IRCT | Evaluation of Combination therapy "SNAG - Lumbar Stabilization Exercise" treatment versus Stabilizing Exercises on improving pain, range of motion , functional disability and postural stability in patients with chronic non-specific low back pain.

Protocol summary

Study aim: Evaluation and comparison of the combined treatment method of"lumbar SNAGS_stabilizing exercise"on improving pain,disability and postural control in patients with nonspecific chronic low back pain after 6 treatment session
Design: Target sample size will be include 10 healthy subjects and 20 subjects with low back pain . Subjects with low back pain will be allocated in two type intervention groups.
Settings and conduct: After entering the subjects, 20 patients with low back pain and 10 healthy subjects completely matched with patients , to the study,then the patients will divide into two intervention groups according to the inclusion and exclusion criteria. As "pre test" changes in the range of motion ,pain and balance in the two groups of patients and the only balance parameters in the healthy people will measure . Then, the patients will enter into one of two 6-day treatment regimens for two weeks.The one day after last session of the treatment period, the same evaluations will then repeated as post test.
Participants/Inclusion and exclusion criteria: Inclusion criteria:having age between 25 to 50 years , pain in lumbar during extension between 3- 6 in sitting position(as visual analog scale). Presence of positive PILL response(pain free,Immediate,Long Lasting). Having disability as Oswestry questionnaire(20%_40%). Exclusion criteria: having a disc protrusion in any lumbar level and radicular pain to the legs(under knee) ,Unwillingness to continue treatment and losing any of the inclusion criteria.
Intervention groups: Applying a lumbar mobilization technique (SNAGS) with stabilizing exercise in the one group and stabilizing exercise in the second group of subjects with chronic low back pain, and no intervention In healthy matched subjects.
Main outcome variables: Postural control, Pain, Functional disability, Range of motion.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20090203001637N9

Registration date: 2018-05-20, 1397/02/30

Registration timing: retrospective

Last update: 2018-05-20, 1397/02/30

Update count: 0
Registration date: 2018-05-20, 1397/02/30

Registrant information: Name

Sedighe Kahrizi

Name of organization / entity

Tarbiat Modares University

Country

Iran (Islamic Republic of)

Phone

+98 21 8288 4511

Email address

kahrizis@modares.ac.ir

Recruitment status: Recruitment complete
Funding source: tarbiat modares university

Expected recruitment start date: 2017-09-23, 1396/07/01
Expected recruitment end date: 2018-05-19, 1397/02/29
Actual recruitment start date: 2017-07-01, 1396/04/10
Actual recruitment end date: 2017-09-21, 1396/06/30
Trial completion date: empty

Scientific title: Evaluation of Combination therapy "SNAG - Lumbar Stabilization Exercise" treatment versus Stabilizing Exercises on improving pain, range of motion , functional disability and postural stability in patients with chronic non-specific low back pain.

Public title: Study and comparison of two therapeutic exercise approach with and without manual therapy on improving pain, range of motion , functional disability and balance in patients with low back pain.
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Having age between 25 to 50. Having at least high school diploma education. Having chronic non-specific chronic back pain for more than three months without neurological deficit. Having body mass index between 20 to 25 (kg/m2). Having localized pain at the waist level between 3 to 6 as VAS (Visual Analog Scale 0-10 centimeter) , during lumbar extension in sitting position on test day. Having positive PILL Response scale(pain free ,immediate ,long lasting ) as Mulligan concept. having functional disability between 20-40 % as Oswestry questionnaire.

Exclusion criteria:

Having history of trauma,surgery in back or stomach ,fracture in vertebral spine . having any sign and symptom of pressure on cauda equinq nerve. Presence of pregnancy, infection, tumor, inflammation and swelling, osteoporosis, rheumatism, systemic and neuromuscular diseases. Having any deformity in vertebral spine. Having a history of physical therapy for back pain in the last 3 months. Use of analgesics. Presence of disk protrusions (based on MRI) and diagnosis of orthopedic surgeon. Presence of referral pain from lumbar to under the legs or the knees. Losing any of inclusion criteria.
Age: From 25 years old to 50 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant

Sample size

Target sample size: 30

Actual sample size reached: 30

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization method is performed by simple randomization with random numbers.

Blinding (investigator's opinion)

Single blinded

Blinding description

Participants were aware of two methods of interventions, but they were blind to the type of treatment intervention used for them .

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Tarbiat Modares University

Street address

Tarbiat Modares University , Nasr bridge , Jalal e al e ahmad street , Tehran

City

Tehran

Province

Tehran

Postal code

14115 _ 111
Approval date: 2017-06-28, 1396/04/07
Ethics committee reference number: IR.TMU.REC.1396.581

Health conditions studied

1

Description of health condition studied: patients with nonspecific chronic low back pain
ICD-10 code: M54.5
ICD-10 code description: Low back pain

Primary outcomes

1

Description: Balance
Timepoint: Pre-post of the interventions in the first session and a day after the last session(seventh session)last session(seventh session)
Method of measurement: Force plate system

Secondary outcomes

1

Description: Functional disability
Timepoint: Pre-post of the interventions in the first session and a day after the last session(seventh session)
Method of measurement: Oswestry Questionaire

2

Description: Pain in lumbar spine
Timepoint: Pre-post of the interventions in the first session and a day after the last session(seventh session)
Method of measurement: Visual analog scale (VAS)

3

Description: Range of motion of lumbar vertebral
Timepoint: Pre-post of the interventions in the first session and a day after the last session(seventh session)
Method of measurement: Modified modified Schober method

Intervention groups

1

Description: Combination of Mulligan Mobilization with Stabilization Exercise
Category: Rehabilitation

2

Description: Intervention group:Stabilization Exercise protocol
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Physical Therapy Department of Shariati hospital

Full name of responsible person

Sedighe Kahrizi

Street address

Tarbiat modares university , Jalal e al ahmad Ave, Kouye Nasr

City

Tehran

Province

Tehran

Postal code

14115_111

Phone

+98 21 8288 4511

Email

kahrizis@modares.ac.ir

1

Sponsor: Name of organization / entity

Research deputy of Tarbiat Modares University

Full name of responsible person

Dr.Yaghoub Fathollahi

Street address

Tarbiat Modares University , jalal al e ahmad avenue, nasr bridge , Tehran

City

Tehran

Province

Tehran

Postal code

14115_111

Phone

+98 21 8288 2009

Email

Res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Research deputy of Tarbiat Modares University
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

Tarbiat Modares University

Full name of responsible person

Mehrnoosh Danaeifar

Position

Student of M.Sc in physical therapy

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat modares university, Tehran, JALAL E al ahmad Avenue , Nasr bridge

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8288 4511

Fax

Email

Mehrnooshdanaeifar@modares.ac.ir

Web page address

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Sedighe Kahrizi

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University, Jalal e Al Ahmad Avenue , Nasr Bridge, Tehran

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8288 4511

Fax

+98 21 8288 4555

Email

kahrizis@modares.ac.ir

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Tarbiat Modares University

Full name of responsible person

Sedighe Kahrizi

Position

Associate Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Tarbiat Modares University , Nasr bridge , Jalal e al ahmad avenue , 14Tehran

City

Tehran

Province

Tehran

Postal code

1411713116

Phone

+98 21 8288 4511

Fax

Email

kahrizis@modares.ac.ir

Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Not applicable
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: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: File of Intervention program protocol and Statistical analysis plan through publication of thesis or writing an article.
When the data will become available and for how long: Starting 6 months after publication of results.
To whom data/document is available: Research team of this study and other clinical academic researchers who are studying in favor of these patients.
Under which criteria data/document could be used: Researchers who intend to write a meta-analysis or systematic review articles are allowed to access documents.
From where data/document is obtainable: Dr.Sedighe Kahrizi(kahrizis@modares.ac.ir) Mehrnoosh Danaeifar(mehrnoosh.danaeifar92@gmail.com)
What processes are involved for a request to access data/document: The request will be responsed after getting the approval of university or the Academic Institution.
Comments

Evaluation of Combination therapy "SNAG - Lumbar Stabilization Exercise" treatment versus Stabilizing Exercises on improving pain, range of motion , functional disability and postural stability in patients with chronic non-specific low back pain.