Effect of 4 weeks comprehensive PREPARE aquatic therapy before Laminectomy and 8 weeks post operation for functional status, foot pressure distribution and EMG activation of core muscle in women with chronic low back pain
The aim of this study is check of Effects of four weeks comprehensive PREPARE aquatic therapy before Laminectomy on functional status, foot pressure distribution and EMG activation of core muscle in chronic low back pain patients.
Design
This study is a randomized clinical trial with parallel group trial and single blinded outcome assessment. Based on G*POWER software 30 patients as sample size were determined and randomly divided into two group of experimental and control group.
Settings and conduct
This study was carried out at Besat Hospital of Hamedan. Patient of excremental group received rehabilitation program 4 weeks before and 8 weeks after surgery while control group only 8 weeks program after surgery. The program designed in different days and patients were unaware of other participants.
Participants/Inclusion and exclusion criteria
Adult between 30 to 60 years old
Chronic low back pain, with or without radiculopathy
Diagnosis of Herniated disc between L5 and S1 by a neurosurgeon with paraclinical procedures such as MRI
No history of lumbar spine surgery / tumors / fractures / pregnancy
Exclusion criteria
Any history of lumbar vertebral fractures, types of tumors, scoliosis, previous spine surgery and severe postural deformities
Neuromuscular diseases like MS
Rheumatoid Arthritis
Osteoporosis
Intervention groups
women with chronic low back pain that candidate Laminectomy divided tow groups 15 person as control and intervention groups. intervention group receive 4 weeks prehabilitation aquatic therapy before Laminectomy. then post operation 8 weeks posthabilitation. control group receive 8 weeks post surgery rehabilitation .
Main outcome variables
in this study functional status, foot pressure distribution and EMG activation of core muscle in chronic low back pain evaluate.
General information
Reason for update
Acronym
PREPARE
IRCT registration information
IRCT registration number:IRCT20200323046838N1
Registration date:2020-05-17, 1399/02/28
Registration timing:registered_while_recruiting
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Azam Bashiri
Name of organization / entity
The Univercity of Kharazmi, international nuit
Country
Iran (Islamic Republic of)
Phone
+98 81 3833 7019
Email address
mary.bashiri53@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-25, 1399/01/06
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 4 weeks comprehensive PREPARE aquatic therapy before Laminectomy and 8 weeks post operation for functional status, foot pressure distribution and EMG activation of core muscle in women with chronic low back pain
Public title
Effect of 4 weeks prehabilitation aquatic therapy to women with chronic low back pain how candidate Laminectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult with 30 - 60 years old
Having chronic low back pain with or with out radicolopathy
herniation of L4, L5, S1 disk by MRI
BMI within 22 - 32
no surgical history on spinal column , Having Tumor or malignancy ,scoliosis, fractures and pregnancy
Having mental health
consent for participation to study
Exclusion criteria:
having surgical history on spinal column
having scoliosis
BMI> 32
having malignancy and tumor
having sevear heart disease
opiate addiction
having MS
having osteoprosis
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
By using random number table participants were divided in to control and intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Clinical care staff or trainer staff were unaware of group division.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committee of hammedan university of medical sciences
Street address
No 54, ferdosi Alley, Morvarid Avenue, Sadaf Street, Hamedan city , Iran
City
Hamedan
Province
Hamadan
Postal code
6515787498
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.UMSHA.REC.1397.993
Health conditions studied
1
Description of health condition studied
patient with chronic low back pain candidate Laminectomy
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region
Primary outcomes
1
Description
pain.
Timepoint
At the baseline (before surgery) and after 8 weeks rehabilitation.
Method of measurement
To assess pain the VAS ruler will be used.
2
Description
Foot pressure distribution
Timepoint
At the baseline (before surgery) and after 8 weeks rehabilitation.
Method of measurement
Foot scan will be used to evaluate foot pressure distribution.
3
Description
Electrical activity of muscles
Timepoint
At the baseline (before surgery) and after 8 weeks rehabilitation.
Method of measurement
By using Electromyography
Secondary outcomes
1
Description
functional status
Timepoint
At the baseline and end of rehabilitation program.
Method of measurement
By using Osvestry Questionnaire Index,
Intervention groups
1
Description
Intervention group or prehabilitation group participate in aquatic training 4 week before and 8 week after surgery. Aquatic exercise training for intervention group or prehabilitation group includes 3 session per week for a 4 week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down before surgery. The same program for 8 weeks including 3 session per week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down will be done by intervention group after surgery.
Category
Rehabilitation
2
Description
Control group: The control group participate only in 8 week aquatic training includes 3 session per week which each session includes 10 minutes warm up, 40 minutes resistant training in water and 10 minutes cooling down as routine rehabilitation program after surgery.