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Comparison of the Effect of low level laser and placebo laser on pain and function in subjects with patellofemoral pain syndrome: A Pilot Randomized Clinical Trial

Protocol summary

Study aim
To compare the effects of three groups including standard physical therapy alone, low level LASER plus standard physical therapy and placebo LASER plus standard physical therapy with each other on pain and function in subjects with patellofemoral pain syndrome.
Design
A pilot randomized clinical trial with placebo and control groups, community based, Triple-blind (participant, examiner and analyzer) with a parallel design
Settings and conduct
Hatef Physical Therapy Center. participant, examiner and analyzer are blind in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: subjects from both genders with patellofemoral pain Exclusion criteria: other problems and diseases associated with knee pain
Intervention groups
Standard physical therapy: education (using a pamphlet), using OFF ultrasound, stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band muscles and ­strengthening exercises for quadriceps and hip muscles. Standard physical therapy plus low level LASER: Standard physical therapy plus 808 nm, 200 mW, 4 J Ga-Al-As LASER over 5 points around the patella for 20 seconds per point Standard physical therapy plus placebo LASER: Standard physical therapy plus OFF LASER over 5 points around the patella for 20 seconds per point The treatment plan will be for each group of ten sessions, three sessions per week.
Main outcome variables
Pain; Function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150131020888N9
Registration date: 2018-08-04, 1397/05/13
Registration timing: registered_while_recruiting

Last update: 2018-08-04, 1397/05/13
Update count: 0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Zahra Sadat Rezaeian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5042
Email address
zrezaeian@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-28, 1397/04/07
Expected recruitment end date
2019-02-26, 1397/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of low level laser and placebo laser on pain and function in subjects with patellofemoral pain syndrome: A Pilot Randomized Clinical Trial
Public title
The Effect of low level LASER on pain and function in subjects with anterior knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence anterior or retro patellar pain only in one limb The report of pain during a day at least in 2 functional activities including prolonged sitting, climbing stairs, squatting, running, double kneeling, jumping Score of at least 3 on the visual analog scale (VAS) The pain will be reported in the squat on one leg for 10 seconds Subjects have anterior knee pain at least in the past three months Age from 18 to 40 years
Exclusion criteria:
Traumatic injuries of the low back and lower extremities Any signs or symptoms or MRI findings based on intra-articular pathologic conditions such as effusion, meniscal, or cruciate or collateral ligament involvement Subluxation and dislocation of the patella Other musculoskeletal injuries in lower extremities hip or lumbar referred pain Any symptoms or evidence of knee osteoarthritis in X-rays Infectious disease, rheumatoid arthritis, autoimmune disease, cancer and systemic diseases Corticosteroid injections and received physical therapy in the last 3 months, and received opioid and analgesic drugs in the last 72 hours Epilepsy, heart problems and heart pacemaker Active athlete BMI>30kg⁄m^2 Surgery of the lower limbs and lower back History the use of LASERs due to prejudices about the effect of the intervention
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The volunteers will be assigned to three groups randomly using the random numbered table codes. an unaware person in the research method will select the codes from the random numbers table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a Triple-blind randomized clinical trial (participant, examiner and analyzer) with a parallel design. LASER is performed by a physical therapist in two groups of laser and placebo. This person has no role in evaluating participants, other sections of treatment and recording information. Participants can not recognize, whether LASER devices is on or off. The same physical therapist who is blind to study groups will supervise standard physical therapy in all groups. to ensure participant blinding to study groups they all will receive therapeutic ultrasound in OFF state. A comprehensive clinical assessment will be performed by a physical therapist who is unaware of the research groups (student ). Data analysis will be done by an unknown person in the research method.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Secretariat of the Ethics Committee, Room 209, Second Floor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745-164
Approval date
2018-07-04, 1397/04/13
Ethics committee reference number
http://ethics.research.ac.ir/IR.MUI.RESEARCH.REC.1397.035

Health conditions studied

1

Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
M22.4
ICD-10 code description
Chondromalacia patellae

Primary outcomes

1

Description
pain
Timepoint
the first session just before the intervention and at the tenth session after the end of the treatment plan
Method of measurement
Visual Analogue Scale (VAS)-Persian version of Kujala questionnaire

2

Description
function
Timepoint
the first session just before the intervention and at the tenth session after the end of the treatment plan
Method of measurement
Persian version of Kujala questionnaire- step down test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: standard physical therapy plus low-level LASER group:Participants in this group receive active LASER plus standard physical therapy. LASERs will be used at the beginning of the session before any other intervention. Subjects will receive LASER in supine position. The probe will be in direct and full contact with the tissue at 90 ° angle. The LASER group will be treated with low level Gallium-Aluminum-Arsenide (Ga-Al-As) LASER, with a wavelength of 808 nm, output power of 200 mW, continuous mode, Beam spot size of 1 cm2, dose of 4 J/cm2 (each point), and energy of 4J for 20 seconds on each point. LASER will be radiated over five points around the patella. The total energy and total radiation time for each session will be 20 Jules and 100 seconds (one minute and 40 seconds) respectively. Participants will receive standard physical therapy after completing laser therapy. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises is the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band).
Category
Rehabilitation

2

Description
Intervention group: standard physical therapy plus placebo LASER group: The participants in this group receive LASER off plus standard physical therapy. In this group, the LASER device will turn off all the time. Participants will receive standard physical therapy after completing the LASER off Program. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises is the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band).
Category
Rehabilitation

3

Description
Control group: standard physical therapy alone: Participants in this group will receive only standard physical therapy. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises are the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hatef Physical Therapy Center
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Street address
No. 16, 2nd Floor, Salam Building., before Ostad Shahriar T intersection, Robat street., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8154739711
Phone
+98 31 3442 1625
Fax
+98 31 3668 7270
Email
zrezaeian@yahoo.com
Web page address
http://scholar.google.com/citations?user=FXzUASAAAAAJ&hl=en

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Vice Chancellery of Research and Technology
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellory of Research and Technology, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
+98 31 3792 5012
Fax
+98 31 3668 7270
Email
zrezaeian@rehab.mui.ac.ir
Web page address
http://scholar.google.com/citations?user=FXzUASAAAAAJ&hl=en
Grant name
Grant code / Reference number
297030
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Vice Chancellery of Research and Technology
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jarib Ave. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
00983137925012; 00983137925042
Fax
+98 31 3668 7270
Email
zrezaeian@yahoo.com
Web page address
http://scholar.google.com/citations?user=FXzUASAAAAAJ&hl=en

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jarib Ave. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
00983137925012; 00983137925042
Fax
+98 31 3668 7270
Email
zrezaeian@yahoo.com
Web page address
http://scholar.google.com/citations?user=FXzUASAAAAAJ&hl=en

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jarib Ave. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences
City
Isfahan
Province
Isfehan
Postal code
81745-164
Phone
00983137925012; 00983137925042
Fax
+98 31 3668 7270
Email
zrezaeian@yahoo.com
Web page address
http://scholar.google.com/citations?user=FXzUASAAAAAJ&hl=en

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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