ThoracicNCT05392517
Effects of Self-mobilization Techniques in Chronic Thoracic Pain
A study testing self-mobilization technique along with conventional therapy and conventional therapy in people with Thoracic, run by Riphah International University at 1 site in Pakistan.
Trial summary
A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Thoracic
- What is being tested?
- self-mobilization technique along with conventional therapy and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2022to 30 Jan 2023
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic thoracic pain minimum 3 months
Who cannot join
- Soft tissues disease
- Bony disease
- Surgical history of thoracic spine
- Fracture history of thoracic spine
- Tumor
- Psychological disorders
- Traumatic injury
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Actilife physiotherapy rehabilitation centre, Horizon hospital
Lahore, Punjab Province
About this study
Official title: Effects of Self-mobilization Techniques on Pain, Range of Motion and Function in Patients With Chronic Pain
A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with the self-mobilization technique of thoracic spine and Group B will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week. Outcome measures will be NPRS, Goniometer, and Oswestry disability index for thoracic spine after 6 weeks. Data will be analyzed during SPSS software version 21.
Read the detailed description
Chronic thoracic pain is pain that originates from the cervicothoracic junction and extends to the lower thoracic vertebrae. It is caused by strain in the thoracic spine area, sustained postures of the neck and thoracic region, sitting on the computer for a long time in slouched position, or overuse of the thoracic spine. This study aims to see the effects of the self-mobilization technique of the thoracic spine on pain, range of motion, and function in patients with chronic thoracic spine pain. A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with the self-mobilization technique of thoracic spine and Group B will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week. Outcome measures will be NPRS, Goniometer, and Oswestry disability index for thoracic spine after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Thoracic
- Being tested
- self-mobilization technique along with conventional therapy, conventional therapy
- Keywords
- manual therapy, pain, Range of motion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-mobilization technique along with conventional therapyOther
Group A will be treated with self-mobilization technique of thoracic spine with the frequency of 2 sets of 10 repetitions thrice per week for a total of six weeks and conventional treatment.
Self-mobilization technique will be comprised of self-mobilization technique using tennis balls and foam roller. The participant will be supine with knees in 90-degree flexion.
- Mobilization Technique 1: Cross your arms over your chest so that you are in slight flexion and then slowly begin to move your shoulders and head closer to the floor placing the mid back into extension over the balls joined to make mobilization device. Hold this position for 3 seconds and then return to the flexed position.
- Mobilization Technique 2: Lying lengthwise on the foam roller, clasp your hands together in front of you, above your chest with arms straight. Slowly move your arms above your head until you feel a good stretch. This exercise should be pain free. Hold stretch for 30- 60 seconds.
conventional therapyOther
Group B will be treated with the conventional treatment (heating pad, ultrasound, thoracic strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | self-mobilization technique Receives: Other: self-mobilization technique along with conventional therapy |
| Group B | Other | : conventional treatment Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain
Measured: 6th Week
Universal Goniometer (UG)
It will measure range of motion of thoracic spine.
Measured: 6th Week
Oswestry disability index
It is a self-reported measurement tool that measures both pain and functional status and is used for evaluating disability caused by thoracic pain.
Measured: 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 May 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ThoracicStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil-ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392517
- Sponsor's protocol ID
- REC/RCR &AHS/22/0123 Ali
- Status last verified
- Mar 2023
- First submitted
- 23 May 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ortega-Santiago R, Maestre-Lerga M, Fernandez-de-Las-Penas C, Cleland JA, Plaza-Manzano G. Widespread Pressure Pain Sensitivity and Referred Pain from Trigger Points in Patients with Upper Thoracic Spine Pain. Pain Med. 2019 Jul 1;20(7):1379-1386. doi: 10.1093/pm/pnz020.
PubMed 30821833Bikbov MM, Kazakbaeva GM, Zainullin RM, Salavatova VF, Gilmanshin TR, Arslangareeva II, Nikitin NA, Mukhamadieva SR, Yakupova DF, Panda-Jonas S, Khikmatullin RI, Aminev SK, Nuriev IF, Zaynetdinov AF, Uzianbaeva YV, Jonas JB. Prevalence of and factors associated with low Back pain, thoracic spine pain and neck pain in Bashkortostan, Russia: the Ural Eye and Medical Study. BMC Musculoskelet Disord. 2020 Feb 1;21(1):64. doi: 10.1186/s12891-020-3080-4.
PubMed 32007098Heneghan NR, Baker G, Thomas K, Falla D, Rushton A. What is the effect of prolonged sitting and physical activity on thoracic spine mobility? An observational study of young adults in a UK university setting. BMJ Open. 2018 May 5;8(5):e019371. doi: 10.1136/bmjopen-2017-019371.
PubMed 29730619de Vitta A, Campos LD, Bento TP, Felippe LA, Ramos WL, Fernandes JAA, et al. Thoracic Spine Pain in Adolescents and Its Association With Electronic Devices and Other Factors. 2020.
Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
PubMed 28750310Yamak B, İmamoğlu O, İslamoğlu İ, Çebi MJETS. The effects of exercise on body posture. 2018;13(18).
Nakamaru K, Aizawa J, Kawarada K, Uemura Y, Koyama T, Nitta O. Immediate effects of thoracic spine self-mobilization in patients with mechanical neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2019 Apr;23(2):417-424. doi: 10.1016/j.jbmt.2018.05.008. Epub 2018 Jun 1.
PubMed 31103129Puntumetakul R, Pithak R, Namwongsa S, Saiklang P, Boucaut R. The effect of massage technique plus thoracic manipulation versus thoracic manipulation on pain and neural tension in mechanical neck pain: a randomized controlled trial. J Phys Ther Sci. 2019 Feb;31(2):195-201. doi: 10.1589/jpts.31.195. Epub 2019 Feb 7.
PubMed 30858662Kim S-j, Kim S-y, Lee M-jJPTK. The Effects of Thoracic Spine Self-mobilization Exercise Using a Tool on Pain, Range of Motion, and Dysfunction of Chronic Neck Pain Patients. 2020;27(1):1-10.
Joshi S, Balthillaya G, Neelapala YVR. Immediate effects of cervicothoracic junction mobilization versus thoracic manipulation on the range of motion and pain in mechanical neck pain with cervicothoracic junction dysfunction: a pilot randomized controlled trial. Chiropr Man Therap. 2020 Aug 7;28(1):38. doi: 10.1186/s12998-020-00327-4.
PubMed 32762708
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-mobilization Techniques on Pain, Range of Motion and Function in Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT05392517
- Acronym / sponsor ID
- REC/RCR &AHS/22/0123 Ali
- Conditions
- Thoracic
- Keywords
- manual therapy, pain, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 26 May 2022 (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.
A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with the self-mobilization technique of thoracic spine and Group B will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week. Outcome measures will be NPRS, Goniometer, and Oswestry disability index for thoracic spine after 6 weeks. Data will be analyzed during SPSS software version 21.
Detailed description
Chronic thoracic pain is pain that originates from the cervicothoracic junction and extends to the lower thoracic vertebrae. It is caused by strain in the thoracic spine area, sustained postures of the neck and thoracic region, sitting on the computer for a long time in slouched position, or overuse of the thoracic spine. This study aims to see the effects of the self-mobilization technique of the thoracic spine on pain, range of motion, and function in patients with chronic thoracic spine pain. A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with the self-mobilization technique of thoracic spine and Group B will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week. Outcome measures will be NPRS, Goniometer, and Oswestry disability index for thoracic spine after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: self-mobilization technique along with conventional therapyself-mobilization technique |
| Group B | Other | Other: conventional therapy: conventional treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- chronic thoracic pain minimum 3 months
Key exclusion criteria (7 listed)
- Soft tissues disease
- Bony disease
- Surgical history of thoracic spine
- Fracture history of thoracic spine
- Tumor
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 |
|---|---|---|
| self-mobilization technique along with conventional therapyGroup A will be treated with self-mobilization technique of thoracic spine with the frequency of 2 sets of 10 repetitions thrice per week for a total of six weeks and conventional treatment. Self-mobilization technique will be comprised of self-mobilization technique using tennis balls and foam roller. The participant will be supine with knees in 90-degree flexion. * Mobilization Technique 1: Cross your arms over your chest so that you are in slight flexion and then slowly begin to move your shoulders and head closer to the floor placing the mid back into extension over the balls joined to make mobilization device. Hold this position for 3 seconds and then return to the flexed position. * Mobilization Technique 2: Lying lengthwise on the foam roller, clasp your hands together in front of you, above your chest with arms straight. Slowly move your arms above your head until you feel a good stretch. This exercise should be pain free. Hold stretch for 30- 60 seconds. | Other | Group A |
| conventional therapyGroup B will be treated with the conventional treatment (heating pad, ultrasound, thoracic strengthening exercises | Other | Group B |
Primary outcome
NPRS
Time frame: 6th Week
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain
Universal Goniometer (UG)
Time frame: 6th Week
It will measure range of motion of thoracic spine.
Oswestry disability index
Time frame: 6th Week
It is a self-reported measurement tool that measures both pain and functional status and is used for evaluating disability caused by thoracic 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 3 Apr 2023.
- Background: PubMed 30821833Ortega-Santiago R, Maestre-Lerga M, Fernandez-de-Las-Penas C, Cleland JA, Plaza-Manzano G. Widespread Pressure Pain Sensitivity and Referred Pain from Trigger Points in Patients with Upper Thoracic Spine Pain. Pain Med. 2019 Jul 1;20(7):1379-1386. doi: 10.1093/pm/pnz020.
- Background: PubMed 32007098Bikbov MM, Kazakbaeva GM, Zainullin RM, Salavatova VF, Gilmanshin TR, Arslangareeva II, Nikitin NA, Mukhamadieva SR, Yakupova DF, Panda-Jonas S, Khikmatullin RI, Aminev SK, Nuriev IF, Zaynetdinov AF, Uzianbaeva YV, Jonas JB. Prevalence of and factors associated with low Back pain, thoracic spine pain and neck pain in Bashkortostan, Russia: the Ural Eye and Medical Study. BMC Musculoskelet Disord. 2020 Feb 1;21(1):64. doi: 10.1186/s12891-020-3080-4.
- Background: PubMed 29730619Heneghan NR, Baker G, Thomas K, Falla D, Rushton A. What is the effect of prolonged sitting and physical activity on thoracic spine mobility? An observational study of young adults in a UK university setting. BMJ Open. 2018 May 5;8(5):e019371. doi: 10.1136/bmjopen-2017-019371.
- Backgroundde Vitta A, Campos LD, Bento TP, Felippe LA, Ramos WL, Fernandes JAA, et al. Thoracic Spine Pain in Adolescents and Its Association With Electronic Devices and Other Factors. 2020.
- Background: PubMed 28750310Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
- BackgroundYamak B, İmamoğlu O, İslamoğlu İ, Çebi MJETS. The effects of exercise on body posture. 2018;13(18).
- Background: PubMed 31103129Nakamaru K, Aizawa J, Kawarada K, Uemura Y, Koyama T, Nitta O. Immediate effects of thoracic spine self-mobilization in patients with mechanical neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2019 Apr;23(2):417-424. doi: 10.1016/j.jbmt.2018.05.008. Epub 2018 Jun 1.
- Background: PubMed 30858662Puntumetakul R, Pithak R, Namwongsa S, Saiklang P, Boucaut R. The effect of massage technique plus thoracic manipulation versus thoracic manipulation on pain and neural tension in mechanical neck pain: a randomized controlled trial. J Phys Ther Sci. 2019 Feb;31(2):195-201. doi: 10.1589/jpts.31.195. Epub 2019 Feb 7.
- BackgroundKim S-j, Kim S-y, Lee M-jJPTK. The Effects of Thoracic Spine Self-mobilization Exercise Using a Tool on Pain, Range of Motion, and Dysfunction of Chronic Neck Pain Patients. 2020;27(1):1-10.
- Background: PubMed 32762708Joshi S, Balthillaya G, Neelapala YVR. Immediate effects of cervicothoracic junction mobilization versus thoracic manipulation on the range of motion and pain in mechanical neck pain with cervicothoracic junction dysfunction: a pilot randomized controlled trial. Chiropr Man Therap. 2020 Aug 7;28(1):38. doi: 10.1186/s12998-020-00327-4.
- Individual participant dataSharing planned: No
Related trials for Thoracic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Syed Shakil-ur Rehman principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-mobilization technique along with conventional therapy and conventional therapy in people with Thoracic, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 7 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 3 Apr 2023. 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 Pakistan. 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?
NPRS (time frame: 6th Week). The study lists 3 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 NCT05392517, which also lists 10 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 3 Apr 2023.