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Effects of Mulligan Mobilization With and Without Dry Needling in Runner's Knee

Primary Purpose

Runner's Knee

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mulligan mobilization with dry needling.
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Runner's Knee focused on measuring Dry needling, pain, range of motion

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients of both genders. Individuals aged 20-45 years with a clinical diagnosis of Runner's Knee. Participants experiencing retropatellar or anterior knee pain during at least two activities such as ascending and descending stairs, squatting, kneeling, or prolonged sitting, jumping or running. Pain scoring rate on numeric pain rating scale (NPRS) ≥ 3 during at least two activities. Duration lasting longer than two months. Exclusion Criteria: Patients with a history of meniscus tears, bursitis, patellar tendon injury, ligamentous injury, joint degeneration, patellofemoral dislocation and / or recurrent subluxation. Participants with a history of arthritis. Individuals with a history of lower extremity surgery. Patients having knee pain referred from hip, lumbar spine and ankle joints. Any systemic disease and/or connective tissue disorders, or lumbosacral nerve root compression. Patients taking any pain medications. Individuals who previously received acupuncture therapy, injection, or dry needling technique for knee extensor muscle in last six months.

Sites / Locations

  • Johar Pain Relief CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mulligan mobilization with dry needling.

Mulligan mobilization without dry needling.

Arm Description

Participants in this group will receive Mulligan mobilization with dry needling.

Participants in this group will receive Mulligan mobilization without dry needling.

Outcomes

Primary Outcome Measures

Pain: Numeric Pain Rating Scale (NPRS)
Patients' overall assessment of pain will be provided using the numeric pain rating scale (NPRS). The NPRS is known to be a sensitive and reliable scale for clinical and experimental evaluation of pain intensity. The score ranges from 0, indicating no pain, to 10, expressing worst imaginable pain. The reliability of numeric pain rating scale (NPRS) is 0.92 (0.87, 0.95).
Functional Disability: Kujala Patellofemoral Scale (KPS)
The Kujala score will be used to evaluate functional disability in patients with patellofemoral disorder. Kujala Patellofemoral Scale (KPS) is a 13-item, self completed instrument with different categories consisted of limping, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting, pain, swelling, painful patellar movements, muscle atrophy and flexion deficiency. The total score ranges from 0 to 100, with higher scores indicating lower levels of pain/ disability. It has been claimed that this tool is user-friendly and the test-retest reliability is highly acceptable. This tool is valid and sensitive for research purposes. The test-retest reliability is excellent with an intra-class correlation coefficient of 0.908 (p < 0.001; 95% CI [0.842-0.947]). The internal consistency is strong with Cronbach's alpha of 0.952 (p < 0.001).
Knee Range of Motion (ROM) (Flexion) : Goniometer
Universal Goniometer is the most commonly utilised clinical tool for measuring joint range of motion due to its ease of use, low cost, and demonstrated reasonable levels of reliability and validity in numerous studies. Validity and intertester reliability (r =.97-.98; ICC =.98-.99) are both high.
Knee Range of Motion (ROM) (Extension) : Goniometer
Universal Goniometer is the most commonly utilised clinical tool for measuring joint range of motion due to its ease of use, low cost, and demonstrated reasonable levels of reliability and validity in numerous studies. Validity and intertester reliability (r =.97-.98; ICC =.98-.99) are both high.
Flexibility: Goniometer
Universal goniometer or inclinometer will be used for evaluating the knee joint range of motion and hamstring flexibility.
Muscle strength: Modified Sphygmomanometer Test (MST)
A sphygmomanometer will be used for the evaluation of all muscular groups. A statistically significant correlation of moderate to high magnitude (0.58 ≤ r ≤ 0.81) is observed for concurrent validity of the MST with fixed stabilization for all muscle groups. Regarding inter-rater reliability, it is observed statistically significant ICC considered excellent to good (0.72 ≤ r ≤ 0.94) for all muscle groups. Regarding test-retest reliability, is good to excellent ICC (0.64 ≤ r ≤ 0.94) for all muscle groups. The MST with fixed stabilization is valid and reliable for clinical measurement of muscle strength.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06086860
Brief Title
Effects of Mulligan Mobilization With and Without Dry Needling in Runner's Knee
Official Title
Effects of Mulligan Mobilization With and Without Dry Needling in Runner's Knee
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
January 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to determine the effects of Mulligan mobilization with and without dry needling on pain, range of motion, flexibility, functional disability and muscle strength in patients with Runner's Knee.
Detailed Description
Runner's knee or patellofemoral pain syndrome (PFPS) is a common cause of anterior knee pain in young active individuals. Patellofemoral pain (PFP), or anterior knee pain (AKP), is a common musculoskeletal disorder. It involves dysfunction in mechanical forces between the patella and the femur. The worldwide PFP prevalence has been reported as 15-45% of population. Females are at two times higher risk of PFP than males, especially young active females. The aim of this study is to determine the effects of Mulligan mobilization with and without dry needling in Runner's Knee in a randomized clinical trial. The study will be randomized clinical trial. The study will be conducted at Johar Pain Relief Center, Lahore. The study will be completed within eight months after synopsis approval from ethical committee of Riphah College of Rehabilitation and Allied Health sciences. Sample size will be 40 (20 in each group). Non-probability convenience sampling technique will be used to recruit the Runner's Knee patients in the study and then they will be divided into two groups by simple randomization through sealed opaque envelope. Mulligan mobilization with dry needling will be given to group A. Mulligan mobilization without dry needling will be given to group B. Outcome measures will be pain, knee range of motion, flexibility, functional disability and muscle strength measured through Numeric pain rating scale (NPRS), goniometer, Kujala Patellofemoral Scale and Modified Sphygmomanometer Test (MST) respectively. Data will be analyzed by SPSS version 25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Runner's Knee
Keywords
Dry needling, pain, range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mulligan mobilization with dry needling.
Arm Type
Experimental
Arm Description
Participants in this group will receive Mulligan mobilization with dry needling.
Arm Title
Mulligan mobilization without dry needling.
Arm Type
Active Comparator
Arm Description
Participants in this group will receive Mulligan mobilization without dry needling.
Intervention Type
Other
Intervention Name(s)
Mulligan mobilization with dry needling.
Other Intervention Name(s)
Mulligan mobilization without dry needling.
Intervention Description
The duration of intervention will be 6 weeks, 2 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 30 minutes.
Primary Outcome Measure Information:
Title
Pain: Numeric Pain Rating Scale (NPRS)
Description
Patients' overall assessment of pain will be provided using the numeric pain rating scale (NPRS). The NPRS is known to be a sensitive and reliable scale for clinical and experimental evaluation of pain intensity. The score ranges from 0, indicating no pain, to 10, expressing worst imaginable pain. The reliability of numeric pain rating scale (NPRS) is 0.92 (0.87, 0.95).
Time Frame
6th Week
Title
Functional Disability: Kujala Patellofemoral Scale (KPS)
Description
The Kujala score will be used to evaluate functional disability in patients with patellofemoral disorder. Kujala Patellofemoral Scale (KPS) is a 13-item, self completed instrument with different categories consisted of limping, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting, pain, swelling, painful patellar movements, muscle atrophy and flexion deficiency. The total score ranges from 0 to 100, with higher scores indicating lower levels of pain/ disability. It has been claimed that this tool is user-friendly and the test-retest reliability is highly acceptable. This tool is valid and sensitive for research purposes. The test-retest reliability is excellent with an intra-class correlation coefficient of 0.908 (p < 0.001; 95% CI [0.842-0.947]). The internal consistency is strong with Cronbach's alpha of 0.952 (p < 0.001).
Time Frame
6th Week
Title
Knee Range of Motion (ROM) (Flexion) : Goniometer
Description
Universal Goniometer is the most commonly utilised clinical tool for measuring joint range of motion due to its ease of use, low cost, and demonstrated reasonable levels of reliability and validity in numerous studies. Validity and intertester reliability (r =.97-.98; ICC =.98-.99) are both high.
Time Frame
6th Week
Title
Knee Range of Motion (ROM) (Extension) : Goniometer
Description
Universal Goniometer is the most commonly utilised clinical tool for measuring joint range of motion due to its ease of use, low cost, and demonstrated reasonable levels of reliability and validity in numerous studies. Validity and intertester reliability (r =.97-.98; ICC =.98-.99) are both high.
Time Frame
6th Week
Title
Flexibility: Goniometer
Description
Universal goniometer or inclinometer will be used for evaluating the knee joint range of motion and hamstring flexibility.
Time Frame
6th Week
Title
Muscle strength: Modified Sphygmomanometer Test (MST)
Description
A sphygmomanometer will be used for the evaluation of all muscular groups. A statistically significant correlation of moderate to high magnitude (0.58 ≤ r ≤ 0.81) is observed for concurrent validity of the MST with fixed stabilization for all muscle groups. Regarding inter-rater reliability, it is observed statistically significant ICC considered excellent to good (0.72 ≤ r ≤ 0.94) for all muscle groups. Regarding test-retest reliability, is good to excellent ICC (0.64 ≤ r ≤ 0.94) for all muscle groups. The MST with fixed stabilization is valid and reliable for clinical measurement of muscle strength.
Time Frame
6th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of both genders. Individuals aged 20-45 years with a clinical diagnosis of Runner's Knee. Participants experiencing retropatellar or anterior knee pain during at least two activities such as ascending and descending stairs, squatting, kneeling, or prolonged sitting, jumping or running. Pain scoring rate on numeric pain rating scale (NPRS) ≥ 3 during at least two activities. Duration lasting longer than two months. Exclusion Criteria: Patients with a history of meniscus tears, bursitis, patellar tendon injury, ligamentous injury, joint degeneration, patellofemoral dislocation and / or recurrent subluxation. Participants with a history of arthritis. Individuals with a history of lower extremity surgery. Patients having knee pain referred from hip, lumbar spine and ankle joints. Any systemic disease and/or connective tissue disorders, or lumbosacral nerve root compression. Patients taking any pain medications. Individuals who previously received acupuncture therapy, injection, or dry needling technique for knee extensor muscle in last six months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, Phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johar Pain Relief Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54782
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, Phd
Phone
03344355660
Email
rabiya.noor@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Mahnoor Shafi, MS(OMPT)

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Mulligan Mobilization With and Without Dry Needling in Runner's Knee

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