Sacroiliac Joint DysfunctionNCT06568887
Effectiveness of 5% Dextrose Water Versus Corticosteroid Injection for Pain Management of SJD
A study testing Dextrose Water and Corticosteroid Injection in people with Sacroiliac Joint Dysfunction, run by Superior University at 1 site in Pakistan.
Trial summary
The sacroiliac joint (SIJ) is identified as a potential origin of low back pain and referred pain to the lower limb, with a prevalence rate ranging from 7% to 30%. Typically, SIJ pain manifests in the buttock and occasionally extends to the posterior aspect of the ipsilateral thigh, resembling pain originating from… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Dextrose Water and Corticosteroid Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Oct 2023to 30 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons with SIJ pain for at least 3 months
Who cannot join
- Pregnancy or breastfeeding
- history of allergy or people contra indicated to our dose
- already received Corticosteroid injection in last 3 months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
Official title: Effectiveness of 5% Dextrose Water (D/W) Versus Corticosteroid Injection for Pain Management of Sacroiliac Joint Dysfuntion
The sacroiliac joint (SIJ) is identified as a potential origin of low back pain and referred pain to the lower limb, with a prevalence rate ranging from 7% to 30%. Typically, SIJ pain manifests in the buttock and occasionally extends to the posterior aspect of the ipsilateral thigh, resembling pain originating from lumbar spine sources, such as the zygapophysial joints or intervertebral discs.
Read the detailed description
For Sacroiliac Joint Dysfunction (SIJD) by examining the comparative effectiveness of two distinct interventions: the innovative 5% Dextrous Water (D/W) solution and the conventional corticosteroid injection. With corticosteroids associated with well-documented side effects and concerns about long-term use, the exploration of 5% D/W is particularly timely and holds promise as a potentially safer alternative.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Dextrose Water, Corticosteroid Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose WaterCombination product
Individuals in this group will receive three injections of 5% dextrose water per week for six weeks period to treat their pain in sacroiliac joint and then their responce will b documented.
Corticosteroid InjectionCombination product
Individuals in this group will receive three corticosteroid injections per week for a period of six weeks to treat their pain in Sacroiliac joint and then their responce will also be documented.
| Study group | Role | What they receive |
|---|---|---|
| Dextrose Water | Experimental | Not described Receives: Combination Product: Dextrose Water |
| Corticosteroid Injection | Active comparator | Not described Receives: Combination Product: Corticosteroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
The Visual Analog Scale is a subjective measurement tool commonly used in research and clinical settings to assess the intensity or magnitude of various subjective characteristics or attitudes. It typically consists of a 100-mm horizontal or vertical line, with anchor points at each end representing extreme states (e.g., no pain to worst pain imaginable). Participants mark their perceived intensity on the line, and the distance from the starting point is measured to determine the score.
Measured: 12 Months
ODI
The Oswestry Disability Index is a widely used and well-established questionnaire designed to assess the impact of musculoskeletal conditions on an individual's daily activities and functionality, making it particularly relevant for conditions like piriformis syndrome. The questionnaire consists of ten sections addressing various aspects of daily life, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Participants rate their level of disability in each section on a scale from 0 to 5, with 0 indicating no disability and 5 indicating maximum disability. The scores from each section are then summed and expressed as a percentage, with higher percentages representing greater disability.
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 posted23 Aug 2024
- Study start30 Oct 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT06568887
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/741
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 23 Aug 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 5% Dextrose Water (D/W) Versus Corticosteroid Injection for Pain Management of Sacroiliac Joint Dysfuntion
- ClinicalTrials.gov ID
- NCT06568887
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/741
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Aug 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.
The sacroiliac joint (SIJ) is identified as a potential origin of low back pain and referred pain to the lower limb, with a prevalence rate ranging from 7% to 30%. Typically, SIJ pain manifests in the buttock and occasionally extends to the posterior aspect of the ipsilateral thigh, resembling pain originating from lumbar spine sources, such as the zygapophysial joints or intervertebral discs.
Detailed description
For Sacroiliac Joint Dysfunction (SIJD) by examining the comparative effectiveness of two distinct interventions: the innovative 5% Dextrous Water (D/W) solution and the conventional corticosteroid injection. With corticosteroids associated with well-documented side effects and concerns about long-term use, the exploration of 5% D/W is particularly timely and holds promise as a potentially safer alternative.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose Water | Experimental | Combination Product: Dextrose Water |
| Corticosteroid Injection | Active comparator | Combination Product: Corticosteroid Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persons with SIJ pain for at least 3 months
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding
- history of allergy or people contra indicated to our dose
- already received Corticosteroid injection in last 3 months
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 |
|---|---|---|
| Dextrose WaterIndividuals in this group will receive three injections of 5% dextrose water per week for six weeks period to treat their pain in sacroiliac joint and then their responce will b documented. | Combination product | Dextrose Water |
| Corticosteroid InjectionIndividuals in this group will receive three corticosteroid injections per week for a period of six weeks to treat their pain in Sacroiliac joint and then their responce will also be documented. | Combination product | Corticosteroid Injection |
Primary outcome
VAS
Time frame: 12 Months
The Visual Analog Scale is a subjective measurement tool commonly used in research and clinical settings to assess the intensity or magnitude of various subjective characteristics or attitudes. It typically consists of a 100-mm horizontal or vertical line, with anchor points at each end representing extreme states (e.g., no pain to worst pain imaginable). Participants mark their perceived intensity on the line, and the distance from the starting point is measured to determine the score.
ODI
Time frame: 12 months
The Oswestry Disability Index is a widely used and well-established questionnaire designed to assess the impact of musculoskeletal conditions on an individual's daily activities and functionality, making it particularly relevant for conditions like piriformis syndrome. The questionnaire consists of ten sections addressing various aspects of daily life, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Participants rate their level of disability in each section on a scale from 0 to 5, with 0 indicating no disability and 5 indicating maximum disability. The scores from each section are then summed and expressed as a percentage, with higher percentages representing greater disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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 Dextrose Water and Corticosteroid Injection in people with Sacroiliac Joint Dysfunction, 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 1 inclusion and 3 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 23 Aug 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?
VAS (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 23 Aug 2024.