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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01137266 |
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Date of registration:
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28/01/2010 |
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Primary sponsor: |
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Public title:
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Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Disability in Patients With Osteoarthritis
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Scientific title:
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Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Disability in Patients With Osteoarthritis |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01137266 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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A Kolen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Philips Research Eindhoven |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- osteo-arthritis patients diagnosed by medical professional
- at least 18 years old
- VAS higher than 40mm, lower than 70mm (on a 100 mm VAS scale) at the moment of the
investigation
- pain symptoms duration longer than 3 months
Exclusion Criteria:
- unable to comprehend instructions
- unable to co-operate
- malignancy
- recent bleeding tissue or haemorrhage in knee
- epilepsy
- advanced cardiovascular conditions, e.g. severe angina or cardiac arrhythmias
- Pacemakers or cochlear implants
- pregnant
- sensory loss of the area to be treated
- devitalised skin e.g. after recent radiotherapy;
- local acute skin conditions e.g. eczema, dermatitis
- doubtful diagnoses
- global, multiple location pain (other than both knees)
- people who undergo currently a TENS treatment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Device: TENS
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Primary Outcome(s)
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Determine the effect of TENS on pain and mobility for each treatment group separately. Also determine the differences of the effect of TENS by comparing different stimulation sites;
[Time Frame: 1 year]
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Secondary Outcome(s)
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relationship between skin resistance values before stimulation with the sensations during TENS.Explore whether there is a relation between physiological or psychological characteristics of patients and outcome of TENS and user satisfaction questionnaire
[Time Frame: 1 year]
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Secondary ID(s)
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NL2073208008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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