Evaluation Outcome of Adding Cupping-therapy to Electro-acupuncture in Accompany with Exercises on Knee Pain, Function and Life Quality at Osteoarthritis
The effect of adding cupping therapy to electroacupuncture with exercise therapy on knee pain and function and quality of life in patients with knee osteoarthritis in sports medicine clinic during 2020-2021
Design
This study is a randomized clinical trial and the analyst does not know the groups. The study is performed in a sports medicine clinic of Imam Hossein hospital and Taleghani hospital. Sampling of patients is done in among patients with osteoarthritis of the knee who refer to a sports medicine clinic and are eligible to participate in the study and are willing to participate in the study.
Settings and conduct
The location of the study is the sports medicine clinic of Imam Hossein Hospital and Ayatollah Taleghani Hospital. Written consent is obtained from the patients to participate in the study. Sampling method will be done by available sampling method and finally, patients will be assigned by lottery from two treatment methods. The sample size of 28 patients in each group is determined. A total of 56 patients with knee osteoarthritis are selected based on the inclusion criteria.
Participants/Inclusion and exclusion criteria
Men and women with knee pain due to osteoarthritis who had knee pain and is now exacerbated.
Intervention groups
We have two groups. Control group receives electroacupuncture and exercise therapy program. In addition to these, intervention group receives cupping. Electroacupuncture is performed for 20 minutes. The intervention group receives the cupping after the electroacupuncture .Number of sessions is twice per week for 4 consecutive weeks.
Main outcome variables
To evaluate the knee pain and function and life quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050381N1
Registration date:2022-09-03, 1401/06/12
Registration timing:registered_while_recruiting
Last update:2022-09-03, 1401/06/12
Update count:0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Maryam Ganjalikhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
ganjalikhani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-22, 1402/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Outcome of Adding Cupping-therapy to Electro-acupuncture in Accompany with Exercises on Knee Pain, Function and Life Quality at Osteoarthritis
Public title
Effect of Adding Cupping Therapy to Electroacupuncture in Patients with Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women over 40 and under 75 years old
Body mass index between 18-35
Knee pain for 6 months or more (chronic pain and acutely pain aggravation)
Normal neurologic examination
Radiology symptoms of osteoarthritis in the knee and at least one osteophyte (grade 2 and 3 criteria of klegran Lawrence) in the tibiofemoral joint of the knee
Exclusion criteria:
Knee pain due to problems other than osteoarthritis (rheumatoid arthritis, other rheumatic diseases, etc.)
Knee or pelvic replacement surgery in the joint involved or any surgical procedures in the lower extremities during the last 6 months
Intra-articular injections of corticosteroids in 6 months, gel and PRP in the last year, the onset of oral opioid or corticosteroid painkillers during the last 4 weeks
Physical disorder that prevents a person from doing exercises.
Wounds or any lesions caused in knee during treatment sessions (for any reason)
taking painkiller other than acetaminophen more than three times at any dose
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the sample size and number of groups, we write on 28 papers of the control group and 28 papers of the intervention group. We fold the papers so that their writing cannot be read. Then we throw them in the lottery container. The secretary of the clinic, who is not one of the researchers of the project, picks the paper in turn without replacement and is registered in front of the numbers 1 to 56 of the control group and the randomization list is prepared in this way. The next step is to hide the random list. To do this, use opaque sealed envelopes with a random sequence. A number of Sequentially numbered, sealed, opaque envelopes with aluminium wrappers (in order to obscure the contents of the envelopes) are prepared and each of the random numbers is recorded on a card and the cards are placed inside the envelope. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. Finally, the lid of the letter envelopes is glued and placed in a box, respectively. The box is given to the person in charge of reception. Each patient enters the clinic to begin their treatment, take one envelope in order.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid Beheshti university of medical sciences
Street address
Exercise and sport medicine department, (Ayatollah) Taleghani Educational Hospital ,erabi avenue, velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.SBMU.MSP.REC.1399.702
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee
2
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee pain
Timepoint
Before intervention and at the end of intervention after eight weeks
Method of measurement
Womac questionnaire, VAS form
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention and at the end of intervention at the eight week
Method of measurement
Vas form,WOMAC questionnaire
2
Description
Knee stiffness
Timepoint
Before intervention and at the end of intervention at the eight week
Method of measurement
WOMAC questionnaire, VAS form
Intervention groups
1
Description
Intervention group: In addition to electroacupuncture and exercise therapy, the intervention group receives a cuping.Cupping therapy, patients are treated with a glass cup at the location of the genicular nerves around the knee. Acuzone branding is made in Korea. The cup is placed on the skin and suction is created with its rifle series. It stays on the skin for 5 minutes and then separates from the skin. It is done twice a week for four weeks. In total, eight sessions are done.
Category
Treatment - Devices
2
Description
The control group receives electroacupuncture and an exercise therapy program. Patients are given exercises. Exercises include isometric quadriceps. While lying on back, keep both knees bent and place a pillow or towel between their knees. Gently apply pressure to the pillow. Hold for five seconds and release. patients do the exercises three sets of five repetitions daily. The intensity of the pressure is to the threshold of pain.Patients also receive electroacupuncture. To do electropuncture: The patient lies on his back on the bed. The site is completely disinfected with an alcohol pad. Electroacupuncture is performed as for 20 minutes (two per week) for a total of 8 sessions. Disposable needles, sterile, 25.25 0. 0.25 mm (disposable needle of Huang Xiu Medical Company, China) will be used in two groups. Electroacupuncture is performed bilaterally and in cases where only one patient has a sore knee, it is performed unilaterally. Acupuncture points are selected according to Chinese acupuncture points. If the patient has a clear trigger point around the knee, a needle should be inserted in this area as well. The needles should not enter the joint space.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam saddat Ganjalikhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1505
Email
Maryam.ganjalikhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam saddat Ganjalikhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1505
Email
Maryam.ganjalikhani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam saddat Ganjalikhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Taleghani Educational Hospital, Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1505
Email
Maryam.ganjalikhani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after disabling individuals.
When the data will become available and for how long
Access period starts six months after the article is published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Written request for access to data is possible.
From where data/document is obtainable
For requesting Documents or data correspond to this address: Taleghani Educational Hospital,
Tabnak St. Velenjak Region, Chamran High Way,
Tehran, Iran
What processes are involved for a request to access data/document
The applicant requests data or study details and provides the contact address. The data is then made available.