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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
Liaquat National Hospital & Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries focused on measuring Lateral Ankle Sprain, Plaster of Paris, Tubigrip

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 31, 2011
Last Updated
December 23, 2011
Sponsor
Liaquat National Hospital & Medical College
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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

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Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains

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