MedTrace Logo

The Effect of Elastic Bandage Compression on Pain and Function in Individuals With Knee Osteoarthritis

NCT04724902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-05-06

No results posted yet for this study

Summary

Introduction and Purpose: Compression is a tactile stimulus that can reduce the perception of pain by stimulating tactile skin receptors and the speed of nerve conduction. It is highly associated with cryotherapy and other non-pharmacological physical agents without musculoskeletal pain control. However, there is still a lack of evidence on its possible effects on the modulation of this type of pain. This study will evaluate the effect of compression by elastic bandages, on pain and on the function of belonging with knee osteoarthritis (KO). Methodology: A randomized, blinded controlled clinical trial will be conducted. Individuals with KO (n = 90; both sexes; between 40 and 75 years old), will be allocated into three groups (n = 30 / group): Compression (submitted to compression by elastic bandage on the affected knee, 20 min, in 4 days consecutive); Sham (submitted to the same protocol with elastic bandage, but without compression); and Control (waiting list, without intervention). All will be taken one day before the start and one day after the last intervention. They will also be adopted in the 12th and 24th weeks after the intervention. The main outcome will be the pain intensity (Visual Analogue Scale). The Western Ontario \& McMaster Universities Osteoarthritis (WOMAC) physical function questionnaire, physical function tests (step test, sit and stand test in 30s, 40m accelerated walk test), and the perception scale global change (GRC). Data analysis: SPSS 24.0 software will be used for descriptive analysis and performance of Kolmogorov-Smirnov tests, two-way ANOVA and multiple comparison tests. A 95% confidence level and a 5% significance level will be adopted.

Conditions

Interventions

OTHER

Elastic bandage compression

The compression will be applied with the volunteer in the supine position on a stretcher, with both lower limbs extended and relaxed. The intervention in the Compression group will be with elastic bandages involving the entire surface of the knee, positioned considering anatomical aspects: femoral condyles and the anterior tibial tuberosity. The level of compression must be maintained between 30 mmHg and 60 mmHg, according to the researched literature. The variations within these values will be stipulated according to the volunteer's self-report (comfortable and painless compression). The Shan Group will have the bandage wrapped around the knee without any compression force being exerted. The intervention will be carried out for 20 minutes, once a day, for 4 consecutive days. The Control group will be composed of volunteers who make up a study waiting list and will carry out the evaluations at the same time intervals as the other groups, but will not receive any type of intervention.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Universidade Federal de Sao Carlos

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-11-30
Completion
2023-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724902 on ClinicalTrials.gov