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

NCT ID: NCT06340542

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-01-31

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.

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

Conditions

Upper Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Thoracic Mobility exercises

Intervention Type: OTHER

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.

Manual Release technique group

Manual therapy including trigger point release and thoracic mobilization were applied for 3 times a week for two weeks.

Group Type: ACTIVE_COMPARATOR

Manual Release technique

Intervention Type: OTHER

Interventions include release the muscle tension, trigger point release and reducing stiffness of spine was administered

Interventions

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.

Intervention Type: OTHER

Manual Release technique

Interventions include release the muscle tension, trigger point release and reducing stiffness of spine was administered

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Dhaka

OTHER

Sponsor Role: lead

Responsible Party

Vithursha Sivakumar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anwar Hossain, PhD

Role: STUDY_CHAIR

Head of Department of Physiotherapy, Professor of Bangladesh Health Professional Institute

Vithursha Sivakumar, B.Sc

Role: PRINCIPAL_INVESTIGATOR

Student of Master of Rehabilitation Science at Bangladesh Health professional Institute

Locations

Vithursha Sivakumar

Jaffna, Northern Province, Sri Lanka

Countries

Sri Lanka

References

Felemban RA, Sofi RA, Alhebshi SA, Alharbi SG, Farsi NJ, Abduljabbar FH, Farsi JMA. Prevalence and Predictors of Musculoskeletal Pain Among Undergraduate Students at a Dental School in Saudi Arabia. Clin Cosmet Investig Dent. 2021 Feb 17;13:39-46. doi: 10.2147/CCIDE.S292970. eCollection 2021.

Reference Type: RESULT

PMID: 33633467 (View on PubMed)

Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.

Reference Type: RESULT

PMID: 28356648 (View on PubMed)

Kim J, Sung DJ, Lee J. Therapeutic effectiveness of instrument-assisted soft tissue mobilization for soft tissue injury: mechanisms and practical application. J Exerc Rehabil. 2017 Feb 28;13(1):12-22. doi: 10.12965/jer.1732824.412. eCollection 2017 Feb.

Reference Type: RESULT

PMID: 28349028 (View on PubMed)

Niemi SM, Levoska S, Rekola KE, Keinanen-Kiukaanniemi SM. Neck and shoulder symptoms of high school students and associated psychosocial factors. J Adolesc Health. 1997 Mar;20(3):238-42. doi: 10.1016/S1054-139X(96)00219-4.

Reference Type: RESULT

PMID: 9069025 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UDhaka

Identifier Type: -

Identifier Source: org_study_id