Ankle InjuriesPOPTuLASNCT01499966
Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains
A study testing Plaster of Paris/ Tubigrip in people with Ankle Injuries, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Plaster of Paris/ Tubigrip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Tubigrip Versus Plaster of Paris in the Treatment of Grade 1 and 2 Lateral Ankle Sprains
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.
Read the 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
- Conditions
- Ankle Injuries
- Being tested
- Plaster of Paris/ Tubigrip
- Keywords
- Lateral Ankle Sprain, Plaster of Paris, Tubigrip
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaster of Paris/ TubigripProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| group POP | Experimental | PLASTER OF PARIS Receives: Procedure: Plaster of Paris/ Tubigrip |
| TG | Experimental | TUBIGRIP Receives: Procedure: Plaster of Paris/ Tubigrip |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain, karlsson score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zaki Idrees, FRCS, Study chair, Liaquat National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499966
- Sponsor's protocol ID
- NRahimnajjad
- Acronym
- POPTuLAS
- Status last verified
- Dec 2011
- First submitted
- 31 Oct 2011
- Last updated
- 26 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24671488
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tubigrip Versus Plaster of Paris in the Treatment of Grade 1 and 2 Lateral Ankle Sprains
- ClinicalTrials.gov ID
- NCT01499966
- Acronym / sponsor ID
- POPTuLAS / NRahimnajjad
- Conditions
- Ankle Injuries
- Keywords
- Lateral Ankle Sprain, Plaster of Paris, Tubigrip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group POP | Experimental | Procedure: Plaster of Paris/ TubigripPLASTER OF PARIS |
| TG | Experimental | Procedure: Plaster of Paris/ TubigripTUBIGRIP |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with age <18 years
- injury >48 hours, fractures
- multiple injuries
- any neurological or musculoskeletal illness
- any co-morbid associated with long term disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plaster of Paris/ TubigripAfter 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 | Procedure or surgery | TG, group POP |
Primary outcome
pain, karlsson score
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2011.
- Derived from this study: PubMed 24671488Naeem 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaki Idrees, FRCS study chair
Liaquat National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaster of Paris/ Tubigrip in people with Ankle Injuries, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain, karlsson score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01499966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2011.