OsteoarthritisNCT01137266
Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Disability in Patients With Osteoarthritis
A study testing TENS in people with Osteoarthritis, run by Maxima Medical Center at 1 site in Netherlands.
Trial 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. the location with the lowest resistance 2. the location that causes an irradiation sensation 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- the location with the lowest resistance
- the location that causes an irradiation sensation
- 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
Read the detailed description
SUMMARY
Rationale: In clinical practice the position of TENS electrodes appears to be critical to success. It is claimed that electrodes should target areas with high neural density and where nerve bundles come close to the body surface. These areas are likely to have low skin resistances. Research in the field of electro-analgesia suggests areas of low skin resistance are linked to TENS stimulation points, and that this lower skin resistance may reflect areas with a higher density of neural tissue. When stimulated these areas are likely to generate larger nerve activity and potentially a greater analgesic outcome. For this reason many acupuncturist use a point finder to locate the optimal site to insert the acupuncture needle. To date the relationship between the skin resistance of the areas stimulated by TENS and pain relief is not known.
At present, optimal sites for electrode positioning is made ad hoc using a trial and error approach. This may result in electrodes being positioned at sub-optimal sites. The Philips new electronic pain relief device contains an array, or matrix, of small electrodes. Using this array, the device can measure electrical skin properties. In addition, the user can select which electrodes in the array are active and can adjust the intensity of those electrodes so that stimulation can be targeted to a specific location. In this way it is possible to investigate whether stimulating areas of low skin resistance has an effect on pain relief.
With a novel matrix TENS electrode we would like to investigate the TENS outcome for different electrode specifically chosen locations versus randomly chosen locations. Randomly chosen locations are defined as an area of approximately 10x10 cm around the specifically chosen location in which the random simulation point is chosen. The outcome of the specific vs. random stimulation will be measured with as primary outcome pain and mobility and as secondary outcome strength, joint range, and quality of life.
Objective: Determine effects of transcutaneous electrical nerve stimulation (TENS) on pain and mobility by comparing different stimulation sites; 1) the location with the lowest resistance, 2) the location that causes an irradiation sensation, 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
Study design: double-blind intervention study
Study population: Patients with chronic pain arise from osteo-arthritis in one or both knees Age (>18y), sex and ethnic background are not relevant
Intervention (if applicable): Patients receive a 3 times 30 minutes TENS treatment.
Main study parameters/endpoints: The primary outcome parameters are pain (VAS) and mobility (PDI and 6 min walk). Secondary outcome parameters are strength (MVC) and range-of-motion (ROM) in knee extension and quality of life (SF36).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk for the patients. The burden for the participants is 3 times 1 hour.
- Conditions
- Osteoarthritis
- Being tested
- TENS
- Keywords
- chronic pain osteo-arthritis in one or both knees, adults
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS
| Study group | Role | What they receive |
|---|---|---|
| skin resistence | Active comparator | 1) the location with the lowest resistance Receives: Device: TENS |
| irradiation | Active comparator | 2) the site that causes an irradiation sensation Receives: Device: TENS |
| random | Active comparator | 3) a random stimulation site. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Electronics Nederland BV
- Investigators
- A Kolen, PhD, Principal investigator, Philips Research Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137266
- Sponsor's protocol ID
- NL2073208008
- Status last verified
- Jul 2009
- First submitted
- 28 Jan 2010
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Disability in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT01137266
- Acronym / sponsor ID
- NL2073208008
- Conditions
- Osteoarthritis
- Keywords
- chronic pain osteo-arthritis in one or both knees, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Collaborators
- Philips Electronics Nederland BV
- Study start
- Jul 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the location with the lowest resistance
- the location that causes an irradiation sensation
- 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
Detailed description
SUMMARY
Rationale: In clinical practice the position of TENS electrodes appears to be critical to success. It is claimed that electrodes should target areas with high neural density and where nerve bundles come close to the body surface. These areas are likely to have low skin resistances. Research in the field of electro-analgesia suggests areas of low skin resistance are linked to TENS stimulation points, and that this lower skin resistance may reflect areas with a higher density of neural tissue. When stimulated these areas are likely to generate larger nerve activity and potentially a greater analgesic outcome. For this reason many acupuncturist use a point finder to locate the optimal site to insert the acupuncture needle. To date the relationship between the skin resistance of the areas stimulated by TENS and pain relief is not known.
At present, optimal sites for electrode positioning is made ad hoc using a trial and error approach. This may result in electrodes being positioned at sub-optimal sites. The Philips new electronic pain relief device contains an array, or matrix, of small electrodes. Using this array, the device can measure electrical skin properties. In addition, the user can select which electrodes in the array are active and can adjust the intensity of those electrodes so that stimulation can be targeted to a specific location. In this way it is possible to investigate whether stimulating areas of low skin resistance has an effect on pain relief.
With a novel matrix TENS electrode we would like to investigate the TENS outcome for different electrode specifically chosen locations versus randomly chosen locations. Randomly chosen locations are defined as an area of approximately 10x10 cm around the specifically chosen location in which the random simulation point is chosen. The outcome of the specific vs. random stimulation will be measured with as primary outcome pain and mobility and as secondary outcome strength, joint range, and quality of life.
Objective: Determine effects of transcutaneous electrical nerve stimulation (TENS) on pain and mobility by comparing different stimulation sites; 1) the location with the lowest resistance, 2) the location that causes an irradiation sensation, 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
Study design: double-blind intervention study
Study population: Patients with chronic pain arise from osteo-arthritis in one or both knees Age (>18y), sex and ethnic background are not relevant
Intervention (if applicable): Patients receive a 3 times 30 minutes TENS treatment.
Main study parameters/endpoints: The primary outcome parameters are pain (VAS) and mobility (PDI and 6 min walk). Secondary outcome parameters are strength (MVC) and range-of-motion (ROM) in knee extension and quality of life (SF36).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk for the patients. The burden for the participants is 3 times 1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| skin resistence | Active comparator | Device: TENS1) the location with the lowest resistance |
| irradiation | Active comparator | Device: TENS2) the site that causes an irradiation sensation |
| random | Active comparator | Device: TENS3) a random stimulation site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- unable to comprehend instructions
- unable to co-operate
- malignancy
- recent bleeding tissue or haemorrhage in knee
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSTENS | Device | irradiation, random, skin resistence |
Primary outcome
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
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2010.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Kolen, PhD principal investigator
Philips Research Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Osteoarthritis, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2010.