Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-02 @ 10:13 PM
Study NCT ID:
NCT02947451
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2016-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis
Sponsor:
Gabriel Peixoto Leão Almeida
Organization:
Study Overview
Official Title:
Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with knee Osteoarthritis have high prevalence of pain , requiring ever more precise interventions in their management. This study aims to investigate the immediate effects of manual therapy and TENS on pain in patients with knee Osteoarthritis. Knowledge of best interventions favors reducing spending on health and safety for the patient.
Detailed Description:
This study aims to compare the efficacy of manual therapy and TENS for immediate control of pain in patients with knee osteoarthritis. They will be included 62 patients with clinical and radiological diagnosis of knee osteoarthritis, presenting pain of at least 3 in VAS, which are recruited from rheumatology and geriatrics clinics in Fortaleza / CE through a prior screening.
Will be three assessments, prior to the intervention, immediately after it and after 72 hours. The data collected shall appear in individual printed records. Participants will be divided into two therapy groups, of which one will be applied manual therapy and other TENS. There will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind.
In manual therapy group will be assigned a protocol with manual passive stretching for the quadriceps muscles, hamstrings, triceps surae, adductors and abductors of the hip; myofascial release peripatellar; joint mobilization grades 1 and 2 for tibiofemoral joint and femoro - patellar in the affected knee.
In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application. The intensity will be defined by the patient, should the stimulus be considered intense, but pleasant to it.
The Kolmogorov - Smirnov test is used to verify the data distribution normality. The characterization of the participants is performed by means of descriptive statistical analysis. Parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. The evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. The difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group."
Will be three assessments, prior to the intervention, immediately after it and after 72 hours. The data collected shall appear in individual printed records. Participants will be divided into two therapy groups, of which one will be applied manual therapy and other TENS. There will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind.
In manual therapy group will be assigned a protocol with manual passive stretching for the quadriceps muscles, hamstrings, triceps surae, adductors and abductors of the hip; myofascial release peripatellar; joint mobilization grades 1 and 2 for tibiofemoral joint and femoro - patellar in the affected knee.
In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application. The intensity will be defined by the patient, should the stimulus be considered intense, but pleasant to it.
The Kolmogorov - Smirnov test is used to verify the data distribution normality. The characterization of the participants is performed by means of descriptive statistical analysis. Parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. The evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. The difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group."
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: