region including neck stretches, stretches of scapular muscles, and myofascial release 3 times a week for 3 weeks on alternate days. Measurements will be taken at the baseline, at the end of the 3rd week and for long-term effects follow up at the 6th week. Data will be analyzed by SPSS version 20.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Relaxation Exercises and Scapular Stabilization exercise programScapular Stabilization exercise program |
| Group B | Other | Other: Relaxation Exercises of cervico- scapular regionRelaxation Exercises of cervico- scapular region |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of age between 18-35 years
Key exclusion criteria (4 listed)
- Structural abnormalities like fractures/spondylosis
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 |
|---|---|---|
| Relaxation Exercises and Scapular Stabilization exercise programScapular Stabilization Program (3 sets of 10 reps each/day). This exercise program is for muscles affecting scapular alignment due to chronic neck pain. A specialized program of non-resistive scapular upward rotation, wall facing arm lift, backward rolling arm lift, overhead arm raise, shoulder abduction in scapular plane above 120˚, shoulder shrugs, levator scapulae and pectoralis minor stretching. Hot pack (10 min) and relaxation exercises including myofascial release and stretching of neck and scapular region muscles. A total of 45 minutes session three times a week on alternate days for 3 weeks. Assessment will be done at baseline, on the end of 3rd week and for long-term effects at the end of 6th week. | Other | Group A |
| Relaxation Exercises of cervico- scapular regionRelaxation exercises of the cervico-scapular region including neck stretches of scapular muscles and myofascial release will be given to patients three times a week on alternate days for 3 weeks. Assessment will be done at baseline, at the end of the 3rd week, and for long-term effects at the end of the 6th week. | Other | Group B |
Primary outcome
NPRS
Time frame: 3rd day
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
Goniometer
Time frame: 3rd day
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Thoracic flexion and extension will be assessed through it.
NDI
Time frame: 3rd day
It is a 10-item questionnaire that measures a patient's self-reported neck pain related disability.
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 3 Apr 2023.
- Background: PubMed 34548044de Melo Castro Deligne L, Rocha MCB, Malta DC, Naghavi M, de Azeredo Passos VM. The burden of neck pain in Brazil: estimates from the global burden of disease study 2019. BMC Musculoskelet Disord. 2021 Sep 21;22(1):811. doi: 10.1186/s12891-021-04675-x.
- Background: PubMed 25317301Sadeghian F, Raei M, Amiri M. Persistent of Neck/Shoulder Pain among Computer Office Workers with Specific Attention to Pain Expectation, Somatization Tendency, and Beliefs. Int J Prev Med. 2014 Sep;5(9):1169-77.
- BackgroundMahmud N, Bahari SF, Zainudin NF. Psychosocial and ergonomics risk factors related to neck, shoulder and back complaints among Malaysia office workers. International Journal of Social Science and Humanity. 2014;4(4):260-3.
- Background: PubMed 20357682Haldeman S, Carroll L, Cassidy JD. Findings from the bone and joint decade 2000 to 2010 task force on neck pain and its associated disorders. J Occup Environ Med. 2010 Apr;52(4):424-7. doi: 10.1097/JOM.0b013e3181d44f3b.
- Background: PubMed 20972341Helgadottir H, Kristjansson E, Mottram S, Karduna AR, Jonsson H Jr. Altered scapular orientation during arm elevation in patients with insidious onset neck pain and whiplash-associated disorder. J Orthop Sports Phys Ther. 2010 Dec;40(12):784-91. doi: 10.2519/jospt.2010.3405. Epub 2010 Oct 22.
- Background: PubMed 28605288Yildiz TI, Turgut E, Duzgun I. Neck and Scapula-Focused Exercise Training on Patients With Nonspecific Neck Pain: A Randomized Controlled Trial. J Sport Rehabil. 2018 Sep 1;27(5):403-412. doi: 10.1123/jsr.2017-0024. Epub 2018 Jul 25.
- Background: PubMed 24816504Cagnie B, Struyf F, Cools A, Castelein B, Danneels L, O'leary S. The relevance of scapular dysfunction in neck pain: a brief commentary. J Orthop Sports Phys Ther. 2014 Jun;44(6):435-9. doi: 10.2519/jospt.2014.5038. Epub 2014 May 10.
- Background: PubMed 21237409Sihawong R, Janwantanakul P, Sitthipornvorakul E, Pensri P. Exercise therapy for office workers with nonspecific neck pain: a systematic review. J Manipulative Physiol Ther. 2011 Jan;34(1):62-71. doi: 10.1016/j.jmpt.2010.11.005.
- Background: PubMed 23832167Andersen CH, Andersen LL, Zebis MK, Sjogaard G. Effect of scapular function training on chronic pain in the neck/shoulder region: a randomized controlled trial. J Occup Rehabil. 2014 Jun;24(2):316-24. doi: 10.1007/s10926-013-9441-1.
- Background: PubMed 29950768Kang JI, Choi HH, Jeong DK, Choi H, Moon YJ, Park JS. Effect of scapular stabilization exercise on neck alignment and muscle activity in patients with forward head posture. J Phys Ther Sci. 2018 Jun;30(6):804-808. doi: 10.1589/jpts.30.804. Epub 2018 Jun 12.
- 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.
Syed Shakil-ur Rehman 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 Relaxation Exercises and Scapular Stabilization exercise program and Relaxation Exercises of cervico- scapular region in people with Neck Pain, 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 4 inclusion and 4 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 3 Apr 2023. 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?
NPRS (time frame: 3rd day). 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 NCT05392023, which also lists 10 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 3 Apr 2023.