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

Ankle Injuries Clinical Trial

— POPTuLAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499966
• Other study ID #: NRahimnajjad
• Status: Completed
• Phase: N/A
• First received: October 31, 2011
• Last updated: December 23, 2011
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: December 2011
• Source: Liaquat National Hospital & Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of HealthPakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries

Intervention

Procedure:
• Plaster of Paris/ Tubigrip
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

Locations

Country	Name	City	State
Pakistan	Liaquat National Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat National Hospital & Medical College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain, karlsson score		6 weeks	No