Effect of Kinesio Taping in Women With Knee Osteoarthritis

NCT ID: NCT03624075

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2019-06-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

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 .

Group Type: NO_INTERVENTION

No interventions assigned to this group

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

application of kinesio taping

Intervention Type: OTHER

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

intervention group

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.

Group Type: EXPERIMENTAL

application of kinesio taping

Intervention Type: OTHER

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

Interventions

application of kinesio taping

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • 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.

Exclusion Criteria

• • 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Caio Alano de Almeida Lins

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculdade de ciências da saúde do trairi - FACISA/UFRN

Santa Cruz, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33328259 (View on PubMed)

Other Identifiers

2.577.088

Identifier Type: -

Identifier Source: org_study_id