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Steroid,Platelet Rich Plasma and Normal Saline in Facet Joint Pain

Steroid,Platelet Rich Plasma and Normal Saline in Facet Joint Pain: A Prospective Interventional Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041405
Enrollment
105
Registered
2022-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M538- Other specified dorsopathies

Interventions

Intervention1: Intra articular Steroid injection: 0.5 ml of Intra-articular depot preparation of methylprednisolone will be injected at each facet joint Intervention2: Platelet Rich Plasma: For autolo

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Suspicion of facet joint mediated low back pain 2.Pain rating of =4/10 on a NRS scale 3.Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology. 4.Symptom duration of 3 or more months

Exclusion criteria

Exclusion criteria: 1.Pain for less than 3 months 2.Neurological deficits 3.Pregnancy and lactating mother 4.Prior low back surgery with or without hardware 5.Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the previous 6 months 6.Primary or metastatic spine tumour or spinal cord injury. 7.Allergy to medications used in procedure, blood coagulation disorder 8.Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period. 9.Patients with rheumatic cause of lumbar facet arthritis. 10.Local or systemic infection or spinal infection

Design outcomes

Primary

MeasureTime frame
Change in pain NRS with back flexion and at rest from baseline after intervention over time.   2.Pain as assessed from 0-10. Where 10 is severe pain and 0 is no pain. Improvement of pain by 50% after intervention is defined as treatment success Timepoint: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention

Secondary

MeasureTime frame
PROMIS Survey for Low Back Pain Function (PROMIS-29)  NIH validated PROMIS score for physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, pain interference, and pain intensity (PROMIS- 29 Profile v2.0). A higher PROMIS T-score represents more of the concept being measured.For negatively-worded concepts like Anxiety,a T-score of 60 is one SD worse than average.By comparison,an Anxiety T-score of 40 is one SD better than average.However,for positively-worded concepts like Physical Function-Mobility,a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average. Timepoint: [ Time Frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention

Countries

India

Contacts

Public ContactBaibhav Bhandari

All India Institute of Medical Sciences, Rishikesh

Ajitdr.Ajit@gmail.com9910789377

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026