Sacro Iliac Joint PainPhase 4CrNCT06709313
Effect of Chromium on Blood Sugar After Sacroiliac Joint Injection
A Phase 4 study testing Chromium in people with Sacro Iliac Joint Pain and Diabetes, run by Fayoum University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate whether oral chromium supplementation can decrease steroid-induced hyperglycemia in diabetic patients undergoing ultrasound-guided sacroiliac joint injections through a randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacro Iliac Joint Pain, Diabetes
- What is being tested?
- Chromium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2024to May 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years).
- Diagnosed with diabetes mellitus.
- Scheduled for ultrasound-guided sacroiliac joint injections for pain management.
Who cannot join
- Patients with contraindications to chromium supplementation like people with kidney or liver disorders or people with iron deficiency.
- Patients with a history of chromium allergy.
- Pregnant or lactating women.
- Patients with uncontrolled diabetes (HbA1c > 9%).
- Cardiac, renal, hepatic, coagulopathy.
- Lumbar Spine deformity.
- Obesity BMI ( 35 kg/m²)
- Local infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Oral Chromium Withstand Steroid Hyperglycemia in Post-interventional Ultrasound Guided Sacroiliac Joint Injection in Diabetic Patients
The aim of this study is to investigate whether oral chromium supplementation can decrease steroid-induced hyperglycemia in diabetic patients undergoing ultrasound-guided sacroiliac joint injections through a randomized controlled trial (RCT).
Read the detailed description
One of the most prevalent complaints these days is sacroiliitis, which affects around 20% of the population.
In roughly 10% to 27% of these cases, the sacroiliac joint has been identified as the major source of pain.
Due to the interrelated causes of facet joint and intervertebral disc pain, a precise diagnosis of sacroiliac joint pain is difficult. Imaging methods, controlled local anesthetic blocks, history taking, and physical examinations can all be used to make a diagnosis.
When people are unable to have surgery because of challenges with their health or other issues, steroids can be used to alleviate severe pain that has to be treated surgically. However, using steroids can have a number of negative consequences, including exhaustion, nausea, face flushing, and fever. One common steroid side effect is the Elevation of blood glucose levels which can be challenging to diabetic patients.
The hypothalamic-pituitary-adrenal (HPA) axis can be inhibited by the administration of steroids, which puts patients at risk for adrenal insufficiency and makes blood glucose management difficult , as it also raises the random blood sugar levels. Additionally, it can increase insulin resistance and blood glucose levels by suppressing the activity of glucose metabolism and promoting gluconeogenesis.
As a result, investigating a way to reduce the difficulty and minimize complications for people with diabetes is needed..
In comparison to those without diabetes mellitus (DM), patients with DM are more susceptible to vascular damage, joint and disk abnormalities, and degenerative changes. They also have a greater frequency of illnesses affecting the shoulders and spine. Because steroid usage increases the risk of high blood glucose in individuals with diabetes mellitus, the active use of steroids in clinical practice is restricted.
Blood glucose rise following steroid injection in particular regions, such as the wrist, finger, shoulder, and knee, has been the subject of many investigations recently.
- Conditions
- Sacro Iliac Joint Pain, Diabetes
- Being tested
- Chromium
- Keywords
- Chromium, Sacroiliac joint injection
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromiumDrug
Also called Chromium picolinate
Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection.
| Study group | Role | What they receive |
|---|---|---|
| chromium group | Experimental | Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection. Receives: Drug: Chromium |
| Non chromium group | No intervention | Participants will not receive chromium after sacroiliac joint injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Random blood sugar
Blood glucose levels will be measured using a glucometer or laboratory analysis.
Measured: Every day for one week, then at 2 Weeks, 3 Weeks, 6 Weeks
Secondary outcomes (5)
Oral hypoglycemic drug dose
It will be assessed through participant self-reporting and clinical evaluation.
Measured: Pre-intervention then post intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks
Total analgesic consumption
It will be assessed through participant self-reporting and clinical evaluation.
Measured: Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.
Vas Score
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Post-intervention at 1 Month, 3 Months, 6 Months
Side effects of chromium supplementation
According to isolated case reports, chromium supplements might cause gastrointestinal symptoms, weight loss, anemia, allergy.
Measured: Post-intervention for 3 months
HbA1c
Glycated hemoglobin test is a blood test that shows what your average blood sugar level was over the past two to three months.
Measured: Pre-intervention and at 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start3 Jun 2024
- Primary completionJan 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Sacro Iliac Joint PainStudies of the same condition, open and under way.
- More trials run by Fayoum 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups: Experimental Group: Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection. Control Group: Participants will not receive chromium after sacroiliac joint injection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University
- Investigators
- Mohamed A Hamed, MD, Principal investigator, Faculty of medicine, Fayoum universityAtef M Sayed, MD, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709313
- Sponsor's protocol ID
- M725
- Acronym
- Cr
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fatoye F, Gebrye T, Odeyemi I. Real-world incidence and prevalence of low back pain using routinely collected data. Rheumatol Int. 2019 Apr;39(4):619-626. doi: 10.1007/s00296-019-04273-0. Epub 2019 Mar 8.
PubMed 30848349Simopoulos TT, Manchikanti L, Singh V, Gupta S, Hameed H, Diwan S, Cohen SP. A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions. Pain Physician. 2012 May-Jun;15(3):E305-44.
PubMed 22622915Hancock MJ, Maher CG, Latimer J, Spindler MF, McAuley JH, Laslett M, Bogduk N. Systematic review of tests to identify the disc, SIJ or facet joint as the source of low back pain. Eur Spine J. 2007 Oct;16(10):1539-50. doi: 10.1007/s00586-007-0391-1. Epub 2007 Jun 14.
PubMed 17566796Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA; ASIPP-IPM. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):699-802.
PubMed 19644537Habib GS, Miari W. The effect of intra-articular triamcinolone preparations on blood glucose levels in diabetic patients: a controlled study. J Clin Rheumatol. 2011 Sep;17(6):302-5. doi: 10.1097/RHU.0b013e31822acd7c.
PubMed 21869712Hart L. Corticosteroid and other injections in the management of tendinopathies: a review. Clin J Sport Med. 2011 Nov;21(6):540-1. doi: 10.1097/01.jsm.0000407929.35973.b9.
PubMed 22064721Stepan JG, London DA, Boyer MI, Calfee RP. Blood glucose levels in diabetic patients following corticosteroid injections into the hand and wrist. J Hand Surg Am. 2014 Apr;39(4):706-12. doi: 10.1016/j.jhsa.2014.01.014.
PubMed 24679910Even JL, Crosby CG, Song Y, McGirt MJ, Devin CJ. Effects of epidural steroid injections on blood glucose levels in patients with diabetes mellitus. Spine (Phila Pa 1976). 2012 Jan 1;37(1):E46-50. doi: 10.1097/BRS.0b013e31821fd21f.
PubMed 21540770Botwin KP, Gruber RD, Bouchlas CG, Torres-Ramos FM, Freeman TL, Slaten WK. Complications of fluoroscopically guided transforaminal lumbar epidural injections. Arch Phys Med Rehabil. 2000 Aug;81(8):1045-50. doi: 10.1053/apmr.2000.7166.
PubMed 10943753Donatti TL, Koch VH, Takayama L, Pereira RM. Effects of glucocorticoids on growth and bone mineralization. J Pediatr (Rio J). 2011 Jan-Feb;87(1):4-12. doi: 10.2223/JPED.2052. Epub 2011 Jan 13. English, Portuguese.
PubMed 21234507Duclos M, Guinot M, Colsy M, Merle F, Baudot C, Corcuff JB, Lebouc Y. High risk of adrenal insufficiency after a single articular steroid injection in athletes. Med Sci Sports Exerc. 2007 Jul;39(7):1036-43. doi: 10.1249/mss.0b013e31805468d6.
PubMed 17596769Iwamoto T, Kagawa Y, Naito Y, Kuzuhara S, Kojima M. Steroid-induced diabetes mellitus and related risk factors in patients with neurologic diseases. Pharmacotherapy. 2004 Apr;24(4):508-14. doi: 10.1592/phco.24.5.508.33355.
PubMed 15098806Lotan R, Oron A, Anekstein Y, Shalmon E, Mirovsky Y. Lumbar stenosis and systemic diseases: is there any relevance? J Spinal Disord Tech. 2008 Jun;21(4):247-51. doi: 10.1097/BSD.0b013e31813707af.
PubMed 18525484Jeffcoate WJ, Game F, Cavanagh PR. The role of proinflammatory cytokines in the cause of neuropathic osteoarthropathy (acute Charcot foot) in diabetes. Lancet. 2005 Dec 10;366(9502):2058-61. doi: 10.1016/S0140-6736(05)67029-8. Epub 2005 Aug 10.
PubMed 16338454Xu G, Pierson CR, Murakawa Y, Sima AA. Altered tubulin and neurofilament expression and impaired axonal growth in diabetic nerve regeneration. J Neuropathol Exp Neurol. 2002 Feb;61(2):164-75. doi: 10.1093/jnen/61.2.164.
PubMed 11855383
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oral Chromium Withstand Steroid Hyperglycemia in Post-interventional Ultrasound Guided Sacroiliac Joint Injection in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06709313
- Acronym / sponsor ID
- Cr / M725
- Conditions
- Sacro Iliac Joint Pain, Diabetes
- Keywords
- Chromium, Sacroiliac joint injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 29 Nov 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 aim of this study is to investigate whether oral chromium supplementation can decrease steroid-induced hyperglycemia in diabetic patients undergoing ultrasound-guided sacroiliac joint injections through a randomized controlled trial (RCT).
Detailed description
One of the most prevalent complaints these days is sacroiliitis, which affects around 20% of the population.
In roughly 10% to 27% of these cases, the sacroiliac joint has been identified as the major source of pain.
Due to the interrelated causes of facet joint and intervertebral disc pain, a precise diagnosis of sacroiliac joint pain is difficult. Imaging methods, controlled local anesthetic blocks, history taking, and physical examinations can all be used to make a diagnosis.
When people are unable to have surgery because of challenges with their health or other issues, steroids can be used to alleviate severe pain that has to be treated surgically. However, using steroids can have a number of negative consequences, including exhaustion, nausea, face flushing, and fever. One common steroid side effect is the Elevation of blood glucose levels which can be challenging to diabetic patients.
The hypothalamic-pituitary-adrenal (HPA) axis can be inhibited by the administration of steroids, which puts patients at risk for adrenal insufficiency and makes blood glucose management difficult , as it also raises the random blood sugar levels. Additionally, it can increase insulin resistance and blood glucose levels by suppressing the activity of glucose metabolism and promoting gluconeogenesis.
As a result, investigating a way to reduce the difficulty and minimize complications for people with diabetes is needed..
In comparison to those without diabetes mellitus (DM), patients with DM are more susceptible to vascular damage, joint and disk abnormalities, and degenerative changes. They also have a greater frequency of illnesses affecting the shoulders and spine. Because steroid usage increases the risk of high blood glucose in individuals with diabetes mellitus, the active use of steroids in clinical practice is restricted.
Blood glucose rise following steroid injection in particular regions, such as the wrist, finger, shoulder, and knee, has been the subject of many investigations recently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups: Experimental Group: Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection. Control Group: Participants will not receive chromium after sacroiliac joint injection.
| Arm | Type | Receives |
|---|---|---|
| chromium group | Experimental | Drug: ChromiumParticipants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection. |
| Non chromium group | No intervention | –Participants will not receive chromium after sacroiliac joint injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years).
- Diagnosed with diabetes mellitus.
- Scheduled for ultrasound-guided sacroiliac joint injections for pain management.
Key exclusion criteria (8 listed)
- Patients with contraindications to chromium supplementation like people with kidney or liver disorders or people with iron deficiency.
- Patients with a history of chromium allergy.
- Pregnant or lactating women.
- Patients with uncontrolled diabetes (HbA1c > 9%).
- Cardiac, renal, hepatic, coagulopathy.
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 |
|---|---|---|
| ChromiumAlso: Chromium picolinateParticipants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection. | Drug | chromium group |
Primary outcome
Random blood sugar
Time frame: Every day for one week, then at 2 Weeks, 3 Weeks, 6 Weeks
Blood glucose levels will be measured using a glucometer or laboratory analysis.
5 secondary outcomes
Oral hypoglycemic drug dose
Time frame: Pre-intervention then post intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks
Total analgesic consumption
Time frame: Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.
Vas Score
Time frame: Post-intervention at 1 Month, 3 Months, 6 Months
Side effects of chromium supplementation
Time frame: Post-intervention for 3 months
HbA1c
Time frame: Pre-intervention and at 6 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 30848349Fatoye F, Gebrye T, Odeyemi I. Real-world incidence and prevalence of low back pain using routinely collected data. Rheumatol Int. 2019 Apr;39(4):619-626. doi: 10.1007/s00296-019-04273-0. Epub 2019 Mar 8.
- Background: PubMed 22622915Simopoulos TT, Manchikanti L, Singh V, Gupta S, Hameed H, Diwan S, Cohen SP. A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions. Pain Physician. 2012 May-Jun;15(3):E305-44.
- Background: PubMed 17566796Hancock MJ, Maher CG, Latimer J, Spindler MF, McAuley JH, Laslett M, Bogduk N. Systematic review of tests to identify the disc, SIJ or facet joint as the source of low back pain. Eur Spine J. 2007 Oct;16(10):1539-50. doi: 10.1007/s00586-007-0391-1. Epub 2007 Jun 14.
- Background: PubMed 19644537Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA; ASIPP-IPM. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):699-802.
- Background: PubMed 21869712Habib GS, Miari W. The effect of intra-articular triamcinolone preparations on blood glucose levels in diabetic patients: a controlled study. J Clin Rheumatol. 2011 Sep;17(6):302-5. doi: 10.1097/RHU.0b013e31822acd7c.
- Background: PubMed 22064721Hart L. Corticosteroid and other injections in the management of tendinopathies: a review. Clin J Sport Med. 2011 Nov;21(6):540-1. doi: 10.1097/01.jsm.0000407929.35973.b9.
- Background: PubMed 24679910Stepan JG, London DA, Boyer MI, Calfee RP. Blood glucose levels in diabetic patients following corticosteroid injections into the hand and wrist. J Hand Surg Am. 2014 Apr;39(4):706-12. doi: 10.1016/j.jhsa.2014.01.014.
- Background: PubMed 21540770Even JL, Crosby CG, Song Y, McGirt MJ, Devin CJ. Effects of epidural steroid injections on blood glucose levels in patients with diabetes mellitus. Spine (Phila Pa 1976). 2012 Jan 1;37(1):E46-50. doi: 10.1097/BRS.0b013e31821fd21f.
- Background: PubMed 10943753Botwin KP, Gruber RD, Bouchlas CG, Torres-Ramos FM, Freeman TL, Slaten WK. Complications of fluoroscopically guided transforaminal lumbar epidural injections. Arch Phys Med Rehabil. 2000 Aug;81(8):1045-50. doi: 10.1053/apmr.2000.7166.
- Background: PubMed 21234507Donatti TL, Koch VH, Takayama L, Pereira RM. Effects of glucocorticoids on growth and bone mineralization. J Pediatr (Rio J). 2011 Jan-Feb;87(1):4-12. doi: 10.2223/JPED.2052. Epub 2011 Jan 13. English, Portuguese.
- Background: PubMed 17596769Duclos M, Guinot M, Colsy M, Merle F, Baudot C, Corcuff JB, Lebouc Y. High risk of adrenal insufficiency after a single articular steroid injection in athletes. Med Sci Sports Exerc. 2007 Jul;39(7):1036-43. doi: 10.1249/mss.0b013e31805468d6.
- Background: PubMed 15098806Iwamoto T, Kagawa Y, Naito Y, Kuzuhara S, Kojima M. Steroid-induced diabetes mellitus and related risk factors in patients with neurologic diseases. Pharmacotherapy. 2004 Apr;24(4):508-14. doi: 10.1592/phco.24.5.508.33355.
- 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.
Mohamed A Hamed, MD principal investigator
Faculty of medicine, Fayoum university
Atef M Sayed, MD principal investigator
Faculty of medicine, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chromium in people with Sacro Iliac Joint Pain and Diabetes, run by Fayoum 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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 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 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Random blood sugar (time frame: Every day for one week, then at 2 Weeks, 3 Weeks, 6 Weeks). 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 NCT06709313, which also lists 17 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 29 Nov 2024.