Burger Allen Exercises in Knee OA With Type II Diabetes

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05878587
Collaborator
(none)
36
1
2
4.2
8.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: thermotherapy+ TENS+ low intensity high repetition exercises and Buerger Allen
  • Other: thermotherapy+ TENS+ low intensity high repetition exercises
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Burger Allen Exercises on Pain, Range of Motion, and Disability in Knee Osteoarthritis With Type II Diabetes
Actual Study Start Date :
Mar 31, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 7, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. KOOS [10 months]

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

  2. Numeric Pain Rating Scale [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 Outcome Measures

  1. Ankle Brachial Index [10 months]

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

Other Outcome Measures

  1. Goniometer [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Both Genders from Age:45-65 year
Exclusion Criteria:
  • Joint Instability

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tehsil headquarter hospital Barnala Azad Kashmir Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Muhammad sanaullah, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05878587
Other Study ID Numbers:
  • REC/23/0109/Ayesha iftikhar
First Posted:
May 26, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2023