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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid group (Group S) | Active Comparator | This group will receive ultrasound and fluoroscopy-guided caudal epidural steroid injection |
|
| Prolotherapy group (Group P) | Experimental | This group will receive ultrasound and fluoroscopy-guided caudal epidural prolotherapy injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medthylprednisolone | Drug | a type of steroids injected in epidural space |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the level reached by the injectate | by using fluoroscopy guidance | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed S shehab | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed S. Shehab | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29883193 | Result | 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. |
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there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
After study ends upon request
Accessible through the web site
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| ID | Term |
|---|---|
| D013256 | Steroids |
| D000075527 | Prolotherapy |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) double blinded
| prolotherapy | Drug | a type of hypertonic glucose |
|
|
assess the satisfaction of the patients |
| 6 months |
| further change in visual analogue scale | in the next follow up periods | 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 | 6 months |