Study of the immediate and after one week effect of dry needling on chronic non-specific low back pain women with hamstring shortness: A placebo controlled RCT
The purpose of this clinical trial is to investigate the immediate effects of dry needles on the flexibility of hamstring muscle in women with chronic non-specific low back pain.
Design
This study is a controlled clinical trial, double blind, randomized, with parallel groups.
Settings and conduct
The place of the study is the physiotherapy clinic of the Tehran University of Medical Sciences rehabilitation faculty. After ensuring about inclusion criteria and after obtaining written consent, the participant is included in the study. Before the intervention, the desired variables including pain intensity, hamstring length and functional disability are investigated by randomized procedure. Participants are randomly assigned to a dry needling group and control group. Immediately and one week after the intervention, the outcome variables are examined. In this study, the assessor and the participants are blind.
Participants/Inclusion and exclusion criteria
In this study, women with chronic non-specific low back pain with hamstring shortness can be included.
Intervention groups
In the intervention group, the hamstring muscle is needling at the muscle end plates for one session, but in the control group, the points determined by the needle are hit.
Main outcome variables
Functional disability was evaluated using the functional rating index questionnaire, the intensity of low back pain by using visual analog scales, the length of the hamstring muscle by the passive knee extension and the middle finger to floor distance test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180511039612N1
Registration date:2018-07-02, 1397/04/11
Registration timing:registered_while_recruiting
Last update:2018-07-02, 1397/04/11
Update count:0
Registration date
2018-07-02, 1397/04/11
Registrant information
Name
Mahnaz Bazzaz yamchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5377 3251
Email address
m-bazzaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the immediate and after one week effect of dry needling on chronic non-specific low back pain women with hamstring shortness: A placebo controlled RCT
Public title
immediate effect of dry needling on hamstring muscle flexibility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic non-specific low back pain , without history of fracture in low back and thigh region
Less than 80◦ of the passive knee extension (PKE) test
Female gender
Intensity of low back pain based on VAS , is being between 3-7
Do not be afraid of needle
Do not use blood thinner such as Warfain
No vascular disease
No history of muscular disease such as Myopathy
No Radicular pain in lower extermity
Not pregnancy
The duration of the low back pain should be more than 3 month
No needle sensitivity
Lack of epilepsy
Lack of diabetes
Exclusion criteria:
Intolerance to the evaluation and treatment steps
Acute low back pain and fracture in the low back and hip area between therapeutic sessions
Unwillingness to continue cooperation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign the participants to the dry needle treatment group and the control group, each participant is assigned a number and then, using the randomized block method, each of the numbers is assigned a drying needling or placebo group ( 1 or 2). These codes are placed inside sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Using sham needle in the placebo group will cause blindness to the participants.
The use of sealed envelopes in the random allocation of participants in a therapeutic groups will result in blind assessments of the consequences.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of nursing and midwifery and rehabilitation schools of Tehran University of Medical
Street address
Ghods Ave , Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
0
Approval date
2018-04-15, 1397/01/26
Ethics committee reference number
IR.TUMS.FNM.REC.1397.4958
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
Intensity of low back pain
Timepoint
Before , after and one week after intervention
Method of measurement
Visual analog scale
2
Description
hamstring muscle length
Timepoint
Before , after and one week after intervention
Method of measurement
Passive knee extension and finger to floor test
Secondary outcomes
1
Description
Functional disability
Timepoint
Before and one week after intervention
Method of measurement
Functional rating index
Intervention groups
1
Description
Intervention group:hamstring muscle is needling cone shape fast in-fast out during a therapeutic session at 3 points of muscle end plate for 1 minute at each point bilaterally.
Category
Rehabilitation
2
Description
Control group: on the muscle end plate is taping by sham needle for 1 minute at each point bilaterally.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic,School of Rehabilitation,Tehran University of Medical Science
Full name of responsible person
mahnaz bazzaz yamchi
Street address
Department of Physiotherapy ,School of Rehabilitation,Pitch-e Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
.
Phone
+98 21 7753 5132
Email
m-bazzaz@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Saharian
Street address
Vice chancellor for research of Tehran University of Medical Science,6th floor, University central office ,Ghods Avenue,Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3623
Email
rmo@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
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
Tehran University of Medical Sciences
Full name of responsible person
mahnaz bazzaz yamchi
Position
master student of Phisotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy,School of rehabilitation,Pitch-e shemirn,Enghelab avenue
City
Tehran
Province
Tehran
Postal code
0
Phone
+98 21 7753 5132
Email
m-bazzaz@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mahnaz bazzaz yamchi
Position
Master student of Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy,School of rehabilitation,Pitch-e shemirn,Enghelab avenue
City
Tehran
Province
Tehran
Postal code
.
Phone
+98 21 7753 5132
Email
m-bazzaz@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mahnaz bazzaz yamchi
Position
Master student of Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy,School of rehabilitation,Pitch-e shemirn,Enghelab avenue
City
Tehran
Province
Tehran
Postal code
.
Phone
+98 21775351332
Email
m-bazzaz@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
...
When the data will become available and for how long
...
To whom data/document is available
...
Under which criteria data/document could be used
...
From where data/document is obtainable
...
What processes are involved for a request to access data/document