Combination of Curcuminoid With Acupressure for Inflammation and Pain in the Elderly With Osteoarthritis Genu

Sponsor

Gadjah Mada University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06105840

Collaborator

(none)

Enrollment

Location

Arms

2.1

Anticipated Duration (Months)

32.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to to investigate the efficacy of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers, endorphin hormones in the blood and quality of life in elderly patient with Osteoarthritis Genu.

The main questions it aims to answer are:

Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers in elderly patients with Osteoarthritis Genu?
Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to endorphin hormones in the blood in elderly patients with Osteoarthritis Genu?
Is there an effect combination of acupressure and standardized curcuminoids from turmeric extract to quality of life in elderly patients with Osteoarthritis Genu?

Participants in the intervention group received 2 treatments, namely acupressure at points that provide osteoarthritis-specific comfort and standardized curcuminoids from turmeric extract capsules. Participant in the control group alo would receive 2 treatments, an active placebo (starch capsules and sham acupressure).

Researchers will compare interventional group and sham group to see efficacy the combination therapy

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Procedure: Acupressure and Standardized Curcuminoid from Turmeric Extract Procedure: Sham Acupressure and Placebo	Phase 1/Phase 2

Detailed Description

Background. One of the degeneration processes that occurs in the elderly is the musculoskeletal system. These deteriorations include bone loss and a decrease in joint fluid volume which is exacerbated by bearing the weight of the body. Pain in Osteoarthritis patients affects many areas of quality of life such as physical function, emotional behavior, and mental health. Osteoarthritis-related pain is a major factor in poor quality of life. The most common pharmacological treatment to control pain is the use of non-steroidal anti-inflammatory drugs (NSAIDs), but these drugs carry the risk of causing side effects. Limitations associated with pharmacologic treatment result in patients choosing commonly available alternative therapies for pain management. Popular alternative therapies include herbal therapy, therapeutic touch, relaxation techniques, music therapy, acupuncture, and acupressure. This alternative therapy, unlike the use of drugs, does not produce dangerous side effects.

Research on the effectiveness of herbal therapy on inflammatory osteoarthritis patients was conducted in Indonesia in 2009 on 80 sufferers with the result that administration of turmeric rhizome extract curcuminoids significantly suppressed the activity of synovial fluid monocytes to secrete Cyclooxygenase-2 (COX-2) and Reactive Oxygen Intermediate (ROI), reduced leukocyte numbers and fluid Malondialdehyde (MDA) levels. synovia and reduces Osteoarthritis (OA) joint pain, with an ability that is not significantly different compared to diclofenac sodium therapy 3x25 mg per day. Furthermore, the development of herbal therapy for Osteoathritis continued with research which proved that the combination of ginger, ginger, soybean and shrimp shell extracts provided significant results in reducing joint pain, stiffness and physical disability which were evaluated based on the Western Ontario and McMaster values. Universities Osteoarthritis Index (WOMAC) and did not show a significant difference when compared with meloxicam.

Research that has been carried out to evaluate the effectiveness of acupressure therapy for the pain of Osteoarthritis patients was also carried out in several countries, including by study on 40 Osteoarthritis patients who were divided into two groups (intervention and control). In the intervention group, acupressure therapy was given for 5 days with a duration of 30 minutes each time. The results showed that the average pain score in the intervention group decreased significantly from 5.89 at the beginning of the study to 4.11 at the end of the study, while the pain score did not change substantially in the control group. These findings remained consistent after adjusting for age, weight, and pretreatment covariates. This study supports the evidence that Acupressure therapy provides an effective option for short-term knee pain relief in patients with knee Osteoarthritis. In line with the results, there was research which was conducted on 51 elderly with osteoarthritis divided into 3 groups (acupressure intervention, placebo and control). This study revealed that respondents who received acupressure therapy for 3-4 weeks with the duration of each therapy being 10-15 minutes, showed a significant reduction in the total WOMAC index, pain and physical dysfunction.

So far, there has been no research combining standardized curcuminoid turmeric extract therapy with acupressure for inflammation and pain in osteoarthritis patients. More clinical trials with appropriate methodology are needed to confirm the effectiveness of standardized turmeric extract, curcuminoids and acupressure to treat physical problems in osteoarthritis patients.

Study Design/Methods. The research will be carried out by design Randomized Controlled Trials (RCT). Respondents will be divided randomly into 2 groups, namely treatment and control. The treatment group will receive interventions, namely herbal therapy and acupressure therapy, while the control group will receive active placebo (capsules containing starch and acupressure massage at points that are not to provide comfort for knee pain). In this study, a double blind technique was used , that is, the subjects and researchers did not know which respondents were in the treatment group and which respondents were in the control group.

Data Analysis Plan

Analysis Descriptive Data obtained done tabulation in accordance with general data grouping and special data results measurement variable pre-test and post-test research . Data analysis will used For get description general from each variable . Data processing uses distribution frequency , reading data distribution (mean, mode, median, etc deviation )
Analysis Inferential For know difference effectiveness on second group , researcher use Test the Difference with using the Independent T-Test and Wilcoxon Sign Rank Test. Analysis done on difference all over variable before And after done intervention on second group

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Combination of Curcuminoid Standardized Turmeric Extract With Acupressure on Inflammatory Markers, Endorphins and Quality of Life in Elderly People With Osteoarthritis Genu

Actual Study Start Date :

Aug 27, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Groups assigned randomly using lottery draw number 1	Procedure: Acupressure and Standardized Curcuminoid from Turmeric Extract capsules containing curcuminoid from Tumeric Extract three times a day for 3 weeks and acupressure massage at points provide comfort for knee pain twice a week for 3 weeks
Sham Comparator: Control Group Groups assigned randomly using lottery draw number 2	Procedure: Sham Acupressure and Placebo capsules containing starch three times a day for 3 weeks and acupressure massage at points that are not to provide comfort for knee pain twice a week for 3 weeks

Arm

Intervention/Treatment

Experimental: Intervention Group

Groups assigned randomly using lottery draw number 1

Procedure: Acupressure and Standardized Curcuminoid from Turmeric Extract

capsules containing curcuminoid from Tumeric Extract three times a day for 3 weeks and acupressure massage at points provide comfort for knee pain twice a week for 3 weeks

Sham Comparator: Control Group

Groups assigned randomly using lottery draw number 2

Procedure: Sham Acupressure and Placebo

capsules containing starch three times a day for 3 weeks and acupressure massage at points that are not to provide comfort for knee pain twice a week for 3 weeks

Outcome Measures

Primary Outcome Measures

Inflammation Marker [Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy]
Inflammation markers are carried out by measuring Leukocyte Number, NLR, Blood Sediment Rate and COX-2 hormone. Outcome measurements will be carried out a complete blood test using a Hematology Analyzer. Leukocyte numbers measured in microliter (mcL). Neutrophil-Lymphocyte Count Ratio can be calculated from the number of neutrophils (cells) and lymphocytes (cells). Neutrophils and lymphocytes will be combined to report Neutrophil-Lymphocyte Count Ratio in %. Blood Sediment Rate is a measurement of the difference in the decrease in height of red blood cells in a test tube (mm) divided by the time (hours) required for all of them to settle to the bottom of the test tube. There will be combined to report Blood Sediment Rate in mm/hr. The COX-2 hormone examination was carried out using the Enzyme Linked Immunosorbent Assay (ELISA). The amount of COX-2 Hormone in the blood in nanograms and blood sample volume in milliliters will be combined to report secretion of COX-2 in ng/mL
Endorphin Hormones [Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy]
Secretion of endorphin hormones Endorphins, in this case beta endorphin, are hormones released by the pituitary gland in response to stress or pain, which are also secreted in blood plasma. Endorphin hormone examination is carried out using the Enzyme Linked Immunosorbent Assay (ELISA) method on blood plasma. The amount of Endorphin Hormone in the blood in nanograms and the blood sample volume in milliliters will be combined to report secretion of COX-2 in ng/mL

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

The inclusion criteria in this study are:

Clinical diagnosis of osteoarthritis which confirmed by physical examination and x-rays
Experience pain with a Numeric Rating scale of 1-7
Must be able to swallow capsules
Must be able to carry out mobility without assistance or with minimal assistance