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Trial record 9 of 15 for:    3741515 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02947451
Recruitment Status : Unknown
Verified October 2016 by Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara.
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Manual Therapy Other: TENS Not Applicable

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."


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis
Study Start Date : March 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Manual therapy
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.
Other: Manual Therapy

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.


Experimental: TENS
In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application.
Other: TENS
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.
Other Name: Transcutaneous electrical nerve stimulation




Primary Outcome Measures :
  1. Pain intensity in Visual Analogic Scale [ Time Frame: Immediately ]
    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.

  2. Pressure Pain Threshold in Algometer [ Time Frame: Immediately ]

    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 :
  1. Global Rating of Change Scale [ Time Frame: Immediately and 72 hours after intervention ]
    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?"

  2. Pain intensity in Visual Analogic Scale 72 hours after intervention [ Time Frame: 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.

  3. Pressure Pain Threshold in Algometer 72 hours after intervention [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947451


Locations
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Brazil
Federal University of Ceara
Fortaleza, Ceará, Brazil, 60430-160
Sponsors and Collaborators
Gabriel Peixoto Leão Almeida

Publications:

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Responsible Party: Gabriel Peixoto Leão Almeida, Master, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT02947451     History of Changes
Other Study ID Numbers: TCC_Isabel
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases