Pain ManagementPhase 2/3NCT03564106
Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
A Phase 2/3 study testing intraarticular radiofrequency + intraarticular methylprednisolone and intraarticular methylprednisolone in people with Pain Management, run by Assiut University at 1 site in Egypt.
Trial summary
The sacroiliac joint is Located between the pelvis and base of the spine, the sacroiliac joints are strong, stable joints that allow for little movement. While these joints do not bend like a knuckle or knee, they are susceptible to degenerative arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain Management
- What is being tested?
- intraarticular radiofrequency + intraarticular methylprednisolone and intraarticular methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 15 Jan 2021
- Phase
- Phase 2/3
- 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
- All patients must have chronic pain more than 6 months and have failed medical treatment.
Who cannot join
- Infection at the site of injection
- Opioids addiction
- Coagulopathy or another bleeding diathesis
- Those who refuse to participate in the study
- Ankylosing Spondylitis patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
The sacroiliac joint is Located between the pelvis and base of the spine, the sacroiliac joints are strong, stable joints that allow for little movement. While these joints do not bend like a knuckle or knee, they are susceptible to degenerative arthritis. Sacroiliac joint pain is one of the most common causes of chronic low back pain, accounting for 10% to 27% of patients with chronic lower back pain. It is known to be caused by abnormal motion in this joint, namely, too much motion or too little motion. Patients with pain experience various degrees of pain in the low back, groin, buttock, or posterior thigh.
Read the detailed description
The pain starts when the Sacroiliac joint gets inflamed. There are several reasons it could happen. It could be hurt when playing sports or if fall down.
Sometimes start hurting when the ligaments that hold the SI joint together are damaged, which may make the joint move abnormally. The pain associated with sacroiliitis most commonly occurs in the buttocks and lower back. It can also affect the legs, groin and even the feet.
- Conditions
- Pain Management
- Being tested
- intraarticular radiofrequency + intraarticular methylprednisolone, intraarticular methylprednisolone
- Keywords
- chronic sacroilitis,radiofrequancy,intraarticular steroids injection
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarticular radiofrequency + intraarticular methylprednisoloneDrug
intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)
intraarticular methylprednisoloneDrug
intraarticular methylprednisolone (30 mg)
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | receive intraarticular radiofrequency + methylprednisolone (30 mg) Receives: Drug: intraarticular radiofrequency + intraarticular methylprednisolone |
| group C | Experimental | receive intraarticular methylprednisolone (30 mg) Receives: Drug: intraarticular methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Numeric Rating Scale (NRS)
Measured: up to 6 months
Secondary outcomes (2)
Patient Impression
Patient Global Impression of Change Scale (PGIC)
Measured: up to 6 months
Pain Disability
Pain Disability Index ( PDI)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Mar 2019
- Primary completion1 Jan 2021
- Study completion15 Jan 2021
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 Pain ManagementStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564106
- Sponsor's protocol ID
- 17200203
- Status last verified
- Jan 2021
- First submitted
- 2 Jun 2018
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bogduk N. Pulsed radiofrequency. Pain Med. 2006 Sep-Oct;7(5):396-407. doi: 10.1111/j.1526-4637.2006.00210.x. No abstract available.
PubMed 17014598Borowsky CD, Fagen G. Sources of sacroiliac region pain: insights gained from a study comparing standard intra-articular injection with a technique combining intra- and peri-articular injection. Arch Phys Med Rehabil. 2008 Nov;89(11):2048-56. doi: 10.1016/j.apmr.2008.06.006.
PubMed 18996232Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PubMed 21055873Do KH, Ahn SH, Jones R, Jang SH, Son SM, Lee DG, Cho HK, Choi GS, Cho YW. A New Sacroiliac Joint Injection Technique and Its Short-Term Effect on Chronic Sacroiliac Region Pain. Pain Med. 2016 Oct;17(10):1809-1813. doi: 10.1093/pm/pnw003. Epub 2016 Feb 25.
PubMed 27738191
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
- ClinicalTrials.gov ID
- NCT03564106
- Acronym / sponsor ID
- 17200203
- Conditions
- Pain Management
- Keywords
- chronic sacroilitis,radiofrequancy,intraarticular steroids injection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 20 Jun 2018 (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 is Located between the pelvis and base of the spine, the sacroiliac joints are strong, stable joints that allow for little movement. While these joints do not bend like a knuckle or knee, they are susceptible to degenerative arthritis. Sacroiliac joint pain is one of the most common causes of chronic low back pain, accounting for 10% to 27% of patients with chronic lower back pain. It is known to be caused by abnormal motion in this joint, namely, too much motion or too little motion. Patients with pain experience various degrees of pain in the low back, groin, buttock, or posterior thigh.
Detailed description
The pain starts when the Sacroiliac joint gets inflamed. There are several reasons it could happen. It could be hurt when playing sports or if fall down.
Sometimes start hurting when the ligaments that hold the SI joint together are damaged, which may make the joint move abnormally. The pain associated with sacroiliitis most commonly occurs in the buttocks and lower back. It can also affect the legs, groin and even the feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: intraarticular radiofrequency + intraarticular methylprednisolonereceive intraarticular radiofrequency + methylprednisolone (30 mg) |
| group C | Experimental | Drug: intraarticular methylprednisolonereceive intraarticular methylprednisolone (30 mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients must have chronic pain more than 6 months and have failed medical treatment.
Key exclusion criteria (5 listed)
- Infection at the site of injection
- Opioids addiction
- Coagulopathy or another bleeding diathesis
- Those who refuse to participate in the study
- Ankylosing Spondylitis patients
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 |
|---|---|---|
| intraarticular radiofrequency + intraarticular methylprednisoloneintraarticular radiofrequency + intraarticular methylprednisolone (30 mg) | Drug | group A |
| intraarticular methylprednisoloneintraarticular methylprednisolone (30 mg) | Drug | group C |
Primary outcome
pain intensity
Time frame: up to 6 months
Numeric Rating Scale (NRS)
2 secondary outcomes
Patient Impression
Time frame: up to 6 months
Pain Disability
Time frame: up to 6 months
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 20 Jan 2021.
- Background: PubMed 17014598Bogduk N. Pulsed radiofrequency. Pain Med. 2006 Sep-Oct;7(5):396-407. doi: 10.1111/j.1526-4637.2006.00210.x. No abstract available.
- Background: PubMed 18996232Borowsky CD, Fagen G. Sources of sacroiliac region pain: insights gained from a study comparing standard intra-articular injection with a technique combining intra- and peri-articular injection. Arch Phys Med Rehabil. 2008 Nov;89(11):2048-56. doi: 10.1016/j.apmr.2008.06.006.
- Background: PubMed 21055873Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
- Background: PubMed 27738191Do KH, Ahn SH, Jones R, Jang SH, Son SM, Lee DG, Cho HK, Choi GS, Cho YW. A New Sacroiliac Joint Injection Technique and Its Short-Term Effect on Chronic Sacroiliac Region Pain. Pain Med. 2016 Oct;17(10):1809-1813. doi: 10.1093/pm/pnw003. Epub 2016 Feb 25.
- 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 Phase 2/3 study testing intraarticular radiofrequency + intraarticular methylprednisolone and intraarticular methylprednisolone in people with Pain Management, run by Assiut University at 1 site in Egypt.
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 5 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 20 Jan 2021. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: up to 6 months). 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 NCT03564106, 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 20 Jan 2021.