Protocol summary

Study aim
To investigate the effect of Gastrocnemius dry needling on athletes with patellofemoral pain syndrome
Design
Twenty four athletes with patellofemoral pain are divided into two control and intervention group with the block randomization method using the randomization.com. The study is single blinded and third phase.
Settings and conduct
In the people with patellofemoral pain, gastrocnemius muscle is on of the most important muscles that get involved and become tight. On the other hand, dry needling is an effective intervention to release muscles. Therefore, in the upcoming study, the effect of gastrocnemius muscle dry needling on athletes with patellofemoral pain will be investigated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Anterior knee pain during activities such as descending stairs, squatting, kneeling, prolonged sitting 2. Positive Clark test 3.Gastrocnemius tightness in affected side Exclusion criteria: 1.Presence conditions such as knee osteoarthritis, patellar tendonitis, bursitis 2.Referral pain from lumbar or hip 3. Contraindications of dry needling such as cardiac and coagulations disease, pregnancy, malignancy and fear of needle
Intervention groups
In the control group, physiotherapy program including TENS and quadriceps strengthening exercises including straight leg raising and single leg squat, will be performed. Intervention group, in addition to the physiotherapy mentioned, will received dry needling in gastrocnemius muscle of affected side.
Main outcome variables
Pain; function; dynamic balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240724062529N1
Registration date: 2024-08-09, 1403/05/19
Registration timing: prospective

Last update: 2024-08-09, 1403/05/19
Update count: 0
Registration date
2024-08-09, 1403/05/19
Registrant information
Name
Elham Tavakoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 3165
Email address
tavakoli-e@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-27, 1403/06/06
Expected recruitment end date
2024-11-26, 1403/09/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dry needling effects of gastrocnemius muscle on pain, function, and dynamic balance in amateur athletes with patellofemoral pain syndrome
Public title
Dry needling effects on athletes with patellofemoral pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Amateur athletes with regular sports activity at least 2h per day 3 times per week Age between 18 and 40 years Anterior knee pain for at least 3 month, aggravated with at least 1 activities such as stair descending, squatting, kneeling or prolonged sitting Positive Clark test Gastrocnemius tightness in affected side by Silfverskiöld test VAS ≥ 30 mm in first assessment Kujala questionnaire score < 85 of 100
Exclusion criteria:
Knee osteoarthritis, patellar tendonitis, bursitis or infrapatellar fat pad Patellar fracture or dislocation history Referred pain from lumbar, hip or ankle Bilateral anterior knee pain Previous surgery in affected lower limb Contraindications of dry needling such as cardiovascular and coagulation disease, anticoagulation therapy, pregnancy, cancer, fear of needles Physical therapy for knee pain within the previous 3 months Genu valgum, genu varum, genurecurvatum and flat foot in affected limb
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
After the baseline assessments, the participants will be randomized into intervention or control group. randomization will be done in block method by Randomization.com. In this way, 6 blocks of 4 people will be used by assigning two by two between two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be single-blinded. In this way, another physiotherapist will do the baseline and post-treatment evaluation without knowing which patients belonged to which group (assessor blinding).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-08-03, 1403/05/13
Ethics committee reference number
IR.TUMS.FNM.REC.1403.052

Health conditions studied

1

Description of health condition studied
Patellofemoral Pain Syndrome
ICD-10 code
M22.2X
ICD-10 code description
Patellofemoral disorders

Primary outcomes

1

Description
Pain
Timepoint
Before intervention, After the last session of intervention, One week after the last session of intervention
Method of measurement
Visual Analogue Scale

2

Description
Function
Timepoint
Before intervention, After the last session of intervention, One week after the last session of intervention
Method of measurement
The Kujala Scale

3

Description
Dynamic Balance
Timepoint
Before intervention, After the last session of intervention, One week after the last session of intervention
Method of measurement
Dynamic Leap and Balance Test (DLBT)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (12 people): In addition to three weeks physiotherapy program (TENS, quadriceps strengthening exercises), will receive dry needling on gastrocnemius muscle in affected side once a week.
Category
Rehabilitation

2

Description
Control group (12 people): will receive physiotherapy program including TENS and quadriceps strengthening exercises (straight leg raising, single leg squat) three times a week for three weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Medicine Federation of Iran
Full name of responsible person
Morteza Ahmadi
Street address
Iran Sports Medicine Federation, No. 17, Varzandeh st., South Mofatteh av., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 83826
Email
mortezaahmadi54@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3639
Fax
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Science
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
Tehran University of Medical Sciences
Full name of responsible person
Behrouz Attarbashi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
attarbashi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behrouz Attarbashi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
attarbashi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Tavakoli
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche shemiran, Enghelab Avenu
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
tavakoli-e@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 3 months after the articles are published.
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in the field of sport physiotherapy
From where data/document is obtainable
Applicants for documentation can contact Elham Tavakoli via email
What processes are involved for a request to access data/document
Once they have the necessary criteria, the information will be provided to them within a month
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