Protocol summary

Study aim
The study of electromyographic variables following the use of dry needling on the popliteus muscle.
Design
A controlled, parallel-group, single-blind, randomized clinical trial of 24 patients. Permutation block randomization is used.
Settings and conduct
Study will be conducted at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences, people with patellar maltracking randomly allocated in control and treatment groups. the evaluator will be blinded to allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-39. Having pain in at least two of the following: climbing and descending stairs, squatting, prolonged sitting, running, isometric quadriceps contraction and kneeling. Pain of at least 30 out of 100 on the Visual Analog Scale in the past three weeks (maximum pain 70). Positive Clarke and McConnell tests. Having at least one period of routine physical therapy without impact for patellar maltracking in the past. Presence of one of the factors that cause disorders in the direction of the patella. Presence of at least one trigger point in the popliteus muscle. Exclusion criteria: Systemic and Neurological diseases. Peripheral nerve entrapment. Connective tissue injuries. History of lower limb surgery. Injury to the lower limb in the past year or fracture, dislocation and sublaxation. Pathologies and other similar anterior knee pain. Receiving medicine in the previous two weeks. People who have received rehabilitation, acupuncture or dry needling for patellar maltracking in the last 6 months. Dry needling contraindications.
Intervention groups
In the intervention group, three dry needling sessions per week (with an interval of 48 hours) are performed for two weeks.
Main outcome variables
Visual analog scale score, Kujala patellofemoral scale score, Signal amplitude and muscle activation time while moving on the stairs.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230512058156N1
Registration date: 2023-05-14, 1402/02/24
Registration timing: prospective

Last update: 2023-05-14, 1402/02/24
Update count: 0
Registration date
2023-05-14, 1402/02/24
Registrant information
Name
Fatemezahra Khammar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 0536
Email address
fkhammar9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Electromyographic Variables in People with Patellar Maltracking Received Dry Needling of Popliteus Muscle: A Randomized Clinical Trial
Public title
The effect of Dry needling on the Popliteus muscle in Patellar maltracking
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-39. Having pain in at least two of the following: climbing stairs, descending stairs, squatting, prolonged sitting, running, isometric quadriceps contraction and kneeling. Pain of at least 30 out of 100 on the Visual Analog Scale in the past three weeks (maximum pain 70). Positive Clarke and McConnell tests. Having at least one period of routine physical therapy without impact for patellar maltracking in the past. Presence of one of the factors that cause disorders in the direction of the patella including defects in supporting muscles and guiding mechanisms, bone abnormalities, lower limb abnormalities, quadriceps muscle abnormalities such as vastus medialis oblique weakness, internal retinaculum laxity, external retinaculum stiffness, iliotibial band stiffness, hamstring shortness, gastrocnemius shortness , patella tendon elongation and patella alta, Q angle increase, genu valgum, genu recurvatum, femoral antiversion, trochlear dysplasia, external tilt of the patella, external displacement of the tibial tubercle or external rotation of the tibia and excessive pronation of the foot. Presence of at least one trigger point in the popliteus muscle.
Exclusion criteria:
Systemic diseases such as diabetes, rheumatoid arthritis, etc. Neurological diseases such as multiple sclerosis, epilepsy, etc. Peripheral nerve entrapment (acute disc herniation, spondylolisthesis, etc). Connective tissue injuries (torn meniscus, ligament, patella tendinopathy, etc). History of knee, hip and lower limb surgery. Injury to the lower limb in the past year or fracture, dislocation and sublaxation. Pathologies and other similar anterior knee pain include knee osteoarthritis, patellar chondromalacia, osteochondritis dissecans, articular cartilage damage, osgood schlatter, plica syndrome, bone tumors, patellar stress fracture, knee and pes anserine bursitis, fat pad impingement, patellar tendonitis and quadriceps tendinopathy. Receiving medicine in the previous two weeks. People who have received rehabilitation treatment, acupuncture or dry needling for patellar maltracking in the last 6 months. Dry needling contraindications, such as pregnancy, cardiovascular diseases, cancer, epilepsy, presence of lymphedema in the body, history of allergy to needles and injections, needle phobia and patient dissatisfaction.
Age
From 18 years old to 39 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
Patients will be entered into the treatment group or the control group by the block randomization method. The sample size for each group is 12 patients (24 patients in total). The patients, the therapist and the evaluator do not know about the grouping. Also, two groups will be homogenized in terms of weight, age and gender distribution. In order to create randomization, we use the permuted block randomization method. Random block sequence was obtained using Random allocation software. In total, we will have 6 blocks of 4 and the patients will enter the study based on it.
Blinding (investigator's opinion)
Single blinded
Blinding description
A physiotherapist will be in charge of the treatment process of the intervention group, and another physiotherapist will evaluate the desired variables. Therefore, the future study will be a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
Basij Blvd, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.SEMUMS.REC.1402.013

Health conditions studied

1

Description of health condition studied
Patellar maltracking
ICD-10 code
M22.2X9
ICD-10 code description
Patellofemoral disorders, unspecified knee

Primary outcomes

1

Description
Signal amplitude
Timepoint
Before and After the Intervention and Follow up
Method of measurement
Surface Electromyography

Secondary outcomes

1

Description
Visual Analog Scale score
Timepoint
Before and After the Intervention and Follow up
Method of measurement
Visual Analog Scale

2

Description
Kujala Patellofemoral Scale System score
Timepoint
Before and After the Intervention and Follow up
Method of measurement
Kujala Patellofemoral Scale System

Intervention groups

1

Description
Intervention group: In the intervention group (12 people), three sessions of dry needling are performed per week (48 hours apart), for two weeks and a total of 6 sessions of dry needling. We should check the popliteus for active or latent myofascial trigger points. The patient is asked to take a bath before the sessions. The area to be needled should be cleaned well with alcohol. The needles used are sterile and disposable. We insert the needle very quickly through the skin with a flick of the wrist or a strong tap into the trigger points. For needling, we place the trigger points between the thumb, index and middle finger, and the needle is directed towards the trigger points, and the therapist's fingers are placed in the lower part of the tissue. The person lies on the side with his knee and hip flexed at 90 degrees, and in this position, the muscle is touched just behind the proximal one-fifth of the tibia. The needle is inserted from the medial to the lateral with a slight superior-anterior orientation towards the trigger points. We keep the needle near the posterior part of the tibia or as a reference, the bone can be touched with the tip of the needle. Needles with a size of 0.3 x 50 mm are inserted into the muscle with a 40 mm tube and remain in the muscle for 6 minutes and are rotated ten times at the beginning, after three minutes and at the end of 6 minutes. In order to reduce the amount and duration of irritation caused by dry needling, after removing the needle, ischemic pressure is applied to the relevant area for one minute.
Category
Treatment - Devices

2

Description
Control group: Due to the invasive nature of dry needling and the difficulty of using placebo studies for this intervention, as well as to find the net effect of dry needling on the myofascial trigger points of the popliteus muscle in people with patellar maltracking, the control group does not receive treatment and they are evaluated only on the first day, the end of the second week, and the end of the fourth week.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Fatemezahra Khammar
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
Fkhammr9@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Fatemezahra Khammar
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
Fkhammar9@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Cyrus Taghizadeh Delkhoush
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
cyrustaghizadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemezahra Khammar
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Quds Blvd.
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
Fkhammar9@gmail.com

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 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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