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Investigation the effect of Gluteus Medius dry needling plus conventional physiotherapy in comparison with conventional physiotherapy on pain and physical function in women with routine daily activities(non-athletic) with unilateral Patellofemoral pain syndrome

Protocol summary

Study aim
The purpose of this study is to determine The effect of using dry needling in Gluteus medius muscle on pain and function of patients with patellofemoral pain syndrome(PFPS)
Design
Two arm parallel group randomized double blind trial with blinded postoperative care and outcome assessment
Settings and conduct
After issuing ethics license from Isfahan University of Medical Sciences in clinics and physiotherapy of hospitals under the supervision of Isfahan University of Medical Sciences. The individual, with the diagnosis of PFPS, previously given by a specialist physician, enters the physiotherapy center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-athlete women; suffering from patellofemoral syndrome; with complaints of gradual anterior knee pain; at least one month; and aged between 17 and 40 years old. Non-inclusion criteria: Patients with any history of knee injury; other pathologies such as rupture of knee ligaments or meniscus.
Intervention groups
Intervention group: Dry needle in gluteus medius muscle with conventional physiotherapy for knee Control group: Conventional physiotherapy for the knee
Main outcome variables
pain - function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160408027287N3
Registration date: 2019-10-17, 1398/07/25
Registration timing: registered_while_recruiting

Last update: 2019-10-17, 1398/07/25
Update count: 0
Registration date
2019-10-17, 1398/07/25
Registrant information
Name
Javid Mostamand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3089
Email address
mostamand@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-26, 1398/05/04
Expected recruitment end date
2019-10-26, 1398/08/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of Gluteus Medius dry needling plus conventional physiotherapy in comparison with conventional physiotherapy on pain and physical function in women with routine daily activities(non-athletic) with unilateral Patellofemoral pain syndrome
Public title
Investigation the effects of dry needling in Gluteus medius muscle on pain and physical function in women with unilateral patellofemoral pain syndrome (PFPS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Report the pain on the anterior knee or around the patella, during at least 3 activities: up or down stairs, squatting, running, kneeling, jumping, or hopping and sitting long Non-athletic woman have unilateral syndrome with positive patellar glide test There are symptoms for at least 4 weeks Full knee range of motion without any history of injury Active trigger point in gluteus medius in opposite side of the affected knee Age of 17 to 40 years
Exclusion criteria:
Meniscal and intra articular injury collateral and cruciate ligament injury tenderness in patellar tendon, iliotibial band and pesansernous tendon patella dislocation knee inflammation the history of knee surgery pregnancy, malignancy, knee arthritis and neurologic impairment neurologic symptom in sensory, motor and reflex knee pain with ankle and foot or hip or lumbar or sacroiliac sources The presence of trigger point of the gluteus medius muscle on both sides
Age
From 17 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization of the subjects was done using a random numbers table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher has been blinded and only applies conventional physiotherapy for both groups. Data analyzer is blinded to the control and treatment group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Azadi Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.229

Health conditions studied

1

Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intensity of pain
Timepoint
At the beginning of the study (before the intervention), after the end of the sixth session (the last session), 1 week after the end of the sessions
Method of measurement
visual analog scale (VAS)

2

Description
physical function
Timepoint
At the beginning of the study (before the intervention), after the end of the sixth session (the last session), 1 week after the end of the sessions
Method of measurement
Kujala Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The intervention group in addition to conventional knee physiotherapy, receives the treatment of dry needling in the gluteus-medius in side effected . Dry needle therapy is performed three sessions (once a week) at the most painful point of the muscle (active trigger point) and with 10 times the technique inside and outside.
Category
Rehabilitation

2

Description
Control group: The control group will receive only conventional knee physiotherapy, which includes: Straight leg raise for 7.5 minutes, single leg squats for a period of 7.5 minutes, and a high frequency TENS device for 15 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic of Isfahan Rehabilitation Sciences Faculty
Full name of responsible person
Fereshteh Karamiani
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Azadi Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5222
Email
karamiani.f92@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Javid Mostamand
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Azadi Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5222
Email
mostamand@rehab.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fereshteh Karamiani
Position
Master's student of Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University of Medical Sciences and Health Services, 1000 Jereyb St., Azadi Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5052
Email
karamiani.f92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Javid Mostamand
Position
Ph.D. of Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Azadi Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5052
Email
mostamand@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fereshteh Karamiani
Position
Master's student of Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University of Medical Sciences and Health Services, Hezarjarib street, Azadi Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5052
Email
karamiani.f92@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
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