Comparing the effects of shock wave therapy and dry needling in reducing the pain of the trigger points of the cuff muscles in order to provide a model for reducing pain in these patients.
Design
A clinical trial with an intervention group and a control group with a sample size of 84 people, as a parallel group, one blind strain, randomized by lottery method.
Settings and conduct
The studied population is patients referred to physical medicine and rehabilitation clinic of Firouzgar Hospital in Tehran. Patients are examined by a physical medicine and rehabilitation specialist and enter the plan if they meet the necessary criteria. This study is a randomized clinical trial with a blind evaluator, who are divided into two groups by lottery.
Participants/Inclusion and exclusion criteria
Conditions for entering the study:
1- Age between 16 and 60 years
2- Patient satisfaction
3-Having at least one active trigger point in the cuff area
4- Duration of symptoms for at least 6 months
Exclusion criteria:
1- Presence of neurological defects (weakness, paraesthesia, etc.)
2- History of lumbar discopathy, lumbar disc herniation, myopathy, fibromyalgia, spondylosis, spinal canal stenosis
3- Current drug treatments or physical therapy, surgery and injection in trigger point in the last 6 months
4- Simultaneous painful disorders so that the main complaint of the patient is simultaneous pain
5- Mental disorder
6-Rheumatological diseases
Intervention groups
For the first intervention group, shock wave therapy is performed and for the second intervention group, dry needling is performed.
Main outcome variables
pain and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230801058995N1
Registration date:2023-10-03, 1402/07/11
Registration timing:prospective
Last update:2023-10-03, 1402/07/11
Update count:0
Registration date
2023-10-03, 1402/07/11
Registrant information
Name
Reza Shokri koltapeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3662 2054
Email address
rezashokri70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ESWT versus Dry Needling in treatment of myofascial trigger points in calf muscle
Public title
Comparison of ESWT versus acupuncture in treatment of myofascial trigger points in calf muscle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 16 and 60 years
Patient satisfaction
Having at least one active trigger point in the cuff area
Duration of symptoms for at least 6 months
Exclusion criteria:
Presence of neurological defects (weakness, paresthesia, etc.)
History of lumbar discopathy, lumbar disc herniation, myopathy, fibromyalgia, spondylosis, spinal canal stenosis
Current drug treatments or physical therapy, surgery and injection in trigger point in the last 6 months
Simultaneous painful disorders so that the main complaint of the patient is simultaneous pain
Mental disorder
Rheumatological diseases
Age
From 16 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into intervention and control groups by randomization method in the form of lottery. In this way, based on the number of samples, half of the lots will receive only shockwave and the other half will receive dry needling. Then, one lot will be drawn for each patient by the person performing it (physical medicine and rehabilitation assistant) who will be constant and not the evaluator of the research. And the intended intervention is implemented for the patient
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding for the analyzer is that the selected intervention for each patient is written in the demographic questionnaire using a lottery by the person performing it, and the analyzer is written on the way of grouping and the type of treatment selected for the patients until the end of the 6-month evaluation. will not be aware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower، 14535
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-09-28, 1401/07/06
Ethics committee reference number
IR.IUMS.FMD.REC.1401.360
Health conditions studied
1
Description of health condition studied
Myofascial trigger point
ICD-10 code
M79.1
ICD-10 code description
Myalgia
Primary outcomes
1
Description
Pain variable is evaluated by two scales.PPT is calculated by using a digital algometer by applying vertical pressure to the trigger points. In order to stimulate the patient's pain, the pressure is increased at a rate of 1Kg/Cm2/s and the subjective reports of the people are recorded. The place of maximum pain is at a distance of 1 minute will be checked again.Visual analog scale (VAS) measures the intensity of the patient's pain. Validation and reliability studies have been done. The VAS scale is divided into 10 vertical or horizontal lines from zero (no pain) to 10 points (the most severe pain).n of general health, vitality, social role function, limitation in emotional function and health. It is fluent. The checklist is attached.Visual analog scale (VAS) measures the intensity of the patient's pain. Validation and reliability studies have been done. The VAS scale is divided into 10 vertical or horizontal lines from zero (no pain) to 10 points (the most severe pain).
Timepoint
VAS and PPT variables are completed for each patient immediately after completing three sessions of shock wave and dry needling, and then one month and three months after the completion of the interventions. Also, the VAS variable is checked again six months after the end of the interventions
Method of measurement
PPT is calculated using a digital algometer (Brandwagner) by applying vertical pressure to the trigger points. In order to stimulate the patient's pain, the pressure is increased at a rate of 1 Kg/Cm2/s and the subjective reports of the people are recorded.The VAS scale is divided into 10 vertical or horizontal lines from zero (no pain) to 10 points (the most severe pain).
Secondary outcomes
1
Description
The quality of life is measured by the 36-item short form (SF-36), which is the most widely used general quality of life scale in the medical field. It includes 8 sub-categories, which are 36 items in total, and evaluates physical and mental health in general. The sub-categories include physical function, difficulty in performing physical activity, pain, perceptio
Timepoint
It is completed immediately after three sessions of shock wave and dry needling, and then one month and three months after the completion of the interventions for each patient.
Method of measurement
In this study, the quality of life is calculated by the SF-36 questionnaire.
Intervention groups
1
Description
The first intervention group is subjected to shockwave therapy, which is provided once a week for three consecutive weeks. Shockwave therapy using Storz medical masterpulse MP100 device is applied in each session with settings: intensity 1.5 to 3 times, 1000 impulses in the trigger point area and 500 impulses around and 10 Hz frequency and for 3-4 minutes.
Category
Treatment - Devices
2
Description
In the dry needling group, the treatment will be done with disposable dong-bang stainless steel needles in sizes 0.25 x 0.4 after sterilizing the needle insertion site in painful points with alcohol cotton. The needles are inserted through the guide tube in the specified painful points, and the depth of the needles is 15-30 mm, and they remain in place for 20 minutes in each session, and at the 10th minute, the needles are rotated for re-stimulation.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital, Tehran
Full name of responsible person
Reza Shokri Koltapeh
Street address
Waliasr Square, Karim Khan Zand St., Beh Afrin St
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8214 1000
Email
firoozgarhospital1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Musavi Zadeh
Street address
Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mousavik@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?