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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06086860
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mulligan mobilization with dry needling.
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Mulligan Mobilization With and Without Dry Needling in Runner's Knee
Actual Study Start Date :
May 8, 2023
Anticipated Primary Completion Date :
Dec 8, 2023
Anticipated Study Completion Date :
Jan 8, 2024

Arms and Interventions

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 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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain: Numeric Pain Rating Scale (NPRS) [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).

    2. Functional Disability: Kujala Patellofemoral Scale (KPS) [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).

    3. Knee Range of Motion (ROM) (Flexion) : Goniometer [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.

    4. Knee Range of Motion (ROM) (Extension) : Goniometer [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.

    5. Flexibility: Goniometer [6th Week]

      Universal goniometer or inclinometer will be used for evaluating the knee joint range of motion and hamstring flexibility.

    6. Muscle strength: Modified Sphygmomanometer Test (MST) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johar Pain Relief Center Lahore Punjab Pakistan 54782

    Sponsors and Collaborators

    • Riphah International University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT06086860
    Other Study ID Numbers:
    • REC/RCR&AHS/23/0137 Mahnoor
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Dry needling, pain, range of motion
    Additional relevant MeSH terms:
    Patellofemoral Pain Syndrome

    Study Results

    No Results Posted as of Oct 17, 2023