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Clinical Trials/NCT01499966
NCT01499966CompletedNot Applicable

Assessment of Tubigrip Versus Plaster of Paris in the Treatment of Grade 1 and 2 Lateral Ankle Sprains

Liaquat National Hospital & Medical College2 sites in 1 country200 target enrollmentStarted: January 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
200
Locations
2
Primary Endpoint
pain, karlsson score

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

pain, karlsson score

Time Frame: 6 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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