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

March 4, 2024 updated by: Riphah International University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54782
        • Johar pain relief center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mulligan mobilization with dry needling.
Participants in this group will receive Mulligan mobilization with dry needling.
Other: Mulligan mobilization with dry needling.
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.
Other Names:
  • Mulligan mobilization without dry needling.
Active Comparator: Mulligan mobilization without dry needling.
Participants in this group will receive Mulligan mobilization without dry needling.
Other: Mulligan mobilization without dry needling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain: Numeric Pain Rating Scale (NPRS)
Time Frame: 6th Week
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).
6th Week
Functional Disability: Kujala Patellofemoral Scale (KPS)
Time Frame: 6th Week
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).
6th Week
Knee Range of Motion (ROM) (Flexion) : Goniometer
Time Frame: 6th Week
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.
6th Week
Knee Range of Motion (ROM) (Extension) : Goniometer
Time Frame: 6th Week
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.
6th Week
Flexibility: Goniometer
Time Frame: 6th Week
Universal goniometer or inclinometer will be used for evaluating the knee joint range of motion and hamstring flexibility.
6th Week
Muscle strength: Modified Sphygmomanometer Test (MST)
Time Frame: 6th Week
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.
6th Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Rabiya Noor, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Actual)

December 8, 2023

Study Completion (Actual)

January 8, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0137 Mahnoor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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