Sensory Retraining for Phantom Limb Pain

Not Applicable

Recruiting

• Conditions: Phantom Limb Pain

• Registration Number: NCT04103983
• Lead Sponsor: Teesside University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-26
• Study Start: 2024-02-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-05-18
• Study Completion: 2025-07-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The short form McGill Pain Questionnaire (SF-MPQ-2)	Day 1 (baseline prior to start) and Day 21 (end) of treatment period	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.

Secondary Outcome Measures

Name	Time	Method
Usability	Day 21 (end) of treatment period	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.
Frequency adjusted pain score: (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	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.
Trinity Amputation and prosthetic evaluation scale (modified) (TAPES)	Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment	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.
Sleep Disturbance	Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment	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).
The short form McGill Pain Questionnaire (SF-MPQ-2)	3 month follow up point post end of treatment period	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.
Overall Pain: Visual Analogue Scale (100mm):	Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment	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.
Concordance with Protocol	Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period	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.
EQ5D5L	DDay 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment	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.
General Subjective Outcome Score (GSOS)	Day 21 (end) of treatment period and at 3 month follow up point post end of treatment	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).
Study Diary (medication use/device use/pain levels)	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	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.
Participant satisfaction	Day 21 (end) of treatment period and at 3 month follow up point post end of treatment	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".
Participant perceptions of usability and acceptability of the device they received	At 3 month follow up point post end of treatment	Semi-structured interview.
Credibility of Devices	At 3 month follow up point post end of treatment	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?
Adverse Events & Reactions	Throughout Data Collection Period	All Adverse \& Reactions will be recorded and reported as required

Trial Locations

Locations (1)

Teesside University; 🇬🇧 Middlesbrough, Tees Valley, United Kingdom