Patellofemoral Pain SyndromeNCT06108804
Comparative Effects of Mulligan Pain Release Phenomenon With and Without Tapping in Patellofemoral Pain Syndrome
A study testing mulligan pain release phenomenon with tapping and mulligan pain release phenomenon in people with Patellofemoral Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to compare the effects of mulligan pain release phenomenon with or without Tapping in management of Patellofemoral pain syndrome Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- mulligan pain release phenomenon with tapping and mulligan pain release phenomenon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2023to 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 40 years
- Both male and female
- NPRS>3
- AKPS ≥6
- ROM<135 ° rarely. Knee range of motion is usually normal in patients of Patellofemoral pain syndrome.
- Positive patellar grind test
- Adults having anterior knee pain from previous duration of 2-3 months which is aggravated by walking, stairs ambulation or prolong sitting.
Who cannot join
- Recent fracture/trauma
- Acute diseased condition
- Knee surgery
- Tumor or infection around the knee
- Rheumatoid Arthritis
- Pregnancy
- Any malformation or joint hypermobility
- patellar tendon pathology
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Kot Khawaja Saeed Hospital
Lahore, Punjab Province, 54600
Humera Mubashar, MS, 03084157979, Humera.mubashar@riphah.edu.pk
Iqra Elahi, MS OMPT
About this study
Official title: Comparative Effects of Mulligan Pain Release Phenomenon With and Without Tapping in Management of Patellofemoral Pain Syndrome
The aim of this study is to compare the effects of mulligan pain release phenomenon with or without Tapping in management of Patellofemoral pain syndrome
Read the detailed description
Patellofemoral pain syndrome is a general phrase that refers to discomfort in the Patellofemoral joint and associated soft tissues, including the kneecap, tendons, and ligaments.
In 2019, a comparative study conducted. They pick 30 respondents randomly, who met the study's inclusion requirements and expressed a willingness to participate. They were split into two groups; fifteen subjects per group. Each group received treatment for four weeks, with sessions occurring every other day. PRP with Kinesiotaping is in Group A(n=15), and traditional therapy is in Group B(n=15). Both groups underwent ultrasonic treatment and VMO strengthening. Data analysis was carried out statistically using paired t tests within groups and unpaired t tests across groups. The study's findings indicated that both groups of therapy were successful, however PRP combined with Kinesiotaping significantly reduced pain and improved functional limits in patients with persistent Patellofemoral OA.
In 2020, a double blind RCT study conductred. Based on the mechanical correction approaches, 43 women with at least a 3-month history of PFPS were randomized into three groups: KT for patellar medialization, KT for lateral rotation of the femur and tibia, and the control group. The identical 12-week muscle- building and motor-control exercises were administered to all groups. The numerical pain rating scale (NPRS) at rest and during exertion, the kujala score (AKPS), and the single jump hop test were used to assess knee pain and function at baseline, at 6 weeks, at the end of therapy (12 weeks), and during the 12-week follow-up. Results of the study showed that, in the 6-week and 12-week follow-ups, there were clinically significant differences between the KT with lateral rotation of femur and tibia and the control group in terms of the AKPS and NPRS scores during effort. Pain and function significantly improved in all groups (within group).
Patellofemoral pain syndrome is a prevalent issue among the adults due to prolong sitting, ascending or descending stairs frequently, crouching and walking. The majority of research studies have primarily focused on other age groups, such as older adults or adolescents and very little study was done regarding this issue among young adults. To the best of our knowledge although in the past many studies have worked on mulligan pain release phenomenon with mobilization, or exercise therapy have been practiced in the treatment of Patellofemoral pain syndrome were found effective individually, but there is a lack of comprehensive studies including randomized clinical trials directly comparing the mulligan pain release phenomenon with or without taping on management of Patellofemoral pain syndrome. This RCT will aims to evaluate the effectiveness of two commonly utilized techniques, Mulligan pain release phenomenon and taping will ascertain that if two of these, Mulligan pain release phenomenon and taping, may have different effects on the Patellofemoral pain syndrome, knee range of motion and pain in young population with PFPS.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- mulligan pain release phenomenon with tapping, mulligan pain release phenomenon
- Keywords
- patellofemoral pain syndrome, mulligan's pain release phenomenon, tapping, kujala scale
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mulligan pain release phenomenon with tappingOther
Also called tapping
Participants in Group A will receive mulligan pain release phenomenon with tapping.First, demographic information will be gathered, pain severity will be measured using NPRS, knee joint range of motion (flexion/extension) will be measured using a goniometer, and functional limitation will be evaluated using a Kujala score.Two sessions of treatment per week with a total of eight session will be given in four weeks
mulligan pain release phenomenonOther
Two sessions of treatment per week with a total of eight session will be given in four weeks.Group B will receive mulligan pain release phenomenon only. First, demographic information will be gathered, pain severity will be measured using NPRS. knee joint range of motion (flexion/extension) will be measured using a goniometer, and functional limitation will be evaluated using a Kujala score.
| Study group | Role | What they receive |
|---|---|---|
| mulligan pain release phenomenon with tapping. | Experimental | Participants in group A will receive mulligan pain release phenomenon with tapping. Receives: Other: mulligan pain release phenomenon with tapping |
| mulligan pain release phenomenon | Active comparator | Participants in group B will receive mulligan pain release phenomenon Receives: Other: mulligan pain release phenomenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Changes from baseline. The NPRS is a self-reporting or clinician-administered measuring tool that has extreme values ranging from "no pain" to "severe pain", on either horizontal or vertical line of scale.NPRS which is an eleven point scale in which no pain (score 0) and highest pain (score 10)
Measured: 4th week
Knee Flexion Range of Motion
Changes from baseline. The measurement of joint range of motion (ROM) is an essential procedure used in physical therapy, known as goniometry
Measured: 4th week
Knee Extension Range of Motion
Changes from baseline. The measurement of joint range of motion (ROM) is an essential procedure used in physical therapy, known as goniometry
Measured: 4th week
Kujala Score (AKPS)
Changes from baseline. Kujala score is a 13 items, self-report questionnaire for the patients having Patellofemoral pain syndrome (PFPS). Kujala has been demonstrated to be valid and reliable in PFPS patients and can be utilized for clinical evaluation as well as research work.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start20 Oct 2023
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- A parallel study is a type of clinical study in which two or more groups of participants receive different interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humera Mubashar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108804
- Sponsor's protocol ID
- REC/RCR&AHS/23/0142
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang WD, Chen FC, Lee CL, Lin HY, Lai PT. Effects of Kinesio Taping versus McConnell Taping for Patellofemoral Pain Syndrome: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:471208. doi: 10.1155/2015/471208. Epub 2015 Jun 21.
PubMed 26185517Baldon Rde M, Nakagawa TH, Muniz TB, Amorim CF, Maciel CD, Serrao FV. Eccentric hip muscle function in females with and without patellofemoral pain syndrome. J Athl Train. 2009 Sep-Oct;44(5):490-6. doi: 10.4085/1062-6050-44.5.490.
PubMed 19771287Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. Br J Sports Med. 2002 Apr;36(2):95-101. doi: 10.1136/bjsm.36.2.95.
PubMed 11916889Pal S, Draper CE, Fredericson M, Gold GE, Delp SL, Beaupre GS, Besier TF. Patellar maltracking correlates with vastus medialis activation delay in patellofemoral pain patients. Am J Sports Med. 2011 Mar;39(3):590-8. doi: 10.1177/0363546510384233. Epub 2010 Nov 12.
PubMed 21076015Leibbrandt DC, Louw QA. The use of McConnell taping to correct abnormal biomechanics and muscle activation patterns in subjects with anterior knee pain: a systematic review. J Phys Ther Sci. 2015 Jul;27(7):2395-404. doi: 10.1589/jpts.27.2395. Epub 2015 Jul 22.
PubMed 26311990Logan CA, Bhashyam AR, Tisosky AJ, Haber DB, Jorgensen A, Roy A, Provencher MT. Systematic Review of the Effect of Taping Techniques on Patellofemoral Pain Syndrome. Sports Health. 2017 Sep/Oct;9(5):456-461. doi: 10.1177/1941738117710938. Epub 2017 Jun 15.
PubMed 28617653Arrebola LS, Teixeira de Carvalho R, Lam Wun PY, Rizzi de Oliveira P, Firmo Dos Santos J, Coutinho de Oliveira VG, Pinfildi CE. Investigation of different application techniques for Kinesio Taping(R) with an accompanying exercise protocol for improvement of pain and functionality in patients with patellofemoral pain syndrome: A pilot study. J Bodyw Mov Ther. 2020 Jan;24(1):47-55. doi: 10.1016/j.jbmt.2019.05.022. Epub 2019 May 22.
PubMed 31987562
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Mulligan Pain Release Phenomenon With and Without Tapping in Management of Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06108804
- Acronym / sponsor ID
- REC/RCR&AHS/23/0142
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- patellofemoral pain syndrome, mulligan's pain release phenomenon, tapping, kujala scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the effects of mulligan pain release phenomenon with or without Tapping in management of Patellofemoral pain syndrome
Detailed description
Patellofemoral pain syndrome is a general phrase that refers to discomfort in the Patellofemoral joint and associated soft tissues, including the kneecap, tendons, and ligaments.
In 2019, a comparative study conducted. They pick 30 respondents randomly, who met the study's inclusion requirements and expressed a willingness to participate. They were split into two groups; fifteen subjects per group. Each group received treatment for four weeks, with sessions occurring every other day. PRP with Kinesiotaping is in Group A(n=15), and traditional therapy is in Group B(n=15). Both groups underwent ultrasonic treatment and VMO strengthening. Data analysis was carried out statistically using paired t tests within groups and unpaired t tests across groups. The study's findings indicated that both groups of therapy were successful, however PRP combined with Kinesiotaping significantly reduced pain and improved functional limits in patients with persistent Patellofemoral OA.
In 2020, a double blind RCT study conductred. Based on the mechanical correction approaches, 43 women with at least a 3-month history of PFPS were randomized into three groups: KT for patellar medialization, KT for lateral rotation of the femur and tibia, and the control group. The identical 12-week muscle- building and motor-control exercises were administered to all groups. The numerical pain rating scale (NPRS) at rest and during exertion, the kujala score (AKPS), and the single jump hop test were used to assess knee pain and function at baseline, at 6 weeks, at the end of therapy (12 weeks), and during the 12-week follow-up. Results of the study showed that, in the 6-week and 12-week follow-ups, there were clinically significant differences between the KT with lateral rotation of femur and tibia and the control group in terms of the AKPS and NPRS scores during effort. Pain and function significantly improved in all groups (within group).
Patellofemoral pain syndrome is a prevalent issue among the adults due to prolong sitting, ascending or descending stairs frequently, crouching and walking. The majority of research studies have primarily focused on other age groups, such as older adults or adolescents and very little study was done regarding this issue among young adults. To the best of our knowledge although in the past many studies have worked on mulligan pain release phenomenon with mobilization, or exercise therapy have been practiced in the treatment of Patellofemoral pain syndrome were found effective individually, but there is a lack of comprehensive studies including randomized clinical trials directly comparing the mulligan pain release phenomenon with or without taping on management of Patellofemoral pain syndrome. This RCT will aims to evaluate the effectiveness of two commonly utilized techniques, Mulligan pain release phenomenon and taping will ascertain that if two of these, Mulligan pain release phenomenon and taping, may have different effects on the Patellofemoral pain syndrome, knee range of motion and pain in young population with PFPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A parallel study is a type of clinical study in which two or more groups of participants receive different interventions.
| Arm | Type | Receives |
|---|---|---|
| mulligan pain release phenomenon with tapping. | Experimental | Other: mulligan pain release phenomenon with tappingParticipants in group A will receive mulligan pain release phenomenon with tapping. |
| mulligan pain release phenomenon | Active comparator | Other: mulligan pain release phenomenonParticipants in group B will receive mulligan pain release phenomenon |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 20 to 40 years
- Both male and female
- NPRS>3
- AKPS ≥6
- ROM<135 ° rarely. Knee range of motion is usually normal in patients of Patellofemoral pain syndrome.
Key exclusion criteria (8 listed)
- Recent fracture/trauma
- Acute diseased condition
- Knee surgery
- Tumor or infection around the knee
- Rheumatoid Arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mulligan pain release phenomenon with tappingAlso: tappingParticipants in Group A will receive mulligan pain release phenomenon with tapping.First, demographic information will be gathered, pain severity will be measured using NPRS, knee joint range of motion (flexion/extension) will be measured using a goniometer, and functional limitation will be evaluated using a Kujala score.Two sessions of treatment per week with a total of eight session will be given in four weeks | Other | mulligan pain release phenomenon with tapping. |
| mulligan pain release phenomenonTwo sessions of treatment per week with a total of eight session will be given in four weeks.Group B will receive mulligan pain release phenomenon only. First, demographic information will be gathered, pain severity will be measured using NPRS. knee joint range of motion (flexion/extension) will be measured using a goniometer, and functional limitation will be evaluated using a Kujala score. | Other | mulligan pain release phenomenon |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4th week
Changes from baseline. The NPRS is a self-reporting or clinician-administered measuring tool that has extreme values ranging from "no pain" to "severe pain", on either horizontal or vertical line of scale.NPRS which is an eleven point scale in which no pain (score 0) and highest pain (score 10)
Knee Flexion Range of Motion
Time frame: 4th week
Changes from baseline. The measurement of joint range of motion (ROM) is an essential procedure used in physical therapy, known as goniometry
Knee Extension Range of Motion
Time frame: 4th week
Changes from baseline. The measurement of joint range of motion (ROM) is an essential procedure used in physical therapy, known as goniometry
Kujala Score (AKPS)
Time frame: 4th week
Changes from baseline. Kujala score is a 13 items, self-report questionnaire for the patients having Patellofemoral pain syndrome (PFPS). Kujala has been demonstrated to be valid and reliable in PFPS patients and can be utilized for clinical evaluation as well as research work.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 26185517Chang WD, Chen FC, Lee CL, Lin HY, Lai PT. Effects of Kinesio Taping versus McConnell Taping for Patellofemoral Pain Syndrome: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:471208. doi: 10.1155/2015/471208. Epub 2015 Jun 21.
- Background: PubMed 19771287Baldon Rde M, Nakagawa TH, Muniz TB, Amorim CF, Maciel CD, Serrao FV. Eccentric hip muscle function in females with and without patellofemoral pain syndrome. J Athl Train. 2009 Sep-Oct;44(5):490-6. doi: 10.4085/1062-6050-44.5.490.
- Background: PubMed 11916889Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. Br J Sports Med. 2002 Apr;36(2):95-101. doi: 10.1136/bjsm.36.2.95.
- Background: PubMed 21076015Pal S, Draper CE, Fredericson M, Gold GE, Delp SL, Beaupre GS, Besier TF. Patellar maltracking correlates with vastus medialis activation delay in patellofemoral pain patients. Am J Sports Med. 2011 Mar;39(3):590-8. doi: 10.1177/0363546510384233. Epub 2010 Nov 12.
- Background: PubMed 26311990Leibbrandt DC, Louw QA. The use of McConnell taping to correct abnormal biomechanics and muscle activation patterns in subjects with anterior knee pain: a systematic review. J Phys Ther Sci. 2015 Jul;27(7):2395-404. doi: 10.1589/jpts.27.2395. Epub 2015 Jul 22.
- Background: PubMed 28617653Logan CA, Bhashyam AR, Tisosky AJ, Haber DB, Jorgensen A, Roy A, Provencher MT. Systematic Review of the Effect of Taping Techniques on Patellofemoral Pain Syndrome. Sports Health. 2017 Sep/Oct;9(5):456-461. doi: 10.1177/1941738117710938. Epub 2017 Jun 15.
- Background: PubMed 31987562Arrebola LS, Teixeira de Carvalho R, Lam Wun PY, Rizzi de Oliveira P, Firmo Dos Santos J, Coutinho de Oliveira VG, Pinfildi CE. Investigation of different application techniques for Kinesio Taping(R) with an accompanying exercise protocol for improvement of pain and functionality in patients with patellofemoral pain syndrome: A pilot study. J Bodyw Mov Ther. 2020 Jan;24(1):47-55. doi: 10.1016/j.jbmt.2019.05.022. Epub 2019 May 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Humera Mubashar, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mulligan pain release phenomenon with tapping and mulligan pain release phenomenon in people with Patellofemoral Pain Syndrome, 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 4th week). The study lists 4 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 NCT06108804, which also lists 7 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 31 Oct 2023.