| Scientific Title of Trial | Effectiveness of early stretching exercises for range of motion of the shoulder joint, state of axillary scar and quality of recovery in burnt patients admitted to Burns Unit of the National Hospital of Sri Lanka | |
| Public Title of Trial (in lay language) | Effectiveness of early stretching exercises for the function of the shoulder joint in burnt patients admitted to Burns Unit of the National Hospital of Sri Lanka | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Burns | |
| What is the research question being addressed? | To evaluate the range of motion (ROM) of shoulder joint, state of the axillary scar and quality of recovery in burnt patients undergoing a rehabilitation programme in comparison to a control group. ? | |
| Study design | A randomized controlled study will be conducted at Burns and Reconstructive Surgical Unit, National Hospital of Sri Lanka. Patients over 13 years of age admitted to the unit with a burn injury involving the shoulder joint will be eligible to participate in the study. The subjects will be randomized into two groups: intervention group and control group using a randomization software. Informed written consent will be obtained from all participants and treatment will be offered as to the study protocol. The control group will undergo treatment as to the usual protocol adopted in the unit for treatment of burn injury patients with shoulder involvement. | |
| Intervention(s) planned | The stretching exercises will be started within 48 hours of post burn injury in superficial (only the epidermis is affected due to the burn) and partial thickness (epidermis and upper part of the dermis is affected) burns. In full thickness burns (epidermis, dermis and underline tissues are affected) it will be started on 5th day after the skin graft. These stretching exercises are done within the pain tolerable limits. The number of repetitions will be increased gradually. | |
| Inclusion criteria | Burn injury Consent to participate in the study |
|
| Exclusion criteria | Shoulder involvement from previous/prior injury or neurological conditions | |
| Target number / sample size | 110 | |
| Primary outcome(s) | The range of motion of the shoulder joint, will be evaluated during and after the intervention phase of the rehabilitation programme by an independent person. Goniometer will be used. | |
| Primary outcome(s) - time of assessment(s) | Measurements will be taken weekly for two weeks and thereafter the measurements will be done at the day of discharge and then one month, three months, six months and twelve months after the Burn injury. | |
| Secondary outcome(s) | Functional recovery and state of the axillary scar will be evaluated. Quick DASH questionnaire, Vancouver scar scale will be used. | |
| Secondary outcome(s) - time of assessment(s) | Measurements will be done at the day of discharge and then one month, three months, six months and twelve months after the Burn injury. | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/02/2012 | |
| Anticipated end date | 31/01/2013 | |
| Recruitment status | Pending | |
| State of ethics review approval | Ethical Review Committee, Faculty of Medicine, University of Kelaniya | |
| Funding source(s) | Self funded | |
| Applicant's Email | amaradamayanthi@yahoo.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Mrs G.A.D. Perera
Physiotherapist 82/2, Ganegoda, Dompe 0714444010 Senior investigator / Dr C Perera Consultant Plastic Surgeon Burns and Reconstrutive Surgical Unit, National Hospital of Sri Lanka amaradamayanthi@yahoo.com |
|
| Primary Study Sponsor/ Organization | Dr. C. Perera -Consultant Plastic Surgeon
Burns and Reconstrutive Surgical Unit, National Hospital of Sri Lanka 0112691111 Ext. 2839, 2455 dinira@slt.lk |
|
| Contact Person for Public Queries | Dr. Aranjan L. Karunanyake Senior Lecturer Department of Anatomy, Faculty of Medicine, University of Kelaniya 0773062184 aranjan13@yahoo.co.uk |
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| Secondary Study Sponsor(s), (if any) | None |
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