Protocol summary

Summary
The purpose of this study was to compare lumbar muscle specific stabilization exercises with general exercises used for reducing pain and disability among patients with spondylolysis and spondylolisthesis.This single-blind, randomized controlled trial was performed at Zahedan University of Medical Sciences, in 2009. Twenty-four patients with spondylolysis and spondylolisthesis participated through simple non-probability sampling. Patients were selected based on following inclusion criteria: Nonspecific LBP for a period of at least 3 months, participants aged over 18 and less than 80 years old, appropriateness of motor control exercise in accordance with clinical assessment, patients who have not been contraindicated from doing exercise based on PARQ, participants diagnosed with Isthmic Spondylolysis or Spondylolisthesis by specialist, and patients who have not been contraindicated from doing exercise based on the (American College of Sports Medicine) ACSM guidelines. Patients were excluded if they had suspected for spinal pathology, pregnancy, nerve root complications, spinal column surgery, insufficient treatment, using other therapeutic modalities during the study. Subjects were randomly assigned to either the stabilization (N=12) or the general exercise group (N=12). Before and after intervention, we assessed pain (ordinal) through Visual Analogue Scale (VAS), lumbar lordosis (degree) with flexible ruler, range of lumbar flexion (centimeter) using Modified Schober test, and disability (ordinal) with The Oswestry Disability Index (ODI). A 24 session's exercise program which lasted 12 weeks, twice per week, and 30 minutes per session was performed for both groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106231675N6
Registration date: 2011-09-21, 1390/06/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-21, 1390/06/30
Registrant information
Name
Asghar Akbari
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1322 8445
Email address
akbaria@zdmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Zahedan University of Medical Sciences
Expected recruitment start date
2009-04-30, 1388/02/10
Expected recruitment end date
2010-03-11, 1388/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of Lumbar Specific Stabilization Exercises and General Exercises for Reducing Pain and Disability: A Randomized Controlled Trial of Patients with Spondylolysis and Spondylolisthesis
Public title
A Comparison of Lumbar Specific Stabilization Exercises and General Exercises for Reducing Pain and Disability: A Randomized Controlled Trial of Patients with Spondylolysis and Spondylolisthesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Nonspecific LBP for a period of at least 3 months; Participants aged over 18 and less than 80 years old; Appropriateness of motor control exercise in accordance with clinical assessment; Patients who have not been contraindicated from doing exercise based on PARQ; Participants diagnosed with Isthmic Spondylolysis or Spondylolisthesis by specialist; and Patients who have not been contraindicated from doing exercise based on the (American College of Sports Medicine) ACSM guidelines. Exclusion criteria: Patients suspected for spinal pathology; Pregnancy; Nerve root complications; Spinal column surgery; Insufficient treatment; Using other therapeutic modalities during the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
No registration
Secondary trial Id
No trial id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq., Zahedan.
City
Zahedan
Postal code
Approval date
2011-07-10, 1390/04/19
Ethics committee reference number
90-874

Health conditions studied

1

Description of health condition studied
Spondylolysis and Spondylolisthesis
ICD-10 code
M43.0 and
ICD-10 code description
Other deforming dorsopathies

Primary outcomes

1

Description
Back pain
Timepoint
Before intervention, 12 weeks after intervention
Method of measurement
Visual Analogue Scale

2

Description
Angle of lumbar lordosis
Timepoint
Before intervention, 12 weeks after intervention
Method of measurement
Flexible ruler

3

Description
Range of lumbar flexion
Timepoint
Before intervention, 12 weeks after intervention
Method of measurement
Modified Schober Test

4

Description
Disability
Timepoint
Before intervention, 12 weeks after intervention
Method of measurement
The Oswestry Disability Index

Secondary outcomes

empty

Intervention groups

1

Description
Lumbar Specific Stabilization Exercises: A 24 session's exercise program which lasted 12 weeks, twice per week, and 30 minutes per session
Category
Rehabilitation

2

Description
General Exercises: Including classic abdominal and back exercises: A 24 session's exercise program which lasted 12 weeks, twice per week, and 30 minutes per session
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razmejo-Moghadam Physiotherapy Clinic
Full name of responsible person
Dr. Asghar Akbari
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mahmodzadeh Sagheb
Street address
Deputy 0f Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq., Zahedan.
City
Zahedan
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 of Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Asghar Akbari
Position
Ph.D in Physiotherapy, Head of Dept. of Physiotherapy.
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1325 8445
Fax
+98 32 15957
Email
akbari_as@yahoo.com; akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Head of Dept. of Physiotherapy, Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1322 8445
Fax
+98 54 1321 5957
Email
akbari_as@yahoo.com; akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Ph.D in Physiotherapy, Head of Dept. of Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St., Zahedan.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 1322 8445
Fax
+98 54 1321 5957
Email
akbari_as@yahoo.com; akbaria@zaums.ac.ir
Web page address
www.zaums.ac.ir

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
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