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Comparison of efficacy of ultrasound guided bursal injection of triamcinolone compared to autologous platelet rich plasma in improving pain and range of motion in shoulder impingement syndrome

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SLCTR Registration Number

SLCTR/2015/016

Date of Registration

04 Sep 2015

The date of last modification

Mar 03, 2019


Application Summary

Scientific Title of Trial

Comparison of efficacy of ultrasound guided bursal injection of triamcinolone compared to autologous platelet rich plasma in improving pain and range of motion in shoulder impingement syndrome

Public Title of Trial

Comparison of efficacy of steroids versus platelet rich plasma in to the shoulder joint under ultra sonographic guidance on patients with severe shoulder joint pain

Disease or Health Condition(s) Studied

Shoulder impingement syndrome

Scientific Acronym

None

Public Acronym

None

Brief title

Comparison of efficacy of steroids versus platelet rich plasma for shoulder impingement

Universal Trial Number

U1111-1172-5180

Any other number(s) assigned to the trial and issuing authority

Research project No 2015/EC/23, University of Peradeniya


Trial Details

What is the research question being addressed?

What is the effect of a single bursal injection of triamcinolone 40mg, compared to a single bursal injection of platelet rich plasma in improving pain and range of motion in shoulder impingement syndrome?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Single blinded

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 3

Intervention(s) planned

The study will be carried out at the Teaching Hospital, Peradeniya. Consenting participants meeting inclusion/exclusion criteria will be allocated into two arms using block randomization technique.

The intervention arm will receive a single dose injection of platelet rich plasma [PRP 4cc with 1 cc of 0.5% bupivacaine] to the subacromial bursa. The control arm will receive a single dose injection of steroids [triamcinolone [40mg] 4 cc with 1 cc of 0.5% bupivacaine]. Injections will be administered by a Consultant Radiologist (PI).

The outcomes will be assessed by independent evaluators, who will be blinded to the treatment

Inclusion criteria

  1. Males and females between 30-70 years of age
  2. Clinical diagnosis of shoulder impingement (SI) (Neer’s stages 1 and 2) with anterolateral shoulder pain for more than 3 months

Exclusion criteria

  1. Full thickness rotator cuff tears [type III impingement]
  2. Other pathological conditions giving pain in the shoulder such as arthropathies [Rheumatoid, osteoarthritis, septic arthritis]
  3. Cervical neuropathy
  4. Intra articular steroid injection within last 6 months
  5. Local or systemic infection
  6. Coagulopathies
  7. Critical thrombocytopaenia
  8. Hypofibrinogenaemia
  9. Increased fasting blood glucose levels [ more than 10 mmol/L] or poorly controlled diabetes mellitus
  10. Pregnancy

Primary outcome(s)

1.
  1. Angle of shoulder abduction at which pain is elicited, measured using a standardized goniometer
  2. Degree of pain will be assessed using a standardized pain score
 [

At baseline (before injection), then at the end of 1 week, 3 months, 6 months and 1 year

]

Secondary outcome(s)

1.

None

 [

None

]

Target number/sample size

(50) 25 in each arm

Countries of recruitment

Sri Lanka

Anticipated start date

2015-09-15

Anticipated end date

2017-09-15

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

University of Peradeniya (Grant no. RG/ EF/2013/09)

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2015-04-24

Approval number

2015/EC/23

Details of Ethics Review Committee

Name: 6. Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address:Galaha Road, Kandy, Sri Lanka
Telephone:+94-812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Prof P B Hewavithana
Professor in Medicine
Department of Radiology, Faculty of Medicine University of Peradeniya
0812396551
0776225268
081239106
padmabh@pdn.ac.lk
http://www.pdn.ac.lk/med/departments/radiology/staff/badra.html

Contact Person for Public Queries

Prof P B Hewavithana
Professor in Medicine
Department of Radiology, Faculty of Medicine University of Peradeniya
0812396551
0776225268
081239106
padmabh@pdn.ac.lk
http://www.pdn.ac.lk/med/departments/radiology/staff/badra.html

Primary study sponsor/organization

University of Peradeniya
Vice Chancellor
University of Peradeniya
+94 81 239 2300
+94 81 238 8102
vc@pdn.ac.lk
www.pdn.ac.lk

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


  • Trial Options