Burger Allen Exercises in Knee OA With Type II Diabetes

NCT05878587 | Completed

• 1 other identifier: REC/23/0109/Ayesha iftikhar
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis; Type II Diabetes

Keywords

Buerger Allen exercises; Diabetes mellitus; Knee osteoarthritis

Outcome Measures

Primary Outcomes (2)

• KOOS

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

  10 months

• 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.

  10 months

Secondary Outcomes (1)

• Ankle Brachial Index

  10 months

Other Outcomes (1)

• Goniometer

  10 months

Study Arms (2)

Group A

EXPERIMENTAL

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

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

Group B control group

ACTIVE COMPARATOR

Thermotherapy+ TENS+ low intensity high repetition exercises.

Other: thermotherapy+ TENS+ low intensity high repetition exercises

Interventions

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

Group A

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.

Group B control group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both Genders from Age:45-65 year

You may not qualify if:

• Joint Instability

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Tehsil headquarter hospital

Barnala, Azad Kashmir, Pakistan

Location

Related Publications (10)

• 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.

  PMID: 13782559 BACKGROUND

• 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.

  PMID: 23002084 BACKGROUND

• 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.

  PMID: 27233479 BACKGROUND

• 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.

  PMID: 11991658 BACKGROUND

• 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.

  PMID: 26749517 BACKGROUND

• 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.

  PMID: 19490621 BACKGROUND

• 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.

  PMID: 23151458 BACKGROUND

• 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.

  PMID: 18212116 BACKGROUND

• 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.

  PMID: 20380516 BACKGROUND

• 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.

  PMID: 33382877 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Muhammad sanaullah

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 26, 2023
• Study Start: March 31, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 7, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)