- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02334475
Steroid Versus Platelet Rich Plasma Injection for Chronic Low Back Pain
January 7, 2015 updated by: varun singla, Postgraduate Institute of Medical Education and Research
Steroid Versus Platelet Rich Plasma in Ultrasound Guided Sacroiliac Joint Injection for Chronic Low Back Pain
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 being currently used do not, in general, address the disease process itself, there is clearly a need to investigate treatments that are more widely applicable for symptom management and which may also directly address the disease process itself.
Current research efforts aim at modifying the rate of healing of joint by using biological healing factors which are various growth factors (transforming growth factor, vascular endothelial growth factor, fibroblast growth factor, epidermal growth factor, platelet derived growth factor etc.) found abundantly in the human blood especially in platelets.
The platelet rich plasma (PRP) is an ideal autologous biological blood-derived product, which can be exogenously applied to various tissues where it releases high concentrations of platelet derived growth factors that enhance the body's natural healing response.
In addition PRP possesses antimicrobial properties that may contribute to the prevention of infections.
PRP is now being widely tested in different fields of medicine for its possibilities in aiding the regeneration of tissue with low healing potential.
Local injection of PRP is a new modality which has been effectively used for the treatment of Achilles tendon injury in athletes, chronic epicondylar tendinopathy, chronic patellar tendinosis, rotator cuff tear, anterior cruciate ligament injury, gonoarthrosis and plantar fasciitis.
The intra-articular injection of PRP into knee joint has been found to reduce the incidence of local inflammatory changes in early knee osteoarthritis.
Recently, PRP has been used for low back pain caused by SIJ laxity showing significant improvement in pain scores.
However, there is no study at present comparing the efficacy of intra-articular injection of PRP with corticosteroids for the treatment of chronic SIJ pain.
Considering the vast potential of PRP and its safety, this study aimed at studying the efficacy of ultrasound guided intra-articular SIJ injection of leukocyte free PRP for chronic low back pain due to SIJ pathology.
In the current study, we tested the hypothesis that the SIJ injection of leukocyte-free PRP may be more effective for the treatment of sacroiliac joint pain as compared with steroid injection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GROUP (P)
Ultrasound guided sacroiliac joint injection of 3 ml of leukocyte free platelet rich plasma with 0.5 ml of calcium chloride(total volume 3.5 ml) per course.
Single injection per course is being given.
|
single intraarticular injection of 3 ml of leukocyte free platelet rich plasma with 0.5 ml of calcium chloride(total volume 3.5 ml)
|
Active Comparator: GROUP (S)
Ultrasound guided sacroiliac joint injection of 1.5 ml of methylprednisolone (40mg/ml) and 1.5 ml of 2% lidocaine (20mg/ml) with 0.5 ml of saline (total volume 3.5 ml).
Single injection per course is being given.
|
single injection 1.5 ml of methylprednisolone (40mg/ml) and 1.5 ml of 2% lidocaine (20mg/ml) with 0.5 ml of saline (total volume 3.5 ml)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain relief as assessed by change from baseline in VAS ( VISUAL ANALOG SCALE)
Time Frame: 0.5, 1, 1.5 and 3 months post-intervention
|
0.5, 1, 1.5 and 3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
functional assessment using change from baseline in MODQ ( MODIFIED OSWESTRY DISABILITY QUESTIONNAIRE)
Time Frame: 0.5, 1, 1.5 and 3 months post-intervention
|
0.5, 1, 1.5 and 3 months post-intervention
|
functional assessment using change from baseline in SF-12 (SHORT FORM HEALTH SURVEY)
Time Frame: 0.5, 1, 1.5 and 3 months post-intervention
|
0.5, 1, 1.5 and 3 months post-intervention
|
treatment emergent adverse drug reactions
Time Frame: 0.5, 1, 1.5 and 3 months post-intervention
|
0.5, 1, 1.5 and 3 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: YATINDER K BATRA, MD, Head of Department and Professor, Anaesthesia, PGIMER, Chandigarh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
October 14, 2014
First Submitted That Met QC Criteria
January 7, 2015
First Posted (Estimate)
January 8, 2015
Study Record Updates
Last Update Posted (Estimate)
January 8, 2015
Last Update Submitted That Met QC Criteria
January 7, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Chronic Pain
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- 9154/PG-2Trg/2012/20886
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Vastra Gotaland RegionCompletedPain, Chronic | Widespread Chronic PainSweden
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Societa Italiana Anestesia Analgesia Rianimazione...RecruitingPost Operative Pain | Postoperative Pain, Chronic | Post Surgical PainItaly
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
Clinical Trials on Platelet Rich Plasma
-
Stanford UniversityPartnership for Clean CompetitionCompletedRheumatic Diseases | TendinopathyUnited States
-
VivaTech International, Inc.RecruitingOsteoarthritisUnited States
-
Genesis Athens ClinicNational and Kapodistrian University of AthensRecruitingMenopause, Premature | Menopausal Syndrome | Premature Ovarian Failure | Ovarian Failure, Premature | Menopause Related ConditionsGreece
-
Cardenal Herrera UniversityCompletedCarpal Tunnel SyndromeSpain
-
Damascus UniversityCompletedBone ResorptionSyrian Arab Republic
-
Peking University Third HospitalRecruiting
-
Rajavithi HospitalRecruitingAutologous Platelet-rich Plasma Supplement | Sperm Cryopreservation | Post-cryopreserved Sperm Quality | Semen AnalysisThailand
-
Matthew GettmanCompleted
-
Sutherland Medical CenterActive, not recruitingRotator Cuff Tears | Rotator Cuff TendinosisPoland
-
Skin Care and Laser Physicians of Beverly HillsEclipse Aesthetics, LLCUnknownAndrogenetic AlopeciaUnited States