Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Disability in Patients With Osteoarthritis

NCT01137266 | Completed

• 1 other identifier: NL2073208008
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of transcutaneous electrical nerve stimulation (TENS) on pain and mobility by comparing different stimulation sitesP:

1. 1.the location with the lowest resistance
2. 2.the location that causes an irradiation sensation
3. 3.a random stimulation site (but within a 10x10cm area of the irradiation site). The effect is defined as the pain VAS baseline-measurement before treatment minus the pain VAS repeat-measurement after the given treatment

Conditions

Osteoarthritis

Keywords

chronic pain osteo-arthritis in one or both knees, adults

Outcome Measures

Primary Outcomes (1)

• 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;

  outcomes of the tests are stored at the PC. If all results of all patients are ready. Results will be statistically analysed.This will be in 1 year.

  1 year

Secondary Outcomes (1)

• 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

  1 year

Study Arms (3)

skin resistence

ACTIVE COMPARATOR

1\) the location with the lowest resistance

Device: TENS

irradiation

ACTIVE COMPARATOR

2\) the site that causes an irradiation sensation

Device: TENS

random

ACTIVE COMPARATOR

3\) a random stimulation site.

Device: TENS

Interventions

TENS DEVICE

TENS

irradiation; random; skin resistence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maxima Medical Center: lead
• Philips Electronics Nederland BV: collaborator

Study Sites (1)

Maxima Medical Centre

Eindhoven, North Brabant, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• A Kolen, PhD

  Philips Research Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: June 4, 2010
• Study Start: July 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 8, 2010

Record last verified: 2009-07

Locations

NL (1)