Effects of Scapular Stabilization Versus Thoracic Spine Extension Exercises in Mechanical Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
scapular stabilization
Thoracic extension exercises
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Disability Physical, muscle strength, range of motion
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cervical radiculopathy
- Traumatic neck injury
- History of cervical and thoracic spine surgery
- Neck pain associated with vertigo
- Osteoporosis
- Vertebral Fractures
- Tumors
- Pregnancy
- Diagnosed psychological disorders
Sites / Locations
- Fatima memorial hospital - Physical therapy clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Scapular stabilization exercises
Thoracic extension exercises
Arm Description
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).
Group B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05353088
First Posted
April 21, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05353088
Brief Title
Effects of Scapular Stabilization Versus Thoracic Spine Extension Exercises in Mechanical Neck Pain
Official Title
Effects of Scapular Stabilization Versus Thoracic Spine Extension Exercises on Pain, Disability and Range Of Motion in Patients With Mechanical Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
November 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Disability Physical, muscle strength, range of motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scapular stabilization exercises
Arm Type
Experimental
Arm Description
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).
Arm Title
Thoracic extension exercises
Arm Type
Active Comparator
Arm Description
Group B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs.
Intervention Type
Other
Intervention Name(s)
scapular stabilization
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Thoracic extension exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
follow up at 6th week
Title
Neck Disability index (NDI)
Description
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.
Time Frame
follow up at 6th week
Title
Range of Motion
Description
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.
Time Frame
follow up at 6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Cervical radiculopathy
Traumatic neck injury
History of cervical and thoracic spine surgery
Neck pain associated with vertigo
Osteoporosis
Vertebral Fractures
Tumors
Pregnancy
Diagnosed psychological disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samrood Akram, MPhil
Organizational Affiliation
Riphah International University,Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatima memorial hospital - Physical therapy clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30586067
Citation
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.
Results Reference
background
PubMed Identifier
30759118
Citation
Masaracchio 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.
Results Reference
background
PubMed Identifier
33187167
Citation
Gonzalez-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.
Results Reference
background
PubMed Identifier
34682453
Citation
Mendes-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.
Results Reference
background
Citation
5. 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.
Results Reference
background
PubMed Identifier
34441791
Citation
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.
Results Reference
background
Citation
Yu L-J, Kim T-H. The Effect of Cervical Stabilization Exercises with Thoracic Spine Extension Exercises on Forward Head Posture. 2021.
Results Reference
background
PubMed Identifier
31668049
Citation
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.
Results Reference
background
Citation
Al-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.
Results Reference
background
PubMed Identifier
28605288
Citation
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.
Results Reference
background
Learn more about this trial
Effects of Scapular Stabilization Versus Thoracic Spine Extension Exercises in Mechanical Neck Pain
We'll reach out to this number within 24 hrs