The aim of the current study is to compare the effects of electroacupuncture on pain and function of the patients with patellofemoral pain syndrome (PFPS). This randomized clinical trial will be conducted in outpatient clinics of Isfahan. We will include a total number of 40 patients with PFPS who will be randomly assigned to receive electroacupuncture (n=20) or sham electroacupuncture (n=20) twice weekly for 10 sessions using a random digit table. The patients also will receive gluteal and quadriceps strengthening exercise. All the patients will be visited 1, 3 and 6 months after the intervention and the pain intensity and functional recovery will be measured using visual analogue scale (VAS) and anterior knee pain scale (AKPS), respectively. Those assessing the outcome are blind toward the study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701242445N4
Registration date:2017-04-06, 1396/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-06, 1396/01/17
Registrant information
Name
Fariborz Ghaffarpasand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4259
Email address
ghafarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-02-01, 1393/11/12
Expected recruitment end date
2016-09-01, 1395/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Electroacupuncture and Sham Acupuncture on Pain and Function of Patients with Patellofemoral Pain Syndrome
Public title
Electroacupuncture for Patellofemoral Pain Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: anterior or retropatellar knee pain from at least two of the following: prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping; insidious onset of symptoms unrelated to a traumatic incident; presence of pain on palpation of the patellar facets, on step down from a 25-cm step, or during a double-legged squat; positive Clarke's test; patella lateral displacement in patellar view radiography; age between 17 and 35 years; disease duration of more than 2 months; irresponsive to at least one month of conservative therapy.
Exclusion criteria: previous history of lumbosacral spine; pelvic or lower extremity surgery; history of severe knee trauma within the past 6 months; minor knee trauma within previous 2 months; symptoms of meniscal or other intraarticular pathologic conditions; evidence of a knee joint effusion or hip or lumbar referred pain; history of patellar dislocation; steroids consumption at time of inclusion; coagulopathies; systemic diseases such as rheumatoid arthritis, diabetes mellitus and dermatitis; presence of scar at the site of acupuncture; needle phobia; pregnancy
Age
From 17 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Isfahan University of Medical Sciences
Street address
Vice Chancellor of Research, Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Postal code
8174675731
Approval date
2017-02-02, 1395/11/14
Ethics committee reference number
IR.MUI.REC.YEAE395102
Health conditions studied
1
Description of health condition studied
Patellofemoral Pain Syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Pain
Timepoint
Baseline and 1, 3, 6 months after the intervention
Method of measurement
Visual Analogue Scale
2
Description
Function
Timepoint
Baseline and 1, 3, 6 months after the intervention
Method of measurement
Anterior Knee Pain Scale (AKPS)
Secondary outcomes
1
Description
Complications
Timepoint
Baseline and 1, 3, 6 months after the intervention
Method of measurement
Evaluating in each visit
Intervention groups
1
Description
Electroacupuncture twice weekly for 10 sessions
Category
Treatment - Other
2
Description
Sham electroacupuncture twice weekly for 10 sessions
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Hoda Jafari
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Hashemi
Street address
Vice Chancellor of Research, Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Isfahan University of Medical Sciences