Comparison between acupuncture with Laser and acupuncture with acupressure on pain and function of patients with knee osteoarthritis.
Design
A clinical trial without a control group with three treatment groups, one-sided blind on 36 patients
Settings and conduct
Patients referred to the physiotherapy clinic of Shahid Beheshti Rehabilitation Faculty and Hakim physiotherapy clinic
with matching
Three groups of acupuncture treatment. Combination with laser acupuncture points and combination with acupressure
blinding the therapist with a separate primary evaluator
Participants/Inclusion and exclusion criteria
Adults aged 40 to 75 years with grade 2 or 3 knee osteoarthritis based on the Kellgren Lawrence criteria, referring to the physiotherapy clinic of Shahid Beheshti Rehabilitation Faculty and Hakim Physiotherapy Clinic
• Target population: eligible patients described to enter the study
Main entry and exit conditions:
Age 40 to 75 years
Chronic one-sided knee pain that has lasted for more than 6 months
Diagnosis of grade 2 or 3 osteoarthritis
BMI: 18.5-29.9
Pain as much as 40 to 90% of the total VAS score
Having no contraindications to acupuncture
Signs of severe chronic diseases and history of knee surgery, as well as signs of physical therapy in the past six months
Absence of patellofemoral joint osteoarthritis
Intervention groups
They are divided into three treatment groups: "acupuncture", "acupuncture and laser acupuncture points" and "acupuncture and acupressure".
Main outcome variables
Primary outcome:Pain level/
Secondary outcomes:The level of physical ability in terms of performance,Movement range of active flexion of the knee,Movement range of active knee extension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221117056531N1
Registration date:2022-12-20, 1401/09/29
Registration timing:prospective
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Aida Zolghadr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6632 5502
Email address
aidazolghadr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between acupuncture with Laser and acupuncture with acupressure on pain and function of patients with knee osteoarthritis.
Public title
Comparison between acupuncture with Laser and acupuncture with acupressure on pain and function of patients with knee arthrosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 75 years
Chronic one-sided knee pain that has been going on for more than 6 months (33)
Diagnosis of grade 2 or 3 osteoarthritis with radiology according to the Kellgren-Lawrence scale (33) diagnosed by the evaluating therapist
BMI: 18.5-29.9
The amount of pain as much as 40 to 90% of the total VAS score6.
Exclusion criteria:
Having contraindications for acupuncture (including infection and open wound or cancer) (20)
Suffering from other chronic diseases in the critical phase
3. Intra-articular injection, use of knee support, surgery or use of drugs that affect treatment and evaluation.
history of joint injections to reduce pain in the past 30 days or the intention to do so during the study (20),
attendance during pregnancy and breastfeeding (30)
history of performing single or combined treatments or physiotherapy in the last 6 months (17)
Having a pacemaker and taking anticoagulant drugs (17) and uncontrolled blood pressure
history of surgery in the considered knee (20)
radiographic evidence of severe osteoarthritis in the patellofemoral joint
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher who conducts the intervention is blinded, and the allocation of people into three groups and the registration of their characteristics will be done by another person.
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
Rajaee St
City
تهران
Province
Tehran
Postal code
1373885693
Approval date
2022-11-16, 1401/08/25
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.506
Health conditions studied
1
Description of health condition studied
knee mosteoarthritis
ICD-10 code
M00-M99
ICD-10 code description
اختلال ماهیچه ای استخوانی= آرتروز زانو
Primary outcomes
1
Description
Pain intensity according to VAS
Timepoint
Baseline - first session - sixth session - after three weeks
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Performance change
Timepoint
Baseline - session one - session six - three weeks later
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index Total score
2
Description
changing the range of motion of Aktiochum and opening the knee
Timepoint
Baseline - session one - session six - three weeks later
Method of measurement
By goniometer
Intervention groups
1
Description
First intervention group: Acupuncture - In this group, during six treatment sessions, first 15 minutes of IR rays and then 5 points of acupuncture XI YAN-SP9-GB34-ST35-ST36 are performed for twenty minutes. Eco needle is used in size 2.5 cm long and 0.25 mm in diameter.
Category
Rehabilitation
2
Description
Intervention group 2: Acupuncture and laser acupuncture points - In this group, during six treatment sessions, first 15 minutes of IR rays are received. Then, for 20 minutes, acupuncture points XI YAN-SP9-GB34-ST35-ST36 are subjected to acupuncture with echo needles of 25 mm size and 0.25 mm diameter. Then laser the same points for 5 minutes with MODE parameters; PULSED- PEAK POWER; 150 mW- AVERAGE POWER: 100 mW- DOSE 6 J PER POINT- NUMBER OF POINT 5 is performed with 870M laser of Novin company
Category
Rehabilitation
3
Description
Intervention group 3: Acupuncture and acupressure - in this group, during six treatment sessions, first 15 minutes of IR rays are received. Then, for 20 minutes, acupuncture points XI YAN-SP9-GB34-ST35-ST36 are subjected to acupuncture with echo needles of size 25 mm and 0.25 mm in diameter. Then, for 7 minutes, acupressure on the same points with thumb pressure Therapist's hand is performed for 80 seconds to create a sensation. Then the patient performs active knee movements for 5 minutes