NCT06086860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

October 11, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

Dry needlingPainRange of motion

Outcome Measures

Primary Outcomes (6)

  • 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).

    6th Week

  • 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).

    6th Week

  • 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.

    6th Week

  • 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.

    6th Week

  • Flexibility: Goniometer

    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)

    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

Study Arms (2)

Mulligan mobilization with dry needling.

EXPERIMENTAL

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

Other: Mulligan mobilization with dry needling.

Mulligan mobilization without dry needling.

ACTIVE COMPARATOR

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

Other: Mulligan mobilization without dry needling

Interventions

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.

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.

Mulligan mobilization without dry needling.

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johar Pain Relief Center

Lahore, Punjab Province, 54782, Pakistan

Location

Related Publications (17)

  • Rehman M, Riaz H. Comparison of mobilization with movement and Mulligan knee taping on Patellofemoral pain syndrome. J Pak Med Assoc. 2021 Sep;71(9):2119-2123. doi: 10.47391/JPMA.04-658.

    PMID: 34580498BACKGROUND
  • Demirci S, Kinikli GI, Callaghan MJ, Tunay VB. Comparison of short-term effects of mobilization with movement and Kinesiotaping on pain, function and balance in patellofemoral pain. Acta Orthop Traumatol Turc. 2017 Dec;51(6):442-447. doi: 10.1016/j.aott.2017.09.005. Epub 2017 Oct 17.

    PMID: 29054803BACKGROUND
  • Behrangrad S, Abbaszadeh-Amirdehi M, Kordi Yoosefinejad A, Esmaeilnejadganji SM. Comparison of dry needling and ischaemic compression techniques on pain and function in patients with patellofemoral pain syndrome: a randomised clinical trial. Acupunct Med. 2020 Dec;38(6):371-379. doi: 10.1177/0964528420912253. Epub 2020 Apr 27.

    PMID: 32338532BACKGROUND
  • Sutlive TG, Golden A, King K, Morris WB, Morrison JE, Moore JH, Koppenhaver S. SHORT-TERM EFFECTS OF TRIGGER POINT DRY NEEDLING ON PAIN AND DISABILITY IN SUBJECTS WITH PATELLOFEMORAL PAIN SYNDROME. Int J Sports Phys Ther. 2018 Jun;13(3):462-473.

    PMID: 30038832BACKGROUND
  • Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13.

    PMID: 28504067BACKGROUND
  • Ma YT, Li LH, Han Q, Wang XL, Jia PY, Huang QM, Zheng YJ. Effects of Trigger Point Dry Needling on Neuromuscular Performance and Pain of Individuals Affected by Patellofemoral Pain: A Randomized Controlled Trial. J Pain Res. 2020 Jul 7;13:1677-1686. doi: 10.2147/JPR.S240376. eCollection 2020.

    PMID: 32753943BACKGROUND
  • Plummer S, Leonard J. Mobilization With Movement as Therapy to Reduce Knee Pain and Increase Knee Range of Motion. J Sport Rehabil. 2022 Jun 20;31(7):950-953. doi: 10.1123/jsr.2021-0294. Print 2022 Sep 1.

    PMID: 35728804BACKGROUND
  • Freedman SR, Brody LT, Rosenthal M, Wise JC. Short-term effects of patellar kinesio taping on pain and hop function in patients with patellofemoral pain syndrome. Sports Health. 2014 Jul;6(4):294-300. doi: 10.1177/1941738114537793.

    PMID: 24982700BACKGROUND
  • da Silva Boitrago MV, de Mello NN, Barin FR, Junior PL, de Souza Borges JH, Oliveira M. Effects of proprioceptive exercises and strengthening on pain and functionality for patellofemoral pain syndrome in women: A randomized controlled trial. J Clin Orthop Trauma. 2021 Apr 19;18:94-99. doi: 10.1016/j.jcot.2021.04.017. eCollection 2021 Jul.

    PMID: 33996453BACKGROUND
  • da Cunha RA, Costa LO, Hespanhol Junior LC, Pires RS, Kujala UM, Lopes AD. Translation, cross-cultural adaptation, and clinimetric testing of instruments used to assess patients with patellofemoral pain syndrome in the Brazilian population. J Orthop Sports Phys Ther. 2013 May;43(5):332-9. doi: 10.2519/jospt.2013.4228. Epub 2013 Mar 13.

    PMID: 23485881BACKGROUND
  • Mustamsir E, Phatama KY, Pratianto A, Pradana AS, Sukmajaya WP, Pandiangan RAH, Abduh M, Hidayat M. Validity and Reliability of the Indonesian Version of the Kujala Score for Patients With Patellofemoral Pain Syndrome. Orthop J Sports Med. 2020 May 28;8(5):2325967120922943. doi: 10.1177/2325967120922943. eCollection 2020 May.

    PMID: 32523969BACKGROUND
  • Negahban H, Pouretezad M, Yazdi MJ, Sohani SM, Mazaheri M, Salavati M, Aryan N, Salehi R. Persian translation and validation of the Kujala Patellofemoral Scale in patients with patellofemoral pain syndrome. Disabil Rehabil. 2012;34(26):2259-63. doi: 10.3109/09638288.2012.683480. Epub 2012 May 27.

    PMID: 22630589BACKGROUND
  • Apivatgaroon A, Angthong C, Sanguanjit P, Chernchujit B. The validity and reliability of the Thai version of the Kujala score for patients with patellofemoral pain syndrome. Disabil Rehabil. 2016 Oct;38(21):2161-4. doi: 10.3109/09638288.2015.1114035. Epub 2016 Jan 5.

    PMID: 26729626BACKGROUND
  • Keogh JWL, Cox A, Anderson S, Liew B, Olsen A, Schram B, Furness J. Reliability and validity of clinically accessible smartphone applications to measure joint range of motion: A systematic review. PLoS One. 2019 May 8;14(5):e0215806. doi: 10.1371/journal.pone.0215806. eCollection 2019.

    PMID: 31067247BACKGROUND
  • Pua YH, Poon CL, Seah FJ, Thumboo J, Clark RA, Tan MH, Chong HC, Tan JW, Chew ES, Yeo SJ. Predicting individual knee range of motion, knee pain, and walking limitation outcomes following total knee arthroplasty. Acta Orthop. 2019 Apr;90(2):179-186. doi: 10.1080/17453674.2018.1560647.

    PMID: 30973090BACKGROUND
  • Souza LA, Martins JC, Moura JB, Teixeira-Salmela LF, De Paula FV, Faria CD. Assessment of muscular strength with the modified sphygmomanometer test: what is the best method and source of outcome values? Braz J Phys Ther. 2014 Mar-Apr;18(2):191-200. doi: 10.1590/s1413-35552012005000149.

    PMID: 24839045BACKGROUND
  • Silva BBC, Venturato ACT, Aguiar LT, Filho LFRM, Faria CDCM, Polese JC. Validity and reliability of the Modified Sphygmomanometer Test with fixed stabilization for clinical measurement of muscle strength. J Bodyw Mov Ther. 2019 Oct;23(4):844-849. doi: 10.1016/j.jbmt.2019.05.008. Epub 2019 May 14.

    PMID: 31733770BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Rabiya Noor, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

May 8, 2023

Primary Completion

December 8, 2023

Study Completion

January 8, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations