Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains (POPTuLAS)
Primary Purpose
Ankle Injuries
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Plaster of Paris/ Tubigrip
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Injuries focused on measuring Lateral Ankle Sprain, Plaster of Paris, Tubigrip
Eligibility Criteria
Inclusion Criteria:
- age 18-40 years
- grade 1 and 2 ankle sprains
- permanent residents in place of study
- no concomitant bone pathology
- have not been recruited in other trial simultaneously
Exclusion Criteria:
- Patients with age <18 years
- injury >48 hours, fractures
- multiple injuries
- any neurological or musculoskeletal illness
- any co-morbid associated with long term disabilities
- grade 3 lateral ankle sprains
Sites / Locations
- Liaquat National Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group POP
TG
Arm Description
PLASTER OF PARIS
TUBIGRIP
Outcomes
Primary Outcome Measures
pain, karlsson score
Secondary Outcome Measures
Full Information
NCT ID
NCT01499966
First Posted
October 31, 2011
Last Updated
December 23, 2011
Sponsor
Liaquat National Hospital & Medical College
1. Study Identification
Unique Protocol Identification Number
NCT01499966
Brief Title
Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains
Acronym
POPTuLAS
Official Title
Assessment of Tubigrip Versus Plaster of Paris in the Treatment of Grade 1 and 2 Lateral Ankle Sprains
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liaquat National Hospital & Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Until now very few studies have been done to compare the efficacy of tubigrips or plaster of paris in the treatment of lateral ankle sprains, the investigators aim to compare the tubigrip against plaster of paris in the treatment of lateral ankle sprains.
Detailed Description
200 patients were enrolled after meeting inclusion criteria.All patients gave the verbal as well as written consent for inclusion in the study. The hospital committee ethical review board gave the permission for this study. Only 126 patients agreed to participate in the study. After informed consent was obtained the patients were randomized such that each patient was allocated to use either a Tubigrip (Group A) or Plaster of Paris (Group B)using the Block randomization. The patients in TG group receive the Tubigrip treatment and the patients in POP group were given a below knee plaster cast. Patients were instructed to follow up at 2 weeks and then at 6 weeks. The functional score and pain were used as outcomes of the study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
Keywords
Lateral Ankle Sprain, Plaster of Paris, Tubigrip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group POP
Arm Type
Experimental
Arm Description
PLASTER OF PARIS
Arm Title
TG
Arm Type
Experimental
Arm Description
TUBIGRIP
Intervention Type
Procedure
Intervention Name(s)
Plaster of Paris/ Tubigrip
Intervention Description
After informed consent was obtained the patients were randomized such that each patient was allocated to use either a Tubigrip (Group A) or Plaster of Paris (Group B). The standardized treatment in the form of RICE (Rest, Ice, Compression and Elevation) protocol was given to all patients. The Patients were randomized using the Block randomization. One hundred and twenty six white papers were taken and "TG" for Tubigrip and "POP" for Plaster of Paris were written and the patients were allowed to pick the envelope of their choice. The authors were blinded till the opening of the envelope by the patients. Patient's usage of analgesia in form of Paracetamol was specifically noted. The patients in TG group receive the Tubigrip treatment and the patients in POP group were given a below knee plaster cast. Patients were instructed to follow up at 2 weeks and then at 6 weeks
Primary Outcome Measure Information:
Title
pain, karlsson score
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-40 years
grade 1 and 2 ankle sprains
permanent residents in place of study
no concomitant bone pathology
have not been recruited in other trial simultaneously
Exclusion Criteria:
Patients with age <18 years
injury >48 hours, fractures
multiple injuries
any neurological or musculoskeletal illness
any co-morbid associated with long term disabilities
grade 3 lateral ankle sprains
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaki Idrees, FRCS
Organizational Affiliation
Liaquat National Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Liaquat National Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24671488
Citation
Naeem M, Rahimnajjad MK, Rahimnajjad NA, Idrees Z, Shah GA, Abbas G. Assessment of functional treatment versus plaster of Paris in the treatment of grade 1 and 2 lateral ankle sprains. J Orthop Traumatol. 2015 Mar;16(1):41-6. doi: 10.1007/s10195-014-0289-8. Epub 2014 Mar 27.
Results Reference
derived
Learn more about this trial
Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains
We'll reach out to this number within 24 hrs