Chronic Pain SyndromePhase 2/3NCT05548738
Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome
A Phase 2/3 study testing medthylprednisolone and prolotherapy in people with Chronic Pain Syndrome, run by Alexandria University at 1 site in Egypt.
Trial summary
This study will be held on patients with failed back surgery syndrome, the investigators are comparing prolotherapy and steroids injections in caudal epidural space to relieve the pain Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Pain Syndrome
- What is being tested?
- medthylprednisolone and prolotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2022to 30 Jun 2024
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with failed back surgery syndrome, having chronic pain for more than 3 months by a detailed assessment including medical history and examination
- patients having positive radiological (MRI) findings of spinal nerve roots being irritated or compressed after having surgery for one of many conditions including: lumbar disc herniation, spinal canal stenosis, osteophytes, spodylolithesis or foramen stenosis
- patients whom another surgery is not indicated
Who cannot join
- patient refusal
- pregnancy
- systemic infection or infection at the site of injection
- patients on anticoagulation
- immunocompromised patients as uncontrolled diabetes, osteoporosis as a contraindication for steroid injection
- patients with renal impairment or on dialysis
Show all 9Show fewer
- acute disc prolapse as it requires immediate surgery
- opioid use
- concurrent significant depressive illness, inflammatory of joint disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome
This study will be held on patients with failed back surgery syndrome, the investigators are comparing prolotherapy and steroids injections in caudal epidural space to relieve the pain
Read the detailed description
This study is a prospective double blinded randomized controlled study. It will be held on patients with failed back surgery syndrome aged between 20 and 70 years old, one group will receive ultrasound and fluoroscopy-guided injection of prolotherapy in caudal epidural space while the other group will receive ultrasound and fluoroscopy-guided injection of steroids in the caudal epidural space 40 patients will be included in each group
- Conditions
- Chronic Pain Syndrome
- Being tested
- medthylprednisolone, prolotherapy
- Keywords
- caudal epidural, prolotherapy, steroids, failed back surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medthylprednisoloneDrug
Also called steroids
a type of steroids injected in epidural space
prolotherapyDrug
Also called dextrose 10%
a type of hypertonic glucose
| Study group | Role | What they receive |
|---|---|---|
| Steroid group (Group S) | Active comparator | This group will receive ultrasound and fluoroscopy-guided caudal epidural steroid injection Receives: Drug: medthylprednisolone |
| Prolotherapy group (Group P) | Experimental | This group will receive ultrasound and fluoroscopy-guided caudal epidural prolotherapy injection Receives: Drug: prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain
A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful
Measured: 2 weeks
Secondary outcomes (4)
the level reached by the injectate
by using fluoroscopy guidance
Measured: at time of injection
assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS) from 0 to 28 where 0 is so dissatisfied and 28 means very satisfied
assess the satisfaction of the patients
Measured: 6 months
further change in visual analogue scale
in the next follow up periods
Measured: 2 weeks till 6 months
recording the number of patients who encountered any complications and treating them accordingly
such as pain, allergy, swelling at the site of injection, nerve injury, elevated blood sugar level, nausea and vomiting
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start20 Apr 2022
- Primary completion30 Nov 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shehab, MD, Alexandria University
- Investigators
- Ahmed S shehab, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548738
- Sponsor's protocol ID
- 0201626
- Status last verified
- Nov 2024
- First submitted
- 14 Sep 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
Publications
Maniquis-Smigel L, Reeves KD, Rosen HJ, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Analgesic Effect and Potential Cumulative Benefit from Caudal Epidural D5W in Consecutive Participants with Chronic Low-Back and Buttock/Leg Pain. J Altern Complement Med. 2018 Dec;24(12):1189-1196. doi: 10.1089/acm.2018.0085. Epub 2018 Jun 8.
PubMed 29883193
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
- The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome
- ClinicalTrials.gov ID
- NCT05548738
- Acronym / sponsor ID
- 0201626
- Conditions
- Chronic Pain Syndrome
- Keywords
- caudal epidural, prolotherapy, steroids, failed back surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Sep 2022 (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 study will be held on patients with failed back surgery syndrome, the investigators are comparing prolotherapy and steroids injections in caudal epidural space to relieve the pain
Detailed description
This study is a prospective double blinded randomized controlled study. It will be held on patients with failed back surgery syndrome aged between 20 and 70 years old, one group will receive ultrasound and fluoroscopy-guided injection of prolotherapy in caudal epidural space while the other group will receive ultrasound and fluoroscopy-guided injection of steroids in the caudal epidural space 40 patients will be included in each group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid group (Group S) | Active comparator | Drug: medthylprednisoloneThis group will receive ultrasound and fluoroscopy-guided caudal epidural steroid injection |
| Prolotherapy group (Group P) | Experimental | Drug: prolotherapyThis group will receive ultrasound and fluoroscopy-guided caudal epidural prolotherapy injection |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients diagnosed with failed back surgery syndrome, having chronic pain for more than 3 months by a detailed assessment including medical history and examination
- patients having positive radiological (MRI) findings of spinal nerve roots being irritated or compressed after having surgery for one of many conditions including: lumbar disc herniation, spinal canal stenosis, osteophytes, spodylolithesis or foramen stenosis
- patients whom another surgery is not indicated
Key exclusion criteria (9 listed)
- patient refusal
- pregnancy
- systemic infection or infection at the site of injection
- patients on anticoagulation
- immunocompromised patients as uncontrolled diabetes, osteoporosis as a contraindication for steroid injection
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 |
|---|---|---|
| medthylprednisoloneAlso: steroidsa type of steroids injected in epidural space | Drug | Steroid group (Group S) |
| prolotherapyAlso: dextrose 10%a type of hypertonic glucose | Drug | Prolotherapy group (Group P) |
Primary outcome
Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain
Time frame: 2 weeks
A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful
4 secondary outcomes
the level reached by the injectate
Time frame: at time of injection
assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS) from 0 to 28 where 0 is so dissatisfied and 28 means very satisfied
Time frame: 6 months
further change in visual analogue scale
Time frame: 2 weeks till 6 months
recording the number of patients who encountered any complications and treating them accordingly
Time frame: 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 29 Nov 2024.
- Results publication: PubMed 29883193Maniquis-Smigel L, Reeves KD, Rosen HJ, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Analgesic Effect and Potential Cumulative Benefit from Caudal Epidural D5W in Consecutive Participants with Chronic Low-Back and Buttock/Leg Pain. J Altern Complement Med. 2018 Dec;24(12):1189-1196. doi: 10.1089/acm.2018.0085. Epub 2018 Jun 8.
- Individual participant dataSharing planned: Yes. there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
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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.
Ahmed S shehab principal investigator
Alexandria University
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 medthylprednisolone and prolotherapy in people with Chronic Pain Syndrome, run by Alexandria 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 9 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 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 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?
Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain (time frame: 2 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 NCT05548738, which also lists 1 linked publication.
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.