Determining the effect of dry needling on pain and activities of daily living in patients with mild and moderate knee osteoarthritis and myofascial pain syndrome in the muscles around the knee.
Design
Before and after quasi experimental clinical trial (pilot study)
Settings and conduct
The study will be held in Sedigheh Tahereh Rehabilitation center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Subjects with knee osteoarthritis who do not have other problems and diseases associated with knee pain and function .
Intervention groups
All of the participants receive dry needling into the trigger points.
Main outcome variables
Pain؛ activities of daily living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180427039430N1
Registration date:2018-08-03, 1397/05/12
Registration timing:registered_while_recruiting
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Mohammad Amani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3420 2870
Email address
m.amani@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of dry needling on pain and activities of daily living in patients with mild and moderate knee osteoarthritis (a pilot study)
Public title
The effect of dry needling on pain and activities of daily living in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Radiological signs of moderate knee osteoarthritis with grade 1 to 3 of Kellgren and Lawrence scale in at least one knee
Knee osteoarthritis (tibiofemoral joint) signs according to American college of rheumatology such as pain in last 3 months ago; crepitus on joint mobilization and morning stiffness lasting 30 min or more
pain level higher than 30 millimeters on visual analogue scale
Having trigger points in muscles surrounding the knee
Exclusion criteria:
History of any severe trauma to lower limbs
Fibromyalgia; Hypothyroidism; Meralgia paresthetica
History of surgery in lower limbs
Radiculopathy or myopathy in lower limbs
Ulceration or skin diseases
Injection of corticosteroids or dry needling in last 6 months
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences, Ethics Committee
Street address
Secretariat of the Ethics Committee, Room 209, Second Floor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81745-164
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.MUI.REC.1397.3.036
Health conditions studied
1
Description of health condition studied
Knee Osteoarthitis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site
Primary outcomes
1
Description
Pain
Timepoint
Before, 4 days and one month after intervention
Method of measurement
Visual analogue scale (VAS)
2
Description
Activities of daily living
Timepoint
Before, 4 days and one month after intervention
Method of measurement
Knee outcome survey (KOS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dry needling includes using of 5 cm needle specified for dry needling. Trigger points of Quadriceps and Gastrocnemius muscles will be choosed for needling. The needle was deeply inserted perpendicular to the skin using fast-in and fast out cone shape technique.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedigheh Tahereh rehabilitation center
Full name of responsible person
Navid Taheri
Street address
Khorram St., Jomhouri-e-Eslami Square, Isfehan town
City
Isfahan
Province
Isfehan
Postal code
8195000000
Phone
+98 31 3337 7880
Email
n_taheri@rehab.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellory of Research and Technology, Isfahan University of Medical Sciences, HezarJarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5012
Email
n_taheri@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
Navid Taheri
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, HezarJarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5012
Email
n_taheri@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5012
Email
n_taheri@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Navid Taheri
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, HezarJarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5012
Email
n_taheri@rehab.mui.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