The effect of topical use of sesame oil extracted from tahini (Ardeh) on pain severity in patients with upper or lower limbs trauma

The aim of this study is to investigate the effect of sesame oil extracted from tahini (Ardeh) on pain severity in patients with upper or lower limbs trauma.

This randomized clinical trial study will be conducted on 120 eligible patients with upper or lower trauma referring to Rajaee Hospital, Shiraz, Iran, in 2016. Patients were randomly allocated to intervention and control groups using block randomization sampling method.

In this study, the patients with upper or lower limbs trauma who refer to emergency department of Shahid Rajaee Hospital, Shiraz, Iran in 2016 and are eligible to enter the study, will be assigned to case and control groups using block randomization. None of the patients and the nurse are aware of the type of treatment they receive. All patients are educated how to take care of their trauma site like putting cold compress on the trauma site at the first day and warm compress on the following days. Also, routine cares are implemented based on cares protocol for all patients with trauma. According to this protocol, the periphery and the center of the trauma site are irrigated and cleaned with 1000 mL sterile normal saline solution (0.9%), and then dried with a sterile gaze. At initial meeting considered as baseline and before getting any treatment, pain severity, pain sensitivity and the level of painful site heaviness are assessed, by the trained nurse using Visual Analogue Scale (VAS) and two other scales measured by a continuous line between two end-points (0 and 10). Both groups received a light massage on trauma site three times of a day with 8 h interval for 2 days duration. At the end of the second day of follow up, pain severity, pain sensitivity and the level of painful site heaviness are scored again in the both groups.

Inclusion criteria are: age range of 15- 40 years; passing at least 1 hour and at most 6 hours from trauma; lack of any sign of bone fractures, internal or external bleeding, dislocation, amputation, presence of a foreign body, nerve damage, fever as well as infection; not using cast or splint at trauma site; having regional pain based on Visual Analog Scale (VAS); lack of any history of addiction, cigarette and alcohol abuse; not receiving drugs or herbal extracts which may interact with the study therapeutic protocol such as anti-coagulants and analgesics; and free from diseases that may affect the pain severity such as diabetes, cardiovascular, liver, kidney and musculoskeletal diseases. Exclusion criteria are: any sign of allergy to the sesame oil or peptic or duodenal ulcers; receiving treatment out of the study like NSAIDs; inappropriate follow up by patients; and patient’s desire to withdraw in any phase of the study.

All eligible patients with one or multiple blunt trauma in upper extremity (wrist, lower arm, elbow, upper arm) or lower extremity (foot, ankle, lower leg, knee, upper leg and lower trunk) will be entered the study and divided into two equal group randomly. The patients in the intervention group will receive sesame oil extracted from tahini (Ardeh) topically and the control group will use cooking oil.

We will expect that the patients who receive sesame oil extracted from tahini (Ardeh) feel less pain severity, pain sensitivity and heaviness of painful site than control group. Also, comparison of mean differences of the baseline and after 48 hours scores between control and intervention groups may show significant difference between groups.

Shiraz University of Medical Sciences

Block randomization

Neither the patients nor the nurse know who is getting a placebo and who is getting the treatment. Both placebo and treatment have the same color and container due to avoid bias in results.