- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878587
Burger Allen Exercises in Knee OA With Type II Diabetes
September 22, 2023 updated by: Riphah International University
Effects of Burger Allen Exercises on Pain, Range of Motion, and Disability in Knee Osteoarthritis 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
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Muhammad sanaullah, MS
- Phone Number: +923224819253
- Email: drmuhammadsanaullah@gmail.com
Study Locations
-
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Azad Kashmir
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Barnala, Azad Kashmir, Pakistan
- Tehsil Headquarter Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Both Genders from Age:45-65 year
Exclusion Criteria:
- Joint Instability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
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
|
Active Comparator: Group B control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KOOS
Time Frame: 10 months
|
An instrument to assess the patient's opinion about their knee and associated problems.
|
10 months
|
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.
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle Brachial Index
Time Frame: 10 months
|
Ankle Brachial Index Will be measured with bp apparatus to measure Perfusion.
|
10 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad sanaullah, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2023
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 7, 2023
Study Registration Dates
First Submitted
April 18, 2023
First Submitted That Met QC Criteria
May 18, 2023
First Posted (Actual)
May 26, 2023
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/23/0109/Ayesha iftikhar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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