AmputeesNCT02761447
Effectivity of Motor Imagery and MirrorTherapy in Amputees
A study testing Treatment Traditional and Imaginary Motor Program and Treatment Traditional and Mirror Therapy in people with Amputees, run by Universidad de Almeria at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of imagery motor on phantom pain and amputation process Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputees
- What is being tested?
- Treatment Traditional and Imaginary Motor Program and Treatment Traditional and Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Oct 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain in the stump area ≥ 3 months, no intermittent
- Have three months elapsed amputation,
- Submit subjective sensation of phantom limb not blinking
Who cannot join
- Clinical signs of radiculopathy.
- Lumbar stenosis, fibromyalgia, spondylolisthesis.
- History of spinal surgery.
- Corticosteroid therapy in the past two weeks.
- Disease of the central nervous system or peripheral.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectivity of Differences Therapies on Central Nerve System for Pain, Phantom, Disability and Quality of Life in Amputees
This study evaluates the effectiveness of imagery motor on phantom pain and amputation process
Read the detailed description
The expected increase in the number of amputations in the coming decades requires special attention to the common effect after called phantom limb amputation. That term refers to the phenomena covering the sensations that occur in the affected limb and whose prevalence rate is an important part of amputees subjects. Developed theories about their origin focus their attention on the central nervous system and the peripheral nervous system. Thus, the imaginary movement is a complex cognitive, sensory and proprioceptive process leading to a mental representation of movement and it is a widely used technique in neurological rehabilitation and complex pain syndrome.
- Conditions
- Amputees
- Being tested
- Treatment Traditional and Imaginary Motor Program, Treatment Traditional and Mirror Therapy
- Keywords
- Motor control Laterality, Pain Perception, Lower Extremity, Complementary Therapies, Physical Therapy Modalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Traditional and Imaginary Motor ProgramOther
Amputees patients also conservative protocol will undergo physiotherapy techniques work Imaginary Motor. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases: a) relaxation of Benson, b) phase external imagination where cycles of normal running on a video provided by the physiotherapist, c) phase internal imagination where the patient will identify the problem discussed compared with the normal course presented in the video, d) recreation of images in the first person made an e normalized locomotion) closing his eyes, prompted the patient to mentally recreate sequences normal gait and analyzed and subsequently verbalize differences of these with respect to their own way of getting around.
Treatment Traditional and Mirror TherapyOther
Amputees patients also conservative protocol will undergo physiotherapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Traditional and Motor Imaginary Program | Experimental | Amputees patients also conservative protocol will undergo physiotherapy techniques work Motor Imaginary Program, based on a system of two videos that allow the patient to recreate the "normal" way. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases. This protocol will be applied 3 days a week (25-30minutos) for one month. Receives: Other: Treatment Traditional and Imaginary Motor Program |
| Treatment Traditional and Mirror Therapy | Active comparator | Amputees patients also conservative protocol will undergo physical therapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation. Receives: Other: Treatment Traditional and Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Measured: Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months
Secondary outcomes (14)
McGiII Pain Questionnaire (MPQ)
Measured: Changes from Baseline McGiII Pain Questionnaire at one month. Changes from Baseline McGiII Pain Questionnaire at three months
The Vividness of Visual Imagery Questionnaire
Measured: Changes from Baseline Vividness of Visual Imagery Questionnaire at one month and three months
Beck Depression Inventory
Measured: Changes from Baseline Beck Depression Inventory at one month. Changes from Baseline Beck Depression Inventory at three months
Neuropathic Pain Questionnaire (DN4)
Measured: Changes from Baseline Neuropathic Pain Questionnaire at one month. Changes from Baseline Neuropathic Pain Questionnaire at three months
Pressure Algometer (kg/cm2)
Pressure algometer in lumbar pain, amputated limb and health limb
Measured: Changes from Baseline Pressure Algometer at one month. Changes from Baseline Pressure Algometer at three months
West-Haven-Yale Multidimensional Pain Inventory
Measured: Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at one month. Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at three months
The Barthel Index of ADLs
Measured: Changes from Baseline Barthel Index of ADLs at one month. Changes from Baseline Barthel Index of ADLs at three months
Instrumental Activities of Daily Living Scale (IADL)
Measured: Changes from Baseline Instrumental Activities of Daily Living Scale at one month. Changes from Baseline Instrumental Activities of Daily Living Scale at three months
The Functional Independence Measure Scale (FIM)
Measured: Changes from Baseline Functional Independence Measure Scale at one month. Changes from Baseline Functional Independence Measure Scale at three months
Quality of Life Questionnaire scoring (SF36)
Measured: Changes from Baseline Quality of Life Questionnaire Scoring at one month. Changes from Baseline Quality of Life Questionnaire Scoring at three months
Multidimensional Body Self Relations Questionnaire (MBSRQ)
Measured: Changes from Baseline Multidimensional Body Self Relations Questionnaire at one month. Changes from Baseline Multidimensional Body Self Relations Questionnaire at three months
Tampa Scale for Kinesiophobia (TSK)
Measured: Changes from Baseline Tampa Scale for Kinesiophobia at one month. Changes from Baseline Tampa Scale for Kinesiophobia at three months
Pain Catastrophizing Scale (PCS)
Measured: Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months
Pain Management Inventory
Measured: Changes from Baseline Pain Management Inventory at one month. Changes from Baseline Pain Management Inventory at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for AmputeesStudies 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
- Investigators
- Adelaida María Castro-Sánchez, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761447
- Sponsor's protocol ID
- CEI15_25
- Status last verified
- Oct 2019
- First submitted
- 21 Apr 2016
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
PubMed 18295618Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005 Oct;86(10):1910-9. doi: 10.1016/j.apmr.2005.03.031.
PubMed 16213230Raichle KA, Hanley MA, Molton I, Kadel NJ, Campbell K, Phelps E, Ehde D, Smith DG. Prosthesis use in persons with lower- and upper-limb amputation. J Rehabil Res Dev. 2008;45(7):961-72. doi: 10.1682/jrrd.2007.09.0151.
PubMed 19165686Foell J, Bekrater-Bodmann R, Flor H, Cole J. Phantom limb pain after lower limb trauma: origins and treatments. Int J Low Extrem Wounds. 2011 Dec;10(4):224-35. doi: 10.1177/1534734611428730.
PubMed 22184752Seidel S, Kasprian G, Furtner J, Schopf V, Essmeister M, Sycha T, Auff E, Prayer D. Mirror therapy in lower limb amputees--a look beyond primary motor cortex reorganization. Rofo. 2011 Nov;183(11):1051-7. doi: 10.1055/s-0031-1281768. Epub 2011 Sep 28.
PubMed 21959885Flor H. Maladaptive plasticity, memory for pain and phantom limb pain: review and suggestions for new therapies. Expert Rev Neurother. 2008 May;8(5):809-18. doi: 10.1586/14737175.8.5.809.
PubMed 18457537Bosmans JC, Geertzen JH, Post WJ, van der Schans CP, Dijkstra PU. Factors associated with phantom limb pain: a 31/2-year prospective study. Clin Rehabil. 2010 May;24(5):444-53. doi: 10.1177/0269215509360645.
PubMed 20442256Priganc VW, Stralka SW. Graded motor imagery. J Hand Ther. 2011 Apr-Jun;24(2):164-8; quiz 169. doi: 10.1016/j.jht.2010.11.002. Epub 2011 Feb 9.
PubMed 21306870Janig W, Baron R. Complex regional pain syndrome: mystery explained? Lancet Neurol. 2003 Nov;2(11):687-97. doi: 10.1016/s1474-4422(03)00557-x.
PubMed 14572737McCabe CS, Haigh RC, Ring EF, Halligan PW, Wall PD, Blake DR. A controlled pilot study of the utility of mirror visual feedback in the treatment of complex regional pain syndrome (type 1). Rheumatology (Oxford). 2003 Jan;42(1):97-101. doi: 10.1093/rheumatology/keg041.
PubMed 12509620Pleger B, Tegenthoff M, Ragert P, Forster AF, Dinse HR, Schwenkreis P, Nicolas V, Maier C. Sensorimotor retuning [corrected] in complex regional pain syndrome parallels pain reduction. Ann Neurol. 2005 Mar;57(3):425-9. doi: 10.1002/ana.20394.
PubMed 15732114Maihofner C, Handwerker HO, Neundorfer B, Birklein F. Patterns of cortical reorganization in complex regional pain syndrome. Neurology. 2003 Dec 23;61(12):1707-15. doi: 10.1212/01.wnl.0000098939.02752.8e.
PubMed 14694034Mercier C, Sirigu A. Training with virtual visual feedback to alleviate phantom limb pain. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):587-94. doi: 10.1177/1545968308328717. Epub 2009 Jan 26.
PubMed 19171946Dickstein R, Deutsch JE. Motor imagery in physical therapist practice. Phys Ther. 2007 Jul;87(7):942-53. doi: 10.2522/ptj.20060331. Epub 2007 May 1.
PubMed 17472948Berthelot JM. Current management of reflex sympathetic dystrophy syndrome (complex regional pain syndrome type I). Joint Bone Spine. 2006 Oct;73(5):495-9. doi: 10.1016/j.jbspin.2005.11.022. Epub 2006 Jun 30.
PubMed 16837228
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Differences Therapies on Central Nerve System for Pain, Phantom, Disability and Quality of Life in Amputees
- ClinicalTrials.gov ID
- NCT02761447
- Acronym / sponsor ID
- CEI15_25
- Conditions
- Amputees
- Keywords
- Motor control Laterality, Pain Perception, Lower Extremity, Complementary Therapies, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 4 May 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.
This study evaluates the effectiveness of imagery motor on phantom pain and amputation process
Detailed description
The expected increase in the number of amputations in the coming decades requires special attention to the common effect after called phantom limb amputation. That term refers to the phenomena covering the sensations that occur in the affected limb and whose prevalence rate is an important part of amputees subjects. Developed theories about their origin focus their attention on the central nervous system and the peripheral nervous system. Thus, the imaginary movement is a complex cognitive, sensory and proprioceptive process leading to a mental representation of movement and it is a widely used technique in neurological rehabilitation and complex pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Traditional and Motor Imaginary Program | Experimental | Other: Treatment Traditional and Imaginary Motor ProgramAmputees patients also conservative protocol will undergo physiotherapy techniques work Motor Imaginary Program, based on a system of two videos that allow the patient to recreate the "normal" way. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases. This protocol will be applied 3 days a week (25-30minutos) for one month. |
| Treatment Traditional and Mirror Therapy | Active comparator | Other: Treatment Traditional and Mirror TherapyAmputees patients also conservative protocol will undergo physical therapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain in the stump area ≥ 3 months, no intermittent
- Have three months elapsed amputation,
- Submit subjective sensation of phantom limb not blinking
Key exclusion criteria (5 listed)
- Clinical signs of radiculopathy.
- Lumbar stenosis, fibromyalgia, spondylolisthesis.
- History of spinal surgery.
- Corticosteroid therapy in the past two weeks.
- Disease of the central nervous system or peripheral.
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 |
|---|---|---|
| Treatment Traditional and Imaginary Motor ProgramAmputees patients also conservative protocol will undergo physiotherapy techniques work Imaginary Motor. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases: a) relaxation of Benson, b) phase external imagination where cycles of normal running on a video provided by the physiotherapist, c) phase internal imagination where the patient will identify the problem discussed compared with the normal course presented in the video, d) recreation of images in the first person made an e normalized locomotion) closing his eyes, prompted the patient to mentally recreate sequences normal gait and analyzed and subsequently verbalize differences of these with respect to their own way of getting around. | Other | Treatment Traditional and Motor Imaginary Program |
| Treatment Traditional and Mirror TherapyAmputees patients also conservative protocol will undergo physiotherapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation. | Other | Treatment Traditional and Mirror Therapy |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months
14 secondary outcomes
McGiII Pain Questionnaire (MPQ)
Time frame: Changes from Baseline McGiII Pain Questionnaire at one month. Changes from Baseline McGiII Pain Questionnaire at three months
The Vividness of Visual Imagery Questionnaire
Time frame: Changes from Baseline Vividness of Visual Imagery Questionnaire at one month and three months
Beck Depression Inventory
Time frame: Changes from Baseline Beck Depression Inventory at one month. Changes from Baseline Beck Depression Inventory at three months
Neuropathic Pain Questionnaire (DN4)
Time frame: Changes from Baseline Neuropathic Pain Questionnaire at one month. Changes from Baseline Neuropathic Pain Questionnaire at three months
Pressure Algometer (kg/cm2)
Time frame: Changes from Baseline Pressure Algometer at one month. Changes from Baseline Pressure Algometer at three months
West-Haven-Yale Multidimensional Pain Inventory
Time frame: Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at one month. Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at three months
The Barthel Index of ADLs
Time frame: Changes from Baseline Barthel Index of ADLs at one month. Changes from Baseline Barthel Index of ADLs at three months
Instrumental Activities of Daily Living Scale (IADL)
Time frame: Changes from Baseline Instrumental Activities of Daily Living Scale at one month. Changes from Baseline Instrumental Activities of Daily Living Scale at three months
The Functional Independence Measure Scale (FIM)
Time frame: Changes from Baseline Functional Independence Measure Scale at one month. Changes from Baseline Functional Independence Measure Scale at three months
Quality of Life Questionnaire scoring (SF36)
Time frame: Changes from Baseline Quality of Life Questionnaire Scoring at one month. Changes from Baseline Quality of Life Questionnaire Scoring at three months
Multidimensional Body Self Relations Questionnaire (MBSRQ)
Time frame: Changes from Baseline Multidimensional Body Self Relations Questionnaire at one month. Changes from Baseline Multidimensional Body Self Relations Questionnaire at three months
Tampa Scale for Kinesiophobia (TSK)
Time frame: Changes from Baseline Tampa Scale for Kinesiophobia at one month. Changes from Baseline Tampa Scale for Kinesiophobia at three months
Pain Catastrophizing Scale (PCS)
Time frame: Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months
Pain Management Inventory
Time frame: Changes from Baseline Pain Management Inventory at one month. Changes from Baseline Pain Management Inventory at three months
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 14 Oct 2019.
- Background: PubMed 18295618Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
- Background: PubMed 16213230Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005 Oct;86(10):1910-9. doi: 10.1016/j.apmr.2005.03.031.
- Background: PubMed 19165686Raichle KA, Hanley MA, Molton I, Kadel NJ, Campbell K, Phelps E, Ehde D, Smith DG. Prosthesis use in persons with lower- and upper-limb amputation. J Rehabil Res Dev. 2008;45(7):961-72. doi: 10.1682/jrrd.2007.09.0151.
- Background: PubMed 22184752Foell J, Bekrater-Bodmann R, Flor H, Cole J. Phantom limb pain after lower limb trauma: origins and treatments. Int J Low Extrem Wounds. 2011 Dec;10(4):224-35. doi: 10.1177/1534734611428730.
- Background: PubMed 21959885Seidel S, Kasprian G, Furtner J, Schopf V, Essmeister M, Sycha T, Auff E, Prayer D. Mirror therapy in lower limb amputees--a look beyond primary motor cortex reorganization. Rofo. 2011 Nov;183(11):1051-7. doi: 10.1055/s-0031-1281768. Epub 2011 Sep 28.
- Background: PubMed 18457537Flor H. Maladaptive plasticity, memory for pain and phantom limb pain: review and suggestions for new therapies. Expert Rev Neurother. 2008 May;8(5):809-18. doi: 10.1586/14737175.8.5.809.
- Background: PubMed 20442256Bosmans JC, Geertzen JH, Post WJ, van der Schans CP, Dijkstra PU. Factors associated with phantom limb pain: a 31/2-year prospective study. Clin Rehabil. 2010 May;24(5):444-53. doi: 10.1177/0269215509360645.
- Background: PubMed 21306870Priganc VW, Stralka SW. Graded motor imagery. J Hand Ther. 2011 Apr-Jun;24(2):164-8; quiz 169. doi: 10.1016/j.jht.2010.11.002. Epub 2011 Feb 9.
- Background: PubMed 14572737Janig W, Baron R. Complex regional pain syndrome: mystery explained? Lancet Neurol. 2003 Nov;2(11):687-97. doi: 10.1016/s1474-4422(03)00557-x.
- Background: PubMed 12509620McCabe CS, Haigh RC, Ring EF, Halligan PW, Wall PD, Blake DR. A controlled pilot study of the utility of mirror visual feedback in the treatment of complex regional pain syndrome (type 1). Rheumatology (Oxford). 2003 Jan;42(1):97-101. doi: 10.1093/rheumatology/keg041.
- Background: PubMed 15732114Pleger B, Tegenthoff M, Ragert P, Forster AF, Dinse HR, Schwenkreis P, Nicolas V, Maier C. Sensorimotor retuning [corrected] in complex regional pain syndrome parallels pain reduction. Ann Neurol. 2005 Mar;57(3):425-9. doi: 10.1002/ana.20394.
- Background: PubMed 14694034Maihofner C, Handwerker HO, Neundorfer B, Birklein F. Patterns of cortical reorganization in complex regional pain syndrome. Neurology. 2003 Dec 23;61(12):1707-15. doi: 10.1212/01.wnl.0000098939.02752.8e.
- 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. This study is not recruiting at the moment.
Adelaida María Castro-Sánchez, PhD principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Traditional and Imaginary Motor Program and Treatment Traditional and Mirror Therapy in people with Amputees, run by Universidad de Almeria at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 14 Oct 2019. 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 Spain. 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?
Numerical Rating Scale (NRS) (time frame: Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months). 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 NCT02761447, which also lists 30 linked publications.
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 14 Oct 2019.