The effect of sheep ghee on pain of the knee joint in older people with osteoarthritis of the knee
| ISRCTN | ISRCTN16332782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16332782 |
- Submission date
- 03/03/2025
- Registration date
- 07/03/2025
- Last edited
- 07/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis, the most common joint disease, often affects the knee and causes pain, stiffness, and limited motion. This condition lowers the quality of life and increases healthcare costs, especially for the elderly. Treatments include medications, topical applications, and surgery, but painkillers can have side effects. Natural remedies like sheep ghee, used traditionally in Iran for burns and wounds, may offer a safer alternative. Sheep ghee contains components that reduce inflammation and aid in healing. This study aims to evaluate the effects of sheep ghee on knee osteoarthritis symptoms in elderly patients, given its cultural use and lower risk of complications.
Who can participate?
Adult patients with knee osteoarthritis
What does the study involve?
Participants are randomly allocated into intervention, placebo and control groups. The intervention group applied 1g of sheep ghee to the painful areas of their knees twice daily for a month. A food laboratory verified the ghee's quality. Each participant received 60g of ghee and Vaseline and was instructed to massage the painful areas for 1 minute without covering them. The placebo group used Vaseline in the same way, while the control group only performed the one-minute massage. All participants continued their usual medications, and researchers made daily phone calls to ensure the instructions were followed correctly.
What are the possible benefits and risks of participating?
Possible Benefits:
1. Pain Relief: Participants may experience a reduced knee pain associated with osteoarthritis.
2. Improved Physical Function: The study may enhance daily activities and overall physical functioning of the knee joint.
3. Increased Range of Motion: Participants might notice an improvement in their knee’s range of motion, facilitating better movement and flexibility.
4. Natural Treatment: Since the study focuses on sheep ghee, participants might benefit from a natural approach that could complement their existing treatment plans.
5. Contributing to Research: Participants will contribute to valuable research that may help others suffering from knee osteoarthritis in the future.
Possible Risks:
1. Limited Follow-Up Duration: While this study is the first to evaluate this topical formulation for knee osteoarthritis, a longer follow-up could have provided insights into symptom recurrence and possible adverse events from ghee
2. Disruption of Current Treatment: Participants may find that introducing sheep ghee affects their existing treatment plans, leading to complications if not monitored adequately.
3. Individual Differences: The effectiveness of the intervention can vary based on individual health conditions, making results unpredictable.
Where is the study run from?
School of Nursing and Midwifery, Rafsanjan University of Medical Sciences, Iran
When is the study starting and how long is it expected to run for?
February 2020 to October 2022
Who is funding the study?
Rafsanjan University of Medical Sciences, Iran
Who is the main contact?
Dr Hadi Khoshab, hadikhoshab@gmail.com
Contact information
Public, Scientific, Principal Investigator
School of Nursing and Midwifery, Bam University of Medical Sciences
Bam
7616767687
Iran
 ORCID ID |
0000-0001-5336-4973 |
|---|---|
| Phone | +989132425700 |
| hadikhoshab@gmail.com |
Study information
| Study design | Non-randomized quasi-experimental design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home, Other therapist office, Telephone |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of sheep ghee on pain, stiffness, physical function, and range of motion of the knee joint in older people with osteoarthritis of the knee |
| Study objectives | Topical application of sheep ghee reduces knee joint pain. |
| Ethics approval(s) |
Approved 23/02/2020, Rafsanjan University of Medical Sciences (Central Organization of Rafsanjan University of Medical Sciences, Rafsanjan, 7717933777, Iran; +98 03434280038; edu@rums.ac.ir), ref: IR.RUMS.REC.1398.202 |
| Health condition(s) or problem(s) studied | Assessing changes in knee joint stiffness, pain, range of motion, and physical function after the use of ghee in elderly people affected by osteoarthritis. |
| Intervention | The intervention group applied 1g (equivalent to a small ice cream spoon) of sheep ghee on painful areas (front, side, and back) of the knee twice daily in the morning and at night for a month. A food laboratory confirmed the quality of ghee. For one month, patients received 60g of ghee and Vaseline. They were instructed to massage painful areas for one minute without covering them. The placebo group used Vaseline the same way as the intervention group in equal doses. The control group received only one-minute massage, and all three groups continued to take their previous medications. Daily phone calls were made to the participants to ensure that the intervention was being carried out correctly. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sheep ghee, vaseline |
| Primary outcome measure | Pain is measured using the Visual Analogue Scale (VAS) before and immediately after the intervention |
| Secondary outcome measures | 1. The range of motion for the knee joint is measured using the distance from the heel to the thigh with a ruler before and immediately after the intervention 2. The condition of patients with knee osteoarthritis, including pain, stiffness, and physical functioning of the joints, is measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and immediately after the intervention. This questionnaire evaluates three subscales on a Likert scale (None, Mild, Moderate, Severe, Extreme): 1) assessment of knee pain over the past 48 hours, 2) joint stiffness, and 3) physical function in the last 48 hours. |
| Overall study start date | 23/02/2020 |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 75 |
| Total final enrolment | 85 |
| Key inclusion criteria | 1. No injury, open wound or skin disease in the knee 2. No recent injury to the affected knee 3. No alcohol or drug addiction 4. No use of other complementary methods such as physiotherapy, acupuncture or percutaneous electrical nerve stimulation 5. No history of knee surgery 6. Insensitivity to Vaseline and sheep ghee 7. No mental illness and cognitive disorder 8. Ability to see and walk 9. Ability to communicate 10. Mild to moderate pain score in VAS (Visual Analogue Scale) 11. No history of intra-articular corticosteroid or hyaluronic acid injection for the past three months |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- Iran
Study participating centre
Rafsanjan
7717933777
Iran
Sponsor information
University/education
Central Organization of Rafsanjan University of Medical Sciences, Building No. 3 and 4
Rafsanjan
7717933777
Iran
| Phone | +98 03434280038 |
|---|---|
| edu@rums.ac.ir | |
| Website | http://rums.ac.ir |
"ROR" |
https://ror.org/01v8x0f60 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- دانشگاه علوم پزشکی رفسنجان
- Location
- Iran
Results and Publications
| Intention to publish date | 20/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hadi Khoshab, hadikhoshab@gmail.com. Except for the demographic characteristics of the participants and their identity, all required information will be available upon request from the corresponding author. |
Editorial Notes
05/03/2025: Study's existence confirmed by the Central Organization of Rafsanjan University of Medical Sciences.
