Investigating the effect of dry needling compared to sham dry needling on the sensitization of the nervous system at peripheral, spinal and cerebral levels in patients with Non-specific Chronic Low Back Pain(NSCLBP)
Dry needling is standardly a short-term treatment and the main aim of the study is to distinguish the real effect of dry needling on sensitization and its comprehensive effect on three levels with its placebo effect.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 56 patients. randomization was done randomizer software.
Settings and conduct
In this study, patients aged 18-45 years with a diagnosis of chronic non-specific back pain who referred to orthopedic clinics under the supervision of Shiraz University of Medical Sciences will be selected and will be randomly divided into two intervention and control groups. needling and the control group will receive dry needling. The following study will be conducted in the laboratory of the Faculty of Rehabilitation. The participants do not know about their therapy group and the therapist and the person doing the assessment are different people.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with non-specific chronic low back pain with a central sensitization inventory score above 40 in the age group of 18-45 years will be included in the study. To enter the study, patients must have 3-7 trigger points in the gluteal, multifidus, paravertebral, quadratus lumborum and piriformis muscles.
Exclusion criteria: Patients with blood coagulation diseases, fear of needles, pregnancy, lymphedema disorders, arthritis symptoms, or slipping and fractures in vertebrae will not be included in the study.
Intervention groups
The intervention group received dry needling technique and the control group received sham dry needling.
Main outcome variables
Sensitization of the nervous system in three peripheral, spinal and brain levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230205057336N2
Registration date:2023-09-27, 1402/07/05
Registration timing:prospective
Last update:2023-09-27, 1402/07/05
Update count:0
Registration date
2023-09-27, 1402/07/05
Registrant information
Name
Narges Meftahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1552
Email address
meftahin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-01, 1402/07/09
Expected recruitment end date
2024-04-02, 1403/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of dry needling compared to sham dry needling on the sensitization of the nervous system at peripheral, spinal and cerebral levels in patients with Non-specific Chronic Low Back Pain(NSCLBP)
Public title
Investigating the effect of dry needling compared to sham dry needling on the sensitization of the nervous system at peripheral, spinal and cerebral levels in patients with Non-specific Chronic Low Back Pain(NSCLBP)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least three months have passed since the onset of their back pain
Have an average age of 18-45 years
There are no signs of involvement of nerve roots, disc inflammation and sciatic nerve
Have at least 3 to a maximum of 7 active trigger points in the gluteus maximus, gluteus medius, quadratus lumbarum, paravertebral and multifidus muscles
The score of the CSI questionnaire is equal to or greater than 40
Numerical evaluation of pain should have at least score of 3
No previous history of dry needling treatment
Exclusion criteria:
History of hemophilia and coagulation disorders
A patient with lymphedema
Pregnancy
Cancer, fracture, infection or immunodeficiency diseases such as AIDS and hepatitis
Specific back pains including back pains originating from disc involvement and nerve roots, spondylolisthesis and spondylolysis
A patient with back pain that is the origin of visceral pain
Use of anticoagulants
Patients with fear of needles in the form of phobia
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to intervention and sham groups by permutation randomization method which is done with the help of randomization program (block number 14 and block size 4).
Allocation of samples is done in a ratio of 1:1. In order to hide the allocation, opaque and sealed envelopes are used.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the study, evaluation tests are performed by one physiotherapist and dry needling treatment techniques are performed by another physiotherapist. Statistical analysis is performed by a person who does not know the grouping of patients. On the other hand, the participants do not know about the group they are randomly placed in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Shiraz Faculty of Rehabilitation Science research
Street address
Abiverdi st 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Approval date
2023-07-26, 1402/05/04
Ethics committee reference number
IR.SUMS.REHAB.REC.1402.016
Health conditions studied
1
Description of health condition studied
Non-specific Chronic Low Back Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Conditioned pain modulation
Timepoint
Before, immediately and six weeks after the intervention
Method of measurement
The difference in pressure pain tolerance threshold with algometer before and after the application of conditioned pain by pressure cuff
2
Description
Temporal summation of pain
Timepoint
Before, immediately and six weeks after the intervention
Method of measurement
The difference in pain report based on numeric rate scale after one stimulation and several repeated painful stimulations
3
Description
Pressure pain threshold both in the pain area and in the distal area
Timepoint
Before, immediately and six weeks after the intervention
Method of measurement
Record the number shown on the algometer display at the moment of pain after applying pressure
4
Description
Central sensitization
Timepoint
Before, immediately and six weeks after the intervention
Method of measurement
Central sensitization inventory
Secondary outcomes
1
Description
Pain
Timepoint
Before, immediately and six weeks after the intervention
Method of measurement
Numeric rate scale
2
Description
Function rate
Timepoint
Before, immediately and six weeks after the intervention
Method of measurement
Extensor muscle endurance test
Intervention groups
1
Description
Intervention group: Patients in this group receives three treatment sessions with an interval of 72 hours. In the range of minimum 3 to maximum 7 muscles from lumbar multifidus muscles, gluteus maximus, gluteus medius, quadratus lumbarum and paravertebral muscles, which is considered as paravertebral muscle, lumbar iliocostalis muscle. All muscles are selected and dry needled based on the number of active trigger points they have. In this dry needling study, the fast in-fast out technique is used. We manipulate the needle in different directions until the first twitch is seen. The size of the needles is selected according to the volume of fat tissue in the patient's body. In cases where it is necessary, strong pressure is applied to compress the skin tissue.
Category
Treatment - Other
2
Description
Control group: Control group: the needle is taken out of the box without tearing its packaging, and its tip is shortened enough that it no longer touches the patient's skin and is placed back in the packaging. The patient is placed exactly like the treatment group for all muscles and an alcohol pad is used. In this treatment, the guide is pressed on the patient's body to create a sensation similar to dry needling. Other interventions will be completely similar to the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Medical Sciences Rehabilitation Center
Full name of responsible person
Narges meftahi
Street address
Abiverdi 1 st, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1552
Email
meftahin@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Meftahi
Street address
Abiverdi st, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
meftahin@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Narges Meftahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Abiverdi st1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
meftahin@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges meftahi
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Abiverdi st 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
meftahin@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Meftahi
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Abiverdi st 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
meftahin@sums.ac.ir
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available