Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Knee
• Intervention / Treatment: Other: Biomechanical corrections; Other: Conventional Physiotherapy

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

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Kurukshetra, Haryana, India, 136118
      • Sunaina Saini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Biomechanical corrections; In this group, biomechanical correction will be perform with the help of mobilization with movement to correct biomechanical misalignment and along with this conventional treatment, in which Hydrocollatoral packs for 20 minutes, Interferential Therapy for 15 minutes with beat frequency 100 Hz, Sweep frequency 150 Hz and exercise program for 3 sessions of 20 minutes on alternative days for 3 weeks. Which will be given for three days a week for three weeks.

Other: Biomechanical corrections; Biomechanical corrections is to be done to correct the varus deformity of knee joint and for pain management.; Other: Conventional Physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lower limb alignment by Trauma CAD software	Trauma CAD Software will be used to measure the misalignment of the lower limb	Baseline, 3 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level by Numeric Pain Rating Scale	This scale will be used for assessment of pain	Baseline, 3 weeks after intervention
Change in joint range of motion by Goniometery	Use for range of motion measurement	Baseline, 3 weeks after intervention
Change in physical performance	WOMAC will be used for assessment	Baseline, 3 weeks after intervention

Collaborators and Investigators

• Sponsor: Asir John Samuel
• Investigators: Principal Investigator: Sunaina Saini, BPT, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• This study has evidenced a large percentage of population as borderline OA; therefore, it depends mainly on the prevention of modifiable risk factors to preserve at ease movement in elderly population through awareness programs.
• the atrophic phenotype of knee OA was associated with a decreased likelihood of progression of JSN and cartilage loss compared to the non-atrophic knee OA phenotype.
• Although elevated BMI increases the risk of knee OA progression, the effect of BMI is limited to knees in which moderate malalignment exists, presumably because of the combined focus of load from malalignment and the excess load from increased weight.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ACTUAL): February 26, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (ACTUAL): March 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 11, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Osteoarthritis; Physical Therapy Modalities
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MMDU/IEC/1527; U1111-1249-3661 (OTHER: World Health Organization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No