Burger Allen Exercises in Knee OA With Type II Diabetes

NCT ID: NCT05878587

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2023-08-07

Brief Summary

There is a potential link between diabetes mellitus (DM) and severity of osteoarthritis .Type 2 diabetes is a part of the metabolic syndrome (Mets) accompanied by ageing and mechanical stress are also a risk factor to osteoarthritis. Every anatomical component of the joint demonstrated faster joint deterioration and elevated inflammation at microcellular environment of individuals with DM. Normal chondrocytes capacity to adapt to the local glucose level is impaired by OA and there is a significant risk of glucose toxicity and increased glucose absorption. The most dependable and effective treatment for mild to early joint osteoarthritis is exercise. Active free exercises i.e. Buerger Allen exercises are used as a conservative perfusion therapy because they rely on how gravity affects the smooth muscles in the valves. Synovial fluid supports the joint's ability to recover while also reducing inflammation and enhancing overall joint function. The aim of the study is to determine the effect of Buerger Allen exercise and low intensity high repetition exercises on pain, range of motion and disability in knee osteoarthritis with type 2 diabetes. The study would be randomized controlled trial. Total thirty-six subjects will be assigned randomly by using lottery randomization into two groups. Group A will receive conventional therapy and an additional Buerger Allen exercise while Group B will be a control group receiving only baseline treatment. Numeric pain rating scale (NPRS), Ankle Brachial Index, KOOS and Goniometer will be used as outcome measure tools for pain, range of motion and disability. Measure will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0.If data will be normally distributed then parametric if not normally distributed than non-parametric

Detailed Description

One of the most common joint conditions, osteoarthritis (OA), causes diarthrodial articular cartilage to deteriorate, which in turn causes disability in adults. Osteoarthritis (OA) and Type 2 diabetes mellitus (T2DM) are common illnesses whose prevalence is projected to increase. The association between diabetes mellitus and OA was originally identified in 1961.After adjusting for body mass index, type 2 diabetes was recently discovered to be an independent risk factor of severe OA, with a Hazard Ratio (HR) of 2.1. One of the most popular forms of exercise for diabetic patients is the Buerger Allen exercise, which improves lower extremity perfusion and alleviates symptoms in those with lower limbs arterial insufficiency by using postural changes, stimulation of peripheral circulation, and application of muscle contraction. It has been found that nurses can prevent foot ulcers and lower limb amputations by educating the public, screening high-risk individuals, and giving medical care.

Conditions

Knee Osteoarthritis; Type II Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen.

Group Type: EXPERIMENTAL

thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen

Intervention Type: OTHER

Patient will be asked to lie down flat on the plinth with legs elevated from 45 degrees until the skin turns pale, it will take approximately 2 minutes to occur. Then the patient turns to sit at the edge of the plinth with feet hanging and doing the following exercises; dorsiflexion, plantar flexion, inversion, eversion, and flexion the extension of toes, this phase may also be maintained for 2 minutes. Finally, the patient lies flat with his leg rested in a horizontal position and covered with a warm blanket for about 5 minutes

Group B control group

Thermotherapy+ TENS+ low intensity high repetition exercises.

Group Type: ACTIVE_COMPARATOR

thermotherapy+ TENS+ low intensity high repetition exercises

Intervention Type: OTHER

The intervention will be repeated 3 times per day and the posttest will be conducted 5th day using KOOS, NPRS and goniometer.

Interventions

thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen

Patient will be asked to lie down flat on the plinth with legs elevated from 45 degrees until the skin turns pale, it will take approximately 2 minutes to occur. Then the patient turns to sit at the edge of the plinth with feet hanging and doing the following exercises; dorsiflexion, plantar flexion, inversion, eversion, and flexion the extension of toes, this phase may also be maintained for 2 minutes. Finally, the patient lies flat with his leg rested in a horizontal position and covered with a warm blanket for about 5 minutes

Intervention Type: OTHER

thermotherapy+ TENS+ low intensity high repetition exercises

The intervention will be repeated 3 times per day and the posttest will be conducted 5th day using KOOS, NPRS and goniometer.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Both Genders from Age:45-65 year

Exclusion Criteria

• Joint Instability

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad sanaullah

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Tehsil headquarter hospital

Barnala, Azad Kashmir, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

PMID: 13782559 (View on PubMed)

Schett G, Kleyer A, Perricone C, Sahinbegovic E, Iagnocco A, Zwerina J, Lorenzini R, Aschenbrenner F, Berenbaum F, D'Agostino MA, Willeit J, Kiechl S. Diabetes is an independent predictor for severe osteoarthritis: results from a longitudinal cohort study. Diabetes Care. 2013 Feb;36(2):403-9. doi: 10.2337/dc12-0924. Epub 2012 Sep 21.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Zaharia OP, Pesta DH, Bobrov P, Kupriyanova Y, Herder C, Karusheva Y, Bodis K, Bonhof GJ, Knitza J, Simon D, Kleyer A, Hwang JH, Mussig K, Ziegler D, Burkart V, Schett G, Roden M, Szendroedi J. Reduced Muscle Strength Is Associated With Insulin Resistance in Type 2 Diabetes Patients With Osteoarthritis. J Clin Endocrinol Metab. 2021 Mar 25;106(4):1062-1073. doi: 10.1210/clinem/dgaa912.

Reference Type: RESULT

PMID: 33382877 (View on PubMed)

Other Identifiers

REC/23/0109/Ayesha iftikhar

Identifier Type: -

Identifier Source: org_study_id