To determine and compare the mean pain, functional disability, sensitization and spinal myofascial pain syndrome in patients before and after lumbar laminectomy surgery and control groups.
Design
Controlled clinical trial with parallel groups and double blinded
Settings and conduct
This study will be performed at Poursina hospital. The study will be single blind and the examiner won't know the grouping and treatments procedures.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 30 to 60 years; L4L5 lumbar disc herniation diagnosis: According to neurosurgeon physician assessment and MRI findings.
Non-inclusion criteria:
The patients with fibromyalgia; subjects with surgical history of cervical, shoulder or other region of the body; Subjects with history of trigger point injection or acupuncture; Patients with laminectomy of other lumbar vertebrae or arthrodesis; Subjects with cauda equina syndrome which is reported by a neurosurgeon.
Intervention groups
Control group receive routine drug therapy treatments and are in waiting list for surgery and intervention group receive routine drug therapy as well as laminectomy surgery.
Main outcome variables
Pain, functional ability, sensitization and active trigger points
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516034003N7
Registration date:2019-06-21, 1398/03/31
Registration timing:registered_while_recruiting
Last update:2019-06-21, 1398/03/31
Update count:0
Registration date
2019-06-21, 1398/03/31
Registrant information
Name
Kamran Ezzati
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0099
Email address
kamranezzati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of laminectomy surgery on pain, functional disability, sensitivity of active trigger points in subjects with lumbar disc herniation
Public title
The influence of laminectomy surgery on subjects with lumbar disc herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-60 years.
L4-L5 Lumbar disc herniation diagnosis: According to neurosurgeon and magnetic resonance imaging(MRI) assessment.
Exclusion criteria:
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The examiner won't know anything about the kind of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
5th floor, Central office of Guilan University of Medical Sciences, Namjoo St., Rasht, Iran
City
Rasht
Province
Guilan
Postal code
۴۱۹۳۷۱۳۱۹۴
Approval date
2018-01-16, 1396/10/26
Ethics committee reference number
IR.GUMS.REC.1396.344
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation
ICD-10 code
M51.1
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
Pain
Timepoint
Before and 1 month after surgery
Method of measurement
Visual Analogue Scale
2
Description
Functional disability
Timepoint
Before and 1 month after surgery
Method of measurement
Oswestry disability index
3
Description
Sensitization
Timepoint
Before and 1 month after surgery
Method of measurement
Pressure algometer
4
Description
Active trigger points
Timepoint
Before and 1 month after surgery
Method of measurement
manual evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group only receive anti-inflammatory drug therapy and are in waiting list for surgery or despite neurosurgeon recommendation don't want to operate for any reason.
Category
Treatment - Surgery
2
Description
Intervention group: In this group, lumbar laminectomy surgery is performed by a neurosurgeon. In order to release the nerve root and widening the lateral canal, the lamina is removed and the lateral canal is decompressed. After surgery, the target area is sutured and dressed and the patient is hospitalized up to 48 hours later.