Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable knee-osteoarthritis
Started Nov 2016
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJuly 8, 2020
July 1, 2020
Same day
September 6, 2016
July 6, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Immediately
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.
Immediately
Secondary Outcomes (3)
Global Rating of Change Scale
Immediately and 72 hours after intervention
Pain intensity in Visual Analogic Scale 72 hours after intervention
72 hours after intervention
Pressure Pain Threshold in Algometer 72 hours after intervention
72 hours after intervention
Study Arms (2)
Manual therapy
EXPERIMENTALIn 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.
TENS
EXPERIMENTALIn TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Ceara
Fortaleza, Ceará, 60430-160, Brazil
Related Publications (25)
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PMID: 26438323BACKGROUNDMcAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
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PMID: 20418016BACKGROUNDCheing GL, Tsui AY, Lo SK, Hui-Chan CW. Optimal stimulation duration of tens in the management of osteoarthritic knee pain. J Rehabil Med. 2003 Mar;35(2):62-8. doi: 10.1080/16501970306116.
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PMID: 15626162BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Master
Study Record Dates
First Submitted
September 6, 2016
First Posted
October 27, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2016
Study Completion
November 1, 2018
Last Updated
July 8, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share