Protocol summary

Study aim
Investigating the effect of adding gastrocnemius muscle dry needling to a common exercise therapy program on pain and performance in people with patellofemoral pain syndrome: a randomized controlled trial.
Design
Clinical trial with sham control group, with parallel groups, double-blind, randomized, on 38 patients. Random Number Generator was used for randomization.
Settings and conduct
Individuals are included in the study after being diagnosed and referred by a doctor specializing in orthopedics, physical medicine, or sports medicine to the orthopedic clinic of the Faculty of Rehabilitation of the University of Iran to receive treatment. People are divided into two intervention and control (sham) groups Participants, evaluators and statistical analysts are blinded. Blinding of the participants is in the form of sham intervention by the control group The evaluator has no knowledge of the grouping and intervention received by the patients. The statistical analyst is an individual outside the study and has no knowledge of the grouping
Participants/Inclusion and exclusion criteria
People diagnosed with femoral patellofemoral pain syndrome who have never received dry needling
Intervention groups
Intervention group: therapeutic exercise + real dry needling of the gastrocnemius muscle Control group: therapeutic exercise + dry needling of the gastrocnemius muscle
Main outcome variables
Usual pain intensity Most pain in the last week Ankle range of motion Degree of disability Modify star excursion test Step down test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240204060899N1
Registration date: 2024-06-01, 1403/03/12
Registration timing: prospective

Last update: 2024-06-01, 1403/03/12
Update count: 0
Registration date
2024-06-01, 1403/03/12
Registrant information
Name
Hossein Moghadasi Chevinlee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4722 4364
Email address
hosseinmghch@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-08, 1403/03/19
Expected recruitment end date
2024-09-13, 1403/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding gastrocnemius dry needling to conventional exercise therapy program on pain and function in individuals with patellofemoral pain syndrome: A randomized controlled trial
Public title
The effect of gastrocnemius dry needling in individuals with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in the anterior part of the knee or the posterior part or border of the patella on one side, which is caused or aggravated by at least two of the following activities: prolonged sitting, prolonged kneeling, squatting, running, hopping, climbing or descending from the stairs Age between 17 and 45 years Presence of at least one trigger point in the gastrocnemius muscle of the involved side Positive glide patella test Presence of symptoms for at least 3 months The average pain intensity in the last week is more than 3 out of 10 based on the VAS scale
Exclusion criteria:
Radiological findings that indicate osteoarthritis History of knee injury, including ligament sprain, meniscus injury, or other intra-articular disorders Sensitivity when touching the patella tendon or Pes anserinus muscle tendon History of knee fracture, patellar dislocation, or lower limb surgery during the past year Existence of musculoskeletal disorders such as disc protrusion or spondylolisthesis, severe structural disorder of the lower limb such as hip or knee osteoarthritis, having a prosthesis Existence of metabolic or neurological disorders such as diabetes, radicular pain or sensory disturbances Existence of systemic diseases or connective tissue disorders Contraindications of dry needling, such as cardiovascular and coagulation problems, pregnancy, cancer and fear of needles The experience of receiving dry needling so far for any part of the body Receiving physiotherapy treatment for knee pain in the last three months
Age
From 17 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is done by block method, 4-letter blocks consisting of letters A and B are randomly selected. Blocks are created by Random Number Generator and their sequence is specified. The letter A represents the intervention group and the letter B represents the control group. A random sequence of random blocks is then generated. The participants are placed in one of two intervention or control groups based on the order of referral with the help of this random sequence. The person generating the randomization sequence will not participate in any other phase of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participant and the examiner are blind to the intervention and grouping. Due to the nature of the intervention (dry needling), it is not possible to blind the therapist. In this study, in order to blind the participants, the dry needling intervention will be given to them as a sham, and the evaluation will be done by a physiotherapist who is blind to the allocation and intervention; Therefore, this study is two-way blind (participant and assessor). Also, to reduce possible biases, both groups will be given the same brochures and videos to teach how to perform therapeutic exercise to reduce the risk of bias in the basic treatment.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Imam Hassan dormitory, between the first and second Golha street, Elahi Square, Ayatollah Kashani Street, Sadeghieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1471835667
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.IUMS.REC.1402.862

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 intensity
Timepoint
At the beginning of the study (before the start of the intervention) - 4 weeks after receiving the intervention (the end of the intervention) - One month after the end of the intervention (follow-up)
Method of measurement
Visual Analogue Scale questionnaire

Secondary outcomes

1

Description
Disability
Timepoint
At the beginning of the study (before the start of the intervention) - 4 weeks after receiving the intervention (the end of the intervention) - One month after the end of the intervention (follow-up)
Method of measurement
Kujala questionnaire

2

Description
Ankle range of motion
Timepoint
At the beginning of the study (before the start of the intervention) - 4 weeks after receiving the intervention (the end of the intervention) - One month after the end of the intervention (follow-up)
Method of measurement
Goniometer

3

Description
Step down test score
Timepoint
At the beginning of the study (before the start of the intervention) - 4 weeks after receiving the intervention (the end of the intervention) - One month after the end of the intervention (follow-up)
Method of measurement
The number of going down the stairs in the Step down test

4

Description
Modify star excursion test score
Timepoint
At the beginning of the study (before the start of the intervention) - 4 weeks after receiving the intervention (the end of the intervention) - One month after the end of the intervention (follow-up)
Method of measurement
Reaching distance in the Modified star excursion test with the tape measure

Intervention groups

1

Description
Intervention group: Individuals in this group receive real dry needling of the gastrocnemius muscle in addition to the basic treatment. Dry needling is applied to the participants for 4 weeks and one session every week (4 sessions in total). For this purpose, a sterile Dong Bang needle with a size of 0.30 x 50 mm is used along with a plastic guide tube without being impregnated with a special medicinal substance in the trigger points of the gastrocnemius muscle.
Category
Treatment - Devices

2

Description
Control group: People in this group, in addition to the basic treatment, receive sham dry needling of the gastrocnemius muscle. This group, like the intervention group (real needling group), received sham dry needling for 4 weeks and one session every week (4 sessions in total).
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthopedic Clinic, Faculty of Rehabilitation, University of Iran
Full name of responsible person
Hossein Moghadasi Chevinlee
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۴۵۹۱۳۴۸۷
Phone
+98 21 2222 2059
Email
info@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Kiwani
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hossein Moghadasi Chevinlee
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Imam Hassan dormitory, between the first and second Golha street, Elahi Square, Ayatollah Kashani Street, Sadeghieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1471835667
Phone
+98 51 4722 4364
Fax
Email
hosseinmghch@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sanaz Shanbehzadeh
Position
Assistant Professor of Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۵۴۵۹۱۳۴۸۷
Phone
+98 21 2222 2059
Email
sanazshanbehzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Moghadasi Chevinlee
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Imam Hassan dormitory, between the first and second Golha street, Elahi Square, Ayatollah Kashani Street, Sadeghieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1471835667
Phone
+98 51 4722 4364
Fax
Email
hosseinmghch@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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