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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Ankle Injuries

Intervention / Treatment
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* Procedure: Plaster of Paris/ Tubigrip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group POP<br>PLASTER OF PARIS | Procedure: Plaster of Paris/ Tubigrip<br>* 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<br>|
| Experimental: TG<br>TUBIGRIP | Procedure: Plaster of Paris/ Tubigrip<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain, karlsson score |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral Ankle Sprain, Plaster of Paris, Tubigrip