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The effects of transcranial direct current stimulation combined with exercise therapy on pain, function and central pain inhibition mechanisms in subjects with Patellofemoral Pain: A clinical trial

Protocol summary

Study aim
The effects of transcranial direct current stimulation combined with exercise therapy on pain, function and central pain inhibition mechanisms in subjects with Patellofemoral Pain
Design
Randomized control trial with 2 group of control and treatment design of 32 patients, Double-blind, with a parallel group.
Settings and conduct
Patients are randomly assigned to either intervention or treatment groups at Golestan Hospital in Ahvaz. In this study, patients and assessors were blinded.
Participants/Inclusion and exclusion criteria
People with patellofemoral pain with over three years of experience, ranging in age from 18 to 40 years, especially with back or around patella pain. The patient will be excluded if he has any previous surgery or joint injury and soft tissue of the knee.
Intervention groups
Patients in the intervention group received TDCS initially and in the control group received sham for 20 minutes.
Main outcome variables
pain, level of function, pressure pain threshold, condition pain modulation, kinesiophobia

General information

Reason for update
Acronym
TDCS
IRCT registration information
IRCT registration number: IRCT20191221045836N1
Registration date: 2020-01-27, 1398/11/07
Registration timing: registered_while_recruiting

Last update: 2020-01-27, 1398/11/07
Update count: 0
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Foruzan Orak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3335 7387
Email address
orak.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of transcranial direct current stimulation combined with exercise therapy on pain, function and central pain inhibition mechanisms in subjects with Patellofemoral Pain: A clinical trial
Public title
The effects of transcranial direct current stimulation combined with exercise therapy on clinical outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Anterior knee pain Provoked pain with two physical activity of functional tasks: stairs climbing, squat, running, biking, jumping, prolonged sitting Painfull quadriceps isometric contraction at 60 degree of squat Pain with medial or lateral patellar facet palpation Minimal pain intensity with visual analog scale 3 of 10 Pain report more than 3 years
Exclusion criteria:
History of knee surgery ligament knee instability Meniscus injury symptoms or intra joint dysfunction Knee tendinitis ( patellat tendinitis, iliotibial band and jumper's knee tendinitis, Pes anserinus tendinitis) Patients with Osgood-Shlatter or Sinding-Larsen-Johanssen Patellar instability and positive apprehension sign Traumatic patellar dislocation Concurrent pain in hip, sacroiliac & lumbar walking with assistance Systematic disorders (cardiovascular or rheumatology) that affect on lower limbs Knee structural disorders including knee varus and valgus Psychiatry disorders that affect on electroencephalography such as depression, autism, Schizophrenia Seizure and epilepsy
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be carried out by a computer-generated random number list prepared by an independent statisticianr with no clinical involvement in the trial. The patients were randomly assigned to one of the following two groups: transcranial direct current stimulation combined with exercise therapy (Group A) or exercise therapy (Group B) The allocation was concealed in opaque, sealed envelope. A research assistant open the envelopes to reveal group allocation before starting the intervention
Blinding (investigator's opinion)
Double blinded
Blinding description
The physiotherapist that collected the data and patients were not aware of the group assignment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.AJUMS.REC.1398.749

Health conditions studied

1

Description of health condition studied
Patellofemoral pain
ICD-10 code
M25.56
ICD-10 code description
Pain in knee

Primary outcomes

1

Description
pain
Timepoint
1 day before first session of treatment, second and twenty first days after end of treatment
Method of measurement
Visual Analog Scale

2

Description
Functional level
Timepoint
1 day before first session of treatment, second and twenty first days after end of treatment
Method of measurement
Lower limb functional scale questioner

3

Description
pressure pain threshold
Timepoint
1 day before first session of treatment, second and twenty first days after end of treatment
Method of measurement
Lutron tension and compression force gauge

4

Description
Conditioned pain modulation
Timepoint
1 day before first session of treatment, second and twenty first days after end of treatment
Method of measurement
Conditioned pain modulation test score

5

Description
Kinesiophobia
Timepoint
1 day before first session of treatment, second and twenty first days after end of treatment
Method of measurement
Tampa Scale for Kinesiophobia questioner

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Combined exercise therapy and transcranial direct current stimulation Control group: Exercise therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Saadat Maryam
Street address
Mofid Ave., Golestan Blvd., Ahvaz Town., Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
411366718596
Phone
+98 61 3374 3001
Fax
Email
Orak.f@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Saadat
Street address
Golestan Blvd, jundishapor universityt of medical scince
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
Ahvaz-rehab@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Foruzan Orak
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Golestan Blvd, Ahvaz Jundishapor of Medical Science, Rehabilitation School
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
orak.f@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Saadat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Golestan Blvd, Ahvaz Jundishapor of medical science, rehabilitation school
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
maryamsaadat2008@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Foruzan Orak
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Golestan Blvd, Ahvaz Jundishapor university of medical science. rehabilitation school
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
orak.f@ajums.ac.ir

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
The person's information will be confidential and the results will be as collective statistics
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This clinical trial will be an research article and its protocol, results report and statistical analysis will be published to be used by therapists.
When the data will become available and for how long
If the journal has requested access to the data at any time, the data will be provided.
To whom data/document is available
Journal editors and Reviewers
Under which criteria data/document could be used
Sometimes for re-analysis or for use in meta-analysis studies
From where data/document is obtainable
Project Manager
What processes are involved for a request to access data/document
It shoulde be send email to project manager and after reviewing the reason for requesting the data, they will be send
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