Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis

NCT04324931 | Completed DMC

• 2 other identifiers: MMDU/IEC/1527U1111-1249-3661
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Knee

Keywords

Obesity; Osteoarthritis; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in pain level by Numeric Pain Rating Scale

  Baseline, 3 weeks after intervention

• Change in joint range of motion by Goniometery

  Baseline, 3 weeks after intervention

• Change in physical performance

  Baseline, 3 weeks after intervention

Study Arms (1)

Biomechanical corrections

EXPERIMENTAL

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; Other: Conventional Physiotherapy

Interventions

Biomechanical corrections OTHER

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

Biomechanical corrections

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.

Biomechanical corrections

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asir John Samuel: lead

Study Sites (1)

Sunaina Saini

Kurukshetra, Haryana, 136118, India

Location

Related Publications (3)

• 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.

  PMID: 27746495 RESULT

• 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.

  PMID: 28606556 RESULT

• 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.

  PMID: 15593215 RESULT

Related 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.

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sunaina Saini, BPT

  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Maharishi Markandeshwar (Deemed to be university)

Model Details: Single Group pre-test, post-test design

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 27, 2020
• Study Start: August 10, 2020
• Primary Completion: February 26, 2021
• Study Completion: March 31, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)