Upper Back PainNCT06340542
Comparison of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Upper Back Pain
A study testing Thoracic Mobility exercises and Manual Release technique in people with Upper Back Pain, run by University of Dhaka at 1 site in Sri Lanka.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Back Pain
- What is being tested?
- Thoracic Mobility exercises and Manual Release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSri Lanka
- Study dates
- 1 Nov 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Participant who have subjected to any recent surgeries, recent fractures, accidents or injuries in upper back will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Thoracic Mobility exercises, Manual Release technique
- Keywords
- Upper Back Pain, Undergraduates, Muscle strength, Thoracic Spine Pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Mobility exercisesOther
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 techniqueOther
Interventions include release the muscle tension, trigger point release and reducing stiffness of spine was administered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Manual Release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: at baseline and after two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Upper Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dhaka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vithursha Sivakumar, University of Dhaka
- Investigators
- Anwar Hossain, PhD, Study chair, Head of Department of Physiotherapy, Professor of Bangladesh Health Professional InstituteVithursha Sivakumar, B.Sc, Principal investigator, Student of Master of Rehabilitation Science at Bangladesh Health professional Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340542
- Sponsor's protocol ID
- UDhaka
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants demographic details such as name, contact details will be kept confidential by primary investigator until the publication. After that it will be discarded
Publications
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.
PubMed 33633467Lee 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.
PubMed 28356648Kim 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.
PubMed 28349028Niemi 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.
PubMed 9069025
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Thoracic Mobility Exercise Versus Manual Release Technique in Minimizing Mechanical Upper Back Pain Among Undergraduates in Sri Lanka
- ClinicalTrials.gov ID
- NCT06340542
- Acronym / sponsor ID
- UDhaka
- Conditions
- Upper Back Pain
- Keywords
- Upper Back Pain, Undergraduates, Muscle strength, Thoracic Spine Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of DhakaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Thoracic Mobility exercisesThoracic 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. |
| Manual Release technique group | Active comparator | Other: Manual Release techniqueManual therapy including trigger point release and thoracic mobilization were applied for 3 times a week for two weeks. |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Participant who have subjected to any recent surgeries, recent fractures, accidents or injuries in upper back will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Mobility exercisesExercises 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. | Other | Exercise Group |
| Manual Release techniqueInterventions include release the muscle tension, trigger point release and reducing stiffness of spine was administered | Other | Manual Release technique group |
Primary outcome
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Results publication: PubMed 33633467Felemban 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.
- Results publication: PubMed 28356648Lee 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.
- Results publication: PubMed 28349028Kim 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.
- Results publication: PubMed 9069025Niemi 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.
- Individual participant dataSharing planned: No. Participants demographic details such as name, contact details will be kept confidential by primary investigator until the publication. After that it will be discarded
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anwar Hossain, PhD study chair
Head of Department of Physiotherapy, Professor of Bangladesh Health Professional Institute
Vithursha Sivakumar, B.Sc principal investigator
Student of Master of Rehabilitation Science at Bangladesh Health professional Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Mobility exercises and Manual Release technique in people with Upper Back Pain, run by University of Dhaka at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: at base line and after two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06340542, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.