Clinical trial NCT04324931: Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis
Official title: Effect of Biomechanical Corrections of Tibia on Medial Joint Space Loading, Varus Deformity and Functional Tasks in Patients With Medial Tibiofemoral Joint Osteoarthritis: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Knee
Keywords: Obesity
Osteoarthritis
Physical Therapy Modalities
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group pre-test, post-test design
Primary purpose: TREATMENT

Brief summary: Effect of Biomechanical Correction of Tibia on Medial Joint space loading, Varus deformity and functional tasks in patients with medial tibiofemoral joint osteoarthritis in which participants will be taken. The outcome measures taken are Trauma CAD Software, NPRS, WOMAC and Goniometery will be measured at the baseline after 3rd week of the intervention.

Detailed description: Background: Knee osteoarthritis (KOA) are very prevalent chronic disease of the joint which causing the functional disability and pain specifically in older adults.

Objective: Purpose of the study is to see that the biomechanical correction on the tibia and varus deformity is effective in the conventional treatment of participants with the KOA.

Study Design: A Randomized single group Pretest-Post test Clinical Trial. Methodology: Total '5' subjects were included in the study with the age of 40 to 60 years based on exclusion and inclusion criteria. For the pain, the NPRS will be taken, goniometer taken for the measurement of range of motion, WOMAC will be taken for the physical activity measurement and CAD Software will be taken to see the alignment of the affected limb. Conventional treatment will also be given.

Conclusion: Biomechanical correction shows the significant improvement and improves the subject's physical activity and reduces the pain and stiffness.

Keywords: Obesity, Osteoarthritis, Pain and Physical therapy modalities

Eligibility criteria: Inclusion Criteria: • 40-60 years of age paients will be included in this study

* BMI (25.1±4.2) kg/m2
* Subjects with stiffness and knee pain
* Subjects with objection of pain in knee joint that was aggravated by performing 2 or more of the following functional activities: prolonged cross sitting, stair assents and descent, squatting and kneeling.
* Subjects who are willing to take participation
* Individuals who obeys the commands properly
* Individuals exhibiting the subsequent biomechanical changes on screening
* Q angle \>12 degree for male and \>15 degree for female, femoral anteversion, external tibial torsion \>15 degree, lack of ≥ 5 degree of knee extension in supine position.

Exclusion Criteria:

* • Knee meniscal injuries or ligament injuries

  * Lately history of lower limb trauma and surgery
  * In recent times fracture in lower extremity
  * In lower extremity metal plantation
  * Cardio vascular conditions
  * Patella Dislocation/subluxation
  * Abnormality in foot or deformity

Primary outcomes:
measure: Change in lower limb alignment by Trauma CAD software
timeFrame: Baseline, 3 weeks after intervention
Secondary outcomes:
measure: Change in pain level by Numeric Pain Rating Scale
timeFrame: Baseline, 3 weeks after intervention
measure: Change in joint range of motion by Goniometery
timeFrame: Baseline, 3 weeks after intervention
measure: Change in physical performance
timeFrame: Baseline, 3 weeks after intervention
Other outcomes:
Locations:
city: Kurukshetra
country: India
facility: Sunaina Saini
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
name: Sunaina Saini, BPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pal CP, Singh P, Chaturvedi S, Pruthi KK, Vij A. Epidemiology of knee osteoarthritis in India and related factors. Indian J Orthop. 2016 Sep;50(5):518-522. doi: 10.4103/0019-5413.189608.
citation: Crema MD, Felson DT, Guermazi A, Nevitt MC, Niu J, Lynch JA, Marra MD, Torner J, Lewis CE, Roemer FW. Is the atrophic phenotype of tibiofemoral osteoarthritis associated with faster progression of disease? The MOST study. Osteoarthritis Cartilage. 2017 Oct;25(10):1647-1653. doi: 10.1016/j.joca.2017.05.019. Epub 2017 Jun 9.
citation: Felson DT, Goggins J, Niu J, Zhang Y, Hunter DJ. The effect of body weight on progression of knee osteoarthritis is dependent on alignment. Arthritis Rheum. 2004 Dec;50(12):3904-9. doi: 10.1002/art.20726.