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Runner's KneeNCT06086860

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

A study testing Mulligan mobilization with dry needling. and Mulligan mobilization without dry needling in people with Runner's Knee, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 45 years
Conditions the study is for
Runner's Knee
What is being tested?
Mulligan mobilization with dry needling. and Mulligan mobilization without dry needling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
8 May 2023to 8 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Johar Pain Relief Center

    Lahore, Punjab Province, 54782

Other trials in Pakistan

About this study

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.

Read the 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.

Conditions
Runner's Knee
Being tested
Mulligan mobilization with dry needling., Mulligan mobilization without dry needling
Keywords
Dry needling, Pain, Range of motion
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mulligan mobilization with dry needling.Other

    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 needlingOther

    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.

Study groups in NCT06086860
Study groupRoleWhat they receive
Mulligan mobilization with dry needling.ExperimentalParticipants in this group will receive Mulligan mobilization with dry needling.
Receives: Other: Mulligan mobilization with dry needling.
Mulligan mobilization without dry needling.Active comparatorParticipants in this group will receive Mulligan mobilization without dry needling.
Receives: Other: Mulligan mobilization without dry needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6th Week

  2. 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).

    Measured: 6th Week

  3. 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.

    Measured: 6th Week

  4. 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.

    Measured: 6th Week

  5. Flexibility: Goniometer

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

    Measured: 6th Week

  6. 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.

    Measured: 6th Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2023
  2. Study start8 May 2023
  3. Primary completion8 Dec 2023
  4. Study completion8 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06086860
Sponsor's protocol ID
REC/RCR&AHS/23/0137 Mahnoor
Status last verified
Mar 2024
First submitted
11 Oct 2023
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34580498
  • 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.

    PubMed 29054803
  • 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.

    PubMed 32338532
  • 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.

    PubMed 30038832
  • 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.

    PubMed 28504067
  • 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.

    PubMed 32753943
  • 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.

    PubMed 35728804
  • 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.

    PubMed 24982700
  • 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.

    PubMed 33996453
  • 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.

    PubMed 23485881
  • 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.

    PubMed 32523969
  • 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.

    PubMed 22630589
  • 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.

    PubMed 26729626
  • 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.

    PubMed 31067247
  • 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.

    PubMed 30973090

Questions about this trial

What is this clinical trial studying?

A study testing Mulligan mobilization with dry needling. and Mulligan mobilization without dry needling in people with Runner's Knee, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain: Numeric Pain Rating Scale (NPRS) (time frame: 6th Week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06086860, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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