Role of Dextrose Prolotherapy and Methyl Prednisolone Injections in Osteoarthritis Knee
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Osteoarthritis Index (WOMAC),
Study Overview
Brief Summary
Damage of the articularcartilage and laxity of the joint lead to worsening of Osteoarthritis knee. Recently prolotherapy has beenshown to decrease looseness of joints and decrease degeneration of articularcartilage in knee arthritis. However, use of prolotherapy has not been rigorouslystudied in osteoarthritic knee. Only limited studies have been done in westerncountries. There is scarcity of literature inIndian Population. Considering this uncertainty in the use of Dextroseprolotherapy in OA, we propose to conduct this study to find out whetherinjection with Dextrose Prolotherapy improves knee symptoms in patients with OAKnee compared to intra-articular steroid injection. We hypothesize that prolotherapy injections for knee OA willbe equally or more beneficial to the patients than steroids. Thepurpose of this study is to determine whether injectionwith Dextrose Prolotherapy, in and around the knee, can decrease painand disability from knee osteoarthritis. Oursecondary objective is to determine if Dextrose Prolotherapy provide bettersymptom relief than intra-articular Steroid injection.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 40.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged 40-65 years, who has 1.Persisting Knee Pain due to OA Knee (Grade II or III, according to radiological classification of knee OA defined by Kellgren and Lawrence) 2.Pain of at-least 40 mm on a 0-100mm VAS when asked “What is the average level of your Left/ Right knee pain over the last week?†3.Willing to participate in all assessment 4.If both knees involved, participants choose one or both knees to be treated.
Exclusion Criteria
- •1.Severe OA Knee (Grade IV , according to Kellgren and Lawrence classification) 2.Inflammatory or post-infectious knee arthritis 3.History of prior knee replacement repair 4.Prior knee Prolotherapy 5.Prior fracture of the knee joint 6.Any Knee injection within 3 months 7.Daily use of opioid medication 8.Other chronic pain diagnoses 9.Diabetes mellitus 10.Body mass index (BMI) > 40 kg/m2 11.H/O Anticoagulation therapy 12.Pregnancy 13.Co-morbidity severe enough to prevent participation in the study protocol including at-home exercise or attendance at scheduled injection appointments.
Outcomes
Primary Outcomes
Osteoarthritis Index (WOMAC),
Time Frame: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 months
VAS Scale
Time Frame: 6 months
Goniometric ROM of affected Knee
Time Frame: 6 months
Western Ontario McMaster University
Time Frame: 6 months
Secondary Outcomes
- Injection procedure related pain (0, 2 days after injection)(Patient Satisfaction)