Sensory Retraining for Phantom Limb Pain

Phantom Limb Pain Clinical Trial

— PHANTOM RELIEF  

Official title:

An Investigation of the Efficacy of a Novel Sensory Discrimination Training Device for the Management of Phantom Limb Pain: A Randomised, Single-blind, Placebo-controlled Trial. [PHANTOM RELIEF Trial]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04103983
• Other study ID #: 2023 July 16692
• Secondary ID: 250337
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: June 4, 2025

Study information

• Verified date: February 2024
• Source: Teesside University
• Contact: Cormac Ryan, Professor
• Phone: 01642 738253
• Email: c.ryan[@]tees.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

86-87% of people who have had an amputation still feel pain in the limb that has been amputated - Phantom limb pain (PLP). Sensory retraining is a form of treatment for PLP where a special form of electrical stimulation is delivered to the residual limb.

The theory is that this stimulation changes activity in the brain that helps to reduce the person's pain. Two new types of sensory retraining device for the treatment of phantom limb pain have been developed. One type requires the user to interact with the device while the other is a non-interactive device. Both devices are new so it is unknown as to how well they may work, or which is best, therefore both will be tested in this study.

This study will be undertaken remotely, using video call, telephone and email for communication. The study will compare the effect of both devices for efficacy. One hundred people with PLP will be recruited from the NHS and the general public and randomised to receive either the interactive or non-interactive device or their placebo equivalents. A health care professional will train the research participants how to use their device. Participants will then use their device at home for 3 weeks. To ensure that they are using their devices as required, the researchers will keep in contact throughout the three week treatment period, using a schedule of video calls, weekly phone calls and daily texts. Pain and function will be measured before treatment, after treatment and at a 3 month follow-up. Twelve participants will also be invited to a one-to-one interview to give their experience of the acceptability and usability of their device.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 4, 2025
• Est. primary completion date: June 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Living in the UK

• All Genders

• Aged =18 years of age

• People who self-declare at that they are not pregnant and could never become pregnant

• Anyone who does not make both of those self-declarations:

if it is at all possible (self-declaration at eligibility checking) they may be pregnant before the Trial but not know they are - will be required to undertake a highly sensitive urine pregnancy test (as close in time as possible to the first video call) and return (and share at the first videocall) a negative result and/or if it is at all possible (self-declaration at eligibility checking) that they may become pregnant, during the 21 days they will be using a device - will be required to use a form of contraception considered to be highly or acceptably effective by the Clinical Trials Facilitation and Coordination Group (CTFG, 2020) (listed below*)

• fully healed residual limb (or stump) **

• single or multi limb amputation with the intervention applied to the participants limb of choice

• experienced PLP rated as =4 on a 0-10 scale on at least 2 days in the week prior to enrolment

• agree to inform us of the use of any new (to them) prescribed drug for their pain during the study

• any prescribed pharmacological treatment for the treatment of PLP stable for one month prior to commencing the study, and agree not to undertake any non-pharmacological treatments for their PLP during the study (e.g., mirror therapy)

• agree to inform us of any other health care received related to the amputated limb during the study (e.g., physiotherapy or occupational therapy) whether specific to PLP or not

• any previous non-pharmacological PLP treatment must have terminated at least 1 month prior to commencing the study

• Participants will need access to a mobile smart phone and a device (laptop, iPad etc.) at home to receive text messages and take part in secure video conference calls and completion of online forms

*Highly effective contraceptive methods being:

• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation either oral, intravaginal, or transdermal

• Progestogen only hormonal contraception associated with inhibition of ovulation, either oral, injectable, or implantable

• Intrauterine device IUD

• Intrauterine hormone-releasing system IUS

• Sexual abstinence

Acceptably effective contraceptive methods being:

• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action

• Male or female condom with or without spermicide

• Cap, diaphragm or sponge with spermicide

• A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) (CTFG, 2020)

• Fully healed criteria: no bleeding, no oozing, no broken skin, no obvious sign of infection, such as swelling or redness, around the scar.

4.1.2 Exclusion criteria

• lacking Mental Capacity to give Informed Consent

• people who self-declare that they are pregnant

• people who self-declare that they will be trying to become pregnant, during the 21 days they will be using a device

• impaired sensation as measured by hot/ cold test and sharp/ blunt test

• known allergy to acrylates***

• unable to read and speak English - the questionnaires being used have not been translated and validated in multiple languages and no facility is available to conduct nor translate/ back-translate semi-structured interview data

• epileptic

• active deep vein thrombosis, thrombophlebitis, or varicose veins

• fitted with a pacemaker or defibrillator (internal or external), implanted neurostimulator, programmable hydrocephalus shunt, cochlear implants, ECG monitors or infusion pumps.

• has a metal implant in the area to be stimulated

• any residual limb complications such as cellulitis, wounds, infections etc.

• Active regions of known or suspected malignancy

• Any actively bleeding tissue or to persons with untreated haemorrhagic disorders

• Participating in any research trial of any intervention hypothesised to affect PLP

• Any current or recent history of substance misuse, alcohol, or drug dependency

• Any person, otherwise eligible, who commences any non-pharmacological treatment for PLP during the study period

• Acrylates can be found in solvent adhesives such as super glue, artificial nail products, nail and eyelash adhesives, hair extensions, denture products and medical adhesives used for dressings, plasters. And body worn sensors (such as blood glucose monitors).

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

Device:
• Sensory retraining device
All participants will be given a device to keep at home and will be asked to use it for 60 minutes each day, as one block, or as multiple shorter sessions of 20 minutes minimum duration. Participants will be asked to use their device on 15 of the 21 days. They will be asked to spread out the use of the device over the 21 days. Participants are asked to record device use in a diary.

Locations

Country	Name	City	State
United Kingdom	Teesside University	Middlesbrough	Tees Valley

Sponsors (3)

Lead Sponsor	Collaborator
Teesside University	2PD Ltd, Royal Commission for the Exhibition of 1851

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The short form McGill Pain Questionnaire (SF-MPQ-2)	The short form McGill Pain Questionnaire (SF-MPQ-2) (Dworkin et al, 2009): The short from McGill Pain Questionnaire (SF-MPQ-2) is a commonly used questionnaire to assess pain levels in a range of pain conditions. Twenty words which describe pain across the sensory, affective, evaluative and miscellaneous domains are presented to the participant who is asked to choose which word best describes their pain in the last week and to rate how intense that descriptor of pain was on a 0-10 scale.	Day 1 (baseline prior to start) and Day 21 (end) of treatment period
Secondary	The short form McGill Pain Questionnaire (SF-MPQ-2)	The short form McGill Pain Questionnaire (SF-MPQ-2) (Dworkin et al, 2009): The short from McGill Pain Questionnaire (SF-MPQ-2) is a commonly used questionnaire to assess pain levels in a range of pain conditions. Twenty words which describe pain across the sensory, affective, evaluative and miscellaneous domains are presented to the participant who is asked to choose which word best describes their pain in the last week and to rate how intense that descriptor of pain was on a 0-10 scale.	3 month follow up point post end of treatment period
Secondary	Overall Pain: Visual Analogue Scale (100mm):	Participants will be asked to rate their phantom limb pain over the last week using a pain visual analogue scale consisting of a 100mm line with anchor statements of 0 representing no pain and 100 the worst pain imaginable. The participant will be asked to place a mark through the line to represent their pain. Participants will be asked to record the number of phantom limb pain episodes they have experienced over the past week.	Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Secondary	Frequency adjusted pain score: (0-100)	Participants will be asked to record the frequency of PLP episodes they have experienced over the past week from 1 = all the time to 5 = Once a day or less per week. The overall pain score will be divided by the frequency value to create a composite frequency adjusted pain score ranging from 0-100.	Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Secondary	Trinity Amputation and prosthetic evaluation scale (modified) (TAPES)	Participants will be asked to complete a modified version of the Trinity Amputation and prosthetics evaluation scale (TAPES scale).The TAPES has been modified in that it only asks about issues specific to PLP, residual limb (or stump) pain, and phantom sensations.	Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Secondary	EQ5D5L	A brief easy to use validated measure of quality of life. The EQ5D contains five items related to mobility, self-care, usual activities, pain and anxiety/depression. It also contains a visual analogue scale for rating general health.	DDay 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Secondary	Sleep Disturbance	Participants will be asked to complete the PROMIS Short Form v.1.0 - Sleep Disturbance 4a questionnaire. This is a self-reported questionnaire reporting perceptions of sleep quality, sleep depth, and restoration associated with sleep. It assesses sleep disturbance over the past seven days. There are four questions, each containing a 5-point Likert Scale, ranging from Very Poor to Very Good. The questions are then combined to create a score out of 100 (Gershan et al. 2010).	Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Secondary	Study Diary (medication use/device use/pain levels)	Participants will be asked to report on their daily medication usage over the duration of the trial in a study diary. The participant will be sent a daily notification by the SMART-TRIAL platform to remind them to complete the study diary for the three week treatment period. The diary will ask for the frequency, dosage and class of medication taken each day. In addition, patients will be asked to rate their phantom limb pain on a scale from 0-10 each day, the frequency of those pain episodes, and to record how many minutes they used the device each day.	Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Secondary	General Subjective Outcome Score (GSOS)	Participants will be asked to rate their level of improvement Choosing one of six options, ranging from "a lot worse" to "completely better" (Harland et al. 2015).	Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Secondary	Participant satisfaction	Six item rating scale. Participants will be asked to answer the question,; "How likely are you to recommend the device to other people who had phantom limb pain following an amputation?" by choosing one of six options, ranging from "extremely likely" to "extremely unlikely".	Day 21 (end) of treatment period and at 3 month follow up point post end of treatment
Secondary	Usability	After treatment, to investigate usability, all participants will be asked to rate how easy do you think the SensTrain was to use on a Visual Analogue Scale (VAS) (100mm) with 0 representing not at all easy to use and 100 representing extremely easy to use.	Day 21 (end) of treatment period
Secondary	Concordance with Protocol	The frequency and duration of use of the SP1X device will be documented in the daily study diary and compared against the protocol that participants were asked to adhere to. This data will also be automatically captured by the device.	Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period
Secondary	Participant perceptions of usability and acceptability of the device they received	Semi-structured interview.	At 3 month follow up point post end of treatment
Secondary	Credibility of Devices	Participants will be asked Which of the following four devices do you think you received? 1. A real interactive device, 2. A sham/placebo interactive device, 3. A real non-interactive device or 4. A sham/placebo non-interactive device? And then How confident are you that your device was (form inserts answer 1,2,3 or 4) on a 0-100 scale with 0 being not at all confident and 100 being completely confident?	At 3 month follow up point post end of treatment
Secondary	Adverse Events & Reactions	All Adverse & Reactions will be recorded and reported as required	Throughout Data Collection Period