Chronic PainNCT02334475
Steroid Versus Platelet Rich Plasma Injection for Chronic Low Back Pain
A study testing Platelet Rich Plasma and methylprednisolone in people with Chronic Pain, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Platelet Rich Plasma and methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Dec 2014
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- Platelet Rich Plasma, methylprednisolone
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
single intraarticular injection of 3 ml of leukocyte free platelet rich plasma with 0.5 ml of calcium chloride(total volume 3.5 ml)
methylprednisoloneBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| GROUP (P) | Experimental | 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. Receives: Biological: Platelet Rich Plasma |
| GROUP (S) | Active comparator | 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. Receives: Biological: methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief as assessed by change from baseline in VAS ( VISUAL ANALOG SCALE)
Measured: 0.5, 1, 1.5 and 3 months post-intervention
Secondary outcomes (3)
functional assessment using change from baseline in MODQ ( MODIFIED OSWESTRY DISABILITY QUESTIONNAIRE)
Measured: 0.5, 1, 1.5 and 3 months post-intervention
functional assessment using change from baseline in SF-12 (SHORT FORM HEALTH SURVEY)
Measured: 0.5, 1, 1.5 and 3 months post-intervention
treatment emergent adverse drug reactions
Measured: 0.5, 1, 1.5 and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, varun singla, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- YATINDER K BATRA, MD, Study director, Head of Department and Professor, Anaesthesia, PGIMER, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334475
- Sponsor's protocol ID
- 9154/PG-2Trg/2012/20886
- Status last verified
- Jan 2015
- First submitted
- 14 Oct 2014
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Versus Platelet Rich Plasma in Ultrasound Guided Sacroiliac Joint Injection for Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02334475
- Acronym / sponsor ID
- 9154/PG-2Trg/2012/20886
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Jan 2015 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP (P) | Experimental | Biological: Platelet Rich PlasmaUltrasound 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. |
| GROUP (S) | Active comparator | Biological: methylprednisoloneUltrasound 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Platelet Rich Plasmasingle intraarticular injection of 3 ml of leukocyte free platelet rich plasma with 0.5 ml of calcium chloride(total volume 3.5 ml) | Biological | GROUP (P) |
| methylprednisolonesingle 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) | Biological | GROUP (S) |
Primary outcome
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
3 secondary outcomes
functional assessment using change from baseline in MODQ ( MODIFIED OSWESTRY DISABILITY QUESTIONNAIRE)
Time frame: 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
treatment emergent adverse drug reactions
Time frame: 0.5, 1, 1.5 and 3 months post-intervention
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 8 Jan 2015.
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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.
YATINDER K BATRA, MD study director
Head of Department and Professor, Anaesthesia, PGIMER, Chandigarh
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma and methylprednisolone in people with Chronic Pain, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 4 inclusion and 10 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2015.