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TENS for Phantom Limb Pain Prevention Following Major Amputation

Primary Purpose

Phantom Limb Pain, Peripheral Vascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TENS INTERVENTION
Sponsored by
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phantom Limb Pain focused on measuring transcutaneous electrical nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age over 18 years of both genders
  • Critical limb ischemia (arteriopathic or diabetic aetiology)
  • "MINI MENTAL TEST" (minimum 24 points)

Exclusion Criteria:

  • Pace marker
  • Don´t speak Spanish
  • Not agreement with the study
  • Dermatological lesion affecting the electrode place

Sites / Locations

  • hospital General Universitario de CastellonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TENS INTERVENTION

TENS NO INTERVENTION

Arm Description

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´´

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

INMEDIATELY POSTOPERATIVE PAIN EVALUATION
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
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.
1 MONTH POSTOPERATIVE PAIN EVALUATION
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
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.
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
1 MONTH POSTOPERATIVE SLEEP EVALUATION
Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation
3 MONTH POSTOPERATIVE PAIN EVALUATION
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
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.
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
3 MONTH POSTOPERATIVE SLEEP EVALUATION
Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation

Full Information

First Posted
July 9, 2015
Last Updated
July 14, 2015
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
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1. Study Identification

Unique Protocol Identification Number
NCT02496351
Brief Title
TENS for Phantom Limb Pain Prevention Following Major Amputation
Official Title
Transcutaneous Electrical Nerve Stimulation (TENS) for Phantom Limb Pain Prevention Following Arteriopathic Major Amputation: Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain, Peripheral Vascular Diseases
Keywords
transcutaneous electrical nerve stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TENS INTERVENTION
Arm Type
Active Comparator
Arm Description
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´´
Arm Title
TENS NO INTERVENTION
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TENS INTERVENTION
Intervention Description
24 hours of TENS treatment in the immediately postoperative of limb amputation
Primary Outcome Measure Information:
Title
PREOPERATIVE PAIN EVALUATION
Description
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.
Time Frame
3 days before intervention
Title
PREOPERATIVE NEUROPAThIC PAIN EVALUATION
Description
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.
Time Frame
3 days before intervention
Secondary Outcome Measure Information:
Title
INMEDIATELY POSTOPERATIVE PAIN EVALUATION
Description
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
Time Frame
3 days after intervention
Title
INMEDIATELY POSTOPERATIVE PAIN EVALUATION
Description
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.
Time Frame
3 days after intervention
Title
1 MONTH POSTOPERATIVE PAIN EVALUATION
Description
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
Time Frame
1 MONTH
Title
1 MONTH POSTOPERATIVE PAIN EVALUATION
Description
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.
Time Frame
1 MONTH
Title
1 MONTH POSTOPERATIVE HEALTH EVALUATION
Description
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
Time Frame
1 MONTH
Title
1 MONTH POSTOPERATIVE SLEEP EVALUATION
Description
Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation
Time Frame
1 MONTH
Title
3 MONTH POSTOPERATIVE PAIN EVALUATION
Description
Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10
Time Frame
3 MONTH
Title
3 MONTH POSTOPERATIVE PAIN EVALUATION
Description
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.
Time Frame
3 MONTH
Title
3 MONTH POSTOPERATIVE HEALTH EVALUATION
Description
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
Time Frame
3 MONTH
Title
3 MONTH POSTOPERATIVE SLEEP EVALUATION
Description
Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation
Time Frame
3 MONTH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years of both genders Critical limb ischemia (arteriopathic or diabetic aetiology) "MINI MENTAL TEST" (minimum 24 points) Exclusion Criteria: Pace marker Don´t speak Spanish Not agreement with the study Dermatological lesion affecting the electrode place
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Bodega, Mrs
Phone
+34696962685
Email
barcabo@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vanesa Rodenas, Mrs
Phone
+34961925963
Email
rodena_van@gva.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Bodega, Mrs
Organizational Affiliation
Hospital General Universitario de Castellon. Avenida Benicassim sn 12004. Castellon. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
hospital General Universitario de Castellon
City
Castellon de la Plana
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Bodega, Mrs
Phone
+34696962685
Email
barcabo@icloud.com
First Name & Middle Initial & Last Name & Degree
Vanesa Rodenas, Mrs
Phone
+34961925963
Email
rodenas_van@gva.es

12. IPD Sharing Statement

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TENS for Phantom Limb Pain Prevention Following Major Amputation

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