Protocol summary

Summary
Objectives: The aim of this study is to investigate hamstring muscle EMG signals, pelvic tilt and back muscle strength changes in chronic LBP patients with hamstring tightness following stretching exerciseusual or strengthening exercise in lengthened position of this muscle. Design: The study is double blind for participants and therapists. Seventy-five 18-60 years chronic non-specific LBP patients with hamstring tightness will be assigned randomly into three groups (25 participants in each) receiving: 1- usual physiotherapy treatment (including: heat, TNS and therapeutic exercise) plus stretching exercise, 2- usual physiotherapy treatment plus strengthening exercise in lengthened position of muscle, and 3- a control group of subjects receiving only usual physiotherapy treatment. Interventions would be with the frequency of three sessions per week for 4 weeks and a total of 12 sessions. Hamstring stretching exercise will be done in lying position for 10 minutes each session. EMG signals from: 1- Hamstring 2- Longisimus 3- Iliocostalis muscles during trunk bending and in full trunk flexion (Flexion Relaxation) will be measured. For each muscle, by dividing root mean square (RMS) value at the end of flexion to RMS of one second of mid flexion, a ratio will be calculated which is the index being assessed. This variable, the RMS of muscles in standing, pelvic tilt and back muscle strength will be measured before and after the intervention too.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201507258035N2
Registration date: 2015-09-16, 1394/06/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-16, 1394/06/25
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
Deputy of research, Kermanshah University of medical sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing electromyographic changes, pelvic tilt and back strength in chronic low back pain sufferers with tight hamstring muscle in stretching exercise group and strength exercise in lengthened position group. A randomized controlled clinical Trial
Public title
Comparing usual physiotherapy treatment and stretching exercise for tight hamstring muscle in chronic low back pain sufferers
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) and 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: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study is double blind as the participants and the tester would not be aware of the research groups.

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
2015-06-23, 1394/04/02
Ethics committee reference number
kums.rec.1394.26

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 hamstring
Timepoint
Before and after the intervention
Method of measurement
with surface EMG equipment

2

Description
Pelvic tilt angle
Timepoint
Before and after the intervention
Method of measurement
With inclinometer

3

Description
Back muscles strength
Timepoint
Before and after the intervention
Method of measurement
With dynamometer

Secondary outcomes

empty

Intervention groups

1

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

2

Description
Usual Physiotherapy Treatment (Including: heat, TNS and therapeutic exercise).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Outpatient Clinic, Kermanshah University of Medical Sciences
Full name of responsible person
MohammadBagher Shamsi
Street address
Dolat Abad St.
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 Farid Najafi
Street address
Shahid Beheshti Boulevard, Deputy of Research, Kermanshah University of Medical Sciences
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
Kermanshah
Postal code
Phone
+98 83 3724 1929
Fax
Email
mshamsi@kums.ac.ir ; mbshamsi@yahoo.com
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...