Comparison of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Upper Back Pain

March 31, 2024 updated by: Vithursha Sivakumar, University of Dhaka

Effectiveness of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Mechanical Upper Back Pain Among Undergraduates in Sri Lanka

Methodology: study aims to evaluate the effectiveness of thoracic mobility exercise and manual release technique in terms of pain intensity, thoracic mobility, muscle strength and improving disability.

Study Design: Study was conducted in Service unit of Department of Physiotherapy at university of peradeniya. Undergraduates who are currently having upper back pain for more than seven days was selected as sample. It is a randomized Controlled trail, Double blinded study. Participants allowed randomly to both groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment. Total sample size was 60.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Population: Undergraduates who are currently having upper back pain for more than seven days was selected as sample. Participants who was have sub-acute and chronic pain which means who will have pain more than a week or seven days will be selected as sample and who have subjected to any recent surgeries, recent fractures, accidents or injuries in upper back will be excluded from the study.

Study Setting:

Study was conducted in Service unit of department of Physiotherapy, University of Peradeniya.

Study Design:

This study is a Randomized Control Trial, Double- Blinded study. Participants and accessors was blinded. Participants was allocated allocated randomly in to two groups which are experimental group which receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment.

Sample size was Calculated by using G*power 3.1.9.4 software by assigning power 80% effective size 0.5, type I error = 0.05 and type II error = 0.2. Therefore calculated sample size was 42. Drop down rate of participants is assigned as 25 %. Therefore final sample size which obtained was 60 (Kang, 2021). Simple Random Sampling was used as sampling technique as well as 30 Participants was randomly allocated to each group. Participant was allocated to the groups by using lottery method. Measurement tool contains two sections such as pre-test and post-test questionnaire. In Pre-test questionnaire, there are six sections which includes personal details of the participants, pain related questions, Measurement of range of motion at base line, muscle strength at base line and pain-self-efficacy Questionnaire (PSEQ) at base line.

In Post-test questionnaire, there are 4 sections which include, pain related questions mainly pain intensity after two weeks, muscle strength after two weeks, Range of motion after two weeks and pain-self-efficacy Questionnaire (PSEQ). Personal details of the participants will be collected separately for the concealed allocation and participants will be identified by code number Ethical approval will be obtained from the Institutional Review Board of Bangladesh Health Professional Institute. Written informed consent will be obtained from all the subjects who are willing to participate in the study. Participation in this research is entirely voluntary basis and the participants have the right to withdraw from the study at any time. Baseline outcome measures are demographic characteristics of participants such as age, gender, BMI, family size, bread winner of the family, monthly income and financial support for study; Pain duration; Pain intensity at present moment, sitting, forward bending, standing, walking, sleeping, transferring and pain when performing day to day activities; Range of Motion of thoraco-lumbar flexion and extension; Muscle strength of thoracic spine extensors and overall scale of Pain-Self- efficacy Questionnaire. After two weeks same outcome measures will be obtained other than demographic characteristics and pain duration Study Duration:This study will be conducted from July 2022 to July 2024, for two years with three months data collection

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
    • Northern
      • Jaffna, Northern, Sri Lanka, 40001
        • Vithursha Sivakumar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Undergraduates who are currently having upper back pain for more than seven days will be selected as sample.
  • Participants who will have sub-acute and chronic pain which means who will have pain more than a week or seven days will be selected as sample

Exclusion Criteria:

  • Participant who have subjected to any recent surgeries, recent fractures, accidents or injuries in upper back will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
Thoracic mobility exercises were given to the participants. Exercises has to be performed with combination of breathing which involve holding time 10 seconds 5 repetition per set, 3 sets Each exercise has to perform 5 days in a week for 2 weeks two times a day.
Other: Thoracic Mobility exercises
Exercises which focus on improve the mobility of the spine especially thoracic region was administered to the patients in different position including quadruped and standing position.
Active Comparator: Manual Release technique group
Manual therapy including trigger point release and thoracic mobilization were applied for 3 times a week for two weeks.
Other: Manual Release technique
Interventions include release the muscle tension, trigger point release and reducing stiffness of spine was administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: at base line and after two weeks
Visual Analogue Scale is used to measure the pain intensity in base line and after intervention in two groups in the following instances, present pain intensity and during sitting, forward bending, standing, walking, sleeping, transferring and performing day to day activities. Its 10 point grading scale, Here maximum value of the scale 10 indicates an unbearable pain and minimum value denotes no pain at all.
at base line and after two weeks
Range of Motion
Time Frame: at baseline and after two weeks
Range of Motion of thoraco-Lumbar Flexion and Extension (Tape Measurement). Normal range of Thoraco lumbar flexion in tape measurement 2.7 cm is normal and for extension 2.5cm is normal
at baseline and after two weeks
Muscle strength
Time Frame: at base line and after two week
Muscle strength of spinal extensors examined by using Manual Muscle Test- Oxford Grading Scale. It is a 6 point grading scale which includes, 0 is considered as no contraction, 1 is palpable contraction, 2 movement with gravity eliminated, 3 is movement against gravity only, 4 movement against gravity with some resistance and 5 is movement against with full resistance
at base line and after two week
Disability level - self perception
Time Frame: at baseline and after two week
Pain-Self-Efficacy-Questionnaire is used to analyse how participants feel confident despite the pain. Total score is 60. If the total score indicates more than 45 patient has a stronger self efficacy believe to the pain and if its less than 30 weak or less self efficacy believe to the pain
at baseline and after two week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dhaka

Investigators

  • Study Chair: Anwar Hossain, PhD, Head of Department of Physiotherapy, Professor of Bangladesh Health Professional Institute
  • Principal Investigator: Vithursha Sivakumar, B.Sc, Student of Master of Rehabilitation Science at Bangladesh Health professional Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDhaka

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants demographic details such as name, contact details will be kept confidential by primary investigator until the publication. After that it will be discarded

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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