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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05395078
Other study ID # REC/RCR &AHS/22/0134 Rubab
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2022
Est. completion date January 30, 2023

Study information

Verified date March 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional physical therapy treatment along with thoracic extension exercises
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.
Conventional physical therapy treatment along with thoracic stabilization exercises
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.

Locations

Country Name City State
Pakistan Riphah Rehabilitation Center, PSRD Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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.

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. — View Citation

Dutton M, Magee D, Hengeveld E, Banks K, Atkinson K, Coutts F, et al. Orthopaedic examination, evaluation, and intervention: McGraw-Hill Medical; 2004.

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. — View 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.

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. — View 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. — View 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. — View 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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3rd Week
Primary 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. 3rd Week
Primary 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. 3rd Week
Primary 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. 3rd Week
Primary 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.
3rd Week
Primary 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. 3rd Week
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