Comparing the effectiveness of dry needling and ischemic compression on the trigger points of the lower half muscles behind the knee on pain and disability and muscle and joint stiffness in knee osteoarthritis patients: randomized clinical trial single-blind
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Protocol summary
Inclusion criteria: mild to moderate osteoarthritis, presence of at least one trigger point, age between 45-70 years, pain level above 30 mm and below 70 mm on the VAS scale.
Exclusion criteria: severe swelling of the knee, systemic disease, contraindications to dry needling, fibromyalgia syndrome, radiculopathy/myopathy
Inclusion criteria: mild to moderate osteoarthritis, presence of at least one trigger point, age between 50-70 years, pain level above 30 mm and below 80 mm on the VAS scale.
Exclusion criteria: severe swelling of the knee, systemic disease, contraindications to dry needling, fibromyalgia syndrome, radiculopathy/myopathy
Inclusion criteria: mild to moderate osteoarthritis, presence of at least one trigger point, age between 4550-70 years, pain level above 30 mm and below 7080 mm on the VAS scale. Exclusion criteria: severe swelling of the knee, systemic disease, contraindications to dry needling, fibromyalgia syndrome, radiculopathy/myopathy
شرایط ورود: استئوآرتریت خفیف تا متوسط، وجود حداقل یک نقطه ماشه ای، سن بین 45 – 70 سال، سطح درد بالاتر از 30 میلیمتر و کمتر از 70 میلیمتر در مقیاس VAS
شرایط عدم ورود: تورم شدید زانو، بیماری سیستمیک، موارد منع مصرف سوزن خشک، سندرم فیبرومیالژیا، رادیکولوپاتی/میوپاتی
شرایط ورود: استئوآرتریت خفیف تا متوسط، وجود حداقل یک نقطه ماشه ای، سن بین 50– 70 سال، سطح درد بالاتر از 30 میلیمتر و کمتر از 80 میلیمتر در مقیاس VAS
شرایط عدم ورود: تورم شدید زانو، بیماری سیستمیک، موارد منع مصرف سوزن خشک، سندرم فیبرومیالژیا، رادیکولوپاتی/میوپاتی
شرایط ورود: استئوآرتریت خفیف تا متوسط، وجود حداقل یک نقطه ماشه ای، سن بین 45 50– 70 سال، سطح درد بالاتر از 30 میلیمتر و کمتر از 7080 میلیمتر در مقیاس VAS شرایط عدم ورود: تورم شدید زانو، بیماری سیستمیک، موارد منع مصرف سوزن خشک، سندرم فیبرومیالژیا، رادیکولوپاتی/میوپاتی
General information
45
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4550
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Referee's recommendation
Referee's recommendation
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توصیه داوران
توصیه داوران
Mild to moderate severity of osteoarthritis (grade I-III in the Kellgren-Lawrence scale)
The presence of at least one trigger point (latent or active) in the gastrocnemius and popliteus muscles based on the criteria of Travell and Simons, which can be detected by touch.
Age between 45-70 years
The pain level of knee osteoarthritis patients should be higher than 30 mm and less than 70 mm on the VAS scale and at least 3 months have passed since its onset.
Morning joint stiffness less than 30 minutes
Mild to moderate severity of osteoarthritis (grade I-III in the Kellgren-Lawrence scale)
The presence of at least one trigger point (latent or active) in the gastrocnemius and popliteus muscles based on the criteria of Travell and Simons, which can be detected by touch.
Age between 50-70 years
The pain level of knee osteoarthritis patients should be higher than 30 mm and less than 80 mm on the VAS scale and at least 3 months have passed since its onset.
Morning joint stiffness less than 30 minutes
Mild to moderate severity of osteoarthritis (grade I-III in the Kellgren-Lawrence scale) The presence of at least one trigger point (latent or active) in the gastrocnemius and popliteus muscles based on the criteria of Travell and Simons, which can be detected by touch. Age between 4550-70 years The pain level of knee osteoarthritis patients should be higher than 30 mm and less than 7080 mm on the VAS scale and at least 3 months have passed since its onset. Morning joint stiffness less than 30 minutes
شدت استئوآرتریت خفیف تا متوسط (گرید I - III در مقیاس کلگرن و لورنس)
وجود حداقل یک نقاط ماشه ای(نهفته یا فعال) در عضلات گاستروکنمیوس و پوپلیتئوس بر اساس معیارهای Travell and Simons که با لمس تشخیص داده شود
سن بین 45 – 70 سال
سطح درد بیماران استئوآرتریت زانو در مقیاس VAS بالاتر از 30 میلیمتر و کمتر از 70 میلیمتر باشد و حداقل 3 ماه از شروع آن گذشته باشد
سفتی مفصلی صبحگاهی کمتر از 30 دقیقه
شدت استئوآرتریت خفیف تا متوسط (گرید I - III در مقیاس کلگرن و لورنس)
وجود حداقل یک نقاط ماشه ای(نهفته یا فعال) در عضلات گاستروکنمیوس و پوپلیتئوس بر اساس معیارهای Travell and Simons که با لمس تشخیص داده شود
سن بین 50– 70 سال
سطح درد بیماران استئوآرتریت زانو در مقیاس VAS بالاتر از 30 میلیمتر و کمتر از 80میلیمتر باشد و حداقل 3 ماه از شروع آن گذشته باشد
سفتی مفصلی صبحگاهی کمتر از 30 دقیقه
شدت استئوآرتریت خفیف تا متوسط (گرید I - III در مقیاس کلگرن و لورنس) وجود حداقل یک نقاط ماشه ای(نهفته یا فعال) در عضلات گاستروکنمیوس و پوپلیتئوس بر اساس معیارهای Travell and Simons که با لمس تشخیص داده شود سن بین 45 50– 70 سال سطح درد بیماران استئوآرتریت زانو در مقیاس VAS بالاتر از 30 میلیمتر و کمتر از 70 میلیمتر80میلیمتر باشد و حداقل 3 ماه از شروع آن گذشته باشد سفتی مفصلی صبحگاهی کمتر از 30 دقیقه
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hamidreza Khankeh
Full name of responsible person - Persian: دکتر حمیدرضا خانکه
Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
Street address - Persian: تهران، اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۹۸۵۷۱۳۸۳۴
Phone: +98 21 7173 2832
Fax:
Email: ha.khankeh@uswr.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hamidreza Khankeh
Full name of responsible person - Persian: دکتر حمیدرضا خانکه
Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
Street address - Persian: تهران، اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7173 2832
Fax:
Email: ha.khankeh@uswr.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Hamidreza Khankeh Full name of responsible person - Persian: دکتر حمیدرضا خانکه Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin Street address - Persian: تهران، اوین ، بلوار دانشجو ، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۹۸۵۷۱۳۸۳۴1985713834 Phone: +98 21 7173 2832 Fax: Email: ha.khankeh@uswr.ac.ir Web page address:
Protocol summary
Study aim
Investigating and comparing the effect of adding dry needling and ischemic pressure to routine physiotherapy on pain, muscle stiffness, knee joint stiffness, disability, pressure pain threshold and knee range of motion in patients with knee osteoarthritis
Design
The clinical trial will have 3 groups, with parallel groups, single blind, randomized, on 60 patients. For randomization, the Block Randomization method is used by the Randomization.com online site.
Settings and conduct
The study is carried out in Farhangian Central Hospital in Tehran. Patients are randomly divided into 3 intervention and control groups of 20 people. Before and after interventions, pain intensity, disability, gastrocnemius and popliteus muscle stiffness, knee joint stiffness, pressure pain threshold and knee range of motion will be measured. This study will be a single blind so that the assessor will not know about the groups allocation and other parts of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: mild to moderate osteoarthritis, presence of at least one trigger point, age between 50-70 years, pain level above 30 mm and below 80 mm on the VAS scale.
Exclusion criteria: severe swelling of the knee, systemic disease, contraindications to dry needling, fibromyalgia syndrome, radiculopathy/myopathy
Intervention groups
1- dry needling plus routine physiotherapy
2- Ischemic pressure plus routine physiotherapy
3- Routine physiotherapy alone
Main outcome variables
Pain intensity, disability, muscle stiffness, joint stiffness, pressure pain threshold and knee range of motion
General information
Reason for update
Referee's recommendation
Acronym
IRCT registration information
IRCT registration number:IRCT20170715035097N2
Registration date:2023-04-13, 1402/01/24
Registration timing:prospective
Last update:2024-12-16, 1403/09/26
Update count:1
Registration date
2023-04-13, 1402/01/24
Registrant information
Name
Mohsen Shams
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7739 2705
Email address
mo.shams@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-01, 1402/02/11
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of dry needling and ischemic compression on the trigger points of the lower half muscles behind the knee on pain and disability and muscle and joint stiffness in knee osteoarthritis patients: randomized clinical trial single-blind
Public title
Comparing the effectiveness of dry needling and ischemic pressure on trigger points in knee osteoarthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate severity of osteoarthritis (grade I-III in the Kellgren-Lawrence scale)
The presence of at least one trigger point (latent or active) in the gastrocnemius and popliteus muscles based on the criteria of Travell and Simons, which can be detected by touch.
Age between 50-70 years
The pain level of knee osteoarthritis patients should be higher than 30 mm and less than 80 mm on the VAS scale and at least 3 months have passed since its onset.
Morning joint stiffness less than 30 minutes
Exclusion criteria:
Severe inflammation/swelling of the knee
Any previous fracture or surgery of the lower limb
Systemic disease (such as rheumatoid arthritis or diabetes)
Contraindications to using dry needling, including pregnancy, malignancy, fear of needles, bleeding disorders (such as hemophilia or thalassemia), taking antiplatelet and anticoagulant drugs
Complete replacement of the knee joint on the affected side
Injection of opioid analgesics or corticosteroids in the last 30 days
Fibromyalgia syndrome
Physical therapy or dry needling in the last 3 months
Radiculopathy/myopathy
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using the block balanced randomization method. Considering that the current study has 3 groups, therefore, blocks of 6 letters are used, which is done by a site called Randomization.com. This site produces a list that is numbered from 1 to 60 according to the sample size of the study and one of the letters A, B or C is randomly written in front of each number. Then 60 envelopes are prepared, which are numbered from 1 to 60, According to the list produced by the site, the letter A, B or C in front of each number is written on a piece of paper and placed in the corresponding envelope, and the envelope is sealed, and before starting the treatment, the first patient is given envelope number 1 and to the second patient envelope number 2 and so on. Therefore, after opening each envelope, it is determined which group each patient belongs to
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blinded to the groups allocation and other parts of the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of social welfare and rehabilitation sciences
Street address
Koodakyar Blind Alley , Daneshjoo Boulevard , Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.USWR.REC.1401.255
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
Primary outcomes
1
Description
Pain Intensity
Timepoint
Before the intervention - immediately after the end of the intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Disability
Timepoint
Before the intervention - immediately after the end of the intervention
Method of measurement
Knee injury and Osteoartritis Outcome Score questionnaire
2
Description
Muscle stiffness
Timepoint
Before the intervention - immediately after the end of the intervention
Method of measurement
Shear wave elastosonography
3
Description
Joint stiffness
Timepoint
Before the intervention - immediately after the end of the intervention
Method of measurement
Electrogoniometer and pendulum test
4
Description
Pressure pain threshold
Timepoint
Before the intervention - immediately after the end of the intervention
Method of measurement
Algometer
5
Description
Rang Of Motion
Timepoint
Before the intervention - immediately after the end of the intervention
Method of measurement
Standard goniometer
Intervention groups
1
Description
First intervention group: 3 sessions of dry needling twice a week on trigger points plus10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles)
Category
Rehabilitation
2
Description
Second intervention group: 3 sessions of ischemic compression (pressure) twice a week on trigger points plus 10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles)
Category
Rehabilitation
3
Description
Control group: 10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhangian Central Hospital
Full name of responsible person
Mohsen Shams
Street address
Imam Khomeini square, next to Fayaz Bakhsh bus terminal
City
Tehran
Province
Tehran
Postal code
1114655111
Phone
+98 21 6672 7313
Fax
Email
dfm@tehranedu.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Hamidreza Khankeh
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2832
Fax
Email
ha.khankeh@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen Shams
Position
PhD Student of Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7736 4525
Email
mohsenshams48@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen Shams
Position
PhD Student of Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7739 4525
Email
mohsenshams48@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen Shams
Position
PhD Student of Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Koodakyar Blind Alley , Daneshjoo Boulevard , Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7739 4525
Email
mohsenshams48@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available