To compare the outcomes of ultrasound guided dry needling in addition to conventional physical therapy on patellar tendonitis, tendon thickness, tendon width, fibrillar echo-pattern and echogenicity of patellar tendon in patients with jumper’s knee.
Design
parallel group, single blinded, randomized controlled trial
Settings and conduct
The institute of physical therapy, The university of Lahore
Participants/Inclusion and exclusion criteria
inclusion criteria: Athletes with medical diagnosis of Jumper’s knee. Aged between 18 to 45 years. Both genders. A score below 80 on the Victorian Institute of Sports Assessment for PT (VISA-P) questionnaire. Pain provocation on Single leg decline squat test as a score >0 on the NRS.
Exclusion Criteria: Knee surgery within the previous 6 months. Chronic knee joint diseases. Corticosteroid injection in the patellar tendon within the last 1 month. Contraindications for needling. Presence of calcification. Use of analgesics for last 48 hours. Any other concomitant treatment for jumper’s knee.
Intervention groups
(Experimental group); it will receive ultrasound guided dry needling(three needle insertions lasting 3 seconds each and the number of times the needle will pass through the tendon will range from 15 to 30 passes, depending on the size of the tendon abnormality) in addition to routine physical therapy.(An exercise program will consist of stretching and strengthening exercises of quadricep & hamstring: mini-squats, seated knee extensions, lunges, and lateral steps (3 sets, 15 reps each) & therapeutic modalities) and activity modifications.
control group will receive same routine physical therapy intervention as of group A
Main outcome variables
Visual analogue scale, Victorian Institute of Sport Assessment Patellar(VISA-P) Score, The Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm score , Sonographic tendon assessment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210409050913N1
Registration date:2021-04-17, 1400/01/28
Registration timing:prospective
Last update:2021-04-17, 1400/01/28
Update count:0
Registration date
2021-04-17, 1400/01/28
Registrant information
Name
Faiza Sharif
Name of organization / entity
The university of lahore
Country
Pakistan
Phone
+92 42 35322501
Email address
faiza.sharif@uipt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-01, 1400/02/11
Expected recruitment end date
2021-10-01, 1400/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
OUTCOME COMPARISON OF ULTRASOUND GUIDED DRY NEEDLING IN ADDITION TO CONVENTIONAL PHYSICAL THERAPY FOR TREATMENT OF PATIENTS WITH JUMPER’S KNEE
Public title
ultrasound guided dry needling for jumper's knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes with medical diagnosis of patellar tendinopathy and anterior knee pain located on the inferior pole of the patella for over 1 month. The intensity of pain of 3.0 or greater on a 0-to-10 visual analog scale while walking up and down stairs and high pain intensity in single leg decline squat test. Palpation tenderness of the superior insertion of the patellar tendon.
Athletes of either genders Age ranges between 18 to 45 years.
A score below 80 on the Victorian Institute of Sports Assessment for PT (VISA-P) questionnaire.
Pain provocation on Single leg decline squat test as a score >0 on the NRS.
Exclusion criteria:
Knee surgery within the previous 6 months.
Chronic knee joint diseases.
Corticosteroid injection in the patellar tendon within the last 1 month.
Contraindications for needling such as allergies/sensitivities, diseases/conditions, implants, areas of acute inflammation, acute systemic infections, on blood thinner or anticoagulants, with known history of bleeding disorders.
Presence of multiple focal areas of calcification within the proximal tendon or radiographic fractures around the knee.
Use of analgesics for last 48 hours.
Any other concomitant treatment for jumper’s knee.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The patients having diagnosed Jumper’s knee will be recruited in the study by convenient sampling, and the patients who fulfill the inclusion and exclusion criteria will be selected, with similar baseline characteristics. The consent will be taken from the subjects to participate in the study.It will be a single blinded trial in which the assessor will be kept blind.The subjects will be randomly assigned to one of two groups by using a table of random numbers generated the randomization sequence, using a restricted randomization scheme to assure equal numbers in each group. Random allocation to all groups will be ensured, from all study personnel and participants by entry of data into computer randomization program immediately.Group assignments will be sealed in opaque envelopes and opened sequentially by the investigators.
Blinding (investigator's opinion)
Single blinded
Blinding description
It will be a single blinded trial in which the assessor will be kept blind.Assessor will be senior physiotherapist who will take measurements after giving consent to participate in the study. He will be blind, not confirmed about the group of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Parallel groups, single blinded, single setting
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board Committee
Street address
1-km defence road, off bhoptian chowk, Lahore Pakistan
City
Lahore
Postal code
0544
Approval date
2021-02-11, 1399/11/23
Ethics committee reference number
IRB-UOL-FAHS/829-I/2021
Health conditions studied
1
Description of health condition studied
Jumper's knee
ICD-10 code
M76.5
ICD-10 code description
Patellar tendinitis
Primary outcomes
1
Description
pain intensity
Timepoint
baseline, 1st, 2nd, and 4th week after the intervention
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
functional disability
Timepoint
baseline, 1st, 2nd and 4th week after the intervention
Method of measurement
VISA-P Score, KOOS Score, Lysholm score
Intervention groups
1
Description
Intervention group: Ultrasound guided dry needling in addition to routine physical therapy. each session of ultrasound guided dry needling will consist of three needle insertions lasting 3 seconds each and the number of times the needle will pass through the tendon will range from 15 to 30 passes, depending on the size of the tendon abnormality. Routine physiotherapy treatment will be administered to the patients which includes these: •An exercise program will consist of stretching and strengthening exercises of quadricep & hamstring: mini-squats, seated knee extensions, lunges, and lateral steps. Each exercise will be conducted in 3 sets of 15 repetitions. Each repetition will begin with the concentric phase, followed by the eccentric phase of the exercise. • Physiotherapy modalities will include 10 minutes of Heat Therapy by moist hot pack, phonophoresis (pulsed ultrasound) and transverse friction massage.•The use of knee strap & activity modification
Category
Treatment - Devices
2
Description
Control group: It will be given same routine physical therapy treatment methods given generally to treat such patients for same time
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
University institute of physical therapy,The University of Lahore
Full name of responsible person
Muhammad Asim Arif
Street address
1-km defence road, off bhoptian chowk, Lahore
City
lahore
Postal code
54000
Phone
+92 42 35322501
Email
asim.pt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Ashfaq Ahmad
Street address
1-km defence road, off bhoptian chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35322501
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Private
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
The University of Lahore
Full name of responsible person
Faiza Sharif
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road, off bhoptian chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35322501
Email
faiza.sharif@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of lahore
Full name of responsible person
Faiza Sharif
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road, off bhoptian chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35322501
Email
faiza.sharif@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The university of lahore
Full name of responsible person
Faiza Sharif
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1-km defence road, off bhoptian chowk Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35322501
Email
faiza.sharif@uipt.uol.edu.pk
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
Not applicable
Analytic Code
Not applicable
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 collected IPD for all outcome measures
When the data will become available and for how long
starting in November 2021 6 months after publication
To whom data/document is available
persons in academic institutes and researchers
Under which criteria data/document could be used
it could be used on permission from investigator
From where data/document is obtainable
through email to investigator faiza.sharif@uipt.uol.edu.pk
What processes are involved for a request to access data/document
through email to investigator faiza.sharif@uipt.uol.edu.pk and call 0092321 4600797