Phantom Limb PainPPSSNCT01913899
Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
A study testing Occupational/ physical therapy and Mirror therapy in people with Phantom Limb Pain, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The aim of the study is the measurement of the short term effect of post surgical mirror therapy concerning pain intensity and frequency of patients with upper or lower amputation in comparison to standard occupational or physical therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Occupational/ physical therapy and Mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- major amputation of lower and upper body
- phantom pain, or pain attacks in combination with a treatment wish
- age of 18 years
- signed informed consent
- linguistic and cognitive comprehension
Who cannot join
- bilateral amputation
- major neurologic comorbidities (stroke, Parkinson disease)
- morbidities of the contralateral side with functional limitations
- experience with long term standardised mirror therapy
- internal comorbidities (pAVK)
- psychological comorbidities
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
Bochum, North Rhine-Westphalia, 44789
Andreas Schwarzer, Dr. Dr., 0049-234-3023430, andreas.schwarzer@rub.de
About this study
The aim of the study is the measurement of the short term effect of post surgical mirror therapy concerning pain intensity and frequency of patients with upper or lower amputation in comparison to standard occupational or physical therapy. The hypothesis is that patients in the intervention group (mirror therapy) suffer significantly less from phantom limb pain and pain attacks within a follow-up period of 4-8 weeks.
Read the detailed description
Aim:
- Measurement of the short term effect of post surgical/ post-operative mirror therapy concerning pain intensity of patients with upper or lower amputation in comparison to standard occupational/ physical therapy
- Hypothesis: patients in the intervention group (mirror therapy) suffer from significant less phantom limb pain and a lower pain frequency within a follow-up period of 4-8 weeks
Methods:
- Design: multicenter, prospective, randomized controlled trial
- Participants: 70, 35 per intervention and con-trol group
- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)
- Control group: receive treatment session of 60 minutes with the same treatment frequency over a period of 14 days
- Measurement tools:
Primary objectives
- pain intensity (11 point NRS, phantom limb in-tensity)
- pain frequency (amount of pain attacks) Secondary objectives
- diary
- daily assessment of mirror and physical thera-py sessions
- analysis:
- in significant differences between the groups a covariance analysis will be performed
- comparison of medians
- Conditions
- Phantom Limb Pain
- Being tested
- Occupational/ physical therapy, Mirror therapy
- Keywords
- phantom limb pain, mirror therapy, amputees, phantom limb, occupational therapy
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational/ physical therapyOther
Mirror therapyOther
- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy | Experimental | 60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery) Receives: Other: Occupational/ physical therapy; Other: Mirror therapy |
| Occupational/ physical therapy | Active comparator | 60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically Receives: Other: Occupational/ physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current pain intensity
Current Pain intensity assessed by the Numeric Rating Scale (0-10)
Measured: after 14 treatment sessions
Secondary outcomes (1)
Frequence of pain attacks
Total number of phantom limb pain attacks per day is documented
Measured: after 14 treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Gesetzliche Unfallversicherung (DGUV)
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Christoph Maier, Prof. Dr., Principal investigator, Ruhr University BochumAndreas Schwarzer, Dr. Dr., Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913899
- Sponsor's protocol ID
- 4318-12
- Acronym
- PPSS
- Status last verified
- Apr 2012
- First submitted
- 30 Jul 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT01913899
- Acronym / sponsor ID
- PPSS / 4318-12
- Conditions
- Phantom Limb Pain
- Keywords
- phantom limb pain, mirror therapy, amputees, phantom limb, occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Deutsche Gesetzliche Unfallversicherung (DGUV)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- 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.
The aim of the study is the measurement of the short term effect of post surgical mirror therapy concerning pain intensity and frequency of patients with upper or lower amputation in comparison to standard occupational or physical therapy. The hypothesis is that patients in the intervention group (mirror therapy) suffer significantly less from phantom limb pain and pain attacks within a follow-up period of 4-8 weeks.
Detailed description
Aim:
- Measurement of the short term effect of post surgical/ post-operative mirror therapy concerning pain intensity of patients with upper or lower amputation in comparison to standard occupational/ physical therapy
- Hypothesis: patients in the intervention group (mirror therapy) suffer from significant less phantom limb pain and a lower pain frequency within a follow-up period of 4-8 weeks
Methods:
- Design: multicenter, prospective, randomized controlled trial
- Participants: 70, 35 per intervention and con-trol group
- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)
- Control group: receive treatment session of 60 minutes with the same treatment frequency over a period of 14 days
- Measurement tools:
Primary objectives
- pain intensity (11 point NRS, phantom limb in-tensity)
- pain frequency (amount of pain attacks) Secondary objectives
- diary
- daily assessment of mirror and physical thera-py sessions
- analysis:
- in significant differences between the groups a covariance analysis will be performed
- comparison of medians
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy | Experimental | Other: Occupational/ physical therapy, Other: Mirror therapy60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery) |
| Occupational/ physical therapy | Active comparator | Other: Occupational/ physical therapy60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- major amputation of lower and upper body
- phantom pain, or pain attacks in combination with a treatment wish
- age of 18 years
- signed informed consent
- linguistic and cognitive comprehension
Key exclusion criteria (6 listed)
- bilateral amputation
- major neurologic comorbidities (stroke, Parkinson disease)
- morbidities of the contralateral side with functional limitations
- experience with long term standardised mirror therapy
- internal comorbidities (pAVK)
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 |
|---|---|---|
| Occupational/ physical therapy | Other | Mirror therapy, Occupational/ physical therapy |
| Mirror therapy- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours) | Other | Mirror therapy |
Primary outcome
Current pain intensity
Time frame: after 14 treatment sessions
Current Pain intensity assessed by the Numeric Rating Scale (0-10)
1 secondary outcome
Frequence of pain attacks
Time frame: after 14 treatment sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
- Deutsche Gesetzliche UnfallversicherungLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Christoph Maier, Prof. Dr. principal investigator
Ruhr University Bochum
Andreas Schwarzer, Dr. Dr. principal investigator
Ruhr University of Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational/ physical therapy and Mirror therapy in people with Phantom Limb Pain, run by Ruhr University of Bochum 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 6 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: status not confirmed, as of the sponsor's last update on 1 Aug 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Schwarzer, Dr. Dr. (0049-234-3023430, andreas.schwarzer@rub.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current pain intensity (time frame: after 14 treatment sessions). 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 1 Aug 2013.