Comparing the Effects of Standard Rehabilitation Protocol and Standard Rehabilitation Protocol in Combination with Exercise Therapy, on Functional Disability and Pain in Subjects Affected by Non Specific Low Back Pain
The aim of present study is to compare the effects of standard rehabilitation protocol with and without exercise therapy in acute nonspecific low back pain. 43 volunteers suffering from acute nonspecific low back pain that do not have any acquired, congenital or traumatic spinal disorder and do not meet contraindications for spinal manipulation will be randomly assigned into experimental group (standard rehabilitation including spinal manipulation plus active exercise, n=21) and control group (standard rehabilitation including spinal manipulation, n=22) using random numbers table. After signing a detailed formal consent, demographic information will be obtained. Both groups will attend physical therapy clinic for eight sessions. Standard rehabilitation protocol will be the same in both groups and consists of TENS, education (pamphlet) and spinal manipulation. Spinal manipulation will be used for both groups in the first 2 sessions by an expert physical therapist certified in spinal manipulation techniques who is blind to the study groups. The manipulation technique will be subject-specific and will be decided according to the comprehensive clinical evaluation results. Immediate analgesic effect of spinal manipulation will be reported using visual analogue scale (VAS) for pain intensity before and immediately after the manipulations in either group. The experimental group will receive subject-specific exercise protocol for eight session while the control group will only receive the standard rehabilitation interventions. Pain intensity and disability score according to Oswestry Disability Index will be reported at the beginning, after the last therapeutic session, and after one month follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080620888N6
Registration date:2016-10-18, 1395/07/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-18, 1395/07/27
Registrant information
Name
Zahra Sadat Rezaeian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5042
Email address
zrezaeian@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Vice Chancellory of Research and Technology
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Standard Rehabilitation Protocol and Standard Rehabilitation Protocol in Combination with Exercise Therapy, on Functional Disability and Pain in Subjects Affected by Non Specific Low Back Pain
Public title
Comparing the Effects of Standard Rehabilitation Protocol and Standard Rehabilitation Protocol in Combination with Exercise Therapy in Subjects with Acute Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: meeting at least 5 items of following items: remaining pain even after 7 days of treatment; pain duration less than 6 weeks; no symptoms distal to the knee; one or more hypo-mobile segments in the lumbar spines; Oswestry disability score ≤ 25%; pain intensity ≥ 30% (Visual Analogue Scale).
Exclusion criteria: spine fracture/surgery in the previous 6 months; pregnancy; neoplasia; infection of the spine; visceral pain; systemic disorders; radicular pain due to radiculopathy in last 6 months; sensory impairments; abnormal deep tendon reflexes or muscular weakness due to nerve compression; neurological claudication; psychiatric disorders; osteoporosis; corticosteroid therapy; receiving spinal manipulation previously for the same LBP episode; back pain; segmental spinal instability; administering narcotics; those who may not cooperate; those with contraindications for spinal manipulation; those who meet red flag conditions like fever; trauma; unusual weight loss.
Age
From 20 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization using random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Postal code
81745-164
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
394009
Health conditions studied
1
Description of health condition studied
Acute Nonspecific Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low Back Pain
Primary outcomes
1
Description
Pain
Timepoint
at the beginning, after first manipulation, after second manipulation, after the 8th therapeutic session, and at one month follow-up
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Functional Disability
Timepoint
at the beginning, after the 8th therapeutic session, and at one month follow-up
Method of measurement
Oswestry Disability Index (ODI)
Secondary outcomes
1
Description
Abdominal Muscle Endurance
Timepoint
at the beginning, after the 8th therapeutic session, and at one month follow-up
Method of measurement
Shirado Test
2
Description
Back Muscle endurance
Timepoint
at the beginning, after the 8th therapeutic session, and at one month follow-up
Method of measurement
Sorensen Test
Intervention groups
1
Description
Intervention Group: this group will receive standard treatment including education to stay active, self-management, lumbar school (a pamphlet is used), manipulation in the first two sessions and 30 minutes of transcotaneus electrical nerve stimulation (TENS) in each session. The standard protocol will be administered by the same physical therapist for all the subjects who is blind to the study design. The experimental group will also take part in 8 sessions of active exercises. The exercises are either flexor or extensor muscle endurance training according to the physical evaluation, subject' condition and subject' symptoms. Each exercise will be repeated three boats a day. The exercise will be cancelled and omitted if it aggravates the symptoms. Training progression is according to subjects' capabilities. A physical therapist who is blind to the study design will supervise the exercises. The exercises are kinesthetic (anterior and posterior pelvic tilt), mobility and flexibility (knee to chest, prone extension), muscle performance (drawing in maneuver, alternating flexion/extension of the upper extremities and heel slide) and functional (walking).
Category
Rehabilitation
2
Description
Control Group: this group will receive standard treatment including education to stay active, self-management, lumbar school (a pamphlet is used), manipulation in the first two sessions and 30 minutes of transcotaneus electrical nerve stimulation (TENS) in each session. The standard protocol will be administered by the same physical therapist for all the subjects who is blind to the study design.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Therapy Clinic of Petroleum Industry Health Organizaion
Full name of responsible person
Sajjad Amel Eini
Street address
Number 9, Sadeghi Street, Water Boulvard
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Vice Chancellory of Research and Technology
Full name of responsible person
Dr. Mehdi Nemat Bakhsh
Street address
Vice Chancellory of Research and Technology, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Grant name
Grant code / Reference number
394009
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Vice Chancellory of Research and Technology
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
Muscoloskeletal Research Center, Department of Physical Therapy, Faculty of Rehabilitation Sciences,
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.
Muscoloskeletal Research Center, Department of Physical Therapy, Faculty of Rehabilitation Sciences,
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.
Muscoloskeletal Research Center, Department of Physical Therapy, Faculty of Rehabilitation Sciences,
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Department of Physical therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.