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Completed

NCT Number: NCT04324931

Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunaina Saini

Kurukshetra, Haryana, 136118, India

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomechanical corrections

Other

Biomechanical corrections is to be done to correct the varus deformity of knee joint and for pain management.

Conventional Physiotherapy

Other

Conventional therapy includes Hydrocollatoral pack for 20 minutes, Interferential therapy for 15 minutes beat frequency 100 Hz, Sweep frequency 150 Hz and exercise program of 3 sessions for 20 minutes on alternative days for 3 weeks for management of knee osteoarthritis.

Primary outcomes

  1. Change in lower limb alignment by Trauma CAD software

    Time frame: Baseline, 3 weeks after intervention

    Trauma CAD Software will be used to measure the misalignment of the lower limb

Secondary outcomes

  1. Change in pain level by Numeric Pain Rating Scale

    Time frame: Baseline, 3 weeks after intervention

    This scale will be used for assessment of pain

  2. Change in joint range of motion by Goniometery

    Time frame: Baseline, 3 weeks after intervention

    Use for range of motion measurement

  3. Change in physical performance

    Time frame: Baseline, 3 weeks after intervention

    WOMAC will be used for assessment

Sponsors and collaborators

Lead sponsor

Asir John Samuel

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2020
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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