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Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis

Primary Purpose

Osteoarthritis Knee

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Biomechanical corrections
Conventional Physiotherapy
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Knee focused on measuring Obesity, Osteoarthritis, Physical Therapy Modalities

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sunaina Saini

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biomechanical corrections

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in lower limb alignment by Trauma CAD software
Trauma CAD Software will be used to measure the misalignment of the lower limb

Secondary Outcome Measures

Change in pain level by Numeric Pain Rating Scale
This scale will be used for assessment of pain
Change in joint range of motion by Goniometery
Use for range of motion measurement
Change in physical performance
WOMAC will be used for assessment

Full Information

First Posted
March 6, 2020
Last Updated
April 11, 2021
Sponsor
Asir John Samuel
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1. Study Identification

Unique Protocol Identification Number
NCT04324931
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Knee
Keywords
Obesity, Osteoarthritis, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group pre-test, post-test design
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biomechanical corrections
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biomechanical corrections
Intervention Description
Biomechanical corrections is to be done to correct the varus deformity of knee joint and for pain management.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Change in lower limb alignment by Trauma CAD software
Description
Trauma CAD Software will be used to measure the misalignment of the lower limb
Time Frame
Baseline, 3 weeks after intervention
Secondary Outcome Measure Information:
Title
Change in pain level by Numeric Pain Rating Scale
Description
This scale will be used for assessment of pain
Time Frame
Baseline, 3 weeks after intervention
Title
Change in joint range of motion by Goniometery
Description
Use for range of motion measurement
Time Frame
Baseline, 3 weeks after intervention
Title
Change in physical performance
Description
WOMAC will be used for assessment
Time Frame
Baseline, 3 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunaina Saini, BPT
Organizational Affiliation
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunaina Saini
City
Kurukshetra
State/Province
Haryana
ZIP/Postal Code
136118
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27746495
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.
Results Reference
result
PubMed Identifier
28606556
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.
Results Reference
result
PubMed Identifier
15593215
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/27746495
Description
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.
URL
https://www.ncbi.nlm.nih.gov/pubmed/28606556
Description
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.
URL
https://www.ncbi.nlm.nih.gov/pubmed/15593215
Description
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.

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Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis

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