Protocol summary

Study aim
To find out the evidence about the improvement in body weight and its impact on the biomechanical changes of pelvis and lumber spine after Dieting alone, Diet +Soft tissue release, Diet +Strength exercise, Diet +Aerobic exercise as well as comparing the biomechanical characteristics between these groups to find out the best method for the management of low back pain.
Design
This is a single blind randomized clinical trial study. 80 participants will be randomly allocated into 4 groups and total 6 weeks interventions would be given consisting of 5 sessions per week (30 sessions) for exercises and soft tissue release group along with continuous dieting.
Settings and conduct
Data would be collected randomly from Karachi, Pakistan population referred to physiotherapy clinic. Before and after 6 weeks interventions, outcome measurements will be assessed in each group.
Participants/Inclusion and exclusion criteria
Non specific low back pain; age between 25 to 40years; Anterior pelvic more than 13.5 degree; Grade I and II obesity without Current dermatological or inflammatory illness,Recent fracture, Congenital lower extremity abnormalities, Breathing difficulties,Cardiovascular, pulmonary, hepatic, renal, and hematological disorders
Intervention groups
The participants aged between 25-40 years will be assigned in four groups according to their BMI. A comprehensive Rehabilitation plan would be formulated after assessment, incorporating diet only as control group, diet +soft tissue release, diet +strengthening exercise group and diet +aerobic exercise group, all following 500 kcal diet deficit in their daily caloric requirement.
Main outcome variables
Pain; disability; Quality of life; pelvic tilt; body fat percentage; muscle strength; muscle thickness; aerobic fitness,waist hip ratio; muscle length for rectus femoris and Iliopsoas

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130121012210N10
Registration date: 2023-03-14, 1401/12/23
Registration timing: prospective

Last update: 2023-03-14, 1401/12/23
Update count: 0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Azadeh Shadmehr
Name of organization / entity
Teharn University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8468
Email address
shadmehr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the different type of corrective exercises along with Diet on Anterior Pelvic Tilt in obesity Impacting Low Back Pain Patients
Public title
Comparison between the different corrective exercises along with Diet on improvement of Low Back Pain Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects with NSLBP Age between 25 to 40years Anterior pelvic tilt more than 13.5 degree Grade I and II obesity
Exclusion criteria:
ِDermatological or inflammatory illness Recent fractures Congenital lower extremity abnormalities Cardiovascular, pulmonary, renal and hematological disorders
Age
From 25 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects in this study are randomly placed in one of the three study groups based on random number table and receive the intervention related to the same group.
Blinding (investigator's opinion)
Single blinded
Blinding description
assessor is blind regarding to the groups and interventions.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commeetee of Tehran University of Medical sciences
Street address
Central building of TUMS,Ghods Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-01-18, 1401/10/28
Ethics committee reference number
IR.TUMS.FNM.REC.1401.144

Health conditions studied

1

Description of health condition studied
low back pain
ICD-10 code
S30.0
ICD-10 code description
Contusion of lower back and pelvis

Primary outcomes

1

Description
pain
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
according to the Visual analog scale

2

Description
Disability
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
Oswestry Disability Index questionnaire

3

Description
Quality of life
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
SF-36 questionnaire

4

Description
Pelvic Tilt
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
photogrammetry

5

Description
body composition
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
Bioelectrical impedance analysis

6

Description
Muscle strength
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
Dynamometer

7

Description
Muscle thickness
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
Ultrasounography

8

Description
Aerobic Fitness
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
Bruce Protocol

9

Description
Waist-Hip Ratio
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
circumference of the waist to that of the hips by tape

10

Description
muscle length
Timepoint
before treatment, at the end of treatment (after the 6th week)
Method of measurement
Thomas Test

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The participants would be assessed by a nutritionist and their basal metabolic rate (BMR) would be calculated and finally Recommended Caloric Requirement (RCR) calculation. In RCR 500 kcal deficit would be given which is equivalent to one pound of fat which contains 3500 kcal in week. The participants will follow the regimen for 6 weeks.
Category
Rehabilitation

2

Description
Intervention group: Diet + Soft tissue release Group, This group would follow the same diet of control group. In Addition soft tissue release for Iliopsoas and Rectus femoris would be given for 6 weeks, 5 times per week (30 sessions)
Category
Rehabilitation

3

Description
Intervention group: Diet + Strengthening exercise Group, The same protocol for diet would be given. In addition strengthening training for Pectoralis major , Lattismus Dorsi , Deltoid , Trapezius , Biceps, Triceps, Quadriceps , Hamstrings, Rectus abdominus , Erector spinae and Gastrocnemius soleus would be formulated and supervised for 6 weeks, 5 sessions per week (30 sessions).
Category
Rehabilitation

4

Description
Intervention group: Diet + Aerobic exercise Group, The same protocol for diet would be given. In addition aerobic training which will be apply by exercise between 70% to 75% of Max Heart Rate for 40 minutes per session for 5 days per week for 6 weeks (30 sessions).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation
Full name of responsible person
Azadeh Shadmehr
Street address
Piche Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 3939
Email
shadmehr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
علی اکبر فتوحی
Street address
Main Campous, Qods Street, Engelab street
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Muhammad Sarfraz
Position
Resident
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Piche Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
mohdpk23@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Piche shemiran, Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
shadmehr@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Muhammad Sarfraz
Position
resident
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Piche shemiran, Enghelab street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Email
mohdpk23@hotmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
No - There is not 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
Data Dictionary
No - There is not a plan to make this available
Loading...