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

NCT04724902 | Completed

• 1 other identifier: CAAE: 28484120.6.0000.5504
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Keywords

Physiotherapy; Rehabilitation; Compression; Analgesia

Outcome Measures

Primary Outcomes (2)

• Change from baseline - Visual Analog Scale (VAS)

  The scale will be made available visually to the individual so that he can classify the intensity of the average pain relative to the last week, and also before and after the performance of each functional physical test. The scale will vary from 0 to 10 cm, with 0 being the complete absence of pain, and 10 being the maximum pain intensity reported by the individual. The 1.75cm reduction will be considered an MDCI.

  Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.

• Change from baseline WOMAC (Western Ontario e o McMaster Universities Osteoarthritis Index) - Pain scale

  Self-report questionnaire, designed to assess problems experienced by individuals with lower limb OA, in the last 72 hours. The volunteer will be asked to answer 24 questions, which comprise three domains: pain, stiffness and physical function. The scores for the items are expressed using the Likert scale, classified as: none = 0, low = 25, moderate = 50, severe = 75 and very severe = 100. Higher scores indicate higher levels of pain, stiffness and physical dysfunction . The reduction of 8.74 points in the pain domain, from the baseline, will be considered an MDCI.

  Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.

Secondary Outcomes (5)

• Change from baseline WOMAC (Western Ontario e o McMaster Universities Osteoarthritis Index) - stiffness and physical dysfunction scales

  Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.

• Sit and stand test - 30 seconds

  Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.

• Step test

  Baseline, immediately after intervention and follow up evaluations of 12 and 24 weeks.

• 40 meter accelerated walk test (4x10m)

  Baseline, immediately after intervention and follow up evaluations of 12 and 24 weeks.

• Global rating of change - GRC scale

  Immediately after intervention and follow up of 12 and 24 weeks.

Other Outcomes (1)

• Blinding and use of elastic bandage.

  Follow up 24 weeks

Study Arms (3)

Compression Group

EXPERIMENTAL

The volunteer must remain supine on a stretcher, with both legs extended and relaxed. The intervention will be performed with elastic bandages (Selecta® of 13cm x 160 cm, composed of 45% cotton, 20% elastodiene and 27% polyamide) involving the entire knee surface, positioned considering anatomical aspects: covering the femoral condyles and the anterior tibial tuberosity). The bandage will involve the knee from the distal to the proximal, respecting the blood flow of the venous return. The level of compression was defined according to recommendations in the literature on compression interventions in lymphedema and venous changes, and should be kept between 30 mmHg and 60 mmHg. Variations on stipulated values may be interfered according to the volunteer's self-report, which should indicate a level of moderate, comfortable and pain-free compression. The intervention will be carried out for 20 minutes, once a day, for 4 consecutive days.

Other: Elastic bandage compression

Sham Group

SHAM COMPARATOR

For Sham application, the volunteer must remain supine on a stretcher, with both lower limbs extended and relaxed. Elastic bandages will be used (Selecta® of 13cm x 160 cm, composed of 45% cotton, 20% elastodiene and 27% polyamide) involving the entire knee surface, positioned considering anatomical aspects: covering the femoral condyles and the anterior tibial tuberosity) . The bandage will involve the knee from the distal (tibial tuberosity) to the proximal (femoral condyles), respecting the blood flow of the venous return. However, in this group, no compression force will be performed, maintaining the pressure at 00 mmHg according to a previous reliability study. The procedure will be carried out for 20 minutes, once a day, for 4 consecutive days.

Other: Elastic bandage compression

Control Group

NO INTERVENTION

The Control group will be composed of individuals with knee osteoarthritis, who make up the study's waiting list and will carry out evaluations at the same time intervals as the other groups, but will not receive any type of intervention and will be instructed not to start another treatment during their participation.

Interventions

Elastic bandage compression OTHER

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.

Compression Group; Sham Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of knee osteoarthritis according to the clinical and radiographic criteria of the American College of Rheumatology: signs of osteoarthritis in at least one of the compartments of the knee joint (tibiofemoral and / or in the patellofemoral joint); grade 2 or 3, according to Kellgren \& Lawrence criteria in the radiographic examination;
• Minimum score of 04 cm on the Visual Analogue Scale (EVA, total of 10 cm);
• Accept and sign the informed consent form.

You may not qualify if:

• Regular practice of moderate or intense physical activity for more than 45 minutes a week;
• Having started physical activity or undergone any physical therapy treatment in the previous 3 months;
• Use of corticosteroid infiltration in the knee (previous 6 months);
• Performing previous surgery on the knee or hip;
• Presence of some clinical restriction that makes it impossible for them to participate in the proposed evaluations or interventions (cardiorespiratory, neurological, musculoskeletal, vascular changes, and / or the presence of skin lesions when applying the bandage).

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Angelica Viana Ferrari

São Carlos, São Paulo, Brazil

Location

Related Publications (1)

• Ferrari AV, Perea JPM, Dantas LO, Silva HJA, Serrao PRMDS, Sendin FA, Salvini TF. Effect of compression by elastic bandages on pain and function in individuals with knee osteoarthritis: protocol of a randomised controlled clinical trial. BMJ Open. 2022 Nov 16;12(11):e066542. doi: 10.1136/bmjopen-2022-066542.

  PMID: 36385041 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The evaluations will be carried out by a "blind" evaluator with no information about the identification of the group to which the volunteer belongs. After the completion of the collections, the data will appear by a "blind" biostatistician, with no information on the identification of the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PT)

Model Details: Randomized controlled clinical trial following guidelines from CONSORT (Consolidated Standards of Reporting Trials), TIDieR (Template for Intervention Description and Replication) and OARSI recommendations for clinical trials with patients with knee osteoarthritis.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: October 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: March 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Participant data that underlie the results reported in this paper will be shared after blinding (text, tables, figures, appendices), immediately following publication.
• Access Criteria: Request for data or any form of analysis should be directed to ferrari.angelicaviana@gmail.com or tania@ufscar.br. Requesters will be asked to sign a data access agreement.

Locations

BR (1)