Objective: Pain is a common complication of patients with knee Osteoarthritis.75% of pain in these patients originates from facial tightness and trigger points. Considering positive effects of dry needling, it might be used as an alternate method to decrease pain and improve function of patients with knee Osteoarthritis.
Methods and Materials: Forty patients (aged 50-70) with moderate knee Osteoarthritis will participate in this RCT using sample of convenience. Patients will be randomly assigned into either intervention or control group. Inclusion criteria: Knee pain؛ Morning stiffness؛ Crepitation in movement؛ Radiologic signs of osteoarthritis؛ have at least one trigger point on muscles around hip and knee.exclusion criteria: extraction of joint fluid or Corticosteroid injection؛ lower limb or spinal surgery؛ systemic diseases.A written informed consent will be signed by the eligible patients. Our outcome measures are functional level (KOOS questionnaire), pain intensity (visual analogue scale), trigger point sensitivity (algometery), balance (Y- test), and performance (40m fast- paced walk and Timed Up and Go test). After initial assessment, patients in intervention group will receive 3 sessions of dry needling in knee and thigh muscles. The control group will not receive treatment. Secondary evaluation in both groups will be performed seven days after the last session. Results will be analysed to evaluate intra-group and inter-group changes of the outcomes measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020415932N9
Registration date:2015-07-01, 1394/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-01, 1394/04/10
Registrant information
Name
Alireza Motealleh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
motealleh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of hip and knee trigger point dry needling on pain, function and balance in patients with knee osteoarthritis
Public title
The effects of hip and knee trigger point dry needling on pain & disability of patients with knee arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Patients with moderate knee Osteoarthritis based on Kellgren scale(have knee pain Morning stiffness less than half an hour
Crepitation in movement
Radiologic signs of Osteoarthritis
have at least one trigger point on muscles around hip and knee
Age 45-70
Visual Analogue Scale 3-7
Literate
Exclusion criteria:
Extraction of joint fluid or Corticosteroid injection
history of surgery in lower limb or spinal
Systemic disease
Acute arthritis
Soft tissue involvement in Rheumatoid arthritis
Acute knee Inflammation
Neurologic disease( such as Epilepsy)
Anticoagulant use( such as Aspirin)
Blood diseases(such as Hemophilia)
Acute Immune disease
Phobia of needle
Lymphedema
Malignancies
AIDS
Hepatitis
Heart valve problem
Acute infection
Cardiovascular disease
Pregnancy
Intact vestibular system
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Fars, Iran
City
Shiraz
Postal code
Approval date
2015-04-30, 1394/02/10
Ethics committee reference number
IR.SUMS.REC.1394.19
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Pain
Timepoint
before treatment and seven days after last session
Method of measurement
Visual analog scale
2
Description
Function
Timepoint
before treatment and seven days after last session
Method of measurement
Koos Questionnaire
3
Description
Balance
Timepoint
Before treatment and seven days after last session
Method of measurement
Y Balance test
Secondary outcomes
1
Description
Performance
Timepoint
before treatment and seven days after last session
Method of measurement
40m fast paced walk test & timed up and go test
Intervention groups
1
Description
The control group will be treated by dry needling 3 sessions (3 days a week) for trigger points around hip and knee joint. After needling, the needle will be moved in different directions to detect muscle twitch.
Category
Treatment - Other
2
Description
The control group will not receive treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation Sciences
Full name of responsible person
Najmeh Abdoldhian
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences ,Zand avenue ,Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Abdolahian
Position
Student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 31 3441 5945
Fax
Email
abdolahiannajmeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Alireza Motealleh
Position
Ph.D
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
pmotealeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Abdolahian
Position
Student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Postal code
Phone
+98 31 3441 5945
Fax
Email
abdolahiannajmeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)