Effect of Kinesio Taping in Women With Knee Osteoarthritis

NCT03624075 | Completed

• 1 other identifier: 2.577.088
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) of the knee is a disease characterized mainly by the wear and tear of the articular structures, which affects 6% to 13% of men and 7% to 19% of women, and their prevalence may be increased proportionally with increasing age. Signs and symptoms include pain, joint stiffness and loss of function. In this perspective, kinesio taping (KT) appears as an alternative therapeutic resource for the treatment of this type of patient. However, the current evidence on this technique is limited and conflicting, making its effects on the symptomatology of the disease still uncertain. Thus, the present study will evaluate the effects of KT application on muscle strength, pain, physical function, edema and quality of life of elderly women with knee OA. It will be a randomized, blind clinical trial in which 45 volunteers will be allocated to three groups: G1 (placebo group), G2 (control group) and G3 (intervention group). The G1 will be submitted to the placebo (no tension) application of KT on rectos femoris muscle and knee; the G2 will receive a protocol of a health education activity session lasting 60 minutes and finally the G3 will be submitted to the simultaneous application (with tension) of two KT techniques on rectos femoris muscle and knee. All groups will be evaluated before, immediately after and 72 hours after the application. To measure the variables, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Numerical Pain Rating Scale (NPRS), 6-minute walk test (6MWT), isometric dynamometer, perimetry and global rating of change. Statistical analysis will be done using SPSS® software (Statistical Package Social Science) version 20.0. The Kolmogorov-Smirnov and Levene tests will be applied to evaluate the normality and homogeneity of the data, respectively. Intra and intergroup comparisons will be evaluated using analysis of variance ANOVA of mixed model. In the presence of a significant F, the Benferroni pot-hoc test will be used to identify where the difference occurred. For all statistical analyzes, a significance level of 5% (p \<0.05) and 95% confidence interval (95% CI) will be adopted.

Conditions

Kinesio Taping; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Numerical Pain Rating Scale (NPRS)

  The primary outcome will pain assessed by the NPRS, whereby participants were asked to choose a number between 0 (no pain) and 10 (worst pain possible). They will instructed to report the level of pain while sitting and rising from a chair.

  Time 0 - baseline

• Numerical Pain Rating Scale (NPRS)

  The pain of the volunteers will be indirectly measured by the Visual Analogue Scale (VAS), which varies from 0 to 10 (unbearable pain) (SCOTT and HUSKISSON, 1976) . The pain will be measured during the activity of climbing stairs. The patient will be directed to go up and down a staircase with two steps. Initially a volunteer will become familiarized. Volunteers will be guided to perform a normal collective activity (the way they are done in the day). In order to, a voluntary test measure will be used while using an VAS. In VAS, the lower the value, the less the pain sensation realatable by the patient and the higher the value, the greater the pain sensation.

  Time 1 - after 10min of the baseline

• Numerical Pain Rating Scale (NPRS)

  The primary outcome will pain assessed by the NPRS, whereby participants were asked to choose a number between 0 (no pain) and 10 (worst pain possible). They will instructed to report the level of pain while sitting and rising from a chair.

  Time 2 - after 72 hours of baseline

Secondary Outcomes (9)

• Perimetry

  Time 0 - baseline

• Perimetry

  Time 2 - after 72 hours of baseline

• Quadriceps muscle strength

  Time 0 - baseline

• Quadriceps muscle strength

  Time 2 - after 72 hours of baseline

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Time 0 - baseline

Study Arms (3)

control group

NO INTERVENTION

The control group had a protocol of a health education / self-gestation session lasting 60 minutes. This session should include topics such as definition of knee OA, guidance on knee anatomy and physiology, prayer over articulation, rehabilitation and practice of exercises, and as volunteer to receive an educational and self explanatory primer with all the content that is exposed during a lesson .

Placebo group

PLACEBO COMPARATOR

The placebo group will simultaneously receive two techniques of applying tensionless KT. The first technique that will be applied is inverted 'Y' on the rectus femoris. In the second technique to be applied, the tape body will be divided lengthwise into four narrow strips. The two pieces intersect the front of the knee. For this application, the volunteer will be positioned in the dorsal position without knee flexion and the tape will be applied by a trained researcher. In the case of bilateral OA, in both techniques of application, the most affected member based on the NPRS score will be the one that will undergo the intervention. All volunteers will remain with the tape for 72 hours.

Other: application of kinesio taping

intervention group

EXPERIMENTAL

The intervention group will receive the same protocol as the placebo group, differing only in relation to the tension of the bandage. According to Kase et al (2003), the techniques recommend the relief of pain and edema and performance. In the second technique to be applied, the tape body will be divided lengthwise into four narrow strips. The two pieces intersect the front of the knee. For this application, the volunteer will be positioned in the dorsal position without knee flexion and the tape will be applied by a trained researcher. In the case of bilateral OA, in both techniques of application, the most affected member based on the NPRS score will be the one that will undergo the intervention. All volunteers will remain with the tape for 72 hours.

Other: application of kinesio taping

Interventions

application of kinesio taping OTHER

application of kinesio taping in the rectus femoris muscle and in the medial and lateral region of the knee

Placebo group; intervention group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects aged 60 years and over, non-obese (BMI between 18.5 and 24.9 kg / m2), with diagnosis of knee OA according to the criteria of the American College of Rheumatology (Altman et al. , 1986), which are: knee pain most of the day during the last weeks and age greater than 60 years (mandatory criteria), and at least two of the following criteria: stiffness after rest less than 30 minutes, crackle in the affected knee , joint increase of firm consistency, absence of temperature increase and painful hypersensitivity to palpation;
• Individuals with radiographic signs of degeneration of the knee joint;
• Individuals with any degree of degeneration according to the Kellgren-Lawrence scale;
• Individuals with a pain scale above 3 according to NPRS;
• Stiffness in the knee for at least 6 months prior to screening;
• Stiffness during the beginning of activities;
• Intermittent swelling;
• Never have used KT;
• Individuals with no history of associated joint disease or systemic rheumatic disease and / or history of surgery in the affected lower limb;
• Individuals who are not under physiotherapeutic treatment during the intervention;
• Individuals without neurological, vestibular, visual or auditory deficits that make evaluations impossible.

You may not qualify if:

• Individuals who report pain during the procedure;
• Individuals who do not complete the treatment time or who do not perform the evaluation procedures correctly, making it impossible to collect any of the data investigated;
• Individuals with allergy to bandage or cutaneous injury in the region where KT will be applied;
• Individuals who present hypertensive peak during the evaluations.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Faculdade de ciências da saúde do trairi - FACISA/UFRN

Santa Cruz, Brazil

Location

Related Publications (1)

• Pinheiro YT, Barbosa GM, Fialho HRF, Silva CAM, Anunciacao JO, Silva HJA, Souza MC, Lins CAA. Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial. BMJ Open. 2020 Dec 16;10(12):e041121. doi: 10.1136/bmjopen-2020-041121.

  PMID: 33328259 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The volunteers will be recruited from the waiting list of the Clinic School of Physiotherapy of the Faculty of Health Sciences of Rio Grande do Norte, as well as the community in general. Initially, a signature will be requested from the TCLE and the next series of personal data. When we are already included, how should participants assess pain, muscular strength, edema and physical function (T0). Then all of them must be allocated to one of the three groups, where due intervention is required for each group. After one session, muscle strength and pain were again assessed (T1) and 72 hours later (T2), all outcomes assessed at time T0 were retested, including the global rating of change.

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: August 9, 2018
• Study Start: June 11, 2018
• Primary Completion: March 11, 2019
• Study Completion: June 11, 2019
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

BR (1)