1. Comparing the intensity of pain between groups
2. Comparing the amount of disability between groups using Oswestry disability questionnaire
3. Comparing passive hip adduction, abduction, internal rotation and external rotation ROM between groups
4. Comparing passive shoulder internal and external rotation ROM between groups
5. Comparing Gleno-humeral internal rotation deficiency(GIRD) between groups
6. Assessment of relation between hip and contralateral shoulder ROM between groups
Design
Single blinded randomized controlled trial, pre-test post-test design. with block Randomization method in 18 patients with chronic non-specific low back pain
Settings and conduct
The process has been performed in a private clinic.
Patients were allocated into control and intervention groups and randomized by block randomization method.
After meeting the inclusion criteria, patients were evaluated at first session and sixth session.
Patients in the treatment group were asked to perform five Postural restoration exercises and patients in the control group were asked to perform five routine exercises.
The process lasted 5 sessions and patients were reevaluated in the sixth session.
Participants/Inclusion and exclusion criteria
1. Patients who had positive Ober`s test on one side indicating pelvic girdle malalignment, and limited contralateral shoulder internal rotation ROM.
2. Patients who didn`t have specific spine pathology like spondylolisthesis, canal stenosis, fracture and infection.
3. At least 3 months had pasted from the first episode of low back pain.
4. Patients who didn`t have any neurologic sign and symptoms like radicular pain, numbness and paresthesia
Intervention groups
Control group: Routine physiotherapy exercise for low back pain
Intervention group: Postural restoration exercise
Main outcome variables
Pain
Disability(Oswestry disability questionnaire)
Hip ROM
Shoulder ROM
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201230049883N1
Registration date:2021-01-18, 1399/10/29
Registration timing:retrospective
Last update:2021-01-18, 1399/10/29
Update count:0
Registration date
2021-01-18, 1399/10/29
Registrant information
Name
Mehran Fathizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6609 8062
Email address
m3hran.fathi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
2019-07-01, 1398/04/10
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-02-20, 1398/12/01
Scientific title
Efficacy of Postural Restoration exercises on pain, ROM and disability of the patients with chronic non-specific low back pain
Public title
Efficacy of Postural Restoration exercises on patients with chronic non-specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pelvic malalignment determined by Ober`s test
Patients with chronic low back pain who has lasted at least 3 months
Patients who don`t have specific pathology causing low back pain like tumors, fractures, infection, spondylolisthesis, canal stenosis
Patients who don`t have previous surgery
BMI less than 30
Patients who don`t have neurologic sign and symptoms like radicular pain or numbness in lower extremities
Patients who are not drug addicted
Patients who are not suffering from mental disorders
Patients who are not pregnant
Patients who don`t have neurological disease like MS or CVA
Patients who don`t have rheumatologic disease
Exclusion criteria:
Inability of the patients to learn the exercises
Bilateral positive Ober`s test
Using pain killers
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
16
Actual sample size reached:
18
Randomization (investigator's opinion)
Randomized
Randomization description
By the use of software, block randomization method was used. There were 5 blocks and patients equally devoted to both control(A) and intervention(B) groups at each block.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were blind to the group(control/intervention) that they were in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of university of social welfare and rehabilitation sciences
Street address
Koodakyar Ave, Daneshjoo Blv, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.USWR.REC.1398.034
Health conditions studied
1
Description of health condition studied
Chronic non-specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before intervention and 12 days later
Method of measurement
Visual analog scale
2
Description
Hip internal and external ROM
Timepoint
Before intervention and 12 days later
Method of measurement
Standard goniometer
3
Description
Hip abduction and adduction ROM
Timepoint
Before intervention and 12 days later
Method of measurement
Inclinometer
4
Description
Score of disability in Oswestry disability questionnaire