Clinical trial NCT06340542: Comparison of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Upper Back Pain
Official title: Effectiveness of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Mechanical Upper Back Pain Among Undergraduates in Sri Lanka
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Back Pain
Keywords: Upper Back Pain
Undergraduates
Muscle strength
Thoracic Spine Pain
Lead sponsor: University of Dhaka
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a Randomized Control Trial, Double- Blinded study. Participants and accessors was blinded. Participants were allocated randomly in to two groups which are experimental group which will receive thoracic mobility exercises and control group which will receive myofascial release and joint mobilization treatment by using lottery method.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pain Intensity
timeFrame: at base line and after two weeks
measure: Range of Motion
timeFrame: at baseline and after two weeks
measure: Muscle strength
timeFrame: at base line and after two week
measure: Disability level - self perception
timeFrame: at baseline and after two week
Secondary outcomes:
Other outcomes:
Locations:
city: Jaffna
country: Sri Lanka
facility: Vithursha Sivakumar
state: Northern
Study officials:
affiliation: Head of Department of Physiotherapy, Professor of Bangladesh Health Professional Institute
name: Anwar Hossain, PhD
role: STUDY_CHAIR
affiliation: Student of Master of Rehabilitation Science at Bangladesh Health professional Institute
name: Vithursha Sivakumar, B.Sc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.