Effect of Biomechanical Correction in Medial Tibiofemoral Joint Osteoarthritis

NCT ID: NCT04324931

Last Updated: 2021-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-03-31

Brief Summary

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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

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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

Conditions

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Osteoarthritis Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group pre-test, post-test design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Biomechanical corrections

Intervention Type OTHER

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

Conventional Physiotherapy

Intervention Type 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.

Interventions

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Biomechanical corrections

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asir John Samuel

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Associate Professor Maharishi Markandeshwar (Deemed to be university)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sunaina Saini, BPT

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

Locations

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Sunaina Saini

Kurukshetra, Haryana, India

Site Status

Countries

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India

References

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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.

Reference Type RESULT
PMID: 27746495 (View on PubMed)

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.

Reference Type RESULT
PMID: 28606556 (View on PubMed)

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.

Reference Type RESULT
PMID: 15593215 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/27746495

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.

https://www.ncbi.nlm.nih.gov/pubmed/28606556

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.

https://www.ncbi.nlm.nih.gov/pubmed/15593215

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.

Other Identifiers

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U1111-1249-3661

Identifier Type: OTHER

Identifier Source: secondary_id

MMDU/IEC/1527

Identifier Type: -

Identifier Source: org_study_id

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