Neck PainNCT05353088
Effects of Scapular Stabilization Versus Thoracic Spine Extension Exercises in Mechanical Neck Pain
A study testing scapular stabilization and Thoracic extension exercises in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- scapular stabilization and Thoracic extension exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Apr 2022to 4 Nov 2022
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and Females between 18 and 40 years of age with mechanical neck pain. (symptoms provoked by neck movement and/or palpation of musculature of the cervical region)
- Chronic mechanical neck pain for more than 3 months.
Who cannot join
- Cervical radiculopathy
- Traumatic neck injury
- History of cervical and thoracic spine surgery
- Neck pain associated with vertigo
- Osteoporosis
- Vertebral Fractures
Show all 9Show fewer
- Tumors
- Pregnancy
- Diagnosed psychological disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fatima memorial hospital - Physical therapy clinic
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Scapular Stabilization Versus Thoracic Spine Extension Exercises on Pain, Disability and Range Of Motion in Patients With Mechanical Neck Pain
Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of scapular stabilization versus thoracic spine extension exercises on pain, disability and range of motion in patients with mechanical neck pain.
Read the detailed description
A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore, FMH Physiotherapy Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with scapular stabilization exercises and Group B will be treated with thoracic extension exercises at the frequency of 2 sets with 10 repetitions and thrice a week. Outcome measures will be conducted through pain, disability and range of motion questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. 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
- Neck Pain
- Being tested
- scapular stabilization, Thoracic extension exercises
- Keywords
- Disability Physical, muscle strength, range of motion
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scapular stabilizationOther
Scapular stabilization exercise aims to restore scapular position, orientations, motor control of muscles, and movement pattern, thereby attaining stability of scapula for better kinematics of shoulder.scapular stabilization exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of four exercise programs (Scapular retraction; Scapular mobilization, Scapular dynamic stabilization I and Scapular dynamic stabilization II)
Thoracic extension exercisesOther
Thoracic extension involves concurrent posterior rotation (external torsion) and depression of the posterior ribs with elevation of the anterior ribs. Bending to the side is a combination of spinal segments side bending, ribs on the same come together while ribs on the opposite side separate.Group B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs.
| Study group | Role | What they receive |
|---|---|---|
| Scapular stabilization exercises | Experimental | Group A performed scapular stabilization exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of four exercise programs (Scapular retraction; Scapular mobilization, Scapular dynamic stabilization I and Scapular dynamic stabilization II). Receives: Other: scapular stabilization |
| Thoracic extension exercises | Active comparator | Group B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs. Receives: Other: Thoracic extension exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain.
The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity;
- High test-retest reliability has been (r = 0.96 and 0.95, respectively)
- For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95.
Measured: follow up at 6th week
Neck Disability index (NDI)
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Every section is marked in each section only the one box that applies to you. We realise you may consider that two or more statements in any one section relate to you, but please just mark the box that most closely describes your problem. Intended population includes: Chronic neck or upper back pain and musculoskeletal neck pain.
Scoring: For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated.
Measured: follow up at 6th week
Range of Motion
A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error.
Measured: follow up at 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start30 Apr 2022
- Primary completion18 Oct 2022
- Study completion4 Nov 2022
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.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, MPhil, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353088
- Sponsor's protocol ID
- REC/RCR & AHS/22/0115 Anam
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.
PubMed 30586067Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
PubMed 30759118Gonzalez-Rueda V, Hidalgo-Garcia C, Rodriguez-Sanz J, Bueno-Gracia E, Perez-Bellmunt A, Rodriguez-Rubio PR, Lopez-de-Celis C. Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8334. doi: 10.3390/ijerph17228334.
PubMed 33187167Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.
PubMed 346824535. Verma CV, Bhosale KS. Evaluation of neck pain and scapular stability in graduate dental students: A cross-sectional study. Indian Journal of Dental Sciences. 2021;13(4):260.
Javdaneh N, Ambrozy T, Barati AH, Mozafaripour E, Rydzik L. Focus on the Scapular Region in the Rehabilitation of Chronic Neck Pain Is Effective in Improving the Symptoms: A Randomized Controlled Trial. J Clin Med. 2021 Aug 8;10(16):3495. doi: 10.3390/jcm10163495.
PubMed 34441791Yu L-J, Kim T-H. The Effect of Cervical Stabilization Exercises with Thoracic Spine Extension Exercises on Forward Head Posture. 2021.
Seo YG, Park WH, Lee CS, Kang KC, Min KB, Lee SM, Yoo JC. Is Scapular Stabilization Exercise Effective for Managing Nonspecific Chronic Neck Pain?: A Systematic Review. Asian Spine J. 2020 Feb;14(1):122-129. doi: 10.31616/asj.2019.0055. Epub 2019 Nov 1.
PubMed 31668049Al-Bassiouny HA, Shendy S, El-Khozamy H. Effect of Upper Thoracic Mobilization on Chronic Mechanical Neck Pain. Med J Cairo Univ. 2019;87(3):1449-57.
Yildiz 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 28605288
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scapular Stabilization Versus Thoracic Spine Extension Exercises on Pain, Disability and Range Of Motion in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05353088
- Acronym / sponsor ID
- REC/RCR & AHS/22/0115 Anam
- Conditions
- Neck Pain
- Keywords
- Disability Physical, muscle strength, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 29 Apr 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.
Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of scapular stabilization versus thoracic spine extension exercises on pain, disability and range of motion in patients with mechanical neck pain.
Detailed description
A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore, FMH Physiotherapy Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with scapular stabilization exercises and Group B will be treated with thoracic extension exercises at the frequency of 2 sets with 10 repetitions and thrice a week. Outcome measures will be conducted through pain, disability and range of motion questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. 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 |
|---|---|---|
| Scapular stabilization exercises | Experimental | Other: scapular stabilizationGroup A performed scapular stabilization exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of four exercise programs (Scapular retraction; Scapular mobilization, Scapular dynamic stabilization I and Scapular dynamic stabilization II). |
| Thoracic extension exercises | Active comparator | Other: Thoracic extension exercisesGroup B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males and Females between 18 and 40 years of age with mechanical neck pain. (symptoms provoked by neck movement and/or palpation of musculature of the cervical region)
- Chronic mechanical neck pain for more than 3 months.
Key exclusion criteria (9 listed)
- Cervical radiculopathy
- Traumatic neck injury
- History of cervical and thoracic spine surgery
- Neck pain associated with vertigo
- Osteoporosis
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 |
|---|---|---|
| scapular stabilizationScapular stabilization exercise aims to restore scapular position, orientations, motor control of muscles, and movement pattern, thereby attaining stability of scapula for better kinematics of shoulder.scapular stabilization exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of four exercise programs (Scapular retraction; Scapular mobilization, Scapular dynamic stabilization I and Scapular dynamic stabilization II) | Other | Scapular stabilization exercises |
| Thoracic extension exercisesThoracic extension involves concurrent posterior rotation (external torsion) and depression of the posterior ribs with elevation of the anterior ribs. Bending to the side is a combination of spinal segments side bending, ribs on the same come together while ribs on the opposite side separate.Group B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs. | Other | Thoracic extension exercises |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: follow up at 6th week
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity; * High test-retest reliability has been (r = 0.96 and 0.95, respectively) * For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95.
Neck Disability index (NDI)
Time frame: follow up at 6th week
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Every section is marked in each section only the one box that applies to you. We realise you may consider that two or more statements in any one section relate to you, but please just mark the box that most closely describes your problem. Intended population includes: Chronic neck or upper back pain and musculoskeletal neck pain. Scoring: For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated.
Range of Motion
Time frame: follow up at 6th week
A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error.
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 9 Nov 2022.
- Background: PubMed 30586067Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.
- Background: PubMed 30759118Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
- Background: PubMed 33187167Gonzalez-Rueda V, Hidalgo-Garcia C, Rodriguez-Sanz J, Bueno-Gracia E, Perez-Bellmunt A, Rodriguez-Rubio PR, Lopez-de-Celis C. Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8334. doi: 10.3390/ijerph17228334.
- Background: PubMed 34682453Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.
- Background5. Verma CV, Bhosale KS. Evaluation of neck pain and scapular stability in graduate dental students: A cross-sectional study. Indian Journal of Dental Sciences. 2021;13(4):260.
- Background: PubMed 34441791Javdaneh N, Ambrozy T, Barati AH, Mozafaripour E, Rydzik L. Focus on the Scapular Region in the Rehabilitation of Chronic Neck Pain Is Effective in Improving the Symptoms: A Randomized Controlled Trial. J Clin Med. 2021 Aug 8;10(16):3495. doi: 10.3390/jcm10163495.
- BackgroundYu L-J, Kim T-H. The Effect of Cervical Stabilization Exercises with Thoracic Spine Extension Exercises on Forward Head Posture. 2021.
- Background: PubMed 31668049Seo YG, Park WH, Lee CS, Kang KC, Min KB, Lee SM, Yoo JC. Is Scapular Stabilization Exercise Effective for Managing Nonspecific Chronic Neck Pain?: A Systematic Review. Asian Spine J. 2020 Feb;14(1):122-129. doi: 10.31616/asj.2019.0055. Epub 2019 Nov 1.
- BackgroundAl-Bassiouny HA, Shendy S, El-Khozamy H. Effect of Upper Thoracic Mobilization on Chronic Mechanical Neck Pain. Med J Cairo Univ. 2019;87(3):1449-57.
- 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.
- 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.
Samrood Akram, MPhil principal investigator
Riphah International University,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scapular stabilization and Thoracic extension exercises 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 2 inclusion and 9 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 9 Nov 2022. 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 Rating Scale (NPRS) (time frame: follow up at 6th week). 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 NCT05353088, 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 9 Nov 2022.