The effect of dry needling of trigger point around knee and hip on pain, function and proprioception in patient with knee OA
Design
The present study is an applied one-blind randomized clinical trial study. The sample size is based on the data obtained from a pilot study of 24 people. We use a simple sampling method and people will be randomly divided into two parallel groups of intervention and control by blocked randomization method.
Settings and conduct
Patient evaluation will be done immediately before and one day after the end of the last treatment session. It should be noted that the evaluation of patients will be done by a person who is not aware of the allocation group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age from 45 to 70 years old; severity of knee osteoarthritis ranging from 2 to 3 using kellgren Lawrence scale; having at least one trigger point in the muscles around knee and thigh.
Exclusion criteria: blood disorders like hemophilia; coagulation and thalassemia; needle phobia.
Intervention groups
Intervention group: the patients treated for one week and three sessions a week, by needling of muscles around the knee (the muscles that have Trigger point). The main physical characteristic to identify a trigger point is being painful during local touch and feeling a painful rigid bundle within the skeletal muscle that produces and distributes pain and discomfort with a continuous compression of about 10 to 20 seconds.
Control group: receive no treatment and for ethical considerations they will be given a useful exercise program at the end of the project.
Main outcome variables
The outcome measures include pain (NRS scale), proprioception (photography method), balance (Star Excursion Balance Test & Timed Up and Go test) and trigger point sensitivity (Algometer).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131225015932N14
Registration date:2018-06-01, 1397/03/11
Registration timing:prospective
Last update:2018-06-01, 1397/03/11
Update count:0
Registration date
2018-06-01, 1397/03/11
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
Expected recruitment start date
2018-07-20, 1397/04/29
Expected recruitment end date
2018-08-20, 1397/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dry needling of trigger point around knee and hip on pain, function and proprioception in patient with knee OA
Public title
The effect of dry needling of trigger point in patient with knee OA
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age from 45 to 70 years
Severity of knee Osteoarthritis ranging from 2 to 3 using kellgren Lawrence scale
Having at least one trigger point in the muscles around the knee and thigh
The target knee is the more painful knee or the knee with more symptoms. If symptoms are similar in both sides the right knee will be considered as the target.
The KOOS score (knee injury and osteoarthritis score ) between 120-80
Exclusion criteria:
Drainage of articular fluid or corticosteroid injection in last year
Any surgery, fracture or dislocation in the lower extremities and the spine
Systemic diseases like diabetes
Soft tissue rheumatism
Active knee inflammation
Any neurological disease, such as epilepsy,... (because it can affect the function and balance of the individual.)
Taking anticoagulants such as aspirin and plavix
Blood disorders like hemophilia, coagulation disorders and Thalassaemia
Auto immune diseases
Needle Phobia
Lymphedema
Malignancy
Hepatitis
Acute infection
Cardiovascular diseases like heart valve problems
Vestibular System Problems
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be allocated to two parallel groups (control and intervention) via blocked randomization method by randomizer software.
Allocation concealment will be performed via SNOSE method. (sequentially numbered , sealed, opaque envelopes)
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will be blinded to group allocation in this study. (single blind study)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2018-02-06, 1396/11/17
Ethics committee reference number
IR.SUMS.REC.1396.169
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site
Primary outcomes
1
Description
Pain
Timepoint
Before treatment, the day after the last treatment session
Method of measurement
Numerical Rating Scale
2
Description
Sensitivity of trigger points
Timepoint
Before treatment, the day after the last treatment session
Method of measurement
Algometer
3
Description
Proprioception
Timepoint
Before treatment, the day after the last treatment session
Method of measurement
Photography method
4
Description
Balance
Timepoint
Before treatment, the day after the last treatment session
Method of measurement
Modified Star Excursion Balance Test & Timed Up and Go test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for one week and three sessions a week, they are treated with a needle in the muscles around the knee (the muscles that have Trp). The main physical characteristic to identify the trigger points is touched by a painful local nail in a rigid bundle within the skeletal muscle that produces and distributes a pain and discomfort with a continuous compression of about 10 to 20 seconds.
Category
Treatment - Other
2
Description
Control group: no treatment has been received, and in order to be ethical the research will give the group a useful exercise program at the end of the project.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
physiotherapy clinic of Shiraz School of Rehabilitation
Full name of responsible person
Dr. Alireza Motealleh
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 1627 1552
Email
motealleh@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz University Of Medical Sciences Building, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1552
Email
hashemib@yahoo.com
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Neda Rahimi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 1627 1552
Email
nedarahimira15273@gmail.com
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.
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 1627 1552
Email
motealleh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Rahimi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 1627 1552
Email
nedarahimira15273@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