Comparing stretching exercise and compression exercise on electeromyography of back muscles and leg muscles innervated by sciatic nerve during flexion relaxation phenomenon in patients suffering from low back pain having piriformis syndrome
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Protocol summary
A clinical trial with the control group, with parallel groups, double-blind, randomised, on 45 patients.
A clinical trial with the control group, with parallel groups, single-blind, randomised, on 45 patients.
A clinical trial with the control group, with parallel groups, doublesingle-blind, randomised, on 45 patients.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده، بر روی 45 بیمار.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور ، تصادفی شده، بر روی 45 بیمار.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دویک سویه کور ، تصادفی شده، بر روی 45 بیمار.
General information
Not blinded
Single blinded
notblsingl
1
1
1
1
The number of patients was not available at first and sampling in this clinical trial was performed continuously and patient selection and sampling based on defined inclusion and exclusion criteria, continued until the desired sample size (from 1397 to Year 1400). For this reason, sampling was continuous and continued
Because of the interventional trial design and type of interventions, it is not possible to blind patients to treatment allocation.
A principal assessor who was responsible for completing all outcome measures was blinded to the patients' allocation up to the end of the trial.
The numberBecause of the interventional trial design and type of interventions, it is not possible to blind patients to treatment allocation. A principal assessor who was not available at first and sampling in this clinical trialresponsible for completing all outcome measures was performed continuously and patient selection and sampling based on defined inclusion and exclusion criteria, continued untilblinded to the desired sample size (from 1397patients' allocation up to Year 1400)the end of the trial. For this reason, sampling was continuous and continued
تعداد بیماران مورد نظر در ابتدا در دسترس نبودند و نمونه گیری در این کارآزمایی بالینی به صورت مستمر انجام شد و انتخاب بیماران و نمونه گیری بر اساس معیارهای ورود و خروج تعریف شده، تا رسیدن به حجم نمونه مورد نظر ادامه داشت (از سال 1397 تا سال1400). به همین دلیل نمونه گیری مستمر بود و ادامه داشت
به دلیل نوع مداخلات، امکان کورسازی بیماران از تخصیص درمان وجود نداشت. با این حال، ارزیاب اصلی که مسئول اندازه گیری پیامدها بود، تا پایان مطالعه نسبت به مداخلات ناآگاه بود.
تعدادبه دلیل نوع مداخلات، امکان کورسازی بیماران مورد نظر در ابتدا در دسترس نبودند و نمونهاز تخصیص درمان وجود نداشت. با این حال، ارزیاب اصلی که مسئول اندازه گیری در این کارآزمایی بالینی به صورت مستمر انجام شد و انتخاب بیماران و نمونه گیری بر اساس معیارهای ورود و خروج تعریف شدهپیامدها بود، تا رسیدنپایان مطالعه نسبت به حجم نمونه مورد نظر ادامه داشت (از سال 1397 تا سال1400). به همین دلیل نمونه گیری مستمرمداخلات ناآگاه بود و ادامه داشت.
A principal assessor who is responsible to complete all outcome measures will be blinded to the patients' allocation.
A principal assessor who is responsible to complete all outcome measures will be blinded to the patients' allocation.
محقق اصلی که مسئول تکمیل و ارزیابی پیامدها است، نسبت به تخصیص بیماران بی اطلاع خواهد بود.
محقق اصلی که مسئول تکمیل و ارزیابی پیامدها است، نسبت به تخصیص بیماران بی اطلاع خواهد بود.
Protocol summary
Study aim
To compare the effect of stretching and compression exercises on FRP (EMG) activity of lumbar muscles in patients with deep gluteal syndrome.
Design
A clinical trial with the control group, with parallel groups, single-blind, randomised, on 45 patients.
Settings and conduct
Among the patients with low back pain with piriformis syndrome referred to the special clinic (Mahdieh) of Kermanshah University of Medical Sciences who have piriformis syndrome, 45 people were randomly divided into one of the groups: 1- Piriformis stretching exercise, 2- Piriformis compression exercise. 3-control.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients with the deep gluteal syndrome, between 18 and 60 years of age. .
Exclusion criteria are the diagnosis of other types of LBP such as disc herniation or spondylolisthesis, any pathology of the hip joint or any recent injury around the pelvis or knee, systemic disease that can affect the general condition of the participant such as severe diabetes and Obesity.
Intervention groups
Patients will be randomly assigned to one of the stretching, compression or control exercises. All treatment groups will receive 10 sessions of physiotherapy 3 times a week.
All patients will receive a general physiotherapy treatment including 15 minutes of hot pack and 15 minutes of electrical stimulation of the nerve.
Main outcome variables
Before and after the intervention, electromyographic signals of the muscles are recorded.
Pain and disability of patients before and after the intervention will be measured by the VAS scale and Oswestry index.
General information
Reason for update
Because of the interventional trial design and type of interventions, it is not possible to blind patients to treatment allocation.
A principal assessor who was responsible for completing all outcome measures was blinded to the patients' allocation up to the end of the trial.
Acronym
IRCT registration information
IRCT registration number:IRCT201604178035N4
Registration date:2017-01-10, 1395/10/21
Registration timing:prospective
Last update:2022-07-15, 1401/04/24
Update count:2
Registration date
2017-01-10, 1395/10/21
Registrant information
Name
MohammadBagher Shamsi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3838 4185
Email address
mshamsi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2021-12-30, 1400/10/09
Actual recruitment start date
2017-03-30, 1396/01/10
Actual recruitment end date
2021-12-30, 1400/10/09
Trial completion date
2021-12-30, 1400/10/09
Scientific title
Comparing stretching exercise and compression exercise on electeromyography of back muscles and leg muscles innervated by sciatic nerve during flexion relaxation phenomenon in patients suffering from low back pain having piriformis syndrome
Public title
The study of stretching exercise and compression exercise on treatment of patients suffering from a specific kind of low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. The age range of the subjects is 18-69 years.
2. Patients must be approved by a physiotherapy specialist.
3. Willingness to participate in the study
Exclusion criteria:
Diagnosed with other types of Low Back Pain such as disc herniation or spondylolisthesis
Patients with severe diabetes and obesity.
Patients with hip or knee injuries.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
.Randomization is performed by Random Allocation computer software by a statistician which has no role in the study in such a way that a random order of three letters A (intervention 1), B (intervention 2) and C (control) in blocks will be made with random numbers 6 (For example ABCACA). Before starting the intervention, a research assistant puts the patients in one of the three intervention groups (stretching or compression exercises) or control (conventional physiotherapy).
Blinding (investigator's opinion)
Single blinded
Blinding description
A principal assessor who is responsible to complete all outcome measures will be blinded to the patients' allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard
Intervention group 1: Stretching Exercise-- Treatment will be three times a week and 10 sessions. patients will be lying flat in a supine position. They will be positioned their healthy foot up against a wall and held the position. They lie on their back and placed their ankle on the affected side over the other knee.
Category
Rehabilitation
2
Description
Intervention group 2: Compression exercises-- Treatment will be three times a week and 10 sessions. patients were sitting on top of a foam roller with the roll positioned on the back of the hip. They cross their affected leg on top of their other knee (to stretch the muscle) and slightly rolled on the lateral buttock area at the point of tenderness.
Category
Rehabilitation
3
Description
Control group: Received conventional physiotherapy-15 minutes of heat (Hot Pack)(8) and 15 minutes of conventional transcutaneous electrical nerve stimulation (TENS)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Clinic of Kermanshah University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Street address
Javanshir Street
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 918 831 0161
Email
MBSHAMSI@YAHOO.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrooz Hamzeh
Street address
Vice Chancellor for Research of Kermanshah University of Medical Sciences , Shahid beheshti Boulevard,
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3816 2315
Email
mbhamsi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical 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
Kermanshah University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3724 1929
Fax
Email
mbshamsi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3724 1929
Fax
Email
mbshamsi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3816 2315
Fax
Email
mbshamsi@yaoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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