Determining the effect of core stability exercises on the quality of life of patients after lumbar spine surgery
Design
Double-blind randomized clinical trial, simple random sampling method. The sample size was determined using the 95% CI and using the sample size formula (Z1=1.96, Z2=0.84, d=0.7, S=16.4) of 64 people.
Settings and conduct
patients who undergo decompression surgery in loghman hakim hospital are included in the study based on random allocation
Participants/Inclusion and exclusion criteria
The population studied in this research includes patients aged 18 to 65 years with lumbar discopathy who are scheduled to undergo decompression surgery
Intervention groups
Patients who visit by a neurosurgeon, if eligible,The information will be collected. the information obtained at the beginning and end of the intervention (on arrival, 1, 3 and 6 months later) is collected as follows. 4 weeks after the operation, the patient is given core stability one exercises. Full exercise is given under the supervision of the person in charge of the treatment and it is explained to the patient that 15 to 20 minutes of exercises should be done at home every day. In case of any problems related to sports or physical problems, the patient can contact a doctor specializing in sports medicine or treatment by phone or other means of communication. three and six months after the surgery, the patient is visited again and he is given level two and three exercises. the patient is evaluated over the phone for daily exercises. In the control group, the sequence of visits is similar to the intervention group, only the type of exercises taught are stretching and strengthening for the abdominal muscles, the muscles of the back of the thigh, and the spine (central stability exercises are not given).
Main outcome variables
Quality of life (completed with the WHOQOL-BREF questionnaire)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220924056027N1
Registration date:2023-04-26, 1402/02/06
Registration timing:registered_while_recruiting
Last update:2023-04-26, 1402/02/06
Update count:0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
omidvar rezaei mirghaed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5596
Email address
dromidvarrezaee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-04-30, 1402/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of core stability exercises on the patient's quality of life after lumbar spine surgery
Public title
the effect of core stability exercises on the patient's quality of life after lumbar spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
-Patients (male and female) aged 18 to 65 with lumbar discopathy who must undergo decompression surgery -Having a referral letter from a neurosurgeon -Full consent of the patient to participate in the research -Mental state of pain - Absence of acute traumatic injury in the spine - Absence of injury in the spine - Absence of malignancy
Exclusion criteria:
-Suffering from neuro-muscular diseases -suffering from a malignant tumor -suffering from chronic diseases or other known conditions that affect the research -participating in physical therapy or exercise therapy programs during the last three months - unwillingness to participate in the research plan -Failure to complete treatment plans -receiving any treatment other than the treatment prescribed in this research plan
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of random allocation was determined by a member of the research team not involved in the selection of samples and was used in sealed sealed envelopes in order of numbering to hide the allocation. Exercise therapy group patients should visit the clinic on even days and control group patients on odd days.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the type of intervention in a sealed envelope that is coded. Coding is done by one of the colleagues, and the patient does not know in which exercise therapy group he is placed, and the quality of life evaluator does not know about the treatment received by the patient.The patients of the exercise therapy group visit the clinic on even days and the control group on odd days. Also, evaluations before and after the intervention are done by a person who does not know about the presence of patients in the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Committee of Ethics in Biomedical Research of Shahid Beheshti University of Medical S
Street address
loghman hakim hospital , makhsos St , south kargar Ave
City
tehran
Province
Tehran
Postal code
1333635445
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.269
Health conditions studied
1
Description of health condition studied
lumbar herniation discopathy
ICD-10 code
M51.8
ICD-10 code description
Other thoracic, thoracolumbar and lumbosacral intervertebral disc disorders
Primary outcomes
1
Description
quality of life
Timepoint
Before, 1, 3 and 6 months after surgery
Method of measurement
WHOQOL-BREF questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, patients receive core stability exercises stage one and two. exercise training is given under the supervision of the person in charge of the treatment and explained to the patient that 15 to 20 minutes of exercises should be done at home every day. Phase one of core stability exercises begins one month after surgery and is performed daily for two months. In the third month, the second stage of core stability are performed that continues for sixth month.
Category
Rehabilitation
2
Description
Control group: In the control group, the usual stretching exercises of the lower limbs and spine are taught, which should be done daily for 15 to 20 minutes. These training are given under the supervision of the person in charge of treatment, and the duration of doing sports, like the intervention group, should continue for 6 months.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
omidvar rezaeimirghaed
Street address
Loghman Hakim Hospital, Makhsos St, South Kargar Ave