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NCT Number: NCT05878587

Burger Allen Exercises in Knee OA With Type II Diabetes

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

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tehsil headquarter hospital

Barnala, Azad Kashmir, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both Genders from Age:45-65 year

Exclusion criteria

  • Joint Instability

Treatment and study plan

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

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

thermotherapy+ TENS+ low intensity high repetition exercises

Other

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

Primary outcomes

  1. KOOS

    Time frame: 10 months

    An instrument to assess the patient's opinion about their knee and associated problems.

  2. Numeric Pain Rating Scale

    Time frame: 10 months

    NPRS is based on 11-point numerical rating scale for determining pain intensity, 0(no pain) to 10(worst pain imaginable) pain intensity.

Secondary outcomes

  1. Ankle Brachial Index

    Time frame: 10 months

    Ankle Brachial Index Will be measured with bp apparatus to measure Perfusion.

Other outcomes

  1. Goniometer

    Time frame: 10 months

    A universal goniometer is an instrument that measures the available range of motion at a joint. Knee flexion and extension will be measured.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Burger Allen Exercises on Pain, Range of Motion, and Disability in Knee Osteoarthritis With Type II Diabetes

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 26, 2023
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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