Phantom Limb Pain After AmputationNCT07324109
Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
A study testing Vibrotactile sensory feedback in people with Phantom Limb Pain After Amputation and Lower Limb Amputation Above Knee, run by Median at 1 site in Germany.
Trial summary
This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks. Participants wear the device daily and report pain levels, walking ability, and quality of life - with no known risks, as it's a CE-certified medical device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain After Amputation, Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
- What is being tested?
- Vibrotactile sensory feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral major lower-limb amputation (transtibial or transfemoral)
- Presence of persistent phantom limb pain, defined as daily pain intensity ≥ 3/10 on the Visual Analog Scale (VAS) during the baseline period
- Regular daily use of a prosthetic limb (minimum 4 hours/day)
- Adequate German language proficiency to understand and complete study questionnaires and follow study procedures
- Ability to provide informed consent
Who cannot join
- Unstable wound or skin condition at the residual limb
- Inconsistent prosthetic use (less than daily or < 4 hours/day)
- Poorly fitting or non-functional prosthesis (as determined by study team)
- Incapacity to provide informed consent (e.g., due to cognitive impairment or severe psychiatric illness)
- Insufficient German language skills to comprehend study materials or complete assessments reliably
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
MEDIAN Rehab Center Wiesbaden Sonnenberg
Wiesbaden, Hesse, 65191
Johannes Schroeter, Dr. med., +49 611 575 811, johannes.schroeter@median-kliniken.de
About this study
Official title: Clinical Application Observation: Evaluation of Phantom Limb Pain After 3 Weeks of Use of a Feedback System Using Vibration (Suralis, Manufacturer: Saphenus)
This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks. Participants wear the device daily and report pain levels, walking ability, and quality of life - with no known risks, as it's a CE-certified medical device. If pain improves, the study team will help participants apply for insurance coverage to keep using the system long-term. The goal is to offer a simple, non-drug option that may help ease chronic pain and improve daily function for amputees. Participation is voluntary and can be stopped anytime without affecting medical care.
Read the detailed description
This observational, prospective, single-arm pilot study evaluates the short-term effects of the Suralis vibrotactile feedback system (Saphenus Medical Technology GmbH) on phantom limb pain intensity, gait stability, and perceived quality of life in individuals with unilateral lower-limb amputation. The Suralis system consists of a sensorized insole with four pressure-sensitive zones (toe, forefoot, midfoot, heel), each mapped to a corresponding vibrotactile actuator embedded in a thigh-mounted cuff. Vibration parameters - including onset threshold, intensity (0-100 % amplitude), duration (50-500 ms), and spatial mapping - are individually calibrated via a proprietary iOS/Android app, allowing for personalized somatosensory substitution. The system operates autonomously during ambulation.
The study protocol includes a 3-week baseline phase to confirm persistent phantom pain (VAS ≥ 3/10 daily), followed by 3 weeks of active intervention, and a 3-week washout/follow-up phase to assess sustainability of effects. All assessments are conducted at the study center and include standardized functional tests (TUG, 6MWT), validated German-language questionnaires (DSF, VR-12, DASS, FW7, GCPS), and daily VAS entries captured via paper-based diaries. The system's CE-marked status (UDI: FBS 1 912012142) confirms conformity with EU MDR 2017/746 for Class IIa medical devices; no adverse events related to device use have been reported in prior clinical use. The study design incorporates no control group or randomization, reflecting its exploratory, real-world application focus. Statistical analysis will be descriptive and exploratory, with non-parametric methods applied to ordinal outcomes (Friedman test) and parametric or non-parametric repeated-measures analyses for continuous variables, depending on distribution. No blinding is feasible due to the nature of the intervention. All procedures comply with the Declaration of Helsinki and have been reviewed by the Ethics Committee of the Hessian Medical Association (approval pending).
- Conditions
- Phantom Limb Pain After Amputation, Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee, Lower Limb Amputation Knee
- Being tested
- Vibrotactile sensory feedback
- Keywords
- Phantom limb pain, Vibrotactile feedback, Lower limb amputation, Suralis system, Pain management
- Medical subject headings
- Phantom Limb, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile sensory feedbackDevice
The Suralis system delivers real-time vibrotactile feedback via four pressure sensors embedded in a prosthetic insole, each mapped to a corresponding vibration motor on a thigh cuff. Participants wear the device during daily ambulation for 3 weeks. Vibration parameters (threshold, intensity, duration, spatial mapping) are individually calibrated via a smartphone app to match each user's sensory perception and gait pattern. The system operates autonomously, requires daily charging, and logs usage data via Bluetooth. No additional therapy or medication is administered alongside the device. The intervention aims to modulate cortical reorganization and reduce phantom limb pain while improving gait confidence and safety, particularly under non-visual conditions (e.g., stepping backward or sideways). The device is CE-marked (UDI: FBS 1 912012142) and classified as a Class IIa medical device under EU MDR 2017/746.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with Suralis System | Experimental | All participants receive a 3-week intervention with the Suralis vibrotactile feedback system, which provides real-time pressure-based sensory feedback via a sensorized insole and thigh-mounted vibrating cuff, calibrated individually via smartphone app to support pain reduction and gait stability. Receives: Device: Vibrotactile sensory feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Scores range from 0 to 100 mm, where 0 mm = "no phantom pain" and 100 mm = "worst imaginable phantom pain"; higher scores indicate greater pain intensity.
Measured: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - assessed via daily VAS entries averaged per time point.
Secondary outcomes (3)
German Pain Questionnaire DSF - subscales
A validated, German-language questionnaire that captures pain intensity, quality, chronicity (GCPS), well-being (FW7), psychological status (DASS) and health-related quality of life (VR-12).
Measured: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - completed in person at study center.
Timed Up-and-Go (TUG) test
Measures dynamic balance and fall risk by timing how long a person rises from a chair, walks 3 m, turns, returns and sits down.
Measured: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - performed once per visit at study center.
6-Minute Walk Test (6MWT)
Assesses ambulatory endurance by recording the total distance walked (meters) in six minutes on a 12-m circuit.
Measured: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - performed once per visit at study center; distance in meters recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Apr 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb Pain After AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Median
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Schroeter, Median
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324109
- Sponsor's protocol ID
- PhantomLimbPain
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Observation: Evaluation of Phantom Limb Pain After 3 Weeks of Use of a Feedback System Using Vibration (Suralis, Manufacturer: Saphenus)
- ClinicalTrials.gov ID
- NCT07324109
- Acronym / sponsor ID
- PhantomLimbPain
- Conditions
- Phantom Limb Pain After Amputation, Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee, Lower Limb Amputation Knee
- Keywords
- Phantom limb pain, Vibrotactile feedback, Lower limb amputation, Suralis system, Pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MedianUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks. Participants wear the device daily and report pain levels, walking ability, and quality of life - with no known risks, as it's a CE-certified medical device. If pain improves, the study team will help participants apply for insurance coverage to keep using the system long-term. The goal is to offer a simple, non-drug option that may help ease chronic pain and improve daily function for amputees. Participation is voluntary and can be stopped anytime without affecting medical care.
Detailed description
This observational, prospective, single-arm pilot study evaluates the short-term effects of the Suralis vibrotactile feedback system (Saphenus Medical Technology GmbH) on phantom limb pain intensity, gait stability, and perceived quality of life in individuals with unilateral lower-limb amputation. The Suralis system consists of a sensorized insole with four pressure-sensitive zones (toe, forefoot, midfoot, heel), each mapped to a corresponding vibrotactile actuator embedded in a thigh-mounted cuff. Vibration parameters - including onset threshold, intensity (0-100 % amplitude), duration (50-500 ms), and spatial mapping - are individually calibrated via a proprietary iOS/Android app, allowing for personalized somatosensory substitution. The system operates autonomously during ambulation.
The study protocol includes a 3-week baseline phase to confirm persistent phantom pain (VAS ≥ 3/10 daily), followed by 3 weeks of active intervention, and a 3-week washout/follow-up phase to assess sustainability of effects. All assessments are conducted at the study center and include standardized functional tests (TUG, 6MWT), validated German-language questionnaires (DSF, VR-12, DASS, FW7, GCPS), and daily VAS entries captured via paper-based diaries. The system's CE-marked status (UDI: FBS 1 912012142) confirms conformity with EU MDR 2017/746 for Class IIa medical devices; no adverse events related to device use have been reported in prior clinical use. The study design incorporates no control group or randomization, reflecting its exploratory, real-world application focus. Statistical analysis will be descriptive and exploratory, with non-parametric methods applied to ordinal outcomes (Friedman test) and parametric or non-parametric repeated-measures analyses for continuous variables, depending on distribution. No blinding is feasible due to the nature of the intervention. All procedures comply with the Declaration of Helsinki and have been reviewed by the Ethics Committee of the Hessian Medical Association (approval pending).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with Suralis System | Experimental | Device: Vibrotactile sensory feedbackAll participants receive a 3-week intervention with the Suralis vibrotactile feedback system, which provides real-time pressure-based sensory feedback via a sensorized insole and thigh-mounted vibrating cuff, calibrated individually via smartphone app to support pain reduction and gait stability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral major lower-limb amputation (transtibial or transfemoral)
- Presence of persistent phantom limb pain, defined as daily pain intensity ≥ 3/10 on the Visual Analog Scale (VAS) during the baseline period
- Regular daily use of a prosthetic limb (minimum 4 hours/day)
- Adequate German language proficiency to understand and complete study questionnaires and follow study procedures
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Unstable wound or skin condition at the residual limb
- Inconsistent prosthetic use (less than daily or < 4 hours/day)
- Poorly fitting or non-functional prosthesis (as determined by study team)
- Incapacity to provide informed consent (e.g., due to cognitive impairment or severe psychiatric illness)
- Insufficient German language skills to comprehend study materials or complete assessments reliably
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrotactile sensory feedbackThe Suralis system delivers real-time vibrotactile feedback via four pressure sensors embedded in a prosthetic insole, each mapped to a corresponding vibration motor on a thigh cuff. Participants wear the device during daily ambulation for 3 weeks. Vibration parameters (threshold, intensity, duration, spatial mapping) are individually calibrated via a smartphone app to match each user's sensory perception and gait pattern. The system operates autonomously, requires daily charging, and logs usage data via Bluetooth. No additional therapy or medication is administered alongside the device. The intervention aims to modulate cortical reorganization and reduce phantom limb pain while improving gait confidence and safety, particularly under non-visual conditions (e.g., stepping backward or sideways). The device is CE-marked (UDI: FBS 1 912012142) and classified as a Class IIa medical device under EU MDR 2017/746. | Device | Intervention with Suralis System |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - assessed via daily VAS entries averaged per time point.
Scores range from 0 to 100 mm, where 0 mm = "no phantom pain" and 100 mm = "worst imaginable phantom pain"; higher scores indicate greater pain intensity.
3 secondary outcomes
German Pain Questionnaire DSF - subscales
Time frame: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - completed in person at study center.
Timed Up-and-Go (TUG) test
Time frame: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - performed once per visit at study center.
6-Minute Walk Test (6MWT)
Time frame: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - performed once per visit at study center; distance in meters recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile sensory feedback in people with Phantom Limb Pain After Amputation and Lower Limb Amputation Above Knee, run by Median at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Schroeter, Dr. med. (+49 611 575 811, johannes.schroeter@median-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - assessed via daily VAS entries averaged per time point.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.