Protocol summary

Study aim
Comparison of immediate effect of sustained natural apophyseal glide and posterior-anterior techniques in non-specific chronic low back pain
Design
A concealed, randomized, double-blinded,multi-center, sham controlled clinical trial with a parallel group design of 45 patients
Settings and conduct
Three physiotherapy centers selected for sampling and 45 patients included to study after receiving informed consent. Each patient were entered to one of three groups (SNAG, PA Mobilization & sham) by block balanced randomization and received intervention by an expert manual therapist. All patients were assessed before and immediately after the intervention by another researcher who was blinded to patients allocation. Also all patients were blinded to groups because sham intervention was similar to SNAG technique.
Participants/Inclusion and exclusion criteria
Patients were included with localized chronic non-specific low back pain, age between 20 to 50 years, that their pain were worsened during flexion and L4 as most painful lumbar segment. Patients with any type of sensory or motor disorders, malignancy, osteoporosis or any type of contraindication of mobilization excluded.
Intervention groups
Sustained natural apophyseal glide (SNAG) on L4 during 4 sets of 6 repetitions with 30 seconds rest between sets with cranial direction. Posterior-anterior mobilization on L4 with grade 3 during 4 sets of 30 seconds duration with 30 seconds rest between them. Sham intervention likes SNAG technique, but only skin touch without mobilization and caudal direction during 2 sets of 4 repetitions.
Main outcome variables
Pin Pressure threshold (PPT) at 3 cm right to L3 spinous process, L3 dermatome, L4 dermatome and S1 dermatome; Flexion, Extention, Right and Left Lateral bendings and rotations range of motions; Pain at rest and during forward flexion.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170117032020N2
Registration date: 2018-07-04, 1397/04/13
Registration timing: retrospective

Last update: 2018-07-04, 1397/04/13
Update count: 0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Mohammad Javaherian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
javaherian_m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
budget thesis of Rehabilitation of Tehran University of medical sciences.
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-09-11, 1396/06/20
Trial completion date
empty
Scientific title
Comparison of immediate effects following postro-anterior mobilization technique and Mulligan sustained natural apophyseal glide on chronic nonspecific low back pain
Public title
Comparison the efficacy of two manual therapy methods (postro-anterior & Mulligan sustained natural apophyseal glide) on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20 to 50 Low back pain for more than 12 weeks Pain at center of lumbar region (with or without radiating to distal of buttock(s) region which intensify with forward flexion, but firs half flexion in painless Pain is equal to or greater than three by VAS Can understand the commands willingness to participate in the study
Exclusion criteria:
Disorders like malignancy, hemorrhagic, wound, infection, sensory-motor deficits or any other pathology Surgery or injection at lumbar region Osteoporosis or history of fracture at lumbar or lower extremity Any factor which prevents patient to lie prone (such as asthma or pacemaker) or limited range of motion in knee or ankle Diabetes melitus Any contraindication of mobilization Sever mental disorder Pregnancy Spondylolisthesis and sacralization Patient withdrawal of cooperation Patient discomfort and intolerance
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Block balanced randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Block balances randomization set before trial starting and was wrote in closed envelopes and sort them by number. Every participant that entered in study, therapist opened one envelope to find participant's grouping, but assessor was not aware about patient's group, because assessment was done in another room. Our sham treatment was very similar to Mulligan technique. therefore, No patient found that this was not real treatment, therefore patients and assessor were not aware about groups and only therapist was aware.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Conrner of Quds street- Keshavarz Street- Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-04-20, 1396/01/31
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2102

Health conditions studied

1

Description of health condition studied
Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Pain Pressure threshold
Timepoint
Before and immediately after intervention
Method of measurement
By pressure algometer at 3 cm right to L4 vertebrae, L3-L4-S1 dermatome of right lower extremity and left mid-deltoid

Secondary outcomes

1

Description
Pain
Timepoint
Before and immediately after intervention
Method of measurement
Visual analog scale

2

Description
Forward flexion
Timepoint
Before and immediately after intervention
Method of measurement
Inclinometery

3

Description
Backward extension
Timepoint
Before and immediately after intervention
Method of measurement
Inclinometery

4

Description
Right and Left side bending
Timepoint
Before and immediately after intervention
Method of measurement
Goniometry

5

Description
Right and left trunk rotation
Timepoint
Before and immediately after intervention
Method of measurement
Goniometry

Intervention groups

1

Description
Intervention 1: Mulligan Sustained natural apophyseal glide technique as intervention with 6 repetition during 4 sets and using mulligan belt
Category
Treatment - Other

2

Description
Intervention 2: Posterior-anterior mobilization technique as intervention30 seconds at 4 sets and 30 seconds rest between them.
Category
Treatment - Other

3

Description
Control group: Sham technique of SNAG4 repetition of 3 sets forward flexion with caudal direction touch
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic, Rehabilitation faculty of Tehran university of medical sciences
Full name of responsible person
Seyyed Mohsen Mir
Street address
No. 336, Corner of Safi-Alishah strett, Enghelab Street
City
Tehran
Province
Tehran
Postal code
111551683
Phone
+98 21 7753 3939
Email
smmir@tums.ac.ir

2

Recruitment center
Name of recruitment center
Physiotherapy clinic at Baharlou Hospital
Full name of responsible person
Amir Mohammadi Nia
Street address
Baharloo Hospital, Behdari street, Rah-Ahan squ.
City
Tehran
Province
Tehran
Postal code
12299
Phone
+98 21 5565 8500
Email
hosp-baharloo@tums.ac.ir

3

Recruitment center
Name of recruitment center
physiotherapy unit of Imam Sadegh clinic
Full name of responsible person
Mojtaba Faraji Rad
Street address
Corner Of Shahed street, Aminibayat squ., Tohid Ave., Imam Sadegh Clinic
City
Ghoum
Province
Ghoum
Postal code
3717993637
Phone
+98 25 3884 4040
Email
Faraji_Mojtaba@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak Bashardoust tajali
Street address
RehNo.336, Corner of Safi-Ali-Shah, Enghelab street
City
Tehran
Province
Tehran
Postal code
111551683
Phone
+98 21 7753 3939
Email
S_Bashardoust@yahoo.com
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
Mohammad Javaherian
Position
PhD. Cand.
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.336, Corner of Safi-Ali-Shah street, Enghelab street
City
Tehran
Province
Tehran
Postal code
111551683
Phone
+98 21 7753 3939
Fax
Email
Javaherian_m@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak Bashardoust Tajali
Position
Assistant professor, PHD, PT
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No.336, Corner of Safi-Ali-Shah street, Enghelab street
City
Tehran
Province
Tehran
Postal code
111551683
Phone
+98 21 7753 3939
Fax
Email
S_Bashardoust@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Javaherian
Position
PhD. Cand.
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No.336, Corner of Safi-Ali-Shah street, Enghelab street
City
Tehran
Province
Tehran
Postal code
111551683
Phone
+98 21 7753 3939
Fax
Email
Javaherian_m@razi.tums.ac.ir
Web page address

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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