Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340542
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-03-25
Brief Title:
Comparison of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Upper Back Pain
Sponsor:
University of Dhaka
Organization:
University of Dhaka
Study Overview
Official Title:
Effectiveness of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Mechanical Upper Back Pain Among Undergraduates in Sri Lanka
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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
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 Gpower 3194 software by assigning power 80 effective size 05 type I error 005 and type II error 02 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 DurationThis study will be conducted from July 2022 to July 2024 for two years with three months data collection
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 Gpower 3194 software by assigning power 80 effective size 05 type I error 005 and type II error 02 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 DurationThis study will be conducted from July 2022 to July 2024 for two years with three months data collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None