In this study, we sought to see if adding a dry gluteus medius needle to common treatment could improve symptoms of low back pain in people with chronic nonspecific low back painand improve their quality of life?
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 20 patients. The group name was used on pieces of paper for randomization.
Settings and conduct
Individuals in the private clinic are initially evaluated the day before the first treatment session. The evaluation includes the VAS chart, PPT, Y Balance Test, and the ODI questionnaire. A physiotherapist evaluates and collects data (which group is being treated The needle is dry (no) and the other physiotherapist treats the two groups.
Participants/Inclusion and exclusion criteria
People of 18 to 35 years who are active in running sports.
People who have had non-specific, unilateral back pain for at least three months in the past year.
People with VAS between 3 and 7
The length of the two lower limbs are equal.
Existence of tenderness in the gluteus medius muscle on the painful side of the lower back
Exit :
People whose back pain is caused by a specific cause such as radiculopathy, fracture, tumor or any other specific cause.
People who have a history of back or pelvic surgery.
Existence of pelvic and knee dysfunction such as valgus or knee vertebrae.
Pregnancy
Having systemic diseases such as arthritis or tuberculosis.
Scoliosis.
People with pelvic pathology.
Intervention groups
The study has two intervention and control groups. Both groups receive routine physiotherapy and the needle treatment group receives routine physiotherapy in addition.
Main outcome variables
VAS ; PPT ; YBT ; ODI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210201050203N1
Registration date:2021-03-14, 1399/12/24
Registration timing:prospective
Last update:2021-03-14, 1399/12/24
Update count:0
Registration date
2021-03-14, 1399/12/24
Registrant information
Name
Benyamin Kianypour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4489 5990
Email address
benykiany@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-30, 1400/01/10
Expected recruitment end date
2021-06-25, 1400/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Gluteus Medius Dry Needling on Management of Nonspecific Chronic Low Back Pain in Athletes
Public title
The Effect of Gluteus Medius Dry Needling on Management of Nonspecific Chronic Low Back Pain in Athletes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes who are active in running sports
People who have had non-specific, unilateral back pain for at least three months in the past year.
People with VAS between 3 and 7
The length of the two lower limbs is equal
Tenderness in the gluteus medius muscle on the painful side of the lower back
Exclusion criteria:
People whose back pain is caused by a specific cause such as radiculopathy, fracture, tumor or any other specific cause.
People who have a history of back or pelvic surgery.
Existence of pelvic and knee dysfunction such as valgus and knee vertebrae.
pregnancy
Having systemic diseases such as arthritis or tuberculosis.
scoliosis
People with pelvic pathology.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
We write the name of one of the two groups on a piece of paper and place it in a container. Each of the volunteers takes one of the papers and randomly places it in one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, outcome assessors are unaware of the allocation of study groups. The therapist was separate from the evaluator and therefore unaware of the assignment of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
NO 12 ; hoseini ave ; adl blvd ; ponak
City
Tehran
Province
Tehran
Postal code
1476676413
Approval date
2021-02-04, 1399/11/16
Ethics committee reference number
IR.tums.medicine.rec.1399.1057
Health conditions studied
1
Description of health condition studied
Non specific chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
pain
Timepoint
The first session, the fifth session and two days after the end of treatment
Method of measurement
Visual Analog Scale
2
Description
pain pressure threshold
Timepoint
The first session, the fifth session and two days after the end of treatment
Method of measurement
algometer device
3
Description
disability
Timepoint
The first session, the fifth session and two days after the end of treatment
Method of measurement
Oswestry Disability Index
4
Description
FUNCTIONAL STATUS
Timepoint
The first session, the fifth session and two days after the end of treatment
Method of measurement
Y BALANCE TEST
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Routine physiotherapy including hot pack for 20 minutes, tennis brace for 20 minutes with a new electric stimulation device made in Iran, home exercises including posterior pelvic tilt and stretching of hip flexors twice a day, three sets each time and each set ten Is repetitive
Category
Treatment - Devices
2
Description
Intervention group: Intervention group: In this group, in addition to routine physiotherapy, dry needle treatment for gluteus medius muscle is also performed in a meeting in between
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Football Federation
Full name of responsible person
Benyamin Kianypour
Street address
No. 4, North Baha'i Alley, Twelve Meter Alley
City
Tehran
Province
Tehran
Postal code
1995873781
Phone
+98 21 8821 3307
Email
Benykiany@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
DR Mohhamad Ali Sahrayian
Street address
Keshavarz Boulevard, Ghods St., Central Organization, 6th floor
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
5
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Azadeh Shadmehr
Position
Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
District 12, Enghelab St, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 7753 3939
Email
Shadmehr@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
District 12, Enghelab St, Pich-e-Shemiran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 7753 3939
Email
Shadmehr@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Benyamin Kiyanipour
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 12; hoseini ave; adl blvd; ponak
City
Tehran
Province
Tehran
Postal code
1476676413
Phone
+98 21 4489 5990
Email
benykiany@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
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