Protocol summary

Study aim
The aim of this study was to investigate the effect of to add dry needling in calf muscles to stretching exercise on improving pain and function in patients with chronic patellofemoral pain.
Design
A randomized clinical trial with parallel, controlled, single blind groups
Settings and conduct
In this clinical trial study, 36 patients with patellofemoral pain who referred to clinics affiliated to Shiraz School of Rehabilitation Sciences will be divided into two groups using a random method: the first group of stretching exercises with dry needling and The second group receive only stretching exercises.
Participants/Inclusion and exclusion criteria
This study are perform in people with patellofemoral pain who have pain for at least 3 months and their average pain during the last week is 4-7 and they have at least one trigger point in each group of gastrocnemius and soleus and peroneal muscles. And if they have special injury to the ankle and knee joint or are prohibited from using dry needling, they will be excluded from the study.
Intervention groups
Stretching Exercise Group: People with patellofemoral pain who receive only gastrocnemius, soleus and peroneal muscle stretching exercises. People do exercises 5 times a week for 10 sessions for 2 weeks. Stretching exercises with dry needling group: People with patellofemoral pain who in addition to stretching exercises of the mentioned muscles according to the routine of the control group, receive 4 sessions of dry needling twice a week for two weeks in the trigger points of gastrocnemius, soleus and peroneal muscles. Samples recruited from rehabilitation clinics of Shiraz University of Medical Sciences.
Main outcome variables
pain and function level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190909044734N3
Registration date: 2022-07-27, 1401/05/05
Registration timing: prospective

Last update: 2022-07-27, 1401/05/05
Update count: 0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Leila Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
leabbasi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2023-01-05, 1401/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Added value of calf muscles dry needling to stretching exercise in improving knee pain and function in patients with chronic patellofemoral pain
Public title
The effect of adding dry needling in calf muscles to stretching exercise in improving pain and function in patients with chronic patellofemoral pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People 18 to 45 years old with unilateral patellofemoral pain Complaints of anterior knee pain in at least 2 daily activities include: prolonged sitting, going up and down stairs, squatting, kneeling, jumping, and running. Report of pain when touching the internal and external patellar procedures and positive Clark test in knee extension and sitting position. Gradual onset of symptoms with no history of trauma or injury for at least the past 3 months. Kujala score level 80-50 with moderate disability. Have an average pain level of 4-7 on a numerical pain scale over the past week. Have at least one active or latent trigger point in each group of gastrosoleus muscles and peroneal muscles of the affected side, which is felt as a taut, sensitive and painful bundle. People with BMI=18.5-25
Exclusion criteria:
Injury of knee joint such as rupture of the meniscus or ligaments and tendons of the knee, osteoarthritis of the knee joint, dislocation of the patella Ankle injuries such as rupture of ligaments and tendons, ankle osteoarthritis, dislocation of ankle Ankle sprain in the last 6 months History of surgery and trauma to the entire lower extremity in the last 6 months Neurological disorders of the lower extremities and neuropathic pain Athletes who engage in certain sports activities at least two hours a day and three times a week People who have received physiotherapy and dry needling for patellofemoral pain in the last 6 months Contraindications to the use of dry needling: - The presence of metabolic diseases such as diabetes, rheumatic diseases - Local or systemic infections - Local ulcers on the skin - Pregnancy - Respiratory and cardiovascular problems (peripheral vascular disease, cancer, hepatitis, AIDS and any Malignancy - Taking immunosuppressive drugs - Any fear and reluctance to needle (needle phobia) - Epilepsy and mental health problems - Bleeding disorders and taking anticoagulants
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Using of randomization software, 36 numbers are considered for each case and the software defines 9 blocks of 4, from 4 to 2 people in the stretching group and 2 people in the stretching group with dry needling. They are dried and thus 36 people are completed
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who will evaluate the patients and analyze the data is completely unaware of the details of the patient grouping and the treatments performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, Shiraz Faculty of Rehabilitation Sciences
Street address
Abiverdi Street 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
1733-71345
Approval date
2022-06-15, 1401/03/25
Ethics committee reference number
IR.SUMS.REHAB.REC.1401.011

Health conditions studied

1

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

Primary outcomes

1

Description
Pain
Timepoint
Before the intervention, after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up
Method of measurement
NPRS

2

Description
Pain pressure threshold
Timepoint
Before the intervention, after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up
Method of measurement
Pressure algometer device

3

Description
Function
Timepoint
Before the intervention, immediately after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up
Method of measurement
Kujala questionnaire

4

Description
ROM of dorsiflexion and inversion
Timepoint
Before the intervention, immediately after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up
Method of measurement
Goniometer

5

Description
Functional tests
Timepoint
Before the intervention, immediately after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up
Method of measurement
Step down and anteromedial lunge tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group : Stretching exercise with dry needling group: People with patellofemoral pain who in addition to stretching exercises of the gastrocnemius, soleus and peroneal muscles according to the routine of the control group, receive 4 sessions of dry needling twice a week for two weeks in the trigger points of gastrocnemius, soleus and peroneal muscles.
Category
Rehabilitation

2

Description
Control group: Stretching Exercise Group: People with patellofemoral pain who receive only gastrocnemius, soleus and peroneal muscle stretching exercises.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz School of Rehabilitation
Full name of responsible person
Leila Abbasi
Street address
Abivardi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
1733-71345
Phone
+98 71 3627 1552
Fax
+98 71 3627 2495
Email
leabbasi@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Research Deputy, Central building of Shiraz University of Medical Sciences, Opposite Palestine St, Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty , Abiverdi 1 street , Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
leabbasi@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
leabbasi@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Abbasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
leabbasi@sums.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
No more 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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