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Patellofemoral Pain SyndromeNCT04225000

Tibiofemoral Mobilization in Patellofemoral Pain Syndrome

A study testing Exercise Group and Mobilization Group in people with Patellofemoral Pain Syndrome, 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 research was to determine the effects of tibiofemoral joint mobilization in patients of patellofemoral pain syndrome. Tibiofemoral joint mobilization effects on pain and Range of Motion (ROM) in knee joint. Read more about this study

Who is it for?
Any age
Conditions the study is for
Patellofemoral Pain Syndrome
What is being tested?
Exercise Group and Mobilization Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 sitePakistan
Study dates
15 Jun 2019to 7 Jan 2020
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Lady Reading Hospital

    Peshawar, Khyber Pakhtunkhwa, 25000

Other trials in Pakistan

About this study

Official title: Effects of Tibiofemoral Mobilization in Patients of Patellofemoral Pain Syndrome

The aim of this research was to determine the effects of tibiofemoral joint mobilization in patients of patellofemoral pain syndrome. Tibiofemoral joint mobilization effects on pain and Range of Motion (ROM) in knee joint. A randomized controlled trial was done at Lady Reading Hospital Peshawar and Hayatabad Medical Complex Peshawar. The sample size was 52. The Participants were divided into two groups, 26 participants in experimental group and 26 in control group. The study duration was 4 months. Sampling technique applied was purposive non probability sampling technique. Only 25 to 35 years participants with patellofemoral pain syndrome were included. Tools used in this study were Numerical pain rating scale (NPRS), Kujala Score Questionnaire, Goniometer and Algometer.

Read the 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.

Being tested
Exercise Group, Mobilization Group
Keywords
Tibiofemoral Mobilization, Kujala Anterior Knee Pain Scale, Numeric Pain Rating Scale, Pressure Pain Threshold
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.

  • Exercise GroupOther

    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.

  • Mobilization GroupOther

    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.

Study groups in NCT04225000
Study groupRoleWhat they receive
Exercise GroupActive comparatorHip \& Knee Exercises
Receives: Other: Exercise Group
Mobilization GroupExperimentalTibiofemoral joint anterior-posterior mobilization combined Hip \& Knee Exercises
Receives: Other: Mobilization Group

What is being measured

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

  1. Numeric Pain Rating Scale (NPRS)

    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

    Measured: 4th week

  2. Range Of Motion of Knee Joint (Flexion)

    Changes from the Baseline ROM range of Motion of knee joint flexion was taken with the Help of Goniometer

    Measured: 4th week

  3. Range Of Motion of Knee Joint (Extension)

    Changes from the Baseline ROM range of Motion of knee joint extension was taken with the Help of Goniometer

    Measured: 4th week

  4. Pressure Pain Threshold (PPT)

    Changes from the Baseline Pressure Pain Threshold (PPT) were taken with the help of Algometer

    Measured: 4th week

Secondary outcomes (1)
  1. Kujala Anterior Knee Pain Scale

    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

    Measured: 4th week

Timeline

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

  1. First posted13 Jan 2020
  2. Study start15 Jun 2019
  3. Primary completion8 Nov 2019
  4. Study completion7 Jan 2020

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
Model description
Randomized Control Trail
Masking
Single blind
Who is masked
Participant
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04225000
Sponsor's protocol ID
REC/00567 Ishrat
Status last verified
Jan 2020
First submitted
8 Jan 2020
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 29925502
  • 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.

    PubMed 28460712
  • 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.

    PubMed 27247098
  • 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.

    PubMed 26039034
  • 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
  • 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.

    PubMed 27274430
  • 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.

    PubMed 34783726

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Group and Mobilization Group 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 3 inclusion and 6 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 23 Jan 2020. 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?

Numeric Pain Rating Scale (NPRS) (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 NCT04225000, 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 23 Jan 2020.

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