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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06086860
Other study ID # REC/RCR&AHS/23/0137 Mahnoor
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 8, 2023
Est. completion date January 8, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 8, 2024
Est. primary completion date December 8, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Pakistan Johar Pain Relief Center Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Pain Res. 2020 Sep 07;13:2237. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary Flexibility: Goniometer Universal goniometer or inclinometer will be used for evaluating the knee joint range of motion and hamstring flexibility. 6th Week
Primary 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
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