History
# Registration date Revision Id
4 2022-06-12, 1401/03/22 233461
3 2022-06-01, 1401/03/11 229516
2 2017-01-10, 1395/10/21 8473
1
This trial has some update history items in old IRCT format. To see these history items click here.
Changes made to previous revision
This is the first revision

Protocol summary

Summary
Thirty low back pain sufferers referred to the outpatient clinic of Kermanshah University of Medical Sciences with piriformis syndrom (having pain in buttock and difficulty in sitting and positive Freiberg's, Pace's and Heel-contralateral knee maneuvers which cause pain in the muscle) will be allocated randomly in two groups: 1- Piriformis stretching exercise, 2- Piriformis compression exercise. Treatment in both groups will be three times a week and 10 sessions totally. Fifteen minutes of local heat (hot pack) and TNS stimulation will be common for all patients. In the first group 3 sets of 2 minutes of muscle stretching will be applied and in the second group 3 sets of 2 minutes of muscle compression will be applied. Before and after the intervention, EMG signals from: 1-Longisimus 2-Iliocostalis muscles 3-Gastrocnemius 4-Tibialis anterior in 4 positions (1-Relaxed standing, 2-Supine lying, 3-Stretching position of the muscle (side lying with flexed upper knee and hip) and 4-Standing with bending trunk) will be measured. The root mean square (RMS) of EMG signals will be our outcome measure. Pain and disability of patients before and after the intervention will be measured by VAS scale and Oswestry index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604178035N4
Registration date: 2017-01-10, 1395/10/21
Registration timing: prospective

Last update:
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
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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: having LBP for more than 3 months; pain intensity from 3 to 6 in visual analogue scale (VAS); positive Freiberg's test; Positive Pace's and Heel-contralateral knee maneuvers; and also age of 18 to 60 years. Exclusion criteria: history of having pathology or anomaly in lower limbs such as malignancy; inflammatory diseases; severe osteoporosis; arthritis; or bone diseases.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
City
Kermanshah
Postal code
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
kums.rec.1395.169

Health conditions studied

1

Description of health condition studied
Low Back Pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified

Primary outcomes

1

Description
Electromyografic amplitude of 1- Longisimus 2- Iliocostalis muscles 3- Gastrocnemius 4- Tibialis anterior
Timepoint
Before and after the intervention
Method of measurement
With surface electromyography

Secondary outcomes

1

Description
Pain
Timepoint
Before and after the intervention
Method of measurement
VAS

2

Description
Disability
Timepoint
Before and after the intervention
Method of measurement
Oswestry Disability Index

Intervention groups

1

Description
Stretching Exercise (Ten minutes of exercises for stretching the piriformis muscle each session)
Category
Rehabilitation

2

Description
Dry needling
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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, 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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Position
PhD
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3724 1929
Fax
Email
mshamsi@kums.ac.ir ; 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
PhD
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3724 1929
Fax
Email
mshamsi@kumms.ac.ir ; 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
PhD
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Behshti Boulevard
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...