Protocol summary
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Study aim
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Comparison of Extracorporeal Shock Wave Therapy Radial Muscle Effect with Corticosteroid Injection for the Treatment of Patients with Preforms Syndrome
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Design
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Clinical trial with intervention and control group with a sample size of 35 people, in parallel group, single blind, randomized with closed envelope
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Settings and conduct
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The study population is patients referred to physical medicine and rehabilitation clinics of Firoozgar and Rasoul Akram hospitals in Tehran. Patients are examined by a specialist in physical medicine and rehabilitation and entered into the plan if necessary. This study is a randomized, single-blind clinical trial that is divided into two groups by randomized closed envelope.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Chronic pain in Batuk at least 3 months
Age over 20 years
Their pain intensity should be at least 5 out of 10 according to the Visual Analogue Scale criteria
Exclusion criteria:
Symptoms of lumbar discus
Have a pregnancy or pregnancy plan
Have a history of disc surgery
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Intervention groups
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Shock therapy group and corticosteroid injection group
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Main outcome variables
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Severity of pain; quality of life
General information
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Reason for update
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According to similar studies, we increased the sample size of the study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191027045252N1
Registration date:
2020-01-10, 1398/10/20
Registration timing:
registered_while_recruiting
Last update:
2020-12-23, 1399/10/03
Update count:
1
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Registration date
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2020-01-10, 1398/10/20
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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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2019-12-22, 1398/10/01
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Expected recruitment end date
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2020-09-22, 1399/07/01
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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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Comparison of the efectiveness of Radial Extracorporeal Shock wave Therapy and corticosteroid injection of piriformis muscle for treatment patients suffering of piriformis syndrome
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Public title
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Comparison of the efficacy of in vivo shock therapy with corticosteroid injection in the treatment of piriformis syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Chronic pain in Batuk, thigh and lower extremity for at least 3 months
Patients must be over 20 years of age
Screening of all patients for lumbar disc herniation and lumbar radiculopathy by MRI.
Their pain intensity should be at least 5 out of 10 according to the Visual Analogue Scale criteria
Exclusion criteria:
Symptoms of lumbar discus, coxopathy, mechanical or inflammatory disorders of the sacroiliac joint
Any inflammatory, infectious, or pelvic abnormalities
Have a pregnancy or pregnancy plan
Have a history of disc surgery and any epidural block over the past 6 months.
Patients who do not go for follow-up for any reason.
Changes in the patient's treatment according to the physician's opinion or other treatment by the patient during the study
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Age
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From 20 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
35
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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, in which each member of society has an equal and independent chance of being elected. The randomization procedure will use a randomized block with quadratic and binary blocks. Given the sample size of 35 people, 8 quadruple blocks and 1 binary blocks will be generated and numbered using the permutations method. Using the random number table, blocks will be placed together to form a sequence of patients assigned to treatment groups. Therefore, prior to selecting the participants, the type of treatment they receive will be unaware, and the random sequence generated during the study will be unpredictable.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Due to the difference in the nature of the therapeutic intervention in the two groups, only the data analyzer will be blind.
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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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2019-09-23, 1398/07/01
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Ethics committee reference number
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IR.IUMS.FMD.REC.1398.234
Health conditions studied
1
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Description of health condition studied
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Piriformis syndrome
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ICD-10 code
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G57.0
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ICD-10 code description
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Lesion of sciatic nerve
Primary outcomes
1
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Description
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Severity of pain
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Timepoint
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Baseline, 7, 30, 60, and 90 days after Intervention
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Method of measurement
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Visual Analogue Scale
2
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Description
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Quality of Life
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Timepoint
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Baseline and 30 days after Intervention
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Method of measurement
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36-Item Short Form Survey (SF-36) questionnaire
Intervention groups
1
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Description
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Intervention group: Patients undergoing shockwave therapy, three sessions, each lasting 7 to 10 days. Shockwave is performed with the Storz Medical Shock Wave MP100. Each session of shockwave therapy with 2000 pulses and a total of 6000 pulses in three sessions, energy flux density equal to 0.18 mJ / mm², 5 Hz frequency, 4 bar pressure rate, Dose per treatment equal to 0.18 mJ / mm2 = 2,000 360 mJ / mm2 and Total energy dose (TED) equal to 1.080 J / mm2.
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Category
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Treatment - Devices
2
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Description
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Control group: Patients treated with 40 mg methylprednisolone plus 1 cc lidocaine 1% undergo sonography in the piriformis muscle.
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Category
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Treatment - Drugs
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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Iran University of Medical 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The extent of pain relief can be shared according to the Visual Analogue Scale.
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When the data will become available and for how long
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Access started from 1400
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To whom data/document is available
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Study data will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Access to the data will be allowed for epidemiological study and can be sent by email.
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From where data/document is obtainable
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To receive data, you could call 00989123190373 or contact arastoo.yousefi@gmail.com.
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What processes are involved for a request to access data/document
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Individuals who request data, must provide their academic, Scientific documents and the reason for their requests to arastoo.yousefi@gmail.com.
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Comments
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