Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains
POPTuLAS
Assessment of Tubigrip Versus Plaster of Paris in the Treatment of Grade 1 and 2 Lateral Ankle Sprains
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedDecember 26, 2011
December 1, 2011
6 months
October 31, 2011
December 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain, karlsson score
6 weeks
Study Arms (2)
group POP
EXPERIMENTALPLASTER OF PARIS
TG
EXPERIMENTALTUBIGRIP
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liaquat National Hospital
Karachi, Sindh, 74200, Pakistan
Related Publications (1)
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.
PMID: 24671488DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zaki Idrees, FRCS
Liaquat National Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2011
First Posted
December 26, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2011
Study Completion
September 1, 2011
Last Updated
December 26, 2011
Record last verified: 2011-12