The Effect of Recreational Physical Activity Combined with Routine Physical Therapy in Comparison with Routine Physical Therapy Alone on Functional Ability and Quality of Life in Patients with Chronic Non-Specific Low Back Pain
Investigating the Effect of Recreational activities along with Routine Physical therapy in Comparison with Conventional Physical therapy alone on Functional tests and Quality of life in Chronic Non-specific low back pain in PatientsقReferring to the Physiotherapy Clinic of the Faculty of Rehabilitation Sciences of Iran University of Medical Sciences in 1397
In this study, people with Chronic Non-Specific Low Back Pain Participated. After the Initial Evaluation and Filling out Questionnaires by Participants of the Project, Individuals are Randomly Assigned to Two Treatment Groups. The Treatment Lasts for 4 Weeks. Before and After Treatment, the pain and Function Variables of the Individuals are Evaluated. People in the Usual Treatment Group, 10 Sessions of "Tens" and Exercises are Performed. For the Physical Activity Group, the Actions Taken in the Usual Treatment Group are the Same, and after that, 30 Minutes of Constant Moderate Cycling is Added to the Program. The sessions are held Every Other Day at the Physiotherapy Clinic of the Faculty of Rehabilitation, University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Entry Requirements:
Age 20-55
Causing Chronic Non-specific Low Back Pain
Pain Intensity 30-60 at Rest Based on Pain Score
Normal Body Mass Index
Non-Entry Conditions:
Severe Heart Disease
Bone Abnormality in the Lumbar and Pelvic Region
Systemic and Autoimmune Diseases
Lumbar Discopathy and Radicular Pain to the Lower Extremity
Trauma that has Recently Entered the Spinal Column
Intervention groups
Routine Physiotherapy Group
Routine Physiotherapy Combine with Recreational Activity Group
Main outcome variables
Reduce Pain
Return to Normal Life
Improve the Person's Performance and Ability to Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180728040618N2
Registration date:2019-09-18, 1398/06/27
Registration timing:retrospective
Last update:2019-09-18, 1398/06/27
Update count:0
Registration date
2019-09-18, 1398/06/27
Registrant information
Name
Holakoo Mohsenifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 6933
Email address
mohsenifar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2019-07-03, 1398/04/12
Actual recruitment end date
2019-09-03, 1398/06/12
Trial completion date
2019-09-09, 1398/06/18
Scientific title
The Effect of Recreational Physical Activity Combined with Routine Physical Therapy in Comparison with Routine Physical Therapy Alone on Functional Ability and Quality of Life in Patients with Chronic Non-Specific Low Back Pain
Public title
The Effect of Recreational Physical Activity On Functional Ability and Quality of Life in Patient with Chronic Non-Specific Low Back Pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patient Without any Precaution or Contraindication to Do Exercise Therapy
Pain Between Twelfth Rib and Inferior Gluteal Fold in More Than Three Months and Without any Specific Reason
Pain Intensity Between 30-60 in Rest Position for the 0-100 Pain Scale
Normal Body Mass Index
Exclusion criteria:
Acute Low Back Pain (Less Than 3 Months)
Bone Anomalies in Lumbar and Hip Region (Such as Scoliosis
Pregnancy
Central or Peripheral Nerve Diseases
Self Immune and Systemic Diseases
Lumbar Discopathy with Radicular Pain in Lower Limb
New Trum
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is "Balanced Block Randomization" which include 4 letters and made from letter A and B. Then, randomization list in the shape of A and B are placed in numbered pockets. "A" is for the control treatment ( routine physiotherapy ) and "B" is for the subject treatment ( routine physiotherapy combined with recreational activities). The randomization process is done before starting the study and by someone who is not in the research team. After the primitive assessment by the researcher, the numbered pockets are given to the subjects with the match numbers. Finally, after entering to the treatment sections the researcher choose the treatment plane due to the numbers in the pockets.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each patient does not know anything the other patient's type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Thirteenth floor, block A, Central Headquarters of the Ministry of Health and Medical Education, Between South Falamak and Zarafshan ,Simaye Iran Street, Ghods(West) Town,Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1916813797
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.IUMS.REC.1398.338
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Functional Ability
Timepoint
Before the Start of the Treatment Period and After it is Completed (Within 4 Weeks)
Method of measurement
Roland Morris Questionnaire Star Excursion Test Side hop test Single hop test
2
Description
Pain
Timepoint
Before the Start of the Treatment Period and After it is Completed (Within 4 Weeks)
Method of measurement
Linear Pain Measurement Score
Secondary outcomes
empty
Intervention groups
1
Description
Control group: For people in this group, the "TENS" treatment is done using the Germany-based 5820SL BTL device and exercise therapy. The sessions are held every other day between 13 and 17 . in each session,Therapy is used for 30 minutes of TENS (fifteen minutes of current with {high frequency; 100 Hz and pulse duration of 40 μs}, and fifteen minutes of low frequency{ 5 Hz and pulse duration of 300μs }). There is no specific sequencing for the use of high and low frequencies for patients. The device used is the same for all people and uses a 60x80mm electrodes in this study. The location of the electrodes for patients can be variable, but their best position is on the site of pain. Therapeutic exercises in this study includes stretching exercises and core stability exercises. Stretching exercises include stretching of the lower limbs hamstrings, stretching of the quadratos lumbar muscle in both sides, knee extension to the chest with one leg and two legs. Each tensile exercise is repeated 10 times and kept for 10 seconds. The number of stretching training sets is set to 3. The core stability exercises include posterior hip tilt in supine position, cat and camel training in quadriceps and hands and feet lifting exercises in the four-legged position. The parameters of core stability exercises are the same with stretching exercises. People are also asked to repeat the exercises 2 or 3 times a day at intervals between therapeutic sessions.
Category
Rehabilitation
2
Description
Intervention group: For groups of recreational activities, previous interventions are exactly the same as the routine treatment group, and after that, 30 minutes of fixed cycling activity is added to the program. Tolerable intensity cycling is done in the way that the patient will perform 50 to 80 cycles per minute on the bike. The fixed bike seat is adjusted so that the knee joint does not reach its full extension and remains at 10 ° F. The fixed bike used in this study was manufactured by Horizon USA.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic, Faculty of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Mahan Shahrooie
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Madadkaran All., Shahnazari St., Madar Sq., Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
4391-15875
Phone
+98 21 2222 2059
Email
mahansh70@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Holako Mohsenifar
Street address
Rehabilitation Facualty of Iran University of Medical Science,Madadkaran alley, Shahnazari street, Madar Square , Mirdamad Boulevard
City
Tehran
Province
Tehran
Postal code
4391-15875
Phone
+98 21 2222 2059
Email
mohsenifar.pt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mahan Shahrooie
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Facualty of Iran University of Medical Science,Madadkaran alley, Shahnazari street, Madar Square , Mirdamad Boulevard
City
Tehran
Province
Tehran
Postal code
4391-15875
Phone
+98 21 2222 2059
Email
mahansh70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamadreza Pourahmadi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Facualty of Iran University of Medical Science,Madadkaran alley, Shahnazari street, Madar Square , Mirdamad Boulevard
City
Tehran
Province
Tehran
Postal code
4391-15875
Phone
+98 21 2222 2059
Email
pourahmadipt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahan Shahrooie
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Facualty of Iran University of Medical Science,Madadkaran alley, Shahnazari street, Madar Square , Mirdamad Boulevard
City
Tehran
Province
Tehran
Postal code
4391-15875
Phone
+98 21 2222 2059
Email
mahansh70@yahoo.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders
Under which criteria data/document could be used
The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain.
From where data/document is obtainable
Applicants can contact the researcher of this study Mahan Sahahrooie by email. Email address: mahansh70@yahoo.com
What processes are involved for a request to access data/document
Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days.