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Burger Allen Exercises in Knee OA With Type II Diabetes

Primary Purpose

Knee Osteoarthritis, Type II Diabetes

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen
thermotherapy+ TENS+ low intensity high repetition exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Buerger Allen exercises, Diabetes mellitus, Knee osteoarthritis

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Both Genders from Age:45-65 year Exclusion Criteria: Joint Instability

Sites / Locations

  • Tehsil headquarter hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B control group

Arm Description

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

Thermotherapy+ TENS+ low intensity high repetition exercises.

Outcomes

Primary Outcome Measures

KOOS
An instrument to assess the patient's opinion about their knee and associated problems.
Numeric Pain Rating Scale
NPRS is based on 11-point numerical rating scale for determining pain intensity, 0(no pain) to 10(worst pain imaginable) pain intensity.

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2023
Last Updated
September 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05878587
Brief Title
Burger Allen Exercises in Knee OA With Type II Diabetes
Official Title
Effects of Burger Allen Exercises on Pain, Range of Motion, and Disability in Knee Osteoarthritis With Type II Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Type II Diabetes
Keywords
Buerger Allen exercises, Diabetes mellitus, Knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen.
Arm Title
Group B control group
Arm Type
Active Comparator
Arm Description
Thermotherapy+ TENS+ low intensity high repetition exercises.
Intervention Type
Other
Intervention Name(s)
thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen
Intervention Description
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
Intervention Name(s)
thermotherapy+ TENS+ low intensity high repetition exercises
Intervention Description
The intervention will be repeated 3 times per day and the posttest will be conducted 5th day using KOOS, NPRS and goniometer.
Primary Outcome Measure Information:
Title
KOOS
Description
An instrument to assess the patient's opinion about their knee and associated problems.
Time Frame
10 months
Title
Numeric Pain Rating Scale
Description
NPRS is based on 11-point numerical rating scale for determining pain intensity, 0(no pain) to 10(worst pain imaginable) pain intensity.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Ankle Brachial Index
Description
Ankle Brachial Index Will be measured with bp apparatus to measure Perfusion.
Time Frame
10 months
Other Pre-specified Outcome Measures:
Title
Goniometer
Description
A universal goniometer is an instrument that measures the available range of motion at a joint. Knee flexion and extension will be measured.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both Genders from Age:45-65 year Exclusion Criteria: Joint Instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad sanaullah
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehsil headquarter hospital
City
Barnala
State/Province
Azad Kashmir
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
13782559
Citation
WAINE H, NEVINNY D, ROSENTHAL J, JOFFE IB. Association of osteoarthritis and diabetes mellitus. Tufts Folia Med. 1961 Jan-Mar;7:13-9. No abstract available.
Results Reference
background
PubMed Identifier
23002084
Citation
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.
Results Reference
background
PubMed Identifier
27233479
Citation
Saw MM, Kruger-Jakins T, Edries N, Parker R. Significant improvements in pain after a six-week physiotherapist-led exercise and education intervention, in patients with osteoarthritis awaiting arthroplasty, in South Africa: a randomised controlled trial. BMC Musculoskelet Disord. 2016 May 27;17:236. doi: 10.1186/s12891-016-1088-6.
Results Reference
background
PubMed Identifier
11991658
Citation
Mobasheri A, Neama G, Bell S, Richardson S, Carter SD. Human articular chondrocytes express three facilitative glucose transporter isoforms: GLUT1, GLUT3 and GLUT9. Cell Biol Int. 2002;26(3):297-300. doi: 10.1006/cbir.2001.0850.
Results Reference
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PubMed Identifier
26749517
Citation
Griffin TM, Huffman KM. Editorial: Insulin Resistance: Releasing the Brakes on Synovial Inflammation and Osteoarthritis? Arthritis Rheumatol. 2016 Jun;68(6):1330-3. doi: 10.1002/art.39586. No abstract available.
Results Reference
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PubMed Identifier
19490621
Citation
Rosa SC, Goncalves J, Judas F, Mobasheri A, Lopes C, Mendes AF. Impaired glucose transporter-1 degradation and increased glucose transport and oxidative stress in response to high glucose in chondrocytes from osteoarthritic versus normal human cartilage. Arthritis Res Ther. 2009;11(3):R80. doi: 10.1186/ar2713. Epub 2009 Jun 2.
Results Reference
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PubMed Identifier
23151458
Citation
Tsai TL, Manner PA, Li WJ. Regulation of mesenchymal stem cell chondrogenesis by glucose through protein kinase C/transforming growth factor signaling. Osteoarthritis Cartilage. 2013 Feb;21(2):368-76. doi: 10.1016/j.joca.2012.11.001. Epub 2012 Nov 11.
Results Reference
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PubMed Identifier
18212116
Citation
Aguiari P, Leo S, Zavan B, Vindigni V, Rimessi A, Bianchi K, Franzin C, Cortivo R, Rossato M, Vettor R, Abatangelo G, Pozzan T, Pinton P, Rizzuto R. High glucose induces adipogenic differentiation of muscle-derived stem cells. Proc Natl Acad Sci U S A. 2008 Jan 29;105(4):1226-31. doi: 10.1073/pnas.0711402105. Epub 2008 Jan 22.
Results Reference
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PubMed Identifier
20380516
Citation
Cramer C, Freisinger E, Jones RK, Slakey DP, Dupin CL, Newsome ER, Alt EU, Izadpanah R. Persistent high glucose concentrations alter the regenerative potential of mesenchymal stem cells. Stem Cells Dev. 2010 Dec;19(12):1875-84. doi: 10.1089/scd.2010.0009. Epub 2010 Sep 11.
Results Reference
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PubMed Identifier
33382877
Citation
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.
Results Reference
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Burger Allen Exercises in Knee OA With Type II Diabetes

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