The Effect of Acupressure in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Pain, Nursing, Acupressure.
Eligibility Criteria
Inclusion Criteria:
- 38 years old and over
- Diagnosed by a doctor with knee OA according to American College of Rheumatology (ACR) criteria
- had three points and over on the VAS pain scale,
- had no communication problems
- did not have any significant knee trauma within the last six months or an intra-articular steroid injection
- did not have any infection in the lower extremities or wounds, surgery or physiotherapy within the last six months
- those who accepted to participate to the study.
Exclusion Criteria:
- the patient is not willing to go on the study in any stage of the study and case of any adverse effect of acupressure.
Sites / Locations
- Nigde Omer Halisdemir University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupressure (intervention group)
Control group
Arm Description
The intervention group was performed with 45 patients. Acupressure was performed two days a week for four weeks with a total of eight sessions on the ST34, ST35, ST36, SP9, SP10, GB34 acupuncture points following an acupressure practice guide prepared by the researcher.
Thecontrol group was performed with 45 patients. Any application was not performed for the control group.
Outcomes
Primary Outcome Measures
Pain level in visual analogue scale (VAS)
Pain severity scores were determined by measuring values that were chosen on VAS by patients. The numerical scale ranges from 0 "No pain", to 10 "Worst pain imaginable", and a numerical value is given to every 1 cm range to measure pain severity.
Secondary Outcome Measures
The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Osteoarthritis Index
Their functional status levels were evaluated by using WOMAC Osteoarthritis Index.Every question is scored between 0 and 4 points evaluated with a five-way Likert-type scale. High scores from the index show increased pain and stiffness and dysfunction in physical function.
36-Item Short-Form Health Survey (SF-36)
Their changes in quality of life levels were evaluated by using SF-36 scale.The scale gives separate scores for every sub-scale, which varies between 0 and 100 points. High scores on the subscales show good health status, while low scores show a deterioration in health
Full Information
NCT ID
NCT05238350
First Posted
December 21, 2021
Last Updated
August 15, 2022
Sponsor
TC Erciyes University
Collaborators
Pınar TEKİNSOY KARTIN, Rabiye ÇIRPAN
1. Study Identification
Unique Protocol Identification Number
NCT05238350
Brief Title
The Effect of Acupressure in Patients With Knee Osteoarthritis
Official Title
The Effect of Acupressure on Pain, Functional Status and Quality of Life in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 7, 2015 (Actual)
Primary Completion Date
June 11, 2015 (Actual)
Study Completion Date
November 11, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
Collaborators
Pınar TEKİNSOY KARTIN, Rabiye ÇIRPAN
4. Oversight
5. Study Description
Brief Summary
Abstract Pain is the most common symptom of osteoarthritis and affects people's functional status with quality of life. This study was conducted to determine the effect of acupressure on pain, functional status, and quality of life in patients living with knee osteoarthritis. Acupressure application and follow-ups were performed by the researcher in the patient's home environment. The study was performed with 90 patients, 45 in the intervention group and 45 in the control group. Acupressure was performed two days a week for four weeks with a total of eight sessions on the ST34, ST35, ST36, SP9, SP10, GB34 acupuncture points following an acupressure practice guide prepared by the researcher. It was determined that while the Visual Analog Scale (VAS), the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores of the intervention group were higher than those of the control group before application, they had decreased after application. It was found that all subscale mean scores of the Short-Form Health Survey (SF-36) quality of life questionnaire increased after application in the intervention group. It was concluded that acupressure has decreased pain severity and increased the functional status and quality of life of patients with knee osteoarthritis.
Keywords: Osteoarthritis, pain, nursing, acupressure.
Detailed Description
Abstract Background: Pain is the most common symptom of osteoarthritis and affects people's functional status with quality of life.
Objective: This study was conducted to determine the effect of acupressure on pain, functional status, and quality of life in patients living with knee osteoarthritis.
Methods/Design: The study was conducted as an experimental study with a pre-posttest and a control group.
Settings: The study was conducted on patients diagnosed with knee osteoarthritis and attended the Physical Therapy and Rehabilitation Polyclinics of Nevşehir government hospital in the Central Anatolia Region of Turkey. Acupressure application and follow-ups were performed by the researcher in the patient's home environment.
Participants: The study was performed with 90 patients, 45 in the intervention group and 45 in the control group.
Intervention: Acupressure was performed two days a week for four weeks with a total of eight sessions on the ST34, ST35, ST36, SP9, SP10, GB34 acupuncture points following an acupressure practice guide prepared by the researcher.
Measurement of efficacy: Data was collected before and after acupressure application by using a Visual Analogue Scale (VAS), the 36-Item Short-Form Health Survey (SF-36), and the Western Ontario and McMaster University Osteoarthritis Index (WOMAC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Pain, Nursing, Acupressure.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was conducted as an experimental study with a pre-posttest and a control group.
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupressure (intervention group)
Arm Type
Experimental
Arm Description
The intervention group was performed with 45 patients. Acupressure was performed two days a week for four weeks with a total of eight sessions on the ST34, ST35, ST36, SP9, SP10, GB34 acupuncture points following an acupressure practice guide prepared by the researcher.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Thecontrol group was performed with 45 patients. Any application was not performed for the control group.
Intervention Type
Procedure
Intervention Name(s)
Acupressure
Other Intervention Name(s)
Control
Intervention Description
Acupressure was performed two days a week for four weeks with a total of eight sessions on the ST34, ST35, ST36, SP9, SP10, GB34 acupuncture points following an acupressure practice guide prepared by the researcher.
Primary Outcome Measure Information:
Title
Pain level in visual analogue scale (VAS)
Description
Pain severity scores were determined by measuring values that were chosen on VAS by patients. The numerical scale ranges from 0 "No pain", to 10 "Worst pain imaginable", and a numerical value is given to every 1 cm range to measure pain severity.
Time Frame
baseline, change from baseline at 4th week;
Secondary Outcome Measure Information:
Title
The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Osteoarthritis Index
Description
Their functional status levels were evaluated by using WOMAC Osteoarthritis Index.Every question is scored between 0 and 4 points evaluated with a five-way Likert-type scale. High scores from the index show increased pain and stiffness and dysfunction in physical function.
Time Frame
baseline, change from baseline at 4th week;
Title
36-Item Short-Form Health Survey (SF-36)
Description
Their changes in quality of life levels were evaluated by using SF-36 scale.The scale gives separate scores for every sub-scale, which varies between 0 and 100 points. High scores on the subscales show good health status, while low scores show a deterioration in health
Time Frame
baseline, change from baseline at 4th week;
10. Eligibility
Sex
All
Minimum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
38 years old and over
Diagnosed by a doctor with knee OA according to American College of Rheumatology (ACR) criteria
had three points and over on the VAS pain scale,
had no communication problems
did not have any significant knee trauma within the last six months or an intra-articular steroid injection
did not have any infection in the lower extremities or wounds, surgery or physiotherapy within the last six months
those who accepted to participate to the study.
Exclusion Criteria:
the patient is not willing to go on the study in any stage of the study and case of any adverse effect of acupressure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuğba AYDEMİR, RN, MSc
Organizational Affiliation
Nigde Omer Halisdemir University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nigde Omer Halisdemir University
City
Niğde
State/Province
Ni̇ğde
ZIP/Postal Code
51240
Country
Turkey
12. IPD Sharing Statement
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The Effect of Acupressure in Patients With Knee Osteoarthritis
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