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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Liaquat National Hospital & Medical College
ClinicalTrials.gov Identifier:
NCT01499966
First received: October 31, 2011
Last updated: December 23, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Ankle Injuries
Procedure: Plaster of Paris/ Tubigrip

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Tubigrip Versus Plaster of Paris in the Treatment of Grade 1 and 2 Lateral Ankle Sprains

Resource links provided by NLM:


Further study details as provided by Liaquat National Hospital & Medical College:

Primary Outcome Measures:
  • pain, karlsson score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group POP
PLASTER OF PARIS
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
Experimental: TG
TUBIGRIP
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499966

Locations
Pakistan
Liaquat National Hospital
Karachi, Sindh, Pakistan, 74200
Sponsors and Collaborators
Liaquat National Hospital & Medical College
Investigators
Study Chair: Zaki Idrees, FRCS Liaquat National Hospital
  More Information

No publications provided

Responsible Party: Liaquat National Hospital & Medical College
ClinicalTrials.gov Identifier: NCT01499966     History of Changes
Other Study ID Numbers: NRahimnajjad
Study First Received: October 31, 2011
Last Updated: December 23, 2011
Health Authority: Pakistan: Ministry of Health
Pakistan: Research Ethics Committee

Keywords provided by Liaquat National Hospital & Medical College:
Lateral Ankle Sprain
Plaster of Paris
Tubigrip

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014