Carpal Tunnel SyndromeMTSTCNCT03169218
Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom
A study testing Mirror therapy in people with Carpal Tunnel Syndrome, run by Olga Del Pozo Blanco at 1 site in Spain.
Trial summary
The purpose of this study was to evaluate pain and function after mirror therapy as well as level of catastrophism in bilateral carpal tunnel syndrome patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Mirror therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Feb 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be signed the informed consent.
- Bilateral carpal tunnel syndrome: clinic and electromiography positive.
- Aged between 18 and 65 years
Who cannot join
- Patients undergoing surgical intervention of carpal tunnel syndrome in one of two hands
- Unilateral carpal tunnel syndrome
- Patients with chronic pain and / or previous injury (wrist tumor, lymphedema ...) in either hand
- Patients with systemic diseases (diabetes, thyroid ...)
- Patients with pharmacological treatment to take analgesia for any other chronic pathologies
- Subjects who have suffered from a neurological disease that affects the musculoskeletal system
Show all 9Show fewer
- Mental illness that prevents the compression and / or realization of the study
- Patients with tattoos, scars and / or marks on any of the hands or distal forearm area
- Pregnant women and minors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom (MTSTC)
The purpose of this study was to evaluate pain and function after mirror therapy as well as level of catastrophism in bilateral carpal tunnel syndrome patients
Read the detailed description
The sample calculation was performed based on the previous pilot study, in which 10 subjects were included. Through this study, a statistically significant effect on the variables analyzed was demonstrated. Therefore, it was determined to duplicate the initial sample to confirm the effect previously studied, assuming losses of 20%. Thus, the value of n for the clinical trial is 20 subjects.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Mirror therapy, Placebo group
- Keywords
- Adult, Chronic pain, Entrapment neuropathy. Carpal tunnel, Exercise therapy, Humans, Neuronal plasticity, Mirror neurons, Pain/cognitive aspects, Physiotherapy, Somatosensory cortex
- Medical subject headings
- Carpal Tunnel Syndrome, Chronic Pain, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyOther
Also called Mirror visual feedback, Mirror box therapy
The treatment proposed for the mirror group consisted of 8 weeks of treatment, performing a series of exercises 2 times a day / 4 times a week. The first 4 weeks the treatment was done in the hospital next to the physiotherapist for 2-3 days a week, and the next 4 weeks the patient performed the exercises following the same guidelines at home.
Placebo groupOther
The treatment was the same than proposed in inference group but with a mirror covered to avoid the reflexion on the hand and looking at the hand that did not remain hidden.
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy group | Experimental | Mirror therapy group: exercises looking at the reflection in the mirror of the hand moving Receives: Other: Mirror therapy |
| Placebo group | Placebo comparator | Placebo group: exercises performed with the mirror turned to avoid the reflection of the hand and looking at the hand that did not remain hidden. Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate changes on pain
Evaluation on pain through McGill Pain Questionnaire This questionnaire is self-administered.
Measured: Changes in 8 weeks
Secondary outcomes (1)
To evaluate changes on the function of the upper limb.
Evaluation on function through disabilities of the arm, shoulder and hand questionnaire (DASH)
Measured: Changes in 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startOct 2015
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olga Del Pozo Blanco
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe, University Rovira i Virgili
- Responsible party
- Sponsor-investigator, Olga Del Pozo Blanco, Hospital de Manises
- Investigators
- Sonia Monterde, PT, Phd, Study director, Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169218
- Sponsor's protocol ID
- HManises
- Other IDs
- 2015/0277
- Acronym
- MTSTC
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lázaro C, Fèlix B, Torrubia R, Baños JE. The development of a Spanish questionnaire for assessing pain: preliminary data concerning reliability and validity. Eur J Psychol assesment. 1994;10(2):145-51.
Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
PubMed 19007576Hervas MT, Navarro Collado MJ, Peiro S, Rodrigo Perez JL, Lopez Mateu P, Martinez Tello I. [Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness]. Med Clin (Barc). 2006 Sep 30;127(12):441-7. doi: 10.1157/13093053. Spanish.
PubMed 17040628
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom (MTSTC)
- ClinicalTrials.gov ID
- NCT03169218
- Acronym / sponsor ID
- MTSTC / HManises
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Adult, Chronic pain, Entrapment neuropathy. Carpal tunnel, Exercise therapy, Humans, Neuronal plasticity, Mirror neurons, Pain/cognitive aspects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Olga Del Pozo BlancoUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe, University Rovira i Virgili
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 30 May 2017 (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 purpose of this study was to evaluate pain and function after mirror therapy as well as level of catastrophism in bilateral carpal tunnel syndrome patients
Detailed description
The sample calculation was performed based on the previous pilot study, in which 10 subjects were included. Through this study, a statistically significant effect on the variables analyzed was demonstrated. Therefore, it was determined to duplicate the initial sample to confirm the effect previously studied, assuming losses of 20%. Thus, the value of n for the clinical trial is 20 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy group | Experimental | Other: Mirror therapyMirror therapy group: exercises looking at the reflection in the mirror of the hand moving |
| Placebo group | Placebo comparator | Other: Placebo groupPlacebo group: exercises performed with the mirror turned to avoid the reflection of the hand and looking at the hand that did not remain hidden. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be signed the informed consent.
- Bilateral carpal tunnel syndrome: clinic and electromiography positive.
- Aged between 18 and 65 years
Key exclusion criteria (9 listed)
- Patients undergoing surgical intervention of carpal tunnel syndrome in one of two hands
- Unilateral carpal tunnel syndrome
- Patients with chronic pain and / or previous injury (wrist tumor, lymphedema ...) in either hand
- Patients with systemic diseases (diabetes, thyroid ...)
- Patients with pharmacological treatment to take analgesia for any other chronic pathologies
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 therapyAlso: Mirror visual feedback, Mirror box therapyThe treatment proposed for the mirror group consisted of 8 weeks of treatment, performing a series of exercises 2 times a day / 4 times a week. The first 4 weeks the treatment was done in the hospital next to the physiotherapist for 2-3 days a week, and the next 4 weeks the patient performed the exercises following the same guidelines at home. | Other | Mirror therapy group |
| Placebo groupThe treatment was the same than proposed in inference group but with a mirror covered to avoid the reflexion on the hand and looking at the hand that did not remain hidden. | Other | Placebo group |
Primary outcome
To evaluate changes on pain
Time frame: Changes in 8 weeks
Evaluation on pain through McGill Pain Questionnaire This questionnaire is self-administered.
1 secondary outcome
To evaluate changes on the function of the upper limb.
Time frame: Changes in 8 weeks
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 30 May 2017.
- BackgroundLázaro C, Fèlix B, Torrubia R, Baños JE. The development of a Spanish questionnaire for assessing pain: preliminary data concerning reliability and validity. Eur J Psychol assesment. 1994;10(2):145-51.
- Background: PubMed 19007576Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
- Background: PubMed 17040628Hervas MT, Navarro Collado MJ, Peiro S, Rodrigo Perez JL, Lopez Mateu P, Martinez Tello I. [Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness]. Med Clin (Barc). 2006 Sep 30;127(12):441-7. doi: 10.1157/13093053. Spanish.
- 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.
Sonia Monterde, PT, Phd study director
Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili
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 therapy in people with Carpal Tunnel Syndrome, run by Olga Del Pozo Blanco 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 9 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 30 May 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 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. Some participants in this study may receive a placebo. 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?
To evaluate changes on pain (time frame: Changes in 8 weeks). 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 NCT03169218, which also lists 3 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 30 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.