TENS for Phantom Limb Pain Prevention Following Major Amputation

Peripheral Vascular Diseases Clinical Trial

Official title:

Transcutaneous Electrical Nerve Stimulation (TENS) for Phantom Limb Pain Prevention Following Arteriopathic Major Amputation: Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02496351
• Other study ID #: 161976BBM
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2015
• Last updated: July 14, 2015
• Start date: May 2015
• Est. completion date: March 2017

Study information

• Verified date: June 2015
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: Barbara Bodega, Mrs
• Phone: +34696962685
• Email: barcabo[@]icloud.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Phantom Limb
• Phantom Limb Pain
• Vascular Diseases

Intervention

Device:
• TENS INTERVENTION
24 hours of TENS treatment in the immediately postoperative of limb amputation

Locations

Country	Name	City	State
Spain	hospital General Universitario de Castellon	Castellon de la Plana

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days before intervention	Yes
Primary	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.	3 days before intervention	Yes
Secondary	INMEDIATELY POSTOPERATIVE PAIN EVALUATION	Analogical Visual Scale: the patient indicate its pain level in the scale witch has an interval between 0-10	3 days after intervention	Yes
Secondary	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.	3 days after intervention	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	1 MONTH POSTOPERATIVE SLEEP EVALUATION	Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation	1 MONTH	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	3 MONTH POSTOPERATIVE SLEEP EVALUATION	Test MOS (Sleep Scale from the Medical Outcomes Study) Some questions for sleep evaluation	3 MONTH	Yes