Comparison of ischemic compression and dry needling as trigger point therapy for patellofemoral pain syndrome in young adults: A double-blind randomized clinical trial
The aim of this study is to compare the effectiveness of ischemic compression (IC) directly to the knee versus dry needling (DN) in improving pain, functional status and sensitivity to mechanical stimulation in patients with patellofemoral pain syndrome (PFPS). 54 patients(according to pilot study) with unilateral PFPS aged 20-30 years will be randomly selected according to the inclusion-exclusion criteria among patients referred to physical therapy clinics of Babol University of Medical Sciences(single center) in Babol, Iran. The inclusion criteria contains reported pain of more than 6 weeks’ duration, reported pain in one of the following tests: vastus medialis coordination test, patellar apprehension test, eccentric step test. Volunteers were excluded if they had a history of any of ligamentous insufficiency of the knee, spine or lower extremity surgery or trauma. A blinded examiner will divide participants into 2 groups by Systematic Randome allocation, also patients would be blinded to treatment allocation. Patients in both groups will treat in three sessions per week alternatively. IC consist of three sets of continuous pressure applied for on the myofascial trigger point (MTrP) of VMO. DN consist inserting a stainless steel needle on the MTrP found in VMO untile fel the first twitch. Main outcome measures include Numeric pain rating scale (VAS) for pain intensity, Kujala questionnaire for functional status, and pressure pain threshold (PPT) for sensitivity to mechanical stimulation. All three were recorded before treatment, 1 week, 1 month and 3 months after the last session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062028542N1
Registration date:2017-03-08, 1395/12/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-08, 1395/12/18
Registrant information
Name
Shabnam` Behrangrad
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 255 3309
Email address
dbehrang@gmail.com
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ischemic compression and dry needling as trigger point therapy for patellofemoral pain syndrome in young adults: A double-blind randomized clinical trial
Public title
dry needling efficacy in patients on pain and function of patient with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria are: 1) reported pain of more than 6 weeks’ duration in at least two of the following situations: patellar compression, squatting, prolonged sitting, walking, stair climbing, isometric quadriceps contraction (Crossley K et al 2002; Whittingham M et al 2004; Iverson et al 2008); 2) reported pain in one of the following tests: vastus medialis coordination test, patellar apprehension test, eccentric step test (Nijs J et al 2006); 3) presence of at least one MTrP in the VMO of the symptomatic knee (pressure applied to the VMO produced pain); 4) Kujala questionnaire score between 40 and 70, and visual analog scale (VAS) score greater than 40.
Volunteers will exclud if they had a history of any of the following: ligamentous insufficiency of the knee, meniscus damage, patellar subluxation or dislocation, nerve root compression, spine or lower extremity surgery, any systemic, orthopedic or neurological disorder, or current physical therapy (Iverson CA et al. 2008; Hains G and Hains F 2010; Grindstaff TL et al 2012).
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
blocking method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol
City
Babol
Postal code
Approval date
2017-01-19, 1395/10/30
Ethics committee reference number
MUBABOL.REC.1395.190
Health conditions studied
1
Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
M70.8
ICD-10 code description
Other soft tissue disorders related to use, overuse and pressure
Primary outcomes
1
Description
pain
Timepoint
before treatment, 1 week after treatment, 1 month after treatment, 3 months after treatment
Method of measurement
NPRS
2
Description
PPT
Timepoint
before treatment, 1 week after treatment, 1 month after treatment, 3 months after treatment
Method of measurement
digital algometry
3
Description
functional status
Timepoint
before treatment, 1 week after treatment, 1 month after treatment, 3 months after treatment
Method of measurement
kujala questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: ischemic compression: Treatment in this group involves applying tolerably painful, persistent manual pressure (usually with the thumb) against the tissue barrier of the MTrP. The examiner sustained the pressure for 90 seconds. Compression was performed three times in each session, with a 30-second rest between applications. Each patient in this group will receive 3 sessions of treatment per week alternatively. Main outcome measures were recorded before treatment, 1 week, 1 month and 3 months after the last session of treatment.
Category
Rehabilitation
2
Description
Intervention group 2: dry needling: the needle was inserted perpendicularly through the skin over the MTrP area, using the fast-in and fast-out technique and moved forward until a local twitch response was obtained. Each patient in this group will receive 3 sessions of treatment per week. Main outcome measures were recorded before treatment, 1 week, 1 month and 3 months after the last session of treatment.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol university of medical sciences
Full name of responsible person
Shabnam Behrangrad
Street address
mazandaran, sari
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
investigator
Full name of responsible person
Shabnam Behrangrad
Street address
mazandaran, sari
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investigator
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
Mazandaran University of Medical Sciences
Full name of responsible person
Shabnam Behrangrad
Position
master of science
Other areas of specialty/work
Street address
mazandaran, sari
City
sari
Postal code
Phone
+98 911 255 3309
Fax
Email
dbehrang@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shabnam Behrangrad
Position
master of sciences
Other areas of specialty/work
Street address
mazanadaran, sari
City
sari
Postal code
Phone
+98 911 255 3309
Fax
Email
dbehrang@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shabnam Behrangrad
Position
master of sciences
Other areas of specialty/work
Street address
mazandaran, sari
City
sari
Postal code
Phone
+98 911 255 3309
Fax
Email
dbehrang@mail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)