- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04225000
Tibiofemoral Mobilization in Patellofemoral Pain Syndrome
Effects of Tibiofemoral Mobilization in Patients of Patellofemoral Pain Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patellofemoral pain syndrome (PFPS) is the most common overuse injury characterized by anterior and peripatellar knee pain, associated with physical activities in Active Daily Living (ADL) such as climbing stairs, squatting, jumping, and running and by sitting with the knees flexed for prolonged periods of time. It mainly affects young women without any structural changes such as increased Q-angle or significant pathological changes in articular cartilage. It mainly affects young women without any structural changes such as increased Q-angle or significant pathological changes in articular cartilage. Patellofemoral pain has prevalence of 23% in adults and 29% in adolescents annually in general population. Its incidence is higher in women as compare to men and is located at 22/1000 person per year. It accounts for 25-40% of all knee complaints in sports medicine. The prevalence of this problem is high because it can occur in patients with a wide range of physical activity levels.
The main symptom of PFPS is anterior knee pain or pain around and behind patella during patellofemoral joint loading activities. The pathophysiology of PFPS is multifactorial. External factors; change in training intensity and frequency, training surfaces and inappropriate shoe wear, while intrinsic factors includes muscle and soft tissue imbalance and malalignment of lower extremity and poor biomechanics of foot. In PFPS patients' dynamic valgus and patellar maltracking is common. Decrease strength of hip abductors, abnormal rear foot eversion can cause dynamic valgus. Further other muscles imbalance is also associated with PFPS i.e. vastus medialis, vastus lateralis, quadriceps, hamstring and iliotibial tract.
Correction of biomechanical imbalance and decreased anterior knee pain as therapeutic exercise has already been shown to be effective in the treatment of PFPS for pain and function. Conservative treatment involves a multimodal physiotherapy approach including patient education, activity modification, neuromuscular electric stimulation on quadriceps, therapeutic ultrasound, biofeedback, exercises for enhancing the activity of Vastus Medialis Obliquus (VMO) muscle, lower extremity-strengthening exercises, and proximal stabilization, stretching exercises on tight structures, bracings, foot orthoses, patellar mobilization and taping techniques. Patellofemoral pain syndrome is treated through conservative methods from long period of time but
tibiofemoral mobilization is not practiced very much while standard mobilization is patellar mobilization, it can be painful to mobilize patella. So the goal of this study is determine the effect of reciprocal joint mobilization i.e. tibiofemoral joint mobilization in patellofemoral joint pain syndrome and enhance the awareness of this in practice.
Literature review A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines. Search term for the initial literature review was patellofemoral Pain Syndrome, Tibiofemoral mobilization, prevalence of patellofemoral pain syndrome, causes of PFPS, pathophysiology of PFPS, treatment option for PFPS, conservative treatment of PFPS, short term effect of Tibiofemoral mobilization, exercise protocol of PFPS. The search was limited to papers in English preferably published since 2010 with full text available. Different studies were available regarding PFPS but limited data were available regarding tibiofemoral mobilization in PFPS.
A consensus statement (2018) on exercise therapy and physical interventions and mentioned that it is recommended that exercise targeting the hip and knee is a key component of management for all patients with patellofemoral pain, particularly when used in combination.
A consensus statement (2016) from the 4th International Patellofemoral Pain Research Retreat, that exercises are best to treat PFPS in short medium and long term goal and also mentioned that instead of only giving exercises of knee alone if combined hip and knee exercises would be given to patient it will show great effect.
The short-term effects of Movement With Mobilization (MWM) and Kinesio Tapping practices performed in addition to the exercises proved to be similar to one another.
The tibiofemoral joint manipulation with exercises for home plane give a successful results in treating patellofemoral pain syndrome.
A systemic review mentioned that the different combinations of Manual Therapy (MT) and physical therapy analyzed in this review suggest that giving more emphasis to proximal stabilization and full kinetic chain treatments in PFPS will help better alleviation of symptoms.
Another study concluded that interventions directed at the lumbopelvic region did not have immediate effects on quadriceps force output or activation. Muscle fatigue might have contributed to decreased force output and activation over 1 hour of testing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Lady Reading Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Symptoms of anterior knee pain for at least 1 month.
- Anterior or retropatellar knee pain on at least 2 of the following activities: prolonged sitting, climbing stairs, squatting, running, kneeling, and hopping/jumping.
- Presence of 2 of the following clinical criteria on assessment: pain during apprehension test, pain during the patellar compression test, and crepitation during the compression test.
Exclusion Criteria:
- Previous knee surgery or arthritis
- History of patellar dislocation or subluxation, malalignment, or ligament laxity
- Spinal referred pain
- History of other abnormalities such as leg length inequalities (.2 cm)
- Medication as a part of the treatment
- Previous physical therapy or acupuncture treatment for the knee within the previous 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise Group
Hip & Knee Exercises
|
Control group included 6 different exercises to treat participants having PFPS.
These exercises included Semi squat with hip adduction and internal rotation, Quads isometrics, Straight Leg Raise (SLR) Hamstring Stretch, Terminal knee extension with elastic band , Adductor squeeze in crook lying (squeeze the ball), Hip abduction in standing with elastic band.
These all exercises were advised to perform 3 x 15 Repetitions with 10 sec hold.
This exercise protocol was for 4 weeks and 3 sessions per week.
|
|
Experimental: Mobilization Group
Tibiofemoral joint anterior-posterior mobilization combined Hip & Knee Exercises
|
Experimental group included Anterior-Posterior (AP) tibiofemoral joint mobilization and all 6 exercises suggested controlled group for treating participants having PFPS; 3 sessions of mobilizations per week and total 4 weeks. These exercises included Semi squat with hip adduction and internal rotation, Quads isometrics, Straight Leg Raise (SLR) Hamstring Stretch, Terminal knee extension with elastic band , Adductor squeeze in crook lying (squeeze the ball), Hip abduction in standing with elastic band. Theses all exercises were advised to perform 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 4th week
|
Changes from base Line Numeric Pain Rating Scale is a scale for pain starting from 0-10.
where 0 indicate no pain and 10 indicate severe pain
|
4th week
|
|
Range Of Motion of Knee Joint (Flexion)
Time Frame: 4th week
|
Changes from the Baseline ROM range of Motion of knee joint flexion was taken with the Help of Goniometer
|
4th week
|
|
Range Of Motion of Knee Joint (Extension)
Time Frame: 4th week
|
Changes from the Baseline ROM range of Motion of knee joint extension was taken with the Help of Goniometer
|
4th week
|
|
Pressure Pain Threshold (PPT)
Time Frame: 4th week
|
Changes from the Baseline Pressure Pain Threshold (PPT) were taken with the help of Algometer
|
4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kujala Anterior Knee Pain Scale
Time Frame: 4th week
|
Changes from the Baseline Kujala Score for Functional activities.
Score starting from 0-100.The zero score indicates the greater limitation of knee function whereas the score 100 indicates the ability to perform most knee function.Score were categorized into different functional activities i.e.
Limp, weight bearing, pain, stairs climbing, walking, running, jumping, prolonged sitting with knee bent, swelling, atrophy of thigh, loss of knee bend,feeling of instability in knee cap, squatting
|
4th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saira Waqqar, PP-DPT, Riphah International University
Publications and helpful links
General Publications
- Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.
- Briani RV, Pazzinatto MF, De Oliveira Silva D, Azevedo FM. Different pain responses to distinct levels of physical activity in women with patellofemoral pain. Braz J Phys Ther. 2017 Mar-Apr;21(2):138-143. doi: 10.1016/j.bjpt.2017.03.009. Epub 2017 Mar 17.
- Crossley KM, van Middelkoop M, Callaghan MJ, Collins NJ, Rathleff MS, Barton CJ. 2016 Patellofemoral pain consensus statement from the 4th International Patellofemoral Pain Research Retreat, Manchester. Part 2: recommended physical interventions (exercise, taping, bracing, foot orthoses and combined interventions). Br J Sports Med. 2016 Jul;50(14):844-52. doi: 10.1136/bjsports-2016-096268. Epub 2016 May 31. No abstract available.
- Santos TR, Oliveira BA, Ocarino JM, Holt KG, Fonseca ST. Effectiveness of hip muscle strengthening in patellofemoral pain syndrome patients: a systematic review. Braz J Phys Ther. 2015 May-Jun;19(3):167-76. doi: 10.1590/bjpt-rbf.2014.0089. Epub 2015 May 29.
- 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.
- Lantz JM, Emerson-Kavchak AJ, Mischke JJ, Courtney CA. TIBIOFEMORAL JOINT MOBILIZATION IN THE SUCCESSFUL MANAGEMENT OF PATELLOFEMORAL PAIN SYNDROME: A CASE REPORT. Int J Sports Phys Ther. 2016 Jun;11(3):450-61.
- Fatimah I, Waqqar S. Effects of tibiofemoral mobilization in patients of Patellofemoral pain syndrome. J Pak Med Assoc. 2021 Nov;71(11):2506-2510. doi: 10.47391/JPMA.04-585.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00567 Ishrat
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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