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Clinical Trials/CTRI/2018/02/011796
CTRI/2018/02/011796
Completed
Phase 2/3

"Efficacy of the Functional Mobilization Approach on Subjects with Patellofemoral Pain Syndrome: A Randomized Clinical Trial"

Sharda University and Hospital1 site in 1 country60 target enrollmentStarted: July 31, 2016Last updated:

Overview

Phase
Phase 2/3
Status
Completed
Sponsor
Sharda University and Hospital
Enrollment
60
Locations
1
Primary Endpoint
1. Pain using the Numeric Pain Rating Scale (0 to 10. Lower scores represent better results)

Overview

Brief Summary

Foot hyperpronation is an abnormal inward rotation of the subtalar joint. Its relation to patellofemoral pain syndrome and was the focus of this study.

This study employed a three dimensional functional manual therapy approach (A combination of Functional joint mobilization, Proprioceptive Neuromuscular Facilitation, and functional soft tissue mobilization) to  treat and adjust both soft and bony tissue involved and the use of full length medial wedge insoles.

Aim and objectives:

  • To investigate the clinical efficacy of functional manual therapy approach of foot and ankle along with routine exercises with respect to pain and function in these subjects.

  • To find out if there’s a significant difference in pain and function with regard to using functional manual therapy of foot and ankle as treatment for patellofemoral pain syndrome

  • To improve knee pain and lower limb function in individuals with patellofemoral pain syndrome

  • To compare the clinical efficacy of functional manual therapy with full flange medial raise insoles in these subjects

Null Hypothesis: Functional manual therapy of foot and ankle will not improve pain and function in young adults with patellofemoral pain syndrome.

Alternate Hypothesis: Functional manual therapy of foot and ankle will improve pain and function in young adults with patellofemoral pain syndrome.

At the end of the study, the null hypothesis was rejected.

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, fixed
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 35.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Clinically diagnosed cases of patellofemoral pain syndrome
  • Presence of unilateral or bilateral foot hyperpronation
  • Duration of PFPS must be more than three weeks (chronic).

Exclusion Criteria

  • 1.Defined injury or pathological conditions of the knee and foot structures (bursitis, tendinopathies, ligament sprains or instability, menisci injuries, dislocations)
  • History of ankle and/or foot surgery 3.Severe or advanced knee osteoarthritis diagnosed based on clinical and radiological assessment
  • Autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus
  • Leg length discrepancy of more than 1 inch
  • Previous physiotherapy treatment (such as exercise therapy, orthosis, mobilization) in the past 12 months 7.

Outcomes

Primary Outcomes

1. Pain using the Numeric Pain Rating Scale (0 to 10. Lower scores represent better results)

Time Frame: Scores taken on first day and on last day (after three months)

2. Foot posture using the Foot Posture Index. Positive values indicate hyperpronation

Time Frame: Scores taken on first day and on last day (after three months)

3. Functional status of the lower extremity using the Lower Extremity Functional Scale with scores from 0 to 80. Higher scores represent better results.

Time Frame: Scores taken on first day and on last day (after three months)

Secondary Outcomes

  • Functional Tests(1. Squatting with ability to keep heels on floor)

Investigators

Sponsor
Sharda University and Hospital
Sponsor Class
Other [Private University and Hospital and Research Institution]

Study Sites (1)

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