Protocol summary
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Study aim
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The aim of this study was to examine the therapeutic aspect of the effect of the dry needling method on the symptoms of piriformis syndrome due to the specialty of this technique. Also in this study, the effect of piriformis dry needling technique on the changes in the range of motion of the lower limb joints while walking and the degree of kinematic variability of the hip, knee and ankle joints are investigated.
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Design
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In this study, patients with piriformis syndrome were first examined for pain and motion analysis during walking. Then, subjects will be divide into treatment and control groups. In the treatment group, patients receive three sessions of dry needling in one week, and the control group will not receive treatment.after then both groups are re-evaluated.
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Settings and conduct
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This study is single-blinded trial and will be carried out in the Clinic of Physiotherapy, Faculty of Rehabilitation Sciences of Iran.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include pain in the buttocks or sciatica nerve, increased symptoms by sitting, tenderness at the the piriformis, tension-demand Maneuver increase symptoms. The patient's pain intensity between 3 to 6 and about atleast12 weeks from the onset of pain. exclusion criteria include contraindication of dry needling, pain in any lower limb joints, pregnancy, flat foot and limping .
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Intervention groups
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The study included two groups of control and treatment. In both groups, a preliminary assessment will be carried out. After that, the control group will not receive treatment for a week and then will assess.in control group after final assessment, physical therapy intervention will be done. the treatment group will receive dry needling technique, a three session per week on the piriformis muscle and under ultrasound and then re-evaluated.
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Main outcome variables
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pain; range of motion; kinematic variability; disability
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151026024729N2
Registration date:
2018-08-24, 1397/06/02
Registration timing:
prospective
Last update:
2019-01-16, 1397/10/26
Update count:
3
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Registration date
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2018-08-24, 1397/06/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-27, 1397/06/05
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Expected recruitment end date
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2019-01-30, 1397/11/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of dry needling technique on pain, disability and lower extremity kinematics during walking in patient with piriformis syndrome
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Public title
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The effect of dry needling technique on walking in subjects with piriformis syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
buttock pain or radicular pain of sciatic nerve
increase symptoms with sitting
tenderness in piriformis muscle
increase symptoms with tension-generated maneuver
Exclusion criteria:
contraindication of dry needling
history of vertebral or lower extremity surgery
pregnancy
hip arthritis or pain
lumbar discopathy or instability
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Age
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From 20 years old to 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization using random block method is performed individually using sealed envelopes.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, evaluator do not know allocation and treatment effects.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-20, 1396/10/30
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Ethics committee reference number
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IR.IUMS.REC1396.9221342202
Health conditions studied
1
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Description of health condition studied
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piriformis syndrome
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ICD-10 code
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S74.0
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ICD-10 code description
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Injury of sciatic nerve at hip and thigh level
Primary outcomes
1
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Description
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pain
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Timepoint
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Before first intervention, 72 hours and 7th days after the last treatment session
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Method of measurement
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visual analog scale
Secondary outcomes
1
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Description
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lower extremity kinematic
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Timepoint
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before first intervention and 72 hours after last treatment session
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Method of measurement
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motion analysis instrument
2
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Description
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pain pressure threshold
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Timepoint
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Before first intervention, 72 hours and 7th days after the last treatment session
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Method of measurement
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algometery
3
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Description
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disability
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Timepoint
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Before first intervention, 72 hours and 7th days after the last treatment session
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Method of measurement
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oswestry questionnaire
4
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Description
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internal and external range of motion of hip joint
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Timepoint
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Before first intervention, 72 hours and 7th days after the last treatment session
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Method of measurement
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by goniometry
Intervention groups
1
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Description
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Control group: In this group, patients will not receive treatment for a week and after a week they will receive physiotherapy for the release of piriformis muscle.
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Category
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Rehabilitation
2
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Description
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Intervention group: In this group, people will be treated with dry needling. In this method, the needle is inserted into the piriformis muscle simultaneously with the help of an ultrasound apparatus, and it is rotated and returned for 60 seconds.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The total data from this study, including demographic information, primary and secondary outcomes are shared after participant being unidentified.
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When the data will become available and for how long
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The start of the access period will be without a time limit from March of 2019.
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To whom data/document is available
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The data from this study will only be available to researchers at academic institutions.
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Under which criteria data/document could be used
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The data from this study will be available for use in secondary or review articles.
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From where data/document is obtainable
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It will be possible for the researchers to access the documentation by email with a personal page on the site
.E-mail address: pt.taba.a@gmail.com
Researchgate address: https://www.researchgate.net/profile/Abbas_Tabatabaiee
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What processes are involved for a request to access data/document
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All requests will be reviewed and answered within a maximum of 3 weeks.
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Comments
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