NCT05395078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

Magnie's thoracic painHyperkyphosisThoracic stabilizationExtension exercises

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

Thoracic extension exercises

Other: Conventional physical therapy treatment along with thoracic extension exercises

Group B

EXPERIMENTAL

Thoracic Stabilization exercises

Other: Conventional physical therapy treatment along with thoracic stabilization exercises

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of age between 20-45 years
  • NPRS value more than or equal to 4
  • Cobb's Angle \> 40°
  • Chronic Maigne's Thoracic pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center, PSRD

Lahore, Punjab Province, Pakistan

Location

Related Publications (10)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 28914720BACKGROUND
  • Dutton M, Magee D, Hengeveld E, Banks K, Atkinson K, Coutts F, et al. Orthopaedic examination, evaluation, and intervention: McGraw-Hill Medical; 2004.

    BACKGROUND
  • 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.

    PMID: 15043351BACKGROUND
  • 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.

    PMID: 20140408BACKGROUND
  • 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.

    PMID: 17433756BACKGROUND
  • 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.

    PMID: 34870115BACKGROUND
  • 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.

    PMID: 28425239BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Syed Shakil-ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 27, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations