The effect of adding training on Biodex Balance system to stabilization exercise on pain and function of patients with low back pain from degenerative spondylolisthesis
Aims:
The aim of this randomized clinical trial is to compare the effect of stabilizing exercises performed with and without using Biodex Balance system on pain and functional disability of patients with low back pain of listethic origin.
Inclusion criteria:
1. Patients with low back pain whose pain has been related to degenerative spondylolisthesis
2. Age between 30 and 70
3. BMI :18.5-30
4. No systemic disease
5. No history of fracture or surgery in low back
6. Not pregnant
7. Not having obvious mental and psychological problems
8. Have not received physiotherapy treatment during last 6 months
Exclusion criteria:
Patients’ disagreement to continue treatment
Using anti pain medicine during treatment
Not complying with the home exercise program
Sample size: there is no similar study. Using data in common field the sample in each group was estimated 15.
Interventions:
Patients in both groups will be visited in physiotherapy clinic every other day for 10 sessions. Both groups will receive conventional TENS (frequency 100 hz and pulse duration 100 micro second) for 25 minutes.
All patients will receive strengthening, stretching and stabilizing exercises of abdominal and low back muscles in a pamphlet. Exercises will be taught and checked gradually during treatment sessions.
Biodex group will receive 15 minute training on Biodex in addition to exercises, each session.
The Biodex Balance System (BBS; Biodex Medical Systems, Shirley, NY), a balance device that has a movable balance platform providing up to 20° of surface tilt . The platform is interfaced with computer software (Biodex, version 3.1) that gives the amount of subject's balance using Overall stability index.
Training on Biodex includes three ,5 minute training with 3 minutes rest in-between, with the Random training option .
Outcome measures:
Primary :
Functional Rating Index questionnaire and VAS
Secondary outcome measure :
Overall postural stability index from Biodex System
All outcome measures will be measured at baseline , after 10 treatment sessions, after 2 months follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111121139N2
Registration date:2017-01-01, 1395/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-01, 1395/10/12
Registrant information
Name
Safoora Ebadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 175 7107
Email address
ebadi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding training on Biodex Balance system to stabilization exercise on pain and function of patients with low back pain from degenerative spondylolisthesis
Public title
The effect of Biodex Balance System on Degenerative Spondylolisthesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1. Patients with low back pain whose pain has been related to degenerative spondylolisthesis; Age between 30 and 70; BMI :18.5-30;No history of fracture or surgery in the vertebral column; Not having obvious mental and psychological problems; Have not received physiotherapy treatment during last 6 months
Exclusion criteria: using anti pain medicine during treatment; If patient disagrees to continue treatment; patient not comply with exercise regimen at home
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done by using sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences ,Shahid Hemmat Highway .Tehran,1449614535,IRAN
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.IUMS.REC.1394 .26070ا
Health conditions studied
1
Description of health condition studied
Degenerative Spondylolisthesis
ICD-10 code
M43.1
ICD-10 code description
Spondylolisthesis
Primary outcomes
1
Description
Functional disability
Timepoint
Baseline, after 10 treatment sessions, after 2 months followup
Method of measurement
Functional Rating Index questionnaire
2
Description
Pain
Timepoint
Baseline- after 10 treatment sessions- after 2 months followup
Method of measurement
Visuall Analougue Scale
Secondary outcomes
1
Description
Postural Stability Index
Timepoint
At baseline-After 10 sessions treatment- After 2 months followup
Method of measurement
Overall stability index given by Biodex software during postural test
Intervention groups
1
Description
Control group will receive conventional TENS (frequency 100 hz and pulse duration 100 micro second) for 30 minutes on the pain area in low back.
In addition strengthening, stretching and stabilizing exercises of abdominal and low back muscles will be instructed and progressed during the treatment.
Category
Rehabilitation
2
Description
Intervention group will receive conventional TENS (frequency 100 hz and pulse duration 100 micro second) for 30 minutes on the pain area in low back. In addition strengthening, stretching and stabilizing exercises of abdominal and low back muscles will be instructed and progressed during the treatment in addition to 15 minutes training on the Biodex.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Javad Ali Musavi
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,1449614535,IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
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
Iran University of Medical sciences, Faculty of Medicine
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant professor, PhD PT
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir; e_safoora@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical sciences, Faculty of Medicine
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant professor, PhD PT
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)