Joint DiseasesNCT06404346
Comparative Effectiveness of HVT and Bowen Technique in Patients of SI Joint Dysfunction With Upslipped Innominates
A study testing High Velocity Thrust and Bowen therapy in people with Joint Diseases, run by Superior University at 1 site in Pakistan.
Trial summary
Sacroiliac joint dysfunction (SIJD) is a common musculoskeletal condition characterized by pain and impaired function in the lower back and pelvis region. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Joint Diseases
- What is being tested?
- High Velocity Thrust and Bowen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 1 Sep 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of sacroiliac joint dysfunction confirmed by clinical assessment and imaging findings.
- The presence of an upslipped innominate observed on imaging studies.
Who cannot join
- History of significant trauma or surgery involving the sacroiliac joint region.
- The presence of inflammatory or infectious conditions affecting the sacroiliac joint.
- Contraindications to manual therapy interventions such as HVT or the Bowen Technique.
- Inability to comprehend study procedures or provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of High Velocity Thrust and Bowen Technique in Patients of SI Joint Dysfunction With Upslipped Innominates. A Randomized Controlled Trial
Sacroiliac joint dysfunction (SIJD) is a common musculoskeletal condition characterized by pain and impaired function in the lower back and pelvis region.
Read the detailed description
The reported prevalence of sacroiliac joint pain in cases of chronic low back and lower extremity pain is estimated to be between 10 - 27%. Manual therapy techniques, such as High-Velocity Thrust (HVT) and the Bowen Technique, have emerged as potential treatment options for SIJD. HVT involves quick, controlled movements applied to specific joints to restore normal range of motion and alleviate pain. Conversely, the Bowen Technique is a gentle, non-invasive form of bodywork that utilizes subtle rolling movements over muscles and connective tissues to promote relaxation and restore balance within the body.
- Conditions
- Joint Diseases
- Being tested
- High Velocity Thrust, Bowen therapy
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Velocity ThrustDiagnostic test
Group A Participants assigned to the HVT will receive manual therapy sessions consisting of specific manipulative techniques targeting the sacroiliac joint and surrounding structures. participant lying on your side or on your stomach, depending on which SI joint needs to be manipulated.The physiotherapist will stabilize body to isolate the specific SI joint that needs adjustment. This may involve holding certain parts of your body in place or using props like a belt or cushion.With precise control and speed, the physiotherapist will apply a sudden thrust to the targeted SI joint. This thrust aims to mobilize the joint and restore its normal function. This procedure will perform in 3 sessions per week for 2 weeks
Bowen therapyOther
participants will undergo sessions involving gentle, rolling movements over muscles, tendons, and ligaments in sacroiliac joint . participant lie comfortably on a treatment bed fully clothed, typically face down or on your side. The physiotherapist will perform a series of gentle, rolling movements with their fingers and thumbs over specific points on your body, including the lower back, hips, and buttocks. These moves are designed to stimulate the nervous system and promote relaxation and healing in the affected area.
| Study group | Role | What they receive |
|---|---|---|
| High Velocity Thrust | Experimental | Not described Receives: Diagnostic Test: High Velocity Thrust |
| Bowen therapy | Other | Not described Receives: Other: Bowen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
used in the management of spinal disorder. The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
Measured: 12 Months
Visual Analog Scale(VAS)
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseasesStudies of the same condition, open and under way.
- More trials run by Superior 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404346
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/705
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of High Velocity Thrust and Bowen Technique in Patients of SI Joint Dysfunction With Upslipped Innominates. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06404346
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/705
- Conditions
- Joint Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 8 May 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.
Sacroiliac joint dysfunction (SIJD) is a common musculoskeletal condition characterized by pain and impaired function in the lower back and pelvis region.
Detailed description
The reported prevalence of sacroiliac joint pain in cases of chronic low back and lower extremity pain is estimated to be between 10 - 27%. Manual therapy techniques, such as High-Velocity Thrust (HVT) and the Bowen Technique, have emerged as potential treatment options for SIJD. HVT involves quick, controlled movements applied to specific joints to restore normal range of motion and alleviate pain. Conversely, the Bowen Technique is a gentle, non-invasive form of bodywork that utilizes subtle rolling movements over muscles and connective tissues to promote relaxation and restore balance within the body.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Velocity Thrust | Experimental | Diagnostic Test: High Velocity Thrust |
| Bowen therapy | Other | Other: Bowen therapy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of sacroiliac joint dysfunction confirmed by clinical assessment and imaging findings.
- The presence of an upslipped innominate observed on imaging studies.
Key exclusion criteria (4 listed)
- History of significant trauma or surgery involving the sacroiliac joint region.
- The presence of inflammatory or infectious conditions affecting the sacroiliac joint.
- Contraindications to manual therapy interventions such as HVT or the Bowen Technique.
- Inability to comprehend study procedures or provide informed consent
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 |
|---|---|---|
| High Velocity ThrustGroup A Participants assigned to the HVT will receive manual therapy sessions consisting of specific manipulative techniques targeting the sacroiliac joint and surrounding structures. participant lying on your side or on your stomach, depending on which SI joint needs to be manipulated.The physiotherapist will stabilize body to isolate the specific SI joint that needs adjustment. This may involve holding certain parts of your body in place or using props like a belt or cushion.With precise control and speed, the physiotherapist will apply a sudden thrust to the targeted SI joint. This thrust aims to mobilize the joint and restore its normal function. This procedure will perform in 3 sessions per week for 2 weeks | Diagnostic test | High Velocity Thrust |
| Bowen therapyparticipants will undergo sessions involving gentle, rolling movements over muscles, tendons, and ligaments in sacroiliac joint . participant lie comfortably on a treatment bed fully clothed, typically face down or on your side. The physiotherapist will perform a series of gentle, rolling movements with their fingers and thumbs over specific points on your body, including the lower back, hips, and buttocks. These moves are designed to stimulate the nervous system and promote relaxation and healing in the affected area. | Other | Bowen therapy |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 12 Months
used in the management of spinal disorder. The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
Visual Analog Scale(VAS)
Time frame: 12 months
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Velocity Thrust and Bowen therapy in people with Joint Diseases, run by Superior 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 May 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?
Results are not available in the source record.
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?
Oswestry Disability Index (ODI) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.