Complex Regional Pain Syndrome Type INCT06100107
Mirror Therapy in Complex Regional Pain Syndrome Type I
A study testing Mirror Therapy exercise in people with Complex Regional Pain Syndrome Type I, run by University Hospital, Motol.
Trial summary
The aim is to evaluate the efficacy of Mirror Therapy on pain reduction and hand function in subjects with unilateral upper extremity Complex Regional Pain Syndrome Type I. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndrome Type I
- What is being tested?
- Mirror Therapy exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2013to 15 Jan 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of CRPS I based on the Budapest criteria
Who cannot join
- failure to meet the diagnostic Budapest clinical criteria for CRPS I
- previous use of Mirror Therapy prior to the commencement of this study
- substantial difficulties in cooperation
- a significant change to the subjects' treatment regimen, outside of the study design
About this study
Official title: Mirror Visual Feedback as Therapeutic Modality in Unilateral Upper Extremity Complex Regional Pain Syndrome Type I
The aim is to evaluate the efficacy of Mirror Therapy on pain reduction and hand function in subjects with unilateral upper extremity Complex Regional Pain Syndrome Type I.
Read the detailed description
Subjects were randomly divided into two groups. Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks. Group B acted as a control group for six weeks followed by six weeks of Mirror Therapy with the same characteristics as Group A. Upper extremity active range of motion, strength, dexterity, limb volume, right-left temperature difference, and health-related quality of life were evaluated before and after each period. Daily records on the visual analogue scale were used for pain evaluation. Effectiveness was calculated using mixed-effects modelling for between-group comparisons and within-group variability and identifying significant predictors.
- Conditions
- Complex Regional Pain Syndrome Type I
- Being tested
- Mirror Therapy exercise
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Therapy exerciseOther
Also called Mirror visual feedback exercise
Mirror Therapy for the upper limb involves the use of a mirror to create a reflected image of the unaffected arm, making it appear as if both arms are moving symmetrically. During the therapy, the patient places their affected arm behind the mirror and their unaffected arm in front. While focusing on the mirror reflection, the patient performs various movements with the unaffected arm, giving the illusion that the affected arm is moving normally.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Mirror Therapy | Experimental | Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks. Receives: Other: Mirror Therapy exercise |
| Group B - control period followed by Mirror Therapy | Experimental | Group B acted as a control group for six weeks (no Mirror Therapy) followed by six weeks of Mirror Therapy with the same characteristics as Group A. Receives: Other: Mirror Therapy exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
The participants in both groups made daily accounts of their pain level using 10 cm long visual analog scale (VAS) at rest as well as typical pain level during hand movement.
Measured: Recordings performed every day from day 0 to day 42 (Group A) and from day 0 to day 84 (Group B); Follow-up on day 72 (Group A) and day 114 (Group B).
Active Range of Motion
Three attributes were measured: maximal active range of wrist flexion and extension (°) determined with goniometer measuring the angle between forearm and metacarpal bones
Measured: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Strength
The outcome parameter is the highest pressure (bar) performed during one maximal grip.
Measured: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Dexterity
Dexterity was evaluated by using a nine-hole PegBoard. The time taken to complete this task was measured.
Measured: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Volume of hand and forearm
The volumetric measurements are based on the principle of water displacement.
Measured: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Temperature
Temperature was measured bilaterally in the thenar area using an infrared thermometer.
Measured: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Health-related Quality of Life
Determined using the European Quality of Life-5 Dimensions-3 Levels questionnaire. A range of 0-100% is used, where a higher score means a better outcome.
Measured: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start9 Sep 2013
- Primary completion30 Sep 2015
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain Syndrome Type IStudies 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
- Model description
- Specifically, the study employs a half cross-over design. Group A begins with the intervention, while Group B starts with a control period of equal length, followed by the intervention. This design facilitates comparisons both between the groups and within Group B across the two periods.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudolf Cerny, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100107
- Sponsor's protocol ID
- EK-1288/14
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Visual Feedback as Therapeutic Modality in Unilateral Upper Extremity Complex Regional Pain Syndrome Type I
- ClinicalTrials.gov ID
- NCT06100107
- Acronym / sponsor ID
- EK-1288/14
- Conditions
- Complex Regional Pain Syndrome Type I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 9 Sep 2013 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 25 Oct 2023 (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.
The aim is to evaluate the efficacy of Mirror Therapy on pain reduction and hand function in subjects with unilateral upper extremity Complex Regional Pain Syndrome Type I.
Detailed description
Subjects were randomly divided into two groups. Group A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks. Group B acted as a control group for six weeks followed by six weeks of Mirror Therapy with the same characteristics as Group A. Upper extremity active range of motion, strength, dexterity, limb volume, right-left temperature difference, and health-related quality of life were evaluated before and after each period. Daily records on the visual analogue scale were used for pain evaluation. Effectiveness was calculated using mixed-effects modelling for between-group comparisons and within-group variability and identifying significant predictors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Specifically, the study employs a half cross-over design. Group A begins with the intervention, while Group B starts with a control period of equal length, followed by the intervention. This design facilitates comparisons both between the groups and within Group B across the two periods.
| Arm | Type | Receives |
|---|---|---|
| Group A - Mirror Therapy | Experimental | Other: Mirror Therapy exerciseGroup A carried out a ten-minute Mirror Therapy exercise daily, for a total duration of six weeks. |
| Group B - control period followed by Mirror Therapy | Experimental | Other: Mirror Therapy exerciseGroup B acted as a control group for six weeks (no Mirror Therapy) followed by six weeks of Mirror Therapy with the same characteristics as Group A. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of CRPS I based on the Budapest criteria
Key exclusion criteria (4 listed)
- failure to meet the diagnostic Budapest clinical criteria for CRPS I
- previous use of Mirror Therapy prior to the commencement of this study
- substantial difficulties in cooperation
- a significant change to the subjects' treatment regimen, outside of the study design
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 Therapy exerciseAlso: Mirror visual feedback exerciseMirror Therapy for the upper limb involves the use of a mirror to create a reflected image of the unaffected arm, making it appear as if both arms are moving symmetrically. During the therapy, the patient places their affected arm behind the mirror and their unaffected arm in front. While focusing on the mirror reflection, the patient performs various movements with the unaffected arm, giving the illusion that the affected arm is moving normally. | Other | Group A - Mirror Therapy, Group B - control period followed by Mirror Therapy |
Primary outcome
Pain perception
Time frame: Recordings performed every day from day 0 to day 42 (Group A) and from day 0 to day 84 (Group B); Follow-up on day 72 (Group A) and day 114 (Group B).
The participants in both groups made daily accounts of their pain level using 10 cm long visual analog scale (VAS) at rest as well as typical pain level during hand movement.
Active Range of Motion
Time frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Three attributes were measured: maximal active range of wrist flexion and extension (°) determined with goniometer measuring the angle between forearm and metacarpal bones
Strength
Time frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
The outcome parameter is the highest pressure (bar) performed during one maximal grip.
Dexterity
Time frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Dexterity was evaluated by using a nine-hole PegBoard. The time taken to complete this task was measured.
Volume of hand and forearm
Time frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
The volumetric measurements are based on the principle of water displacement.
Temperature
Time frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Temperature was measured bilaterally in the thenar area using an infrared thermometer.
Health-related Quality of Life
Time frame: On day 0 (Group A, Group B); on day 42 (Group A, Group B); on day 84 (Group B)
Determined using the European Quality of Life-5 Dimensions-3 Levels questionnaire. A range of 0-100% is used, where a higher score means a better outcome.
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 25 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy exercise in people with Complex Regional Pain Syndrome Type I, run by University Hospital, Motol.
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 1 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 25 Oct 2023. 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?
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?
Pain perception (time frame: Recordings performed every day from day 0 to day 42 (Group A) and from day 0 to day 84 (Group B); Follow-up on day 72 (Group A) and day 114 (Group B).). The study lists 7 primary outcomes in all. 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 25 Oct 2023.