Investigating the efficacy of Core Stability Exercise therapy and Feldenkaris Method in Patients with CNSLBP
Design
This study was designed as a double-blind randomized controlled trial. 60 patients with diagnosis of CLBP for at least 3 months were randomly allocated to the (FG) or (CSEG) (mean age 38.8 years). Pain was assessed using the McGill Pain Questionnaire (MPQ), disability was evaluated with the Oswestry Disability Index (ODI), quality of life was measured with the WHOQOL-BREF, and mind–body interactions were studied by the Multidimensional Assessment of Interoceptive Awareness Questionnaire (MAIA). Abdominal transverse muscle (TrA) diameter at rest and draw-in maneuver were assessed by ultrasonography before and after the intervention. Data were collected at baseline, at the end of treatment.
Settings and conduct
The study was performed at the sport medicine center of MAZUMS. The study was a double-blind, parallel, randomized clinical trial. Both participants and evaluators were unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• History of low back pain: at least for three months
• Clinical Diagnosis of nonspecific low back pain:
• Pain severity in pain assessment questionnaire: between 3 and 6 out of 10
• Patients of 18 to 60 years old
Exclusion criteria:
Patients under 18 or above 68 yrs
Diagnosis of acute or specific low back pain
Intervention groups
The study constituted of two interventing exercise therapy, the gropus of core stability exercise and and Feldenkaris, performed on patients with chronic non-specific low back pain.
Main outcome variables
This study investigates the impacts of the two types of exercise therapy on pain, disability, body awareness, quality of life, and transverse abdominal muscle diameter in patients with CNSLBP.
General information
Reason for update
Acronym
NSLBP
IRCT registration information
IRCT registration number:IRCT20200117046160N1
Registration date:2020-03-08, 1398/12/18
Registration timing:retrospective
Last update:2020-03-08, 1398/12/18
Update count:0
Registration date
2020-03-08, 1398/12/18
Registrant information
Name
Hanieh Adib
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 4163
Email address
hanieadib@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-19, 1397/12/28
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
2019-04-04, 1398/01/15
Actual recruitment end date
2019-11-19, 1398/08/28
Trial completion date
2019-11-21, 1398/08/30
Scientific title
Comparing the effect of Feldnkaris method and core stability exercise on pain and disability of patients with Non specific Low Back Pain
Public title
Exercises impacts on patients with chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of CNSLBP (Chronic non specific low back pain)
Patients age:18-68
Exclusion criteria:
Patients with diagnosis of specific or acute low back pain
Patients under 18 or above 68 yrs
Age
From 18 years old to 68 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
66
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Systematic random allocation of patients will be done using "Random allocation Generation web site"
Blinding (investigator's opinion)
Double blinded
Blinding description
The survey was double blinded. Both participants and valuator were not aware of the allocation method of study groups. although participants were unaware of two different exercise groups of study, they knew about their own group of exercise therapy group. the final valuator was not informed about the course of exercise therapy in each particiapnt
Placebo
Not used
Assignment
Parallel
Other design features
Patients have inclusion criteria were randomly divided into two groups: Feldenkrais and Core stability exercise therapy. They received exercise therapy for 5 weeks. At the beginning and the end of the study same measurements were evaluated for both groups. for both groups were evaluated.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences, Imam Hospital
Street address
Imam Hospital, Amir Mazandarani St, Imam Sq, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2019-03-19, 1397/12/28
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.108
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Chronic low back pain
Primary outcomes
1
Description
Low back pain score in McGill questionnaire
Timepoint
Before and after intervention
Method of measurement
McGill questionnaire
Secondary outcomes
1
Description
Low Back Pain Disability Score in Oswestry questionnaire
Timepoint
Before and after intervention
Method of measurement
Oswestry questionnaire
Intervention groups
1
Description
Core stability exercises group were performed for 5 weeks. Patients were trained every two weeks in the clinic and were required to perform the exercise three times a day, ten times each, with a 10-second isometric contraction. Patients were followed up by a researcher over the phone for two weeks. If the pain rises to above three score, exercises were stopped or they would be taken to the previous stage, if physician agreed. The exercises were progressive in two models on the ground and sport ball.
Category
Treatment - Other
2
Description
The Feldnkaris is a body-mind exercise method, included from 5 weeks of treatment protocol based exercises. All the exercises were taught under the supervision of the researcher, in groups of 10, twice a week and 1 to 2 hours each session. the exercises consisted of: breathing techniques, cervical, thoracic, lumbar spine mobilization, shoulder and hip joint range of motion, concentration and body awareness and relaxation exercises, correction of posture in lying, sitting, standing, and stretching exercises and improved flexibility and reduce motor resistance were in the aforementioned joints and muscles and spine.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Medicine Center of Imam Khomeini Hospital
Full name of responsible person
Hanieh Adib
Street address
No6, 3th Ave, Razi St,Sport center of Mostafavian Clinic
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
Hanieadib@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saidi
Street address
Central Headquarters of Mazandaran University of Medical Sciences, Valiasr Highway, Jouybari Road
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
Majidsaidi@gmail.com
Grant name
1290004
Grant code / Reference number
1602001000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hanieh Adib
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 6, 3th Ave, Razi St, Mostafavian Clinic
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
hanieadib@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanieh Ahmadi
Position
Assistant of Sport Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No 6, 3th Ave, Razi St, Mostafavian Clinic,
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
hani.medico@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Science
Full name of responsible person
Hanie Ahmadi
Position
Medical Resident of Sport Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
No 6, Sport center of Mostafavian Clinic, 3th Ave, Razi St,
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
hani.medico@gmail.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
All recorded data will be reachable for clinical and academic researchers for one year after the article publications as non-identifiable files.
When the data will become available and for how long
Accessibility to the data will be possible 6 months after the article publication for the applicants, for one year.
To whom data/document is available
Clinical and academic researchers
Under which criteria data/document could be used
Using the documents only under the permission of the head researcher, providing participation in the ongoing research.
From where data/document is obtainable
1.Hanieh Adib by Email Address: Hanieadib@gmail.com
2. Hanieh Ahmadi by Email Address: Hani.medico@gmail.com
What processes are involved for a request to access data/document
The request should be emailed to corresponding author, identifiable ID card and reason of request must be noted . After confirmation of their documents, data would be emailed within a week.