Cost-benefit analysis, Cost-Utility, Cost effectiveness and Global rate of perception for change after Extracorporeal Shockwave Therapy on Frozen Shoulder in Patients with Diabetes: Preliminary Randomized control Trial
Last registered on October 08, 2018

Pre-Trial

Trial Information
General Information
Title
Cost-benefit analysis, Cost-Utility, Cost effectiveness and Global rate of perception for change after Extracorporeal Shockwave Therapy on Frozen Shoulder in Patients with Diabetes: Preliminary Randomized control Trial
RCT ID
AEARCTR-0003390
Initial registration date
October 07, 2018
Last updated
October 08, 2018 12:22 AM EDT
Location(s)
Region
Primary Investigator
Affiliation
GULF MEDICAL UNIVERSITY
Other Primary Investigator(s)
PI Affiliation
Gulf Medical University
Additional Trial Information
Status
On going
Start date
2018-01-01
End date
2019-01-31
Secondary IDs
Abstract
The primary purpose of trial is to compare and analyze Cost-benefit, utility, effectiveness and Global rate of perception for change after Extracorporeal Shockwave Therapy (ESWT) versus ultrasound combined with exercise therapy options on both groups, in patients with diabetic Frozen Shoulder. The secondary outcomes of the trial are to compare insurance coverage difference on diabetic versus non diabetic frozen shoulder. Thirty two participants are currently screened and randomly selected 21 with acceptable eligibility criteria were included in this study during this point.The study was/will be conducted and continued at outpatient physiotherapy clinics of Umm-Al-Quwain and Ajman, U.A.E. The participants are allocated into two groups; experimental group i.e., Extracorporeal Shockwave Therapy with exercises and control group i.e., ultrasound therapy with exercises. The primary economic outcomes are a) ESWT treatment cost; to provide solid evidence that ESWT treatment will provide lower expenditure b) cost incurred for both treatments group i.e, ESWT versus Ultrasound group c) point score improvement on a generic or pain condition-specific health status measure using pain-free day and d) to support procurement decision on additional units in rehabilitation/physiotherapy department. The primary clinical outcomes are pain, range of motion on shoulder joint, disability and impairment scores. The data of the study will be analysed using SPSS-12 version at the end of trail date. Observational and percentage analysis of clinical outcomes study currently favours ESWT treatment group by improvements recorded in pain, range of motion and satisfaction scores after treatment compared to control group. The current cost benefit analysis favours ESWT intervention. ESWT intervention provided 3 times lesser medical rehabiliation cost compared to control group. Current percenatege analysis of this study supports the decision to procurement of ESWT in outpatient physiotherapy departments.
External Link(s)
Registration Citation
Citation
MUTHUKRISNAN, RAMPRASAD and Ayesha Rashid. 2018. "Cost-benefit analysis, Cost-Utility, Cost effectiveness and Global rate of perception for change after Extracorporeal Shockwave Therapy on Frozen Shoulder in Patients with Diabetes: Preliminary Randomized control Trial ." AEA RCT Registry. October 08. https://www.socialscienceregistry.org/trials/3390/history/35399
Experimental Details
Interventions
Intervention(s)
Control and experimental group will/receive(d) health education on diabetic control and information on diabetic and its impact on shoulder joint mobility. All participant will/receive(d) exercise therapy standard protocol with supervision of expert musculoskeletal physiotherapist. Experimental group will/receive(d) Extracorporeal shock wave therapy and control group will/receive(d) ultrasound therapy.
Intervention Start Date
2018-02-02
Intervention End Date
2018-12-31
Primary Outcomes
Primary Outcomes (end points)
Cost of treatment is the prime outcome variable. From the cost incurred for both treatments, cost-benefit, cost-effectiveness and utility will be analyzed. Patient satisfaction for both treatment will be recorded. Other clinical variables were reduction of pain and improvement in range of motion of shoulder joint.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Cost–utility analysis will be analysed in the form of financial analysis. This data will be used to guide procurement decisions.
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
This is Randomized control trial. currently this study followed. step 1: Prospective random selection of participants, step 2) Random allocation into groups 3) No-blinding for treatment provider, rater and patients. Consent was/will be taken from all participants in a written format, freedom to withdraw anytime during trial, and non-compensation benefits were/willbe explained.
Experimental Design Details
Randomization Method
A prospective list was generated using random number sequence using computer.
Randomization Unit
age based stratification was also used to age match the groups.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
Two outpatient physiotherapy units
Sample size: planned number of observations
Fifty participant with diabetic frozen shoulder
Sample size (or number of clusters) by treatment arms
10-12 in each group; i.e., control and experimental group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
As this was preliminary trail targeting specific disease population, the study will achieve minimum 10 participants in each arm
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Department of Physiotherapy, College of Health Sciences, Gulf Medial University
IRB Approval Date
2018-02-01
IRB Approval Number
N/A
IRB Name
Department of Physiotherapy, College of Health Sciences, Gulf Medial University
IRB Approval Date
2018-02-01
IRB Approval Number
N/A
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers