Sensory Retraining for Phantom Limb Pain

NCT04103983 | Completed DMC

• 2 other identifiers: 2023 July 16692250337
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

• The short form McGill Pain Questionnaire (SF-MPQ-2)

  The primary outcome will be the total score of the McGill Pain Questionnaire revised (SF-MPQ-2)8 20 at the 3-week time point. The SF-MPQ-2 is a commonly used questionnaire to assess pain levels in a range of pain conditions. There are 22 items/ pain descriptors across 4 pain sub-scales/ domains: continuous, intermittent, neuropathic, and affective. Participants rate each item on an 11-point (0-10) scale, where 0 = none and 10 = worst possible pain. The mean of the 22 items provides the SF-MPQ-2 total score. Two or more missing responses on any sub-scale results in an invalid outcome. A targeted effect size of 1 unit difference between groups will be used.

  Day 1 (baseline prior to start) and Day 21 (end) of treatment period

Secondary Outcomes (12)

• 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

• 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

• General Subjective Outcome Score (GSOS)

  Day 21 (end) of treatment period and at 3 month follow up point post end of treatment

• The short form McGill Pain Questionnaire (SF-MPQ-2)

  3 month follow up point post end of treatment period

• 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

Study Arms (2)

Sensory Retraining Interactive Device

ACTIVE COMPARATOR

The interactive device is a sensory retraining device. A pad consisting of twelve equally spaced electrodes is placed over the residual limb. This pad is connected to a handheld device which delivers an electrical current to the electrodes. The type of electrical current is similar to a TENS device. The device stimulates the skin via one of the electrodes, with either a single, or a rapid burst of pulse(s). The device touch screen then presents the questions, Which electrode (location) was stimulated? Was a single continuous or a rapid burst of pulses given (stimulation type)? The user responds via the screen and is told if they are correct. If correct, a new stimulus is delivered (different location and type) and the process repeated. If incorrect, the user is informed of the correct response, the same stimulation (location and type) is repeated once before moving onto to a new stimulus.

Device: Sensory retraining device

Placebo Sensory Retraining Non-Interactive Device

PLACEBO COMPARATOR

The placebo non-interactive device is physically visually identical to the interactive device. This device delivers the stimulation using microcurrents that the participants may or may not feel. There is no interaction required with this device i.e. there is no Q\&A element, feedback nor response dependent progression.

Device: Sensory retraining device

Interventions

Sensory retraining device 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.

Placebo Sensory Retraining Non-Interactive Device; Sensory Retraining Interactive Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in the UK
• All Genders
• Aged ≥18 years of age
• Women who self-declare:
• that they are post-menopausal, or permanently sterile\*,
• \- or -
• that it is physiologically impossible that they could be pregnant and not be aware they are.
• Women who do not make one of the two declarations above, are only eligible if:
• they undertake a highly sensitive urine pregnancy test which is negative, prior (and as close in time as is possible) to beginning the treatment phase of the Trial,
• and -
• they agree to use a highly, or acceptably effective, contraceptive measure\*\* during the treatment phase of the Trial.
• 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 trial

You may not qualify if:

• lacking Mental Capacity to give Informed Consent
• women who self-declare that they are pregnant, or that they will be trying to become pregnant, during the treatment phase of the Trial\*
• impaired sensation as measured by hot/ cold test and sharp/ blunt test
• 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
• 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 trial period

Sponsors & Collaborators

• Teesside University: lead
• 2PD Ltd: collaborator
• Royal Commission for the Exhibition of 1851: collaborator

Study Sites (1)

Teesside University

Middlesbrough, Tees Valley, TS1 3BX, United Kingdom

Location

Related Publications (1)

• Oatway S, Martin D, Graham A, Batterham A, MacSween A, Smith S, Ravindran D, Ryan C. Efficacy of a novel sensory discrimination training device for the management of phantom limb pain: protocol for a randomised placebo-controlled trial. BMJ Open. 2025 Nov 9;15(11):e101657. doi: 10.1136/bmjopen-2025-101657.

  PMID: 41213687 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Cormac Ryan, Professor

  Teesside University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and statistician will be blinded to treatment allocation. Outcome measures will be self reported by the participants. The care provider will not be blind, as they are required to provide specific instructions for each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Manager

Model Details: Randomised, single blind, controlled, mixed-methods study.

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 26, 2019
• Study Start: February 9, 2024
• Primary Completion: May 18, 2025
• Study Completion: July 18, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)