A Randomised controlled study on outcome of Intrarticular steroid injection versus Intraarticular steroid injection with Manipulation under Anaesthesia for treating unilateral Frozen shoulder
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Self
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- 1. At each subsequent visiting on 2,4,6,8,10 and 12week ,4, 5 and 6months after first intervention, pain intensity and activities of daily living , movements and strength will be evaluated by the Constant Murley Score.
Study Overview
Brief Summary
1)The Patient fulfilling the inclusion criteria will be enrolled for the study after obtaining informed written consent.
2)Patients satisfying inclusion criteria will be numbered and allocated in one of the two groups with odd numbered patients in group A and even numbered patients in group B .
3)52 patients of either sex will be randomly allocated to either of two study groups of 26 each as described .
4)A proforma will be used to collect the data which includes patients particulars , indication for manipulation , the anesthesia details , intraoperative monitoring etc.,
5)Group A will be administered 40mg of methyl prednisolone through intraarticular route
6)Group B will undergo manipulation under anesthesia with intraarticular steroid injection
7)Patients will be followed up as mentioned and "constant murley score" will be used to evaluate pain intensity and activities of daily living, movements and strength.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Atleast 3 month history of unilateral shoulder pain and stiffness with normal imaging studies 2) The passive shoulder movement with a reduction of more than 30 degree in atleast 2 planes when compared with oppposite side 3) Refractory to conservative treatments , such as medications and physiotherapy.
Exclusion Criteria
- •Age less than 40 years or older than 80 years 2)Infection at the site of injection 3)Patients on oral corticosteroids and having hypersensitivity reactions 4)Patients with severe osteoporosis.
Outcomes
Primary Outcomes
1. At each subsequent visiting on 2,4,6,8,10 and 12week ,4, 5 and 6months after first intervention, pain intensity and activities of daily living , movements and strength will be evaluated by the Constant Murley Score.
Time Frame: Baseline at 2weeks and them at 4,6,8,10 and 12week ,4, 5 and 6months
Secondary Outcomes
- To assess the range of movements in each & every follow up visits(Baseline at 2weeks, & then at 4,6,8,10,12 weeks , 4, 5 & 6th month .)
Investigators
Dr P K Raju
BMCRI