Effects of Thoracic Extension Versus Thoracic Stabilization Exercises in Patients With Maigne's Thoracic Pain
Primary Purpose
Thoracic
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional physical therapy treatment along with thoracic extension exercises
Conventional physical therapy treatment along with thoracic stabilization exercises
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic focused on measuring Magnie's thoracic pain, Hyperkyphosis, Thoracic stabilization, Extension exercises
Eligibility Criteria
Inclusion Criteria:
- Patients of age between 20-45 years
- NPRS value more than or equal to 4
- Cobb's Angle > 40°
- Chronic Maigne's Thoracic pain
Exclusion Criteria:
- Structural abnormalities
- Neoplasm
- Neurogenic problem
- H/o cervical or thoracic surgery
- H/o whiplash injury
- Muscular strain
- Lactating mothers
- Pregnant or 6 months post-partum females
Sites / Locations
- Riphah Rehabilitation Center, PSRD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Thoracic extension exercises
Thoracic Stabilization exercises
Outcomes
Primary Outcome Measures
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
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.
Standing Thoracic X-ray
One lateral view X-ray of each subject will be taken of the thoracic spine at the hospital radiography department. Subjects will stand in a relaxed position with arms elevated in front of them for the X-ray. Cobb's angle will be measured from X-ray.
Kyphosis Index (KI)
Kyphosis Index will be measured using Flexi curve ruler, which is a flexible plastic 60-cm ruler to evaluate surface contour of thoracic curvature. The KI will be calculated by multiplying 100 by the value of thoracic width divided by thoracic length or KI = (thoracic width/length) ×100.
Thoracic Stiffness Index (TSI):
The TSI will be calculated as the value of the:
KI in relaxed posture divided by the KI in best posture.
Revised Oswestry Thoracic Pain Disability Questionnaire (ROTPDQ)
It is a self-reported measurement tool that measures both pain and functional status and is used for evaluating disability caused by thoracic pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT05395078
First Posted
May 23, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05395078
Brief Title
Effects of Thoracic Extension Versus Thoracic Stabilization Exercises in Patients With Maigne's Thoracic Pain
Official Title
Effects of Thoracic Extension Versus Thoracic Stabilization Exercises on Pain, Stiffness, Range of Motion, Disability and Posture in Patients With Maigne's Thoracic Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare the effects of thoracic extension versus thoracic stabilization exercises on pain, stiffness, range of motion, disability and posture in patients with Maigne's thoracic pain.This study will be a randomized clinical trial and 32 patients fulfilling the inclusion criteria will be included in the study. they will be allocated into 2 groups using non- probability purposive sampling technique. Group A will receive conventional treatment, myofascial release, thoracic spine mobilization with Thoracic Extension exercise program, while Group B will receive conventional treatment, myofascial release, thoracic spine mobilization with Thoracic Stabilization exercise program. Outcome measure: Numeric Pain Rating Scale, Goniometer, Thoracic Stiffness Index, Revised Oswestry Thoracic Pain Disability Questionnaire, standing thoracic X-ray and Flexi curve ruler, will measure pain, thoracic flexion and extension, Cobb's angle, kyphosis index, thoracic stiffness index and disability. Both groups will receive a total of 45 minutes session, thrice a week for 3 weeks. Measurements will be taken at the baseline, at the end of 3rd week and for long-term effects at the end of 6th week. Data will be analyzed by SPSS version 21.
Detailed Description
Maigne's thoracic pain is a condition in which pain originates from the thoracic spine, but according to Maigne, in most cases, its origin lies in the lower three cervical segments. It is common among both men and women, but it is most common among women. Common symptoms of Maigne's thoracic pain are tenderness and stiffness of thoracic muscles, especially interscapular muscles. The most important and chief complaint reported by patients of this condition is unilateral and severe pain which increases with static sitting and with carrying or lifting heavyweight. Physical examination of tenderness on the interscapular region at the level of T5-T6, 1-2 cm lateral to the midline. Pressure reproduces the patient's pain. Several clinical trials have established therapeutic guidelines and protocols for the rehabilitation of hyperkyphosis. These trials have typically focused on the use of spinal bracing, therapeutic taping, manual therapy, and therapeutic exercise for postural training. Studies have been conducted on the effectiveness of combination therapy of thoracic extension exercises with other therapeutic exercises. Similarly, many studies have been conducted on thoracic stabilization exercises for posture correction. It is quite difficult to judge which exercise is more effective than the other. Moreover, typically for the management of Maigne's Thoracic pain, the efficacy of therapeutic treatment is quite underexplored. The rationale of this study is that it will provide evidence that may improve treatment strategies for the management of Maigne's Thoracic pain, majorly focusing on the muscular component of the thoracic region.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic
Keywords
Magnie's thoracic pain, Hyperkyphosis, Thoracic stabilization, Extension exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Thoracic extension exercises
Arm Title
Group B
Arm Type
Experimental
Arm Description
Thoracic Stabilization exercises
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy treatment along with thoracic extension exercises
Intervention Description
Thoracic Extension Exercises (2 sets of 10 reps each/day). This exercise program will target thoracic spine extension and trunk muscle flexibility. A specialized program of thoracic extension in sitting, in prone lying, in quadruped position, on foam roller, wall angle stretch, corner stretch + hot pack (10 min) + Trapezius and Levator Scapulae stretching + Myofascial Release + Thoracic spinal mobilization (3 sets of 3 reps each/day). 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.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy treatment along with thoracic stabilization exercises
Intervention Description
Thoracic Stabilization Exercises (2 sets of 10 reps each/day). This exercise program will target thoracic musculature, static and dynamic thoracic posture. A specialized program of Draw- in and chin tucks in crook lying, prone, sitting and standing, prone chin- tuck elevation exercises with arm at sides, arms behind head or overhead (4) + hot pack (10 min) + Trapezius and Levator Scapulae stretching + Myofascial Release + Thoracic spinal mobilization (3 sets of 3 reps each/day). 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.
Primary Outcome Measure Information:
Title
NPRS
Description
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
Time Frame
3rd Week
Title
Goniometer
Description
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.
Time Frame
3rd Week
Title
Standing Thoracic X-ray
Description
One lateral view X-ray of each subject will be taken of the thoracic spine at the hospital radiography department. Subjects will stand in a relaxed position with arms elevated in front of them for the X-ray. Cobb's angle will be measured from X-ray.
Time Frame
3rd Week
Title
Kyphosis Index (KI)
Description
Kyphosis Index will be measured using Flexi curve ruler, which is a flexible plastic 60-cm ruler to evaluate surface contour of thoracic curvature. The KI will be calculated by multiplying 100 by the value of thoracic width divided by thoracic length or KI = (thoracic width/length) ×100.
Time Frame
3rd Week
Title
Thoracic Stiffness Index (TSI):
Description
The TSI will be calculated as the value of the:
KI in relaxed posture divided by the KI in best posture.
Time Frame
3rd Week
Title
Revised Oswestry Thoracic Pain Disability Questionnaire (ROTPDQ)
Description
It is a self-reported measurement tool that measures both pain and functional status and is used for evaluating disability caused by thoracic pain.
Time Frame
3rd Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of age between 20-45 years
NPRS value more than or equal to 4
Cobb's Angle > 40°
Chronic Maigne's Thoracic pain
Exclusion Criteria:
Structural abnormalities
Neoplasm
Neurogenic problem
H/o cervical or thoracic surgery
H/o whiplash injury
Muscular strain
Lactating mothers
Pregnant or 6 months post-partum females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil-ur Rehman
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Center, PSRD
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Jain A, Srivastava D, Mishra A. Effects of targeted back muscle exercises in reducing thoracic kyphosis in patients of hyperkyphosis. International Journal of Orthopaedics. 2020;6(4):885-90.
Results Reference
background
Citation
Almujel KN, Almhmd AE, Alharfy AAN, Albalawi IAS, Alanazi TBF, Alshehri AJ, et al. Causes and Management of Hyperkyphosis. Journal of Pharmaceutical Research International, July. 2021:1-8.
Results Reference
background
PubMed Identifier
28914720
Citation
Jang HJ, Hughes LC, Oh DW, Kim SY. Effects of Corrective Exercise for Thoracic Hyperkyphosis on Posture, Balance, and Well-Being in Older Women: A Double-Blind, Group-Matched Design. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):E17-E27. doi: 10.1519/JPT.0000000000000146.
Results Reference
background
Citation
Dutton M, Magee D, Hengeveld E, Banks K, Atkinson K, Coutts F, et al. Orthopaedic examination, evaluation, and intervention: McGraw-Hill Medical; 2004.
Results Reference
background
PubMed Identifier
15043351
Citation
Pfeifer M, Begerow B, Minne HW. Effects of a new spinal orthosis on posture, trunk strength, and quality of life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil. 2004 Mar;83(3):177-86. doi: 10.1097/01.phm.0000113403.16617.93.
Results Reference
background
PubMed Identifier
20140408
Citation
Bautmans I, Van Arken J, Van Mackelenberg M, Mets T. Rehabilitation using manual mobilization for thoracic kyphosis in elderly postmenopausal patients with osteoporosis. J Rehabil Med. 2010 Feb;42(2):129-35. doi: 10.2340/16501977-0486.
Results Reference
background
PubMed Identifier
17433756
Citation
Greig AM, Bennell KL, Briggs AM, Hodges PW. Postural taping decreases thoracic kyphosis but does not influence trunk muscle electromyographic activity or balance in women with osteoporosis. Man Ther. 2008 Jun;13(3):249-57. doi: 10.1016/j.math.2007.01.011. Epub 2007 Apr 12.
Results Reference
background
PubMed Identifier
34870115
Citation
Kang NY, Im SC, Kim K. Effects of a combination of scapular stabilization and thoracic extension exercises for office workers with forward head posture on the craniovertebral angle, respiration, pain, and disability: A randomized-controlled trial. Turk J Phys Med Rehabil. 2021 Sep 1;67(3):291-299. doi: 10.5606/tftrd.2021.6397. eCollection 2021 Sep.
Results Reference
background
PubMed Identifier
28425239
Citation
Toprak Celenay S, Ozer Kaya D. An 8-week thoracic spine stabilization exercise program improves postural back pain, spine alignment, postural sway, and core endurance in university students:a randomized controlled study. Turk J Med Sci. 2017 Apr 18;47(2):504-513. doi: 10.3906/sag-1511-155.
Results Reference
background
Citation
Piri H, Hajian M, Mirkarimpour SH, Sheikhhoseini R, Rahimi M. The Effect of 12-Week Corrective Exercises on the Postural Angles of Beautician Females with Upper Crossed Syndrome: a Clinical Trial Study. Women's Health Bulletin. 2021:63-70.
Results Reference
background
Learn more about this trial
Effects of Thoracic Extension Versus Thoracic Stabilization Exercises in Patients With Maigne's Thoracic Pain
We'll reach out to this number within 24 hrs