Comparison of specific and routine therapeutic exercises after cervical spine disc herniation surgery on functional disability, pain and neck muscle morphology
Comparison of specific and routine therapeutic exercise after cervical spine disc herniation surgery on functional disability, pain and neck muscle morphology.
Design
The study is a double-blind parallel randomized controlled clinical trial, with a control group and an experimental group, which is conducted on 60 patients. Random Allocation software was used for randomization.
Settings and conduct
This study will be conducted in the biomechanics laboratory of Rehabilitation Faculty of Babol University of Medical Sciences, on patients who have undergone anterior approach surgery due to cervical disc herniation. Two methods of routine and specific therapeutic exercise are examined and compared. The study is double-blind, so that both the patient and the person who evaluates the results are unaware of which group the respective patient belongs to.
Participants/Inclusion and exclusion criteria
1- aged 46 to 70 years old; 2- Continuous and treatment-resistant pain caused by cervical spine disc herniation for at least 2 consecutive months; 3- Clinical findings confirmed by MRI; 4- Patients who underwent surgery with an anterior approach;
5- Weakness of limbs or upper limbs before surgery.
Intervention groups
The control group includes patients who receive usual care after surgery.
The intervention group includes patients who receive specific therapeutic exercises in addition to usual care.
Main outcome variables
The main outcomes include: functional disability; pain intensity; range of motion and morphological changes (cross-sectional area and thickness) of the cervical longus colli and multifidus muscles.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221019056245N2
Registration date:2023-08-20, 1402/05/29
Registration timing:prospective
Last update:2023-08-20, 1402/05/29
Update count:0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Khodabakhsh Javanshir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 6419
Email address
k.javanshir@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of specific and routine therapeutic exercises after cervical spine disc herniation surgery on functional disability, pain and neck muscle morphology
Public title
Comparison of routine and specific therapeutic exercise after cervical spine disc herniation surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 46 - 70 years old
Continuous and treatment-resistant pain caused by cervical spine disc herniation for at least 2 months
Clinical findings confirmed by MRI
Weakness of upper limb or limbs before surgery
Patients who underwent surgery with an anterior approach
Exclusion criteria:
History of previous surgery
Pain greater than score 8 after surgery based on VAS
Need for re-surgery
Surgery caused by systemic diseases
Surgery due to fracture
Surgery caused by infection
Decreased range of motion due to osteophyte and fusion of vertebrae
Age
From 46 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, eligible participating patients, after receiving informed consent, according to the block randomization protocol (produced by Random Allocation Software) were divided into one of two control and intervention groups with a ratio of 1:1 and in blocks of 6 will be allocated, in such a way that the researcher cannot predict in which intervention group the next person will be placed. The codes will be placed inside the opaque envelopes, and with the arrival of each new person, the envelope will be opened and the person's belonging to the relevant group will be determined.
Allocation concealment
In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be placed in.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in a double-blind manner. In this way, both the patients and the evaluator (physiotherapist colleague) will be completely unaware of which group the patient belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj afrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.MUBABOL.REC.1402.063
Health conditions studied
1
Description of health condition studied
Neck surgery due to cervical disc herniation
ICD-10 code
M50.3
ICD-10 code description
Other cervical disc degeneration
Primary outcomes
1
Description
Functional ability
Timepoint
Before the intervention and after the intervention
Method of measurement
Neck Pain Disability Questionnaire
2
Description
morphology of the deep cervical muscles
Timepoint
Before the intervention and after the intervention
Method of measurement
By the ultrasonography device
Secondary outcomes
1
Description
Pain intensity
Timepoint
Before the intervention and after the intervention
Method of measurement
Pain intensity Visual Analogue Scale
Intervention groups
1
Description
Intervention group: The intervention group will perform routine care in addition to specific exercises for eight weeks, three times a week for forty minutes each time.
Category
Rehabilitation
2
Description
Control group: Patients in the control group will receive training such as daily care, walking and maintaining posture, which will be provided to them in the form of an educational brochure, for 8 weeks. Once a week, therapist will communicate with patients by phone.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Yhayanahad hospital
Full name of responsible person
Payam saadat
Street address
Shahid mostafa khomeini St., modarres St., Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3223 5947
Email
yahyanejad@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganjafrooz St., Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganjafrooz St., Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
khodabakhshjavanshir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganjafrooz St, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
khodabakhshjavanshir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Babol University of Medical Sciences, Ganjafrooz St., Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
khodabakhshjavanshir@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available