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Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Manual Therapy
TENS
Sponsored by
Gabriel Peixoto Leão Almeida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Knee osteoarthritis diagnosed by clinical criteria established by the American College of Rheumatology and radiological criteria of Kelgren-Lawrence
  • Age over 50 years
  • Pain intensity above 2 on the VAS

Exclusion Criteria:

  • Other systemic inflammatory disease
  • Changes in sensitivity
  • Use of anti-inflammatory steroids, tranquillizers and/or antidepressants in the last month
  • Analgesic in last 24 hours
  • Use of cardiac pacemaker

Sites / Locations

  • Federal University of Ceara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual therapy

TENS

Arm Description

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 a single application.

In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application.

Outcomes

Primary Outcome Measures

Pain intensity in Visual Analogic Scale
It consists of 11 points, ranging from 0 ( no pain) to 10 ( maximum possible pain ), the volunteer instructed to quantify their knee pain present at the time of evaluation.
Pressure Pain Threshold in Algometer
They will be scored 7 points, the first being located at the apex of the patella, the second three cm medial to the apex of the patella, the third two centimeters higher than the second, the fourth two centimeters lower than the second, the fifth three centimeters lateral to the apex of the patella, the sixth two centimeters above the fifth and seventh two centimeters below the fifth. Participants will be instructed to report to the appraiser whenever the feeling in the stimulus site becomes clearly painful. There will be two measurements at each point, each starting from point 1 to 7. It shall be considered the average of each isolated point and the average of the averages of the points how test result.

Secondary Outcome Measures

Global Rating of Change Scale
Used to evaluate the self- perception of the volunteer about the overall state of the affected knee. It is formed by 11 points, ranging from -5 (much worse), 0 (unchanged) to +5 (completely better), the participant instructed to quantify their perception with the question: "Compared to their condition before the treatment, how would you describe your knee right now?"
Pain intensity in Visual Analogic Scale 72 hours after intervention
It consists of 11 points, ranging from 0 ( no pain) to 10 ( maximum possible pain ), the volunteer instructed to quantify their knee pain present at the time of evaluation.
Pressure Pain Threshold in Algometer 72 hours after intervention
They will be scored 7 points, the first being located at the apex of the patella, the second three cm medial to the apex of the patella, the third two centimeters higher than the second, the fourth two centimeters lower than the second, the fifth three centimeters lateral to the apex of the patella, the sixth two centimeters above the fifth and seventh two centimeters below the fifth. Participants will be instructed to report to the appraiser whenever the feeling in the stimulus site becomes clearly painful. There will be two measurements at each point, each starting from point 1 to 7. It shall be considered the average of each isolated point and the average of the averages of the points how test result.

Full Information

First Posted
September 6, 2016
Last Updated
July 6, 2020
Sponsor
Gabriel Peixoto Leão Almeida
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1. Study Identification

Unique Protocol Identification Number
NCT02947451
Brief Title
Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis
Official Title
Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gabriel Peixoto Leão Almeida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy
Arm Type
Experimental
Arm Description
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 a single application.
Arm Title
TENS
Arm Type
Experimental
Arm Description
In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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. Stretching, myofascial release and mobilizations will be held for 30 seconds, with three repetitions of each. The intervention will be applied only once.
Intervention Type
Other
Intervention Name(s)
TENS
Other Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity in Visual Analogic Scale
Description
It consists of 11 points, ranging from 0 ( no pain) to 10 ( maximum possible pain ), the volunteer instructed to quantify their knee pain present at the time of evaluation.
Time Frame
Immediately
Title
Pressure Pain Threshold in Algometer
Description
They will be scored 7 points, the first being located at the apex of the patella, the second three cm medial to the apex of the patella, the third two centimeters higher than the second, the fourth two centimeters lower than the second, the fifth three centimeters lateral to the apex of the patella, the sixth two centimeters above the fifth and seventh two centimeters below the fifth. Participants will be instructed to report to the appraiser whenever the feeling in the stimulus site becomes clearly painful. There will be two measurements at each point, each starting from point 1 to 7. It shall be considered the average of each isolated point and the average of the averages of the points how test result.
Time Frame
Immediately
Secondary Outcome Measure Information:
Title
Global Rating of Change Scale
Description
Used to evaluate the self- perception of the volunteer about the overall state of the affected knee. It is formed by 11 points, ranging from -5 (much worse), 0 (unchanged) to +5 (completely better), the participant instructed to quantify their perception with the question: "Compared to their condition before the treatment, how would you describe your knee right now?"
Time Frame
Immediately and 72 hours after intervention
Title
Pain intensity in Visual Analogic Scale 72 hours after intervention
Description
It consists of 11 points, ranging from 0 ( no pain) to 10 ( maximum possible pain ), the volunteer instructed to quantify their knee pain present at the time of evaluation.
Time Frame
72 hours after intervention
Title
Pressure Pain Threshold in Algometer 72 hours after intervention
Description
They will be scored 7 points, the first being located at the apex of the patella, the second three cm medial to the apex of the patella, the third two centimeters higher than the second, the fourth two centimeters lower than the second, the fifth three centimeters lateral to the apex of the patella, the sixth two centimeters above the fifth and seventh two centimeters below the fifth. Participants will be instructed to report to the appraiser whenever the feeling in the stimulus site becomes clearly painful. There will be two measurements at each point, each starting from point 1 to 7. It shall be considered the average of each isolated point and the average of the averages of the points how test result.
Time Frame
72 hours after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Knee osteoarthritis diagnosed by clinical criteria established by the American College of Rheumatology and radiological criteria of Kelgren-Lawrence Age over 50 years Pain intensity above 2 on the VAS Exclusion Criteria: Other systemic inflammatory disease Changes in sensitivity Use of anti-inflammatory steroids, tranquillizers and/or antidepressants in the last month Analgesic in last 24 hours Use of cardiac pacemaker
Facility Information:
Facility Name
Federal University of Ceara
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-160
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis

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