Protocol summary

Summary
The aim of this study was to compare the effects of the motor control exercises and back muscle endurance exercises with Kinesio taping on balance indices in patients with nonspecific chronic low back pain. This randomized clinical trial was performed in Zahedan University of Medical Sciences, in 2015 2016. 33 Patients with nonspecific chronic low back pain were selected through non probability sampling method. The patients were selected based on following inclusion criteria: no history of vestibular disorders, hip and lower extremity musculoskeletal disorders, cardiovascular disorders, uncorrectable vision problems, and age between 18 to 58 years. Exclusion criteria included: more than three consecutive absences from the treatment sessions, Exercises aggravate patients' pain and receiving or doing other therapies during the study. The subjects were randomly allocated to two groups: motor control Exercises group and back muscle endurance exercises with Kinesio taping group. Each of the two groups received their interventions for 5 weeks and 3 sessions per week. Before and after the period of the interventions, overall, anteroposterior and mediolateral stability indices were measured through the postural stability test of Biodex Balance System.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201306121675N12
Registration date: 2016-05-29, 1395/03/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-29, 1395/03/09
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
2015-11-11, 1394/08/20
Expected recruitment end date
2016-03-16, 1394/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motor control exercises versus back muscle endurance training with kinesio taping on the balance indices in patients with nonspecific chronic low back pain
Public title
The effect of motor control exercises and back muscle endurance training with kinesio taping on balance of patients with low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 58 years; patients with nonspecific chronic low back pain who their pain improved with rest and got worse during activity; no history of vestibular disorders and musculoskeletal disorders in hip and lower extremities; no history of radicular pain, spinal stenosis, any neurologic sign, systemic infection, cardiovascular and balance disorders, uncorrectable vision problems, severe deformity of musculoskeletal injury to the leg or medication one week before the test session; not pregnant; no history of diabetes, respiratory disorders, spinal surgery, nerve root pain, severe spinal deformity or disease; no history of metabolic, systemic, inflammatory diseases, arthritis and malignancies. Exclusion criteria: patients who were absent more than three consecutive sessions of treatment; patients who doing exercises aggravated their pain; receiving or doing other therapies during the study.
Age
From 18 years old to 58 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Subjects were randomly assigned into two groups by random draw.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
Zahedan
Postal code
9816843463
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
ir.zaums.rec.1394.276

Health conditions studied

1

Description of health condition studied
Nonspecific chronic low back pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified

Primary outcomes

1

Description
Overall stability index
Timepoint
Before and after the period of the interventions
Method of measurement
Biodex Balance System

2

Description
Anteroposterior stability index
Timepoint
Before and after the period of the interventions
Method of measurement
Biodex Balance System

3

Description
Mediolateral stability index
Timepoint
Before and after the period of the interventions
Method of measurement
Biodex Balance System

Secondary outcomes

empty

Intervention groups

1

Description
Back muscles endurance training with Kinesio Taping group: Fifteen training sessions during 5 consecutive weeks, three times per week, 30 or 40 minutes per session including: Twenty minutes for receiving hot pack and TENS and 10 or 20 minutes for training the exercises and applying the Kinesio Taping.
Category
Rehabilitation

2

Description
Motor control exercises group: Fifteen training sessions during 5 consecutive weeks, three times per week, 30 or 40 minutes per session including: Twenty minutes for receiving hot pack and TENS and 10 or 20 minutes for training the exercises
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.
City
zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hoshang rafigdost
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
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, 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
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 3342 4675
Fax
+98 54 3342 4675
Email
akbari_as@yahoo.com; a.akbari@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
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 3342 4675
Fax
+98 54 3342 4675
Email
akbari_as@yahoo.com; a.akbari@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
Other areas of specialty/work
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
Zahedan
Postal code
64855-98136
Phone
+98 54 3342 4675
Fax
+98 54 3342 4675
Email
akbari_as@yahoo.com; a.akbari@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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