Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.

Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05355922
Collaborator
(none)
40
1
2
30
1.3

Study Details

Study Description

Brief Summary

Introduction: Osteoarthritis (OA) of the knee is a musculoskeletal disorder and is associated with significant implications related to public health and socioeconomic factors resulting in leave from work. Currently, there are several types of conservative treatment for this pathology, such as medications and mainly muscle strengthening, recommended by international guidelines. It can be associated with neuromuscular electrostimulation (NMES) as with the

Aussie Current, for example, which aims to increase strength and function earlier. Objective:

To determine whether the effectiveness of adding NMES to the Aussie Current in patients with knee OA who receive treatment based on the principles of conventional physiotherapy, in relation to pain relief, improvement of functional disability and muscle strength. Materials and Method: Forty individuals will be randomly distributed in two groups, with group 1 (G1) exercises and placebo application of electrostimulation and group 2 (G2) exercises and application of NMES with the Aussie current in the quadriceps femoris muscle. In the treatment, 24 sessions will be carried out in a period of 12 weeks based on the gold standard for the treatment of knee OA. Clinical outcomes of pain intensity, functional disability and muscle strength will be measured at baseline, immediately after 12-week treatment and after 24-week follow-up by a single blinded evaluator at all stages. All statistical procedures will be carried out following the principles of "intention to treat" and the comparison between groups will be carried out through the test of Mixed Linear Models. Expected Results: It is expected that there will be improvement in the variables: pain, functional capacity and strength in both the groups, however in the group that carried out the application of the Aussie Current, the gains would be more precocious, when compared to the group that did not carry out the NMES.

Condition or Disease Intervention/Treatment Phase
  • Other: Electrical electrostimulation of the quadriceps muscle
  • Other: Electrical electrostimulation of the quadriceps muscle (placebo)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of the Aussie Current Associated With Exercise in the Treatment of Patients With Knee Osteoarthritis: a Randomized, Double-blind Clinical Trial.
Actual Study Start Date :
Feb 10, 2020
Actual Primary Completion Date :
Dec 10, 2020
Anticipated Study Completion Date :
Aug 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Aussie current (placebo) and Exercises

Other: Electrical electrostimulation of the quadriceps muscle (placebo)
Exercises associated with electrical electrostimulation (placebo) of the quadriceps muscle of patients with knee osteoarthritis

Experimental: Aussie current and Exercises

Other: Electrical electrostimulation of the quadriceps muscle
Exercises associated with electrical electrostimulation of the quadriceps muscle of patients with knee osteoarthritis

Outcome Measures

Primary Outcome Measures

  1. Muscle strength [Baseline muscle strength (First day)]

    Assessment of quadriceps muscle strength with manual dynamometer

  2. Change from Baseline muscle strength at 12 weeks [Change from Baseline muscle strength at 12 weeks]

    Assessment of quadriceps muscle strength with manual dynamometer

  3. Change from Baseline muscle strength at 24 weeks [Change from Baseline muscle strength at 24 weeks]

    Assessment of quadriceps muscle strength with manual dynamometer

  4. Pain intensity [baseline pain intensity (First day)]

    The numerical pain scale

  5. Change from Baseline pain intensity at 12 weeks [Change from Baseline pain intensity at 12 weeks]

    The numerical pain scale

  6. Change from Baseline pain intensity at 24 weeks [Change from Baseline pain intensity at 24 weeks]

    The numerical pain scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • medical diagnosis of OA in the knees,

  • pain for another 06 months

  • both genders

  • age between 45 and 80 years

  • Grade I to III, according to Kellgren-Lawrence.

Exclusion Criteria:
  • bearers of severe spine, hip and ankle diseases (fractures and tumors and inflammatory pathologies)

  • neurological impairment

  • Severe cardiorespiratory diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Claudio Cazarini Júnior Sao Paulo São Paulo Brazil 03156001

Sponsors and Collaborators

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Claudio Cazarini Junior, Doctor of Health Sciences, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:
NCT05355922
Other Study ID Numbers:
  • Samir Asbahan
First Posted:
May 2, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2022