NCT06340542

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

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

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 25, 2024

Last Update Submit

March 31, 2024

Conditions

Keywords

Upper Back PainUndergraduatesMuscle strengthThoracic Spine Pain

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity

    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

    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

    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

    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

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Manual Release technique group

ACTIVE COMPARATOR

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

Other: Manual Release technique

Interventions

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.

Exercise Group

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

Manual Release technique group

Eligibility Criteria

Age20 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vithursha Sivakumar

Jaffna, Northern Province, 40001, Sri Lanka

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anwar Hossain, PhD

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

    STUDY CHAIR
  • Vithursha Sivakumar, B.Sc

    Student of Master of Rehabilitation Science at Bangladesh Health professional Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants' allocation was concealed by using lottery method whether there are in exercise group or manual therapy group. Accessors was blinded which means they were not aware about the treatment or therapy which was obtained by the participants
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

November 1, 2023

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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

Locations