Steroid Versus Platelet Rich Plasma Injection for Chronic Low Back Pain
CompletedNot applicableNCT02334475
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic low back pain, with or without lower extremity pain, which arises from various structures of the spine constitutes a majority of pain complaints. The sacroiliac joint (SIJ) has been implicated as the primary source of pain in 10% to 27% of patients with mechanical low back pain below L5 vertebra. The common causes of SIJ pain include a trauma like direct fall on the buttocks, a rear-end or broad-side type motor vehicle accident, and an unanticipated step into a hole or from a miscalculated height, fusion surgery, anterior dislocation, inflammatory and degenerative sacroiliac joint disease and idiopathic. The treatment of SIJ pain remains a therapeutic challenge. Besides physiotherapy and systemic therapies including non-steroidal anti-inflammatory drugs (NSAIDs) and biologic agents, intra-articular and peri articular injections of SIJ, radiofrequency neurotomy and surgical fusion are often performed for pain relief. However, the success of these interventions has been determined according to the therapeutic efficacy and correct placement of the drug. The image guidance of SIJ injections seems to be important due to the complex anatomy of the joint causing a low accuracy when performed according to clinical judgement only. The feasibility of ultrasound (USG) guided injection of SIJ has recently been demonstrated resulting in very high success rates up to 90%. Various agents being used in SIJ injections include local anaesthetics, corticosteroid, botulinum toxin-A, 12.5% dextrose, phenol-glycerine-glucose (P2G) and sodium morrhuate (cod liver oil extract). SIJ steroid injection is commonly used technique and has been found to be effective to treat SIJ pain. However, the main drawback is short term effect. Borowsky et al reported improvement in visual analog score (VAS) of 14.1% and reduction of VAS ≥ 50% in only 12.50% patients at 3 months after intra-articular steroid (2 mL 0.5% bupivacaine plus 40 mg methylprednisolone) SIJ injection. Treatment modalities be…
Study details
- Official title
- Steroid Versus Platelet Rich Plasma in Ultrasound Guided Sacroiliac Joint Injection for Chronic Low Back Pain
- Conditions
- Interventions
- Biological: Platelet Rich Plasma
- Biological: methylprednisolone
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Organization
- PIMERIndia
- Start date
- 2013-07
- Primary completion
- 2014-12
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria: * Chronic low back pain (predominantly below L5 vertebra) of moderate intensity (visual analog scale score more than 3) for greater than 3 months * Patients with 3 or more positive provocative tests out of 6 (Annexure-1) * Positive X-ray, MRI or nuclear scan findings * Failure to achieve adequate improvement with comprehensive non-operative treatments, including but not limited to activity alteration, NSAIDS, physiotherapy and/or psychological counselling Exclusion criteria: * Systemic infection (H/O fever, chills and/or night sweats) or localized infection at anticipated introducer entry site * Spinal pathology that may impede recovery such as spondylolisthesis at L5/S1, or scoliosis * Symptomatic foraminal or central canal stenosis * H/O potentially confounding intervertebral disc disease or zygapophyseal joint pain * Pregnancy * Active radicular pain * Immunosuppressive conditions (H/O TB, AIDS, cancer, diabetes, surgery \<3 months) * Allergy to medications used in the procedure * High narcotic use (\>30 mg morphine daily or equivalent) * Contraindications pertaining to the use of platelet concentrate like history of thrombocytopenia, use of anticoagulant therapy, active infection, tumor and metastatic disease
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02334475