Phantom Limb PainNCT02912975
A Clinical Trial of Mirror Treatment for Phantom Pain
A study testing Mirror treatment and Tactile treatment in people with Phantom Limb Pain and Complex Regional Pain Syndromes, run by Trauma Care Foundation, Norway at 1 site in Cambodia.
Trial summary
A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study will be conducted with a semi-crossover design using self-rated pain and function as the main result variables. Read more about this study
- Who is it for?
- Ages 16 months and olderHealthy volunteers can take part
- Conditions the study is for
- Phantom Limb Pain, Complex Regional Pain Syndromes
- What is being tested?
- Mirror treatment and Tactile treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCambodia
- Study dates
- Mar 2016to 15 Jul 2017
- 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 16 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Present age >16 years.
- Unilateral trans-tibial land mine amputation more than 12 months before entering the study.
- Suffering from phantom limb pain and/or CRPS-2.
Who cannot join
- Amputation stump anomalies that require surgical reconstructions such as chronic infections, neuroma or major soft tissue deformities.
- Chronic alcoholism or drug abuse.
- Loss or deformities of limbs other than the actual amputation.
- Mental and/or cognitive disorders making self-reporting unreliable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial of Mirror Treatment in the Management of Phantom and Residual Limb Pain in Patients With Trans-tibial Land Mine Amputations in Cambodia
A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study will be conducted with a semi-crossover design using self-rated pain and function as the main result variables.
Read the detailed description
The study will be conducted in two phases: Firstly, the effects of mirror treatment (M) versus tactile treatment (T) will be compared in an open, randomized, semi-cross-over case-control design study. The second phase includes the responders from the initial treatment (M or T), the duration of the initial treatment effect will be observed, and the effect of a second round of similar treatment will be registered.
Phase one: The study patients will be randomized for M or T treatment. The main outcome variables will be gathered before the initial randomization and after an initial treatment period of three weeks. Non-responders (NR) will be allocated for an immediate second three-weeks treatment period of combined treatment (M+T); the responders (R) of the M, T and M+T enter the second phase of the study. The M+T non-responders discontinue the study.
Phase two: The responders will be observed for a period of maximum three months. When symptoms of phantom limb pain and/or CRPS resume, the patients will undergo a second treatment period with the same treatment as during phase one. The duration of the second treatment period will be maximum three weeks, but each patient may decide to interrupt the treatment at an earlier stage if he finds the effect satisfactory. The main outcome indicators will be gathered at the start and the end of the second treatment period.
The study closes at the end of the second treatment period. For both study phases the treatment effects will be compared between the strata and also inside each stratum, using each patient as his own control.
- Conditions
- Phantom Limb Pain, Complex Regional Pain Syndromes
- Being tested
- Mirror treatment, Tactile treatment
- Medical subject headings
- Phantom Limb, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror treatmentOther
The mirror treatment: The patient sits on a chair, both knees in 90 degrees flexion, both lower limbs undressed, and places a mirror of 100 cm x 25 cm along the trans-tibial amputation stump so that the uninjured limb is reflected in the mirror while the amputation stump can not be seen by the patient. The patient then performs slow repeated movements of the foot from neutral position into maximum flexion while closely observing the reflected image of the uninjured limb - the illusion of a limb regained - in the mirror. The procedure goes on uninterrupted for five minutes in the morning and in the evening in the home of the study patient.
Tactile treatmentOther
In Tactile Treatment five different sensory stimuli is applied repeatedly to the skin of the affected part of the limb, in the actual case to the amputated limb from ten cm above the knee joint and distally to include the entire amputation stump: gentle touch with a feather, a brush, a piece of paper, a stone and a wooden stick. The stimuli are applied two times daily for five 5 minutes each time, one minute per material.
| Study group | Role | What they receive |
|---|---|---|
| Mirror treatment | Experimental | Five minutes treatment period twice a day for three weeks Receives: Other: Tactile treatment |
| Tactile treatment | Active comparator | Tactile massage twice a day for three weeks Receives: Other: Mirror treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phantom limb pain
Assessed by self-rating by each study patient
Measured: Change after three months as compared to preintervention level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completion15 Jul 2017
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trauma Care Foundation, Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, NCHADS - Ministry of Health of Cambodia
- Responsible party
- Principal investigator, Hans Husum, Trauma Care Foundation, Norway
- Investigators
- Snorre Sollied, MD, PhD, Study director, Department of Intensive Care, University Hospital North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912975
- Sponsor's protocol ID
- 975 905 055
- Status last verified
- Oct 2017
- First submitted
- 3 Jan 2016
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Mirror Treatment in the Management of Phantom and Residual Limb Pain in Patients With Trans-tibial Land Mine Amputations in Cambodia
- ClinicalTrials.gov ID
- NCT02912975
- Acronym / sponsor ID
- 975 905 055
- Conditions
- Phantom Limb Pain, Complex Regional Pain Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Trauma Care Foundation, NorwayUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, NCHADS - Ministry of Health of Cambodia
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 23 Sep 2016 (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.
A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study will be conducted with a semi-crossover design using self-rated pain and function as the main result variables.
Detailed description
The study will be conducted in two phases: Firstly, the effects of mirror treatment (M) versus tactile treatment (T) will be compared in an open, randomized, semi-cross-over case-control design study. The second phase includes the responders from the initial treatment (M or T), the duration of the initial treatment effect will be observed, and the effect of a second round of similar treatment will be registered.
Phase one: The study patients will be randomized for M or T treatment. The main outcome variables will be gathered before the initial randomization and after an initial treatment period of three weeks. Non-responders (NR) will be allocated for an immediate second three-weeks treatment period of combined treatment (M+T); the responders (R) of the M, T and M+T enter the second phase of the study. The M+T non-responders discontinue the study.
Phase two: The responders will be observed for a period of maximum three months. When symptoms of phantom limb pain and/or CRPS resume, the patients will undergo a second treatment period with the same treatment as during phase one. The duration of the second treatment period will be maximum three weeks, but each patient may decide to interrupt the treatment at an earlier stage if he finds the effect satisfactory. The main outcome indicators will be gathered at the start and the end of the second treatment period.
The study closes at the end of the second treatment period. For both study phases the treatment effects will be compared between the strata and also inside each stratum, using each patient as his own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror treatment | Experimental | Other: Tactile treatmentFive minutes treatment period twice a day for three weeks |
| Tactile treatment | Active comparator | Other: Mirror treatmentTactile massage twice a day for three weeks |
Who may qualify
- Ages
- 16 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Present age >16 years.
- Unilateral trans-tibial land mine amputation more than 12 months before entering the study.
- Suffering from phantom limb pain and/or CRPS-2.
Key exclusion criteria (4 listed)
- Amputation stump anomalies that require surgical reconstructions such as chronic infections, neuroma or major soft tissue deformities.
- Chronic alcoholism or drug abuse.
- Loss or deformities of limbs other than the actual amputation.
- Mental and/or cognitive disorders making self-reporting unreliable.
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 |
|---|---|---|
| Mirror treatmentThe mirror treatment: The patient sits on a chair, both knees in 90 degrees flexion, both lower limbs undressed, and places a mirror of 100 cm x 25 cm along the trans-tibial amputation stump so that the uninjured limb is reflected in the mirror while the amputation stump can not be seen by the patient. The patient then performs slow repeated movements of the foot from neutral position into maximum flexion while closely observing the reflected image of the uninjured limb - the illusion of a limb regained - in the mirror. The procedure goes on uninterrupted for five minutes in the morning and in the evening in the home of the study patient. | Other | Tactile treatment |
| Tactile treatmentIn Tactile Treatment five different sensory stimuli is applied repeatedly to the skin of the affected part of the limb, in the actual case to the amputated limb from ten cm above the knee joint and distally to include the entire amputation stump: gentle touch with a feather, a brush, a piece of paper, a stone and a wooden stick. The stimuli are applied two times daily for five 5 minutes each time, one minute per material. | Other | Mirror treatment |
Primary outcome
Phantom limb pain
Time frame: Change after three months as compared to preintervention level
Assessed by self-rating by each study patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
Related trials for Phantom Limb Pain
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Lower Limb Amputation
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
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.
Snorre Sollied, MD, PhD study director
Department of Intensive Care, University Hospital North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror treatment and Tactile treatment in people with Phantom Limb Pain and Complex Regional Pain Syndromes, run by Trauma Care Foundation, Norway at 1 site in Cambodia.
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: finished, as of the sponsor's last update on 18 Oct 2017. 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 Cambodia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phantom limb pain (time frame: Change after three months as compared to preintervention level). 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 18 Oct 2017.