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

NCT06105840 | Unknown Phase 1 DMC

• 1 other identifier: KE/FK/0674/EC/2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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:

1. 1.Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers in elderly patients with Osteoarthritis Genu?
2. 2.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?
3. 3.Is there an effect combination of acupressure and standardized curcuminoids from turmeric extract to quality of life in elderly patients with Osteoarthritis Genu?

Conditions

Osteoarthritis, Knee

Keywords

curcuminoid; acupressure; osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Inflammation Marker

  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

  Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy

• Endorphin Hormones

  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

  Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy

Study Arms (2)

Intervention Group

EXPERIMENTAL

Groups assigned randomly using lottery draw number 1

Procedure: Acupressure and Standardized Curcuminoid from Turmeric Extract

Control Group

SHAM COMPARATOR

Groups assigned randomly using lottery draw number 2

Procedure: Sham Acupressure and Placebo

Interventions

Acupressure and Standardized Curcuminoid from Turmeric Extract PROCEDURE

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

Intervention Group

Sham Acupressure and Placebo PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Parkinson's disease
• Dementia disease
• Psychosis disease
• New bone fractures
• Joint dislocations
• Cancer
• Rheumatic diseases other than osteoarthritis (rheumatoid arthritis)
• Undergoing joint replacement therapy.
• Analgesic dependent disease

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Padukuhan Tanjungsari Kelurahan Sukoharjo Ngaglik

Sleman, Special Region of Yogyakarta, Indonesia

Location

Related Publications (18)

• Alinaghizadeh M, Hawkins J, Abbassian A, Seif Barghi T, Ayati MH, Alizadeh Vaghasloo M. Effect of Persian acupressure (Ghamz) on Patients with Knee Osteoarthritis: A Single-Blinded Parallel Clinical Trial. Pain Manag Nurs. 2021 Dec;22(6):820-827. doi: 10.1016/j.pmn.2021.06.002. Epub 2021 Jul 11.

  PMID: 34261600 RESULT

• Cheung DST, Yeung WF, Suen LK, Chong TC, Ho YS, Yu BY, Chan LY, Chen HY, Lao LX. Self-administered acupressure for knee osteoarthritis in middle-aged and older adults: a pilot randomized controlled trial. Acupunct Med. 2020 Apr;38(2):75-85. doi: 10.1177/0964528419883269. Epub 2019 Nov 13.

  PMID: 31718229 RESULT

• Guo D, Ma S, Zhao Y, Dong J, Guo B, Li X. Self-administered acupressure and exercise for patients with osteoarthritis: A randomized controlled trial. Clin Rehabil. 2022 Mar;36(3):350-358. doi: 10.1177/02692155211049155. Epub 2021 Oct 18.

  PMID: 34658285 RESULT

• Ho KK, Kwok AW, Chau WW, Xia SM, Wang YL, Cheng JC. A randomized controlled trial on the effect of focal thermal therapy at acupressure points treating osteoarthritis of the knee. J Orthop Surg Res. 2021 Apr 27;16(1):282. doi: 10.1186/s13018-021-02398-2.

  PMID: 33906695 RESULT

• Lee WJ, Park H. Effects of auricular acupressure on sleep and pain in elderly people who have osteoarthritis and live in nursing homes: A randomized, single-blind, placebo-controlled trial. Explore (NY). 2023 Mar-Apr;19(2):214-222. doi: 10.1016/j.explore.2022.07.001. Epub 2022 Jul 5.

  PMID: 35835645 RESULT

• Li LW, Harris RE, Tsodikov A, Struble L, Murphy SL. Self-Acupressure for Older Adults With Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Feb;70(2):221-229. doi: 10.1002/acr.23262. Epub 2017 Dec 29.

  PMID: 28437570 RESULT

• Sorour AS, Ayoub AS, Abd El Aziz EM. Effectiveness of acupressure versus isometric exercise on pain, stiffness, and physical function in knee osteoarthritis female patients. J Adv Res. 2014 Mar;5(2):193-200. doi: 10.1016/j.jare.2013.02.003. Epub 2013 Apr 8.

  PMID: 25685487 RESULT

• Kertia N, Asdie AH, Rochmah W, Marsetyawan. Ability of curcuminoid compared to diclofenac sodium in reducing the secretion of cycloxygenase-2 enzyme by synovial fluid's monocytes of patients with osteoarthritis. Acta Med Indones. 2012 Apr;44(2):105-13.

  PMID: 22745140 RESULT

• Adamczak A, Ozarowski M, Karpinski TM. Curcumin, a Natural Antimicrobial Agent with Strain-Specific Activity. Pharmaceuticals (Basel). 2020 Jul 16;13(7):153. doi: 10.3390/ph13070153.

  PMID: 32708619 RESULT

• Gomes TPO, Souza JIN, Somerlate LC, Mendonca VA, Lima NM, Carli GP, Castro SBR, de Jesus A S Andrade T, Dias JVL, Oliveira MAL, Alves CCS, Carli AP. Miconia albicans and Curcuma longa herbal medicines positively modulate joint pain, function and inflammation in patients with osteoarthritis: a clinical study. Inflammopharmacology. 2021 Apr;29(2):377-391. doi: 10.1007/s10787-020-00781-9. Epub 2021 Jan 16.

  PMID: 33452967 RESULT

• Kare SK, Vinay V, Maresz K, Prisk V, Vik H. Tamarindus indica Seed Extract-Based Botanical Compositions Alleviate Knee Pain and Improve Joint Function in Mild-to-Moderate Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. Evid Based Complement Alternat Med. 2022 Jan 19;2022:2226139. doi: 10.1155/2022/2226139. eCollection 2022.

  PMID: 35096104 RESULT

• Madhu K, Chanda K, Saji MJ. Safety and efficacy of Curcuma longa extract in the treatment of painful knee osteoarthritis: a randomized placebo-controlled trial. Inflammopharmacology. 2013 Apr;21(2):129-36. doi: 10.1007/s10787-012-0163-3. Epub 2012 Dec 16.

  PMID: 23242572 RESULT

• Pinsornsak P, Niempoog S. The efficacy of Curcuma Longa L. extract as an adjuvant therapy in primary knee osteoarthritis: a randomized control trial. J Med Assoc Thai. 2012 Jan;95 Suppl 1:S51-8.

  PMID: 23964444 RESULT

• Rahimnia AR, Panahi Y, Alishiri G, Sharafi M, Sahebkar A. Impact of Supplementation with Curcuminoids on Systemic Inflammation in Patients with Knee Osteoarthritis: Findings from a Randomized Double-Blind Placebo-Controlled Trial. Drug Res (Stuttg). 2015 Oct;65(10):521-5. doi: 10.1055/s-0034-1384536. Epub 2014 Jul 22.

  PMID: 25050518 RESULT

• Raj JP, Venkatachalam S, Racha P, Bhaskaran S, Amaravati RS. Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants - A randomized placebo-controlled trial. Complement Ther Med. 2020 Sep;53:102522. doi: 10.1016/j.ctim.2020.102522. Epub 2020 Jul 22.

  PMID: 33066856 RESULT

• Srivastava S, Saksena AK, Khattri S, Kumar S, Dagur RS. Curcuma longa extract reduces inflammatory and oxidative stress biomarkers in osteoarthritis of knee: a four-month, double-blind, randomized, placebo-controlled trial. Inflammopharmacology. 2016 Dec;24(6):377-388. doi: 10.1007/s10787-016-0289-9. Epub 2016 Oct 19.

  PMID: 27761693 RESULT

• Wan Y, Sun W, Yang J, Ren J, Kou Q. The comparison of curcuminoid formulations or its combination with conventional therapies versus conventional therapies alone for knee osteoarthritis. Clin Rheumatol. 2022 Jul;41(7):2153-2169. doi: 10.1007/s10067-022-06105-2. Epub 2022 Mar 16.

  PMID: 35294665 RESULT

• Mahanani S, Kertia N, Madyaningrum E. Combination of Curcuminoids and Acupressure for Inflammation and Pain in Older People with Osteoarthritis Genu: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 24;13:e54970. doi: 10.2196/54970.

  PMID: 38771152 DERIVED

Related Links

• The effect of acupressure therapy on pain, stiffness and physical functioning of knees among older adults diagnosed with osteoarthritis: A pilot randomized control trial.
• Effectiveness of knee acupressure along with herbal knee poultice for knee osteoarthritis treatment: A pilot pre-post clinical study.
• Effects of auricular acupressure on joint pain, range of motion, and sleep in the elderly with knee osteoarthritis
• Adjunctive effects of acupressure therapy on pain and quality of life in patients with knee osteoarthritis: an interventional study.
• Acujoint, a highly efficient formulation with natural bioactive compounds, exerts potent anti-arthritis effects in human osteoarthritis - A pilot randomized double blind clinical study compared to combination of glucosamine and chondroitin

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Srinalesti Mahanani, Magister

  Faculty of Medicine University of Gadjah Mada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 30, 2023
• Study Start: August 27, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)