Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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1- dry needling plus routine physiotherapy
2- Ischemic pressure plus routine physiotherapy
3- Routine physiotherapy alone
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Main outcome variables
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Pain intensity, disability, muscle stiffness, joint stiffness, pressure pain threshold and knee range of motion
General information
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Reason for update
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Referee's recommendation
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Acronym
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IRCT registration information
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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
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Registration date
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2023-04-13, 1402/01/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-05-01, 1402/02/11
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Expected recruitment end date
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2023-10-22, 1402/07/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Comparing the effectiveness of dry needling and ischemic pressure on trigger points in knee osteoarthritis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 50 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the outcome assessor is blinded to the groups allocation and other parts of the study
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-15, 1401/12/24
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Ethics committee reference number
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IR.USWR.REC.1401.255
Health conditions studied
1
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Description of health condition studied
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Knee osteoarthritis
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ICD-10 code
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M17.0
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ICD-10 code description
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Bilateral primary osteoarthritis of knee
Primary outcomes
1
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Description
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Pain Intensity
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Timepoint
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Before the intervention - immediately after the end of the intervention
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Method of measurement
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Visual Analog Scale
Secondary outcomes
1
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Description
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Disability
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Timepoint
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Before the intervention - immediately after the end of the intervention
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Method of measurement
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Knee injury and Osteoartritis Outcome Score questionnaire
2
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Description
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Muscle stiffness
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Timepoint
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Before the intervention - immediately after the end of the intervention
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Method of measurement
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Shear wave elastosonography
3
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Description
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Joint stiffness
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Timepoint
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Before the intervention - immediately after the end of the intervention
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Method of measurement
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Electrogoniometer and pendulum test
4
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Description
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Pressure pain threshold
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Timepoint
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Before the intervention - immediately after the end of the intervention
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Method of measurement
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Algometer
5
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Description
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Rang Of Motion
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Timepoint
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Before the intervention - immediately after the end of the intervention
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Method of measurement
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Standard goniometer
Intervention groups
1
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Description
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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)
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Category
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Rehabilitation
2
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Description
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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)
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Category
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Rehabilitation
3
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Description
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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)
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of social welfare and rehabilitation sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available