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Investigation of the effect of Sahrmann exercises on lumbo-pelvic motor control, balance, pain and disability in chronic low back pain patients with lumbar rotation-extension syndrome: A randomized clinical trial

Protocol summary

Summary
Objectives: investigation of the effect of Sahrmann exercises on lumbo-pelvic motor control, balance, pain and disability in chronic low back pain patients with rotation-extension syndrome. Design: in this randomized controlled trial study (phase 2), patients were selected through nonprobability simple sampling and were assigned randomly to 2 groups by using consecutive assignment, Sahrmann exercises group and control group. Setting: this randomized clinical trial was performed in Zahedan University of Medical Sciences, from 22-10-2016 to 11-02-2017. Inclusion criteria: chronic pain located between costal margin to gluteal fold with or without radiation to lower limb, age between 18 to 50 years old and positive lumbar rotation-extension syndrome according to diagnostice tests. Exclusion criteria: pregnancy, vertebral fracture, vestibular system disorders. Sample size: 30 subjects (15 person in each group). Intervention group: Sahrmann exercises for 4 weeks, 3 days per week, Control group: electrotherapy (Trans Cutaneous Electrical Neuromuscular Stimulation device, UltraSound, HotPack) for 4 weeks, 3 days per week. Outcomes: variables were include of lumbo-pelvic motor control, balance, pain and disability that measured one day before of the intervension and one day after the intervention. The lumbo-pelvic motor control measured using pressure biofeedback, balance measured using biodex, the pain measured using Visual Analog Scale (VAS) and the disability measured using Oswestry Disability Index (ODI).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012028186N2
Registration date: 2017-03-06, 1395/12/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-06, 1395/12/16
Registrant information
Name
Mohammad Hosseinifar
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 1692
Email address
fardash_s@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Zahedan University of Medical Sciences
Expected recruitment start date
2016-10-26, 1395/08/05
Expected recruitment end date
2017-02-16, 1395/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Sahrmann exercises on lumbo-pelvic motor control, balance, pain and disability in chronic low back pain patients with lumbar rotation-extension syndrome: A randomized clinical trial
Public title
Investigation of the effect of Sahrmann exercises in chronic low back pain patients with lumbar rotation-extension syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic pain located between costal margin to gluteal fold with or without radiation to lower limbs, age between 18 to 50 years old, positive lumbar rotation-extension syndrome according to diagnostic tests. Exclusion criteria: pregnancy, vertebral fracture, tumor, infection, spine surgery, serious deformation of the spine, cardiovascular disorders, vestibular system disorders, central nervous system disorders, vision problems, sensory defects or motor paralysis, neurological and rheumatological diseases and not complete of the assessment and treatment sessions regularly.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this clinical trial (phase 2) patients by using consecutive assignment were assigned into two groups, Sahrmann exercises(15 subjects) and control group(15 subjects).  

Secondary Ids

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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
9816743463
Approval date
2016-10-23, 1395/08/02
Ethics committee reference number
IR.ZAUMS.REC.1395.192

Health conditions studied

1

Description of health condition studied
chronic low back pain with rotation-extension syndrome
ICD-10 code
M95-M99
ICD-10 code description
Other disorders of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
lumbo-pelvic motor control
Timepoint
Before and after the period of the interventions
Method of measurement
Using pressure biofeedback

2

Description
Balance
Timepoint
Before and after the period of the interventions
Method of measurement
Using biodex

Secondary outcomes

1

Description
Pain
Timepoint
Before and after the period of the interventions
Method of measurement
Using Visual Analog Scale (VAS) questionnaire

2

Description
Disability
Timepoint
Before and after the period of the interventions
Method of measurement
Using Oswestry Disability Index(ODI) questionnaire

Intervention groups

1

Description
Control group: 12 sessions treatment during 4 consecutive weeks, three times per week, each session including: 15 minutes TENS, 20 minutes Hot Pack and 5 minutes UltraSound
Category
Rehabilitation

2

Description
Sahrmann exerciseS group: 12 sessions exercise during 4 consecutive weeks, three times per week, 30 minutes pre session including: exercises just 10-15 times for 10-15 seconds with 2 minutes of rest between exercises in 8 positions: supine, sidelying, prone, quadruped, sitting, sitting to standing, standing and walking from easy to difficult done.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razmjo Moghadam Physiotherapy Clinic
Full name of responsible person
Dr.Mohammad Hosseinifar
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 Rafighdost
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. Mohammad Hosseinifar
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
Email
fardash_s@yahoo.com; faedash_s@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.Mohammad Hosseinifar
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
Email
fardash_s@yahoo.com; fardash_s@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.Mohammad Hosseinifar
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 3329 5742
Email
fardash_s@yahoo.com; fardash_s@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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