ThoracicNCT06049264
Thoracic Spine Manual Traction With Mobilization Versus Manipulation
A study testing Thoracic spine manual traction with mobilization protocol. and Thoracic manipulation protocol in people with Thoracic, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project will be a Randomized clinical trial conducted to compare Short-term effects of thoracic spine manual traction with mobilization and Thoracic manipulation in patients with mid thoracic pain and pseudo visceral symptoms. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Thoracic
- What is being tested?
- Thoracic spine manual traction with mobilization protocol. and Thoracic manipulation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Sep 2023to 15 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group between 20 to 40 years
- Both male and female gender.
- Mid thoracic pain with pseudo visceral symptoms.
- Participants with moderate and severe pain as ODI score should be within range of 30% to 68%.
- Referred by physician after exclusion of visceral symptoms
Who cannot join
- Post-surgical condition (6 months)
- Neurological Conditions
- Pulmonological conditions
- Cardiac conditions such as angina pectoris, coronary artery disease, Arrhythmia, pericarditis or aortic aneurysm.
- Musculoskeletal disorders
- Esophageal disorders
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sehat Medical Complex, Hanjarwal Lahore
Lahore, Punjab Province
About this study
Official title: Short-term Effects of Thoracic Spine Manual Traction With Mobilization Versus Thoracic Manipulation in Patients With Mid Thoracic Pain and Pseudo Visceral Symptoms
This project will be a Randomized clinical trial conducted to compare Short-term effects of thoracic spine manual traction with mobilization and Thoracic manipulation in patients with mid thoracic pain and pseudo visceral symptoms. Sample will be collected through non-probability convenient sampling, following eligibility criteria from Sehat Medical complex, Lahore. Eligibility criteria will be Age group between 20 to 40 years both male and female genders with mid thoracic pain having pseudo visceral symptoms. Referred by physician after exclusion of post-surgical condition from past 6 months Neurological, Pulmonological, Cardiac, Musculoskeletal and Esophageal conditions. Participants will be randomly allocated in two groups via sealed envelope method, baseline assessment will be done, Group A participants will be given baseline treatment along with Thoracic spine manual traction with mobilization, Group B participants will be given baseline treatment along with Thoracic manipulation protocol. Pre and post intervention assessment will be done via, Numeric pain rating scale(NPRS), Revised Oswestry thoracic pain disability questionnaire (ODI) and Inclinometer to measure ROM of Thoracic spine,3 sessions per week will be given for 4 weeks, data will be analyzed by using SPSS version 29.
Read the detailed description
Spinal pain is a well-recognized condition associated with significant personal and community burdens. Compared to the lumbar and cervical spine, the thoracic spine has received less attention in terms of clinical, genetic and epidemiologic research, yet pain experienced in the thoracic spine can be equally disabling, imposing similar burdens on the individual, community and workforce. Pseudo visceral symptoms refer to physical sensations or symptoms that mimic those associated with underlying medical condition affecting the internal organs, but without any organic cause or pathology. Manipulation and mobilization are two manual techniques that are commonly used by osteopaths, chiropractors and physiotherapists to treat spinal pain and dysfunction. This study aims to compare Short-term effects of thoracic spine manual traction with mobilization and Thoracic manipulation in patients with mid thoracic pain and pseudo visceral symptoms.
This randomized clinical trial will be conducted at Sehat medical complex, Lahore. It will include patients with age group between 20 to 40 years, both male and female gender with mid thoracic pain and pseudo visceral symptoms referred by physician after exclusion of visceral symptoms. Those patients with post-surgical condition from past 6 months, Neurological, Pulmonological or Cardiac conditions will be excluded. Participants will be divided into two groups. Group A will receive of thoracic spine manual traction with mobilization treatment protocol and Group B will receive Thoracic manipulation protocol. Both groups will receive baseline treatment including TENS and Hot pack. Short term effects would be assessed after treatment for 4 weeks. Patients will be assessed by Numeric pain rating scale, Inclinometer and Revised Oswestry thoracic pain disability questionnaire. The findings can contribute to the growing evidence based supporting whether the use of thoracic spine manual traction with mobilization or Thoracic manipulation improve pain, ROM and disability in patients with mid thoracic pain and pseudo visceral symptoms. Analysis will be done by statistical package for social sciences SPSS 29.
- Conditions
- Thoracic
- Being tested
- Thoracic spine manual traction with mobilization protocol., Thoracic manipulation protocol
- Keywords
- Manipulation, Mobilization, Pseudo visceral symptoms, Pain, Spinal Traction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic spine manual traction with mobilization protocol.Other
The therapist will perform one 30-second bout of grade I or II central posterior-anterior mobilization at the T3 spinous process as described by Maitland et al. After the 30-second bout, the therapist proceeded to T4 and performed the same technique. This process was continued sequentially in a caudal direction to T8, for an overall intervention time of approximately 3 minutes. In addition to mobilization, thoracic spine traction will be also given in sitting position.
Thoracic manipulation protocolOther
To perform the manipulation, the stabilizing hand will be placed at the level immediately caudal to the restricted segment using a ''pistol grip''. Once the pre manipulative position will be achieved the patient will be instructed to take a deep inhalation and exhale. During the exhalation the treating clinician performed a high velocity, small amplitude thrust in a direction to facilitate relative closing or opening of the respective facet joint as indicated by the segmental examination.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Spine Manual Traction with Mobilization | Experimental | Thoracic Spine Manual Traction with Mobilization Receives: Other: Thoracic spine manual traction with mobilization protocol. |
| Thoracic Spine Manual Traction with Manipulation | Active comparator | Thoracic Spine Manual Traction with Manipulation Receives: Other: Thoracic manipulation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Measured: 4th Week
Revised Oswestry thoracic pain disability questionnaire for disability
This questionnaire is designed to evaluate Level of Disability in thoracic Pain patients. Disability was measured using the Oswestry Disability Index (ODI: range 0-no disability to 50-maximum disability possible). The ODI is a commonly used outcome measure amongst LBP patient.
Measured: 4th Week
Inclinometer measurement of Thoracic ROM
Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry. Inclinometers are typically found in clinics and are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87-0.95.
Measured: 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start25 Sep 2023
- Primary completion10 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ThoracicStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 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, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049264
- Sponsor's protocol ID
- REC/RCR&AHS/23/0132 Feroza
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Izzo R, Popolizio T, D'Aprile P, Muto M. Spinal pain. Eur J Radiol. 2015 May;84(5):746-56. doi: 10.1016/j.ejrad.2015.01.018. Epub 2015 Feb 13.
PubMed 25824642Briggs AM, Smith AJ, Straker LM, Bragge P. Thoracic spine pain in the general population: prevalence, incidence and associated factors in children, adolescents and adults. A systematic review. BMC Musculoskelet Disord. 2009 Jun 29;10:77. doi: 10.1186/1471-2474-10-77.
PubMed 19563667Romanchuk O. The Immediate Effects of the Manual Therapy Traction Manipulations on Parameters of Cardiorespiratory System Functioning. International Journal of Human Movement and Sports Sciences. 2022;10(4):832-40.
Morningstar MW. Cervical hyperlordosis, forward head posture, and lumbar kyphosis correction: A novel treatment for mid-thoracic pain. J Chiropr Med. 2003 Summer;2(3):111-5. doi: 10.1016/S0899-3467(07)60055-X.
PubMed 19674605Manchikanti L, Singh V, Pampati V, Beyer CD, Damron KS. Evaluation of the prevalence of facet joint pain in chronic thoracic pain. Pain Physician. 2002 Oct;5(4):354-9.
PubMed 16886012Takatalo J, Ylinen J, Pienimaki T, Hakkinen A. Intra- and inter-rater reliability of thoracic spine mobility and posture assessments in subjects with thoracic spine pain. BMC Musculoskelet Disord. 2020 Aug 10;21(1):529. doi: 10.1186/s12891-020-03551-4.
PubMed 32778081Cleland JA, Flynn TW, Childs JD, Eberhart S. The audible pop from thoracic spine thrust manipulation and its relation to short-term outcomes in patients with neck pain. J Man Manip Ther. 2007;15(3):143-54. doi: 10.1179/106698107790819828.
PubMed 19066662. Fryer G, Carub J, McIver S. The effect of manipulation and mobilisation on pressure pain thresholds in the thoracic spine. Journal of Osteopathic Medicine. 2004;7(1):8-14.
Vicenzino B, Collins D, Wright A. The initial effects of a cervical spine manipulative physiotherapy treatment on the pain and dysfunction of lateral epicondylalgia. Pain. 1996 Nov;68(1):69-74. doi: 10.1016/S0304-3959(96)03221-6.
PubMed 9252000Park SJ, Kim SH, Kim SH. Effects of Thoracic Mobilization and Extension Exercise on Thoracic Alignment and Shoulder Function in Patients with Subacromial Impingement Syndrome: A Randomized Controlled Pilot Study. Healthcare (Basel). 2020 Sep 2;8(3):316. doi: 10.3390/healthcare8030316.
PubMed 32887287Anandkumar S M Sc Pt Bpt C-Ompt Cafs Cert Dnt, Manivasagam M Bpt Dyt Comt Fsr Dnp Ces. Effect of fascia dry needling on non-specific thoracic pain - A proposed dry needling grading system. Physiother Theory Pract. 2017 May;33(5):420-428. doi: 10.1080/09593985.2017.1318423. Epub 2017 May 8.
PubMed 28481688
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Thoracic Spine Manual Traction With Mobilization Versus Thoracic Manipulation in Patients With Mid Thoracic Pain and Pseudo Visceral Symptoms
- ClinicalTrials.gov ID
- NCT06049264
- Acronym / sponsor ID
- REC/RCR&AHS/23/0132 Feroza
- Conditions
- Thoracic
- Keywords
- Manipulation, Mobilization, Pseudo visceral symptoms, Pain, Spinal Traction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 22 Sep 2023 (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.
This project will be a Randomized clinical trial conducted to compare Short-term effects of thoracic spine manual traction with mobilization and Thoracic manipulation in patients with mid thoracic pain and pseudo visceral symptoms. Sample will be collected through non-probability convenient sampling, following eligibility criteria from Sehat Medical complex, Lahore. Eligibility criteria will be Age group between 20 to 40 years both male and female genders with mid thoracic pain having pseudo visceral symptoms. Referred by physician after exclusion of post-surgical condition from past 6 months Neurological, Pulmonological, Cardiac, Musculoskeletal and Esophageal conditions. Participants will be randomly allocated in two groups via sealed envelope method, baseline assessment will be done, Group A participants will be given baseline treatment along with Thoracic spine manual traction with mobilization, Group B participants will be given baseline treatment along with Thoracic manipulation protocol. Pre and post intervention assessment will be done via, Numeric pain rating scale(NPRS), Revised Oswestry thoracic pain disability questionnaire (ODI) and Inclinometer to measure ROM of Thoracic spine,3 sessions per week will be given for 4 weeks, data will be analyzed by using SPSS version 29.
Detailed description
Spinal pain is a well-recognized condition associated with significant personal and community burdens. Compared to the lumbar and cervical spine, the thoracic spine has received less attention in terms of clinical, genetic and epidemiologic research, yet pain experienced in the thoracic spine can be equally disabling, imposing similar burdens on the individual, community and workforce. Pseudo visceral symptoms refer to physical sensations or symptoms that mimic those associated with underlying medical condition affecting the internal organs, but without any organic cause or pathology. Manipulation and mobilization are two manual techniques that are commonly used by osteopaths, chiropractors and physiotherapists to treat spinal pain and dysfunction. This study aims to compare Short-term effects of thoracic spine manual traction with mobilization and Thoracic manipulation in patients with mid thoracic pain and pseudo visceral symptoms.
This randomized clinical trial will be conducted at Sehat medical complex, Lahore. It will include patients with age group between 20 to 40 years, both male and female gender with mid thoracic pain and pseudo visceral symptoms referred by physician after exclusion of visceral symptoms. Those patients with post-surgical condition from past 6 months, Neurological, Pulmonological or Cardiac conditions will be excluded. Participants will be divided into two groups. Group A will receive of thoracic spine manual traction with mobilization treatment protocol and Group B will receive Thoracic manipulation protocol. Both groups will receive baseline treatment including TENS and Hot pack. Short term effects would be assessed after treatment for 4 weeks. Patients will be assessed by Numeric pain rating scale, Inclinometer and Revised Oswestry thoracic pain disability questionnaire. The findings can contribute to the growing evidence based supporting whether the use of thoracic spine manual traction with mobilization or Thoracic manipulation improve pain, ROM and disability in patients with mid thoracic pain and pseudo visceral symptoms. Analysis will be done by statistical package for social sciences SPSS 29.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Spine Manual Traction with Mobilization | Experimental | Other: Thoracic spine manual traction with mobilization protocol.Thoracic Spine Manual Traction with Mobilization |
| Thoracic Spine Manual Traction with Manipulation | Active comparator | Other: Thoracic manipulation protocolThoracic Spine Manual Traction with Manipulation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group between 20 to 40 years
- Both male and female gender.
- Mid thoracic pain with pseudo visceral symptoms.
- Participants with moderate and severe pain as ODI score should be within range of 30% to 68%.
- Referred by physician after exclusion of visceral symptoms
Key exclusion criteria (6 listed)
- Post-surgical condition (6 months)
- Neurological Conditions
- Pulmonological conditions
- Cardiac conditions such as angina pectoris, coronary artery disease, Arrhythmia, pericarditis or aortic aneurysm.
- Musculoskeletal disorders
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 spine manual traction with mobilization protocol.The therapist will perform one 30-second bout of grade I or II central posterior-anterior mobilization at the T3 spinous process as described by Maitland et al. After the 30-second bout, the therapist proceeded to T4 and performed the same technique. This process was continued sequentially in a caudal direction to T8, for an overall intervention time of approximately 3 minutes. In addition to mobilization, thoracic spine traction will be also given in sitting position. | Other | Thoracic Spine Manual Traction with Mobilization |
| Thoracic manipulation protocolTo perform the manipulation, the stabilizing hand will be placed at the level immediately caudal to the restricted segment using a ''pistol grip''. Once the pre manipulative position will be achieved the patient will be instructed to take a deep inhalation and exhale. During the exhalation the treating clinician performed a high velocity, small amplitude thrust in a direction to facilitate relative closing or opening of the respective facet joint as indicated by the segmental examination. | Other | Thoracic Spine Manual Traction with Manipulation |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4th Week
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Revised Oswestry thoracic pain disability questionnaire for disability
Time frame: 4th Week
This questionnaire is designed to evaluate Level of Disability in thoracic Pain patients. Disability was measured using the Oswestry Disability Index (ODI: range 0-no disability to 50-maximum disability possible). The ODI is a commonly used outcome measure amongst LBP patient.
Inclinometer measurement of Thoracic ROM
Time frame: 4th Week
Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry. Inclinometers are typically found in clinics and are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87-0.95.
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 30 Jan 2024.
- Background: PubMed 25824642Izzo R, Popolizio T, D'Aprile P, Muto M. Spinal pain. Eur J Radiol. 2015 May;84(5):746-56. doi: 10.1016/j.ejrad.2015.01.018. Epub 2015 Feb 13.
- Background: PubMed 19563667Briggs AM, Smith AJ, Straker LM, Bragge P. Thoracic spine pain in the general population: prevalence, incidence and associated factors in children, adolescents and adults. A systematic review. BMC Musculoskelet Disord. 2009 Jun 29;10:77. doi: 10.1186/1471-2474-10-77.
- BackgroundRomanchuk O. The Immediate Effects of the Manual Therapy Traction Manipulations on Parameters of Cardiorespiratory System Functioning. International Journal of Human Movement and Sports Sciences. 2022;10(4):832-40.
- Background: PubMed 19674605Morningstar MW. Cervical hyperlordosis, forward head posture, and lumbar kyphosis correction: A novel treatment for mid-thoracic pain. J Chiropr Med. 2003 Summer;2(3):111-5. doi: 10.1016/S0899-3467(07)60055-X.
- Background: PubMed 16886012Manchikanti L, Singh V, Pampati V, Beyer CD, Damron KS. Evaluation of the prevalence of facet joint pain in chronic thoracic pain. Pain Physician. 2002 Oct;5(4):354-9.
- Background: PubMed 32778081Takatalo J, Ylinen J, Pienimaki T, Hakkinen A. Intra- and inter-rater reliability of thoracic spine mobility and posture assessments in subjects with thoracic spine pain. BMC Musculoskelet Disord. 2020 Aug 10;21(1):529. doi: 10.1186/s12891-020-03551-4.
- Background: PubMed 19066662Cleland JA, Flynn TW, Childs JD, Eberhart S. The audible pop from thoracic spine thrust manipulation and its relation to short-term outcomes in patients with neck pain. J Man Manip Ther. 2007;15(3):143-54. doi: 10.1179/106698107790819828.
- Background. Fryer G, Carub J, McIver S. The effect of manipulation and mobilisation on pressure pain thresholds in the thoracic spine. Journal of Osteopathic Medicine. 2004;7(1):8-14.
- Background: PubMed 9252000Vicenzino B, Collins D, Wright A. The initial effects of a cervical spine manipulative physiotherapy treatment on the pain and dysfunction of lateral epicondylalgia. Pain. 1996 Nov;68(1):69-74. doi: 10.1016/S0304-3959(96)03221-6.
- Background: PubMed 32887287Park SJ, Kim SH, Kim SH. Effects of Thoracic Mobilization and Extension Exercise on Thoracic Alignment and Shoulder Function in Patients with Subacromial Impingement Syndrome: A Randomized Controlled Pilot Study. Healthcare (Basel). 2020 Sep 2;8(3):316. doi: 10.3390/healthcare8030316.
- Background: PubMed 28481688Anandkumar S M Sc Pt Bpt C-Ompt Cafs Cert Dnt, Manivasagam M Bpt Dyt Comt Fsr Dnp Ces. Effect of fascia dry needling on non-specific thoracic pain - A proposed dry needling grading system. Physiother Theory Pract. 2017 May;33(5):420-428. doi: 10.1080/09593985.2017.1318423. Epub 2017 May 8.
- Individual participant dataSharing planned: No
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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.
Syed Shakil ur Rehman principal investigator
Riphah International University, Lahore
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 spine manual traction with mobilization protocol. and Thoracic manipulation protocol 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 5 inclusion and 6 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 30 Jan 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 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?
Numeric Pain Rating Scale (time frame: 4th 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 NCT06049264, which also lists 11 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 30 Jan 2024.