Phantom Limb PainNCT02496351
TENS for Phantom Limb Pain Prevention Following Major Amputation
A study testing TENS INTERVENTION in people with Phantom Limb Pain and Peripheral Vascular Diseases, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
A growing body of literature indicates that up to 80% of amputees may have phantom limb pain (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain, Peripheral Vascular Diseases
- What is being tested?
- TENS INTERVENTION
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Mar 2017
- 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
- Age over 18 years of both genders
- Critical limb ischemia (arteriopathic or diabetic aetiology)
- "MINI MENTAL TEST" (minimum 24 points)
Who cannot join
- Pace marker
- Don´t speak Spanish
- Not agreement with the study
- Dermatological lesion affecting the electrode place
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
hospital General Universitario de Castellon
Castellon, Castellon de La Plana, 12004
Barbara Bodega, Mrs, +34696962685, barcabo@icloud.com
Vanesa Rodenas, Mrs, +34961925963, rodenas_van@gva.es
About this study
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) for Phantom Limb Pain Prevention Following Arteriopathic Major Amputation: Clinical Trial
A growing body of literature indicates that up to 80% of amputees may have phantom limb pain (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. The etiology and pathophysiology of PLP are poorly understood. Some studies suggest a somatosensory cortex reorganization. Transcutaneous Electrical Nerve Stimulation (TENS) is a analgesic technique. TENS apply a low voltage electrical current through the skin using surface electrodes in order to stimulate afferent nerve fibbers. Because of the lack of evidence to support any treatment for PLP, interest has turned to preventing it instead.
The aim of this study is to assess if the early use of TENS in the immediately postoperative of major limb amputation due to peripheral vascular disease, should decrease the PLP incidence. TENS should interfere in the mechanism of PLP production to level of the pain fibers conduction.
Read the detailed description
Introduction:
Postamputation pain is highly prevalent after vascular limb amputation. The physiopathological basis should be divided in supraspinal, spinal and peripheral mechanisms. Supraspinal mechanism involve somatosensory cortical reorganization; spinal reorganization in the dorsal horn, occurs after deafferentation from peripheral nerve injury and peripherical nerve injury begins with the nerve section in surgery. All this factors seems to end into a somatosensory cortex reorganization. In this sense, it seems that our ability to prevent PLP depend on the capability to modulate the plasticity of the Central Nervous System (CNS).
Transcutaneous electrical nerve stimulation it´s a safe, easy and inexpensive analgesic technique acting on the conduction pathways of pain. An adequated program is mandatory: balanced symmetrical biphasic pulse, pulse length greater than 250microsg, modulated high frequency and electrodes placed over the dermatomes corresponding to lumbar-sacral spine; will be used in the intervention patients
Hypothesis:
In patients with TENS use during the immediately postoperative of major limb amputation due to peripheral vascular disease, phantom limb pain will appear with less frequency than in control patients.
Study population:
Patients undergoing major limb amputation for peripheral vascular disease.
Study design:
A randomized, prospective, blinded (patient, physician, statistician),clinical trial placebo versus intervention group study has been design.
In the intervention arm, TENS should be applied during the 24 hours immediately after limb amputation. The placebo arm, also will carry TENS but without an active program.
All patients should receive the standard analgesic treatment for limb amputation during their hospitalization time.
Evaluation and objectives:
Before surgery all patients made two test for pain evaluation: The Analogical Visual Scale and the DN4 questionnaire for neuropathic pain.
At 3 days, 1 month and 3 months after surgery, all patients will be evaluated about their pain using the recommended test for neuropathic pain:The Analogical Visual Scale and the DN4 (neuropathic pain 4) questionnaire for neuropathic pain . Also, at month 1 and 3th, two more test should be done in order to evaluate quality of life: The SF-12 (short form-12) health survey questionnaire about health and the Medical Outcomes Study (MOS) for sleep test.
- Conditions
- Phantom Limb Pain, Peripheral Vascular Diseases
- Being tested
- TENS INTERVENTION
- Keywords
- transcutaneous electrical nerve stimulation
- Medical subject headings
- Phantom Limb, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS INTERVENTIONDevice
24 hours of TENS treatment in the immediately postoperative of limb amputation
| Study group | Role | What they receive |
|---|---|---|
| TENS INTERVENTION | Active comparator | In the immediately postoperative of limb amputation, TENS will be use in this patients during 24 hours. The intensity of the impulse will be determined in a test carried out 3 days before surgery. The other parameters will be continuous, biphasic, compensated and symmetric impulse, frequency of 80 Hz, time impulse between 250 and 290 microseconds, modulation time 5´´ Receives: Device: TENS INTERVENTION |
| TENS NO INTERVENTION | Placebo comparator | In the immediately postoperative of limb amputation, TENS will be use in this patients during 24 hours, but in this case TENS just will be on. No intensity impulse should be programmed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PREOPERATIVE PAIN EVALUATION
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10 DN4 Test ( for neurophatic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neurophatic pain.
Measured: 3 days before intervention
PREOPERATIVE NEUROPAThIC PAIN EVALUATION
DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.
Measured: 3 days before intervention
Secondary outcomes (10)
INMEDIATELY POSTOPERATIVE PAIN EVALUATION
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
Measured: 3 days after intervention
INMEDIATELY POSTOPERATIVE PAIN EVALUATION
DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.
Measured: 3 days after intervention
1 MONTH POSTOPERATIVE PAIN EVALUATION
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
Measured: 1 MONTH
1 MONTH POSTOPERATIVE PAIN EVALUATION
DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.
Measured: 1 MONTH
1 MONTH POSTOPERATIVE HEALTH EVALUATION
Test SF-12 about health situation. This is the recommended test of the Spanish Pain society for subjective evaluation of health situations. It consist in 12 questions about its own perceptions, employment status, daily activities, frame of mind
Measured: 1 MONTH
1 MONTH POSTOPERATIVE SLEEP EVALUATION
Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation
Measured: 1 MONTH
3 MONTH POSTOPERATIVE PAIN EVALUATION
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
Measured: 3 MONTH
3 MONTH POSTOPERATIVE PAIN EVALUATION
DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.
Measured: 3 MONTH
3 MONTH POSTOPERATIVE HEALTH EVALUATION
Test SF-12 about health situation. This is the recommended test of the Spanish Pain society for subjective evaluation of health situations. It consist in 12 questions about its own perceptions, employment status, daily activities, frame of mind
Measured: 3 MONTH
3 MONTH POSTOPERATIVE SLEEP EVALUATION
Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation
Measured: 3 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Bodega, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Barbara Bodega, Mrs, Principal investigator, Hospital General Universitario de Castellon. Avenida Benicassim sn 12004. Castellon. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496351
- Sponsor's protocol ID
- 161976BBM
- Status last verified
- Jun 2015
- First submitted
- 9 Jul 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) for Phantom Limb Pain Prevention Following Arteriopathic Major Amputation: Clinical Trial
- ClinicalTrials.gov ID
- NCT02496351
- Acronym / sponsor ID
- 161976BBM
- Conditions
- Phantom Limb Pain, Peripheral Vascular Diseases
- Keywords
- transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 14 Jul 2015 (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.
A growing body of literature indicates that up to 80% of amputees may have phantom limb pain (PLP). The first cause for limb loss is vascular disease. Usually, amputees who suffer from PLP are suboptimal treated. Therefore, many amputees are disabled by their chronic pain. The etiology and pathophysiology of PLP are poorly understood. Some studies suggest a somatosensory cortex reorganization. Transcutaneous Electrical Nerve Stimulation (TENS) is a analgesic technique. TENS apply a low voltage electrical current through the skin using surface electrodes in order to stimulate afferent nerve fibbers. Because of the lack of evidence to support any treatment for PLP, interest has turned to preventing it instead.
The aim of this study is to assess if the early use of TENS in the immediately postoperative of major limb amputation due to peripheral vascular disease, should decrease the PLP incidence. TENS should interfere in the mechanism of PLP production to level of the pain fibers conduction.
Detailed description
Introduction:
Postamputation pain is highly prevalent after vascular limb amputation. The physiopathological basis should be divided in supraspinal, spinal and peripheral mechanisms. Supraspinal mechanism involve somatosensory cortical reorganization; spinal reorganization in the dorsal horn, occurs after deafferentation from peripheral nerve injury and peripherical nerve injury begins with the nerve section in surgery. All this factors seems to end into a somatosensory cortex reorganization. In this sense, it seems that our ability to prevent PLP depend on the capability to modulate the plasticity of the Central Nervous System (CNS).
Transcutaneous electrical nerve stimulation it´s a safe, easy and inexpensive analgesic technique acting on the conduction pathways of pain. An adequated program is mandatory: balanced symmetrical biphasic pulse, pulse length greater than 250microsg, modulated high frequency and electrodes placed over the dermatomes corresponding to lumbar-sacral spine; will be used in the intervention patients
Hypothesis:
In patients with TENS use during the immediately postoperative of major limb amputation due to peripheral vascular disease, phantom limb pain will appear with less frequency than in control patients.
Study population:
Patients undergoing major limb amputation for peripheral vascular disease.
Study design:
A randomized, prospective, blinded (patient, physician, statistician),clinical trial placebo versus intervention group study has been design.
In the intervention arm, TENS should be applied during the 24 hours immediately after limb amputation. The placebo arm, also will carry TENS but without an active program.
All patients should receive the standard analgesic treatment for limb amputation during their hospitalization time.
Evaluation and objectives:
Before surgery all patients made two test for pain evaluation: The Analogical Visual Scale and the DN4 questionnaire for neuropathic pain.
At 3 days, 1 month and 3 months after surgery, all patients will be evaluated about their pain using the recommended test for neuropathic pain:The Analogical Visual Scale and the DN4 (neuropathic pain 4) questionnaire for neuropathic pain . Also, at month 1 and 3th, two more test should be done in order to evaluate quality of life: The SF-12 (short form-12) health survey questionnaire about health and the Medical Outcomes Study (MOS) for sleep test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS INTERVENTION | Active comparator | Device: TENS INTERVENTIONIn the immediately postoperative of limb amputation, TENS will be use in this patients during 24 hours. The intensity of the impulse will be determined in a test carried out 3 days before surgery. The other parameters will be continuous, biphasic, compensated and symmetric impulse, frequency of 80 Hz, time impulse between 250 and 290 microseconds, modulation time 5´´ |
| TENS NO INTERVENTION | Placebo comparator | –In the immediately postoperative of limb amputation, TENS will be use in this patients during 24 hours, but in this case TENS just will be on. No intensity impulse should be programmed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years of both genders
- Critical limb ischemia (arteriopathic or diabetic aetiology)
- "MINI MENTAL TEST" (minimum 24 points)
Key exclusion criteria (4 listed)
- Pace marker
- Don´t speak Spanish
- Not agreement with the study
- Dermatological lesion affecting the electrode place
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 |
|---|---|---|
| TENS INTERVENTION24 hours of TENS treatment in the immediately postoperative of limb amputation | Device | TENS INTERVENTION |
Primary outcome
PREOPERATIVE PAIN EVALUATION
Time frame: 3 days before intervention
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10 DN4 Test ( for neurophatic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neurophatic pain.
PREOPERATIVE NEUROPAThIC PAIN EVALUATION
Time frame: 3 days before intervention
DN4 Test ( for neuropathic pain). This is the recommended test of the Spanish association on Anesthesiology for determinate neuropathic pain. It consist in several questions to evaluate the clinical situation and some others about the physical situation.
10 secondary outcomes
INMEDIATELY POSTOPERATIVE PAIN EVALUATION
Time frame: 3 days after intervention
INMEDIATELY POSTOPERATIVE PAIN EVALUATION
Time frame: 3 days after intervention
1 MONTH POSTOPERATIVE PAIN EVALUATION
Time frame: 1 MONTH
1 MONTH POSTOPERATIVE PAIN EVALUATION
Time frame: 1 MONTH
1 MONTH POSTOPERATIVE HEALTH EVALUATION
Time frame: 1 MONTH
1 MONTH POSTOPERATIVE SLEEP EVALUATION
Time frame: 1 MONTH
3 MONTH POSTOPERATIVE PAIN EVALUATION
Time frame: 3 MONTH
3 MONTH POSTOPERATIVE PAIN EVALUATION
Time frame: 3 MONTH
3 MONTH POSTOPERATIVE HEALTH EVALUATION
Time frame: 3 MONTH
3 MONTH POSTOPERATIVE SLEEP EVALUATION
Time frame: 3 MONTH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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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.
Barbara Bodega, Mrs principal investigator
Hospital General Universitario de Castellon. Avenida Benicassim sn 12004. Castellon. Spain
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 INTERVENTION in people with Phantom Limb Pain and Peripheral Vascular Diseases, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Jul 2015. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Bodega, Mrs (+34696962685, barcabo@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PREOPERATIVE PAIN EVALUATION (time frame: 3 days before intervention). The study lists 2 primary outcomes in all. 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 15 Jul 2015.