Clinical trial NCT03624075: Effect of Kinesio Taping in Women With Knee Osteoarthritis
Official title: Effect of Kinesio Taping on Muscle Force, Pain, Edema, Physical Function and Global Perception of Change of Women With Knee Osteoarthritis: Randomized and Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kinesio Taping
Knee Osteoarthritis
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 45
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Time 0 - baseline
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Time 1 - after 10min of the baseline
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Time 2 - after 72 hours of baseline
Secondary outcomes:
measure: Perimetry
timeFrame: Time 0 - baseline
measure: Perimetry
timeFrame: Time 2 - after 72 hours of baseline
measure: Quadriceps muscle strength
timeFrame: Time 0 - baseline
measure: Quadriceps muscle strength
timeFrame: Time 2 - after 72 hours of baseline
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Time 0 - baseline
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Time 2 - after 72 hours of baseline
measure: 6-minute walk (6MWT)
timeFrame: Time 0 - baseline
measure: 6-minute walk (6MWT)
timeFrame: Time 2 - after 72 hours of baseline
measure: Global rating of change
timeFrame: Time 2 - after 72 hours of baseline
Other outcomes:
Locations:
city: Santa Cruz
country: Brazil
facility: Faculdade de ciências da saúde do trairi - FACISA/UFRN
Study officials:
References:
citation: 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.