Protocol summary

Summary
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders in young adults. The pain existing in anterior knee or posterior patellar without other knee pathologies is called patellofemoral pain syndrome. In prospective studies the prevalence of this disease is reported to be 7% in active young adults and 15% in military staff. Although the main cause of this syndrome is unknown, some researchers believe that the pain can be attributed to some biomechanical, soft tissue or muscle abnormalities. This syndrome causes pain and functional disorder in the corresponding patients and if not treated well, it may result in chronic pain and/or weaknesses in quadriceps muscles. In the studies conducted so far, a variety of treatments including low power laser, orthoses, ultrasonography and rehabilitative exercises has been investigated while none of them has been proved to be significantly effective. Moreover, despite the growing use of high power lasers in alleviating musculoskeletal pains and its confirmed physiologic effects, studies investigating the effect of high power laser in pain management and function of patients with patellofemoral pain syndrome are very limited. Thus, the focus of this study is on analyzing the efficacy of high power laser in treatment of patients with patellar chondromalacia. To do so, a double blinded randomized clinical trial for the new treatment is designed in order to compare the efficacy of high power laser with the control group of isometric knee exercise, as the standard treatment for patellofemoral pain syndrome. In this study, 44 patients from PM&R clinic of Modarres and Shohada hospitals diagnosed with patellofemoral pain syndrome by clinical tests (Shrug test, Grind test,Perkins test) having the symptoms for three months with normal AP , lateral and patellar view knee xray are selected and divided into control and intervention groups, randomly. Five session of high power laser in 2 weeks along with training isometric knee exercises are carried out on the intervention group. On the other hand, the control group undergoes 5 sessions of sham laser in 2 weeks accompanied by training isometric knee exercises. To evaluate and compare the two groups, the outcome of treatments will be measured by VAS score, WOMAC and kujala questionnaires. These measurements will be performed before intervention and 1 and 3 months after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017100713442N19
Registration date: 2017-10-29, 1396/08/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical Medicine and Rehabilitation Research Center of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of high power laser in pain, stiffness and function of patients with patellofemoral pain syndrome (patellar chondromalacia)
Public title
Efficacy of high power laser in treatment of patients with patellar chondromalacia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 15 to 40 years; referring to the outpatient clinic of physical medicine and rehabilitation in year 1396; having positive exclusive patellofemoral syndrome maneuvers including Shrug test, Grind test and Perkins test (at least 2 of them being positive); symptoms duration of at least 3 months; having normal knee x-ray in 3 dimensions. Exclusion criteria: patients aged younger than 15 years or older than 40; with history of knee surgery; having a body mass index of 30 kg/cm2 or more; any systemic diseases such as diabetes mellitus, immunodeficiency and collagen vascular disorders; history or presence of malignant cancer; history of recent knee trauma; any infection; pregnancy; breastfeeding; genu varum greater than 20 degrees; genu valgum greater than 20 degree; any knee deformity in knee x-ray; signs of knee osteoarthritis in knee x-ray
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Arabi Ave., Yaman St., Shahid Chamran highway
City
Tehran
Postal code
1985717443
Approval date
2017-06-13, 1396/03/23
Ethics committee reference number
IR.SBMU.MSP.REC.1396.197

Health conditions studied

1

Description of health condition studied
Patellar chondromalacia
ICD-10 code
M22.4
ICD-10 code description
Chondromalacia patellae

Primary outcomes

1

Description
Knee pain
Timepoint
Before, 1 month and 3 months after intervention
Method of measurement
Womac, VAS, Kujala questionnaires score

2

Description
Joint stiffness
Timepoint
Before, 1 month and 3 months after intervention
Method of measurement
Womac, Kujala questionnaires score

3

Description
Function
Timepoint
Before, 1 month and 3 months after intervention
Method of measurement
Womac, kujala questionnaires score

Secondary outcomes

empty

Intervention groups

1

Description
High power laser for 5 session in 2 weeks and multiangular isometric knee exercises for intervention group
Category
Rehabilitation

2

Description
Sham laser for 5 session in 2 weeks and multiangular isometric knee exercise in control group
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Maryam Sadat Rahimi
Street address
Tajrish square, Shohada Tajrish Hospital
City
Tehran

2

Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Maryam Sadat Rahimi
Street address
shahid modares hospital, kaj square, saadat abad
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physical Medicina and Rehabilitation Department
Full name of responsible person
Seyyed Ahmad Raeissadat
Street address
Shahid Modarres Hospital, Kaj Square, Saadat abad, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicina and Rehabilitation Department
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
Physical Medicine and Rehabilitation Departme
Full name of responsible person
Maryam Sadat Rahimi
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shahid Modares Hospital
City
Tehran
Postal code
Phone
+98 21 4443 1716
Fax
Email
maryam.sadat.rahimi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shadid Beheshti University of Medical Science
Full name of responsible person
Seyyed Ahmad Raeissadat
Position
Professer of Physical Medicine and Rehabilitation Department
Other areas of specialty/work
Street address
Shahid arabi ave., Yaman st., Shahid chamran highway
City
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
Email
a_raeissadat@sbmu.ac.ir, info@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Maryam Sadat Rahimi
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Shahid Modares Hospital
City
Tehran
Postal code
Phone
00
Fax
Email
maryam.sadat.rahimi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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