Phantom Limb PainNCT02076490
Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.
A study testing Physical/Occupational therapy in people with Phantom Limb Pain, run by Zuyd University of Applied Sciences.
Trial summary
The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Physical/Occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower limb amputation
- At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week.
- Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists.
Who cannot join
- Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
- Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study.
- Severe psychiatric disorders that preclude patients from participating in the trial.
- Intensive course of mirror therapy in the past (> 6 treatments during the last three months).
About this study
Official title: The PACT Trial - PAtient Centered Telerehabilitation: Effectiveness of Software-supported and Traditional Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation: Design of a Randomized Controlled Trial.
The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.
Read the detailed description
Up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. The treatment of phantom limb pain is still challenging. Despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. Alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. In this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients.
In the developmental phase of the project, a user-centred design is applied. Patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. Additionally, two focus groups with each five participants will be conducted. Subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. This prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. Accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.
- Conditions
- Phantom Limb Pain
- Being tested
- Physical/Occupational therapy
- Keywords
- Telerehabilitation, mirror therapy, phantom limb pain
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical/Occupational therapyOther
At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
| Study group | Role | What they receive |
|---|---|---|
| Software Supported Mirror Therapy | Experimental | First experimental condition Physical/Occupational Therapy Receives: Other: Physical/Occupational therapy |
| Traditional mirror therapy | Experimental | Second experimental condition Physical/Occupational Therapy Receives: Other: Physical/Occupational therapy |
| Sensomotor exercises without mirror | Active comparator | Control condition Physical/Occupational Therapy Receives: Other: Physical/Occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average intensity of phantom limb pain
Measurement instrument: 11-point NRS
Measured: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in frequency of phantom limb pain
Measured: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in duration of phantom limb pain
Measured: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Secondary outcomes (5)
Change in pain related limitations in daily activities
Measurement instrument: PDI, PSFS
Measured: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in pain specific self-efficacy
Measurement instrument: Pain specific self-efficacy scale
Measured: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in quality of life
Measurement instrument: EQ-5D-5L
Measured: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in global perceived effect
Measurement instrument: GPE scale
Measured: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in dimensions of phantom limb pain
Measurement instrument: Neuropathic Pain Symptom Inventory (NPSI)
Measured: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyd University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Rob J Smeets, Prof., Dr., Study director, Research School CAPHRI, Maastricht University, Maastricht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076490
- Sponsor's protocol ID
- 005-GW02-035
- Status last verified
- Feb 2014
- First submitted
- 3 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rothgangel AS, Braun S, Schulz RJ, Kraemer M, de Witte L, Beurskens A, Smeets RJ. The PACT trial: PAtient Centered Telerehabilitation: effectiveness of software-supported and traditional mirror therapy in patients with phantom limb pain following lower limb amputation: protocol of a multicentre randomised controlled trial. J Physiother. 2015 Jan;61(1):42; discussion 42. doi: 10.1016/j.jphys.2014.08.006. Epub 2014 Oct 16.
PubMed 25439709
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PACT Trial - PAtient Centered Telerehabilitation: Effectiveness of Software-supported and Traditional Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation: Design of a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02076490
- Acronym / sponsor ID
- 005-GW02-035
- Conditions
- Phantom Limb Pain
- Keywords
- Telerehabilitation, mirror therapy, phantom limb pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Zuyd University of Applied SciencesUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Mar 2014 (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 overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.
Detailed description
Up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. The treatment of phantom limb pain is still challenging. Despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. Alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. In this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients.
In the developmental phase of the project, a user-centred design is applied. Patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. Additionally, two focus groups with each five participants will be conducted. Subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. This prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. Accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Software Supported Mirror Therapy | Experimental | Other: Physical/Occupational therapyFirst experimental condition Physical/Occupational Therapy |
| Traditional mirror therapy | Experimental | Other: Physical/Occupational therapySecond experimental condition Physical/Occupational Therapy |
| Sensomotor exercises without mirror | Active comparator | Other: Physical/Occupational therapyControl condition Physical/Occupational Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lower limb amputation
- At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week.
- Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists.
Key exclusion criteria (4 listed)
- Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
- Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study.
- Severe psychiatric disorders that preclude patients from participating in the trial.
- Intensive course of mirror therapy in the past (> 6 treatments during the last three months).
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 |
|---|---|---|
| Physical/Occupational therapyAt least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase. | Other | Sensomotor exercises without mirror, Software Supported Mirror Therapy, Traditional mirror therapy |
Primary outcome
Change in average intensity of phantom limb pain
Time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Measurement instrument: 11-point NRS
Change in frequency of phantom limb pain
Time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in duration of phantom limb pain
Time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
5 secondary outcomes
Change in pain related limitations in daily activities
Time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in pain specific self-efficacy
Time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in quality of life
Time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in global perceived effect
Time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in dimensions of phantom limb pain
Time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Derived from this study: PubMed 25439709Rothgangel AS, Braun S, Schulz RJ, Kraemer M, de Witte L, Beurskens A, Smeets RJ. The PACT trial: PAtient Centered Telerehabilitation: effectiveness of software-supported and traditional mirror therapy in patients with phantom limb pain following lower limb amputation: protocol of a multicentre randomised controlled trial. J Physiother. 2015 Jan;61(1):42; discussion 42. doi: 10.1016/j.jphys.2014.08.006. Epub 2014 Oct 16.
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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.
Rob J Smeets, Prof., Dr. study director
Research School CAPHRI, Maastricht University, Maastricht, The Netherlands
Questions about this trial
What is this clinical trial studying?
A study testing Physical/Occupational therapy in people with Phantom Limb Pain, run by Zuyd University of Applied Sciences.
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 3 inclusion and 4 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 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average intensity of phantom limb pain (time frame: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02076490, which also lists 1 linked publication.
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 3 Mar 2014.