Carpal Tunnel SyndromeNCT05184413
Telerehabilitation in Carpal Tunnel Syndrome
A study testing Multimodal treatment and Unimodal treatment in people with Carpal Tunnel Syndrome, run by Hospital Clínico La Florida at 1 site in Chile.
Trial summary
Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy characterized by pain, tingling sensation and paresthesia in the territory of the median nerve. These symptoms cause significant functional impairment that affects patients' quality of life. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Multimodal treatment and Unimodal treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 15 Jan 2022to 6 Jul 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 20 years of age, severe CTS medical diagnosis, duration of symptoms for more than three months, access to a smartphone with internet, and acceptance to participate in the study.
Who cannot join
- Inability to understand instructions, non-controlled mental health pathology, cognitive problems and previous surgery in the upper limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Multimodal Telerehabilitation Program Combining Pain Neuroscience Education and Therapeutic Exercise for Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial
Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy characterized by pain, tingling sensation and paresthesia in the territory of the median nerve. These symptoms cause significant functional impairment that affects patients' quality of life. Pain neuroscience education (PNE) combined with therapeutic exercise (TE) has shown good results in patients with chronic pain, but the effects of this multimodal treatment via telerehabilitation have not been studied in patients with CTS. Telerehabilitation has demonstrated clinical and functional outcomes as effective as face-to-face interventions, being a good alternative to improve accessibility to rehabilitation care in a context of pandemic and social distancing. The purpose of this study is to provide coordinated, patient-centered care by implementing a Telerehabilitation model for patients with severe CTS. The objective of this study was to compare the effectiveness of a multimodal therapy program (TE plus PNE) versus a unimodal treatment (TE) in patients with CTS.
A Randomized Controlled Trial, simple-blind and multicenter study will be conducted. Patients will be randomly assigned to the multimodal treatment group (TE plus PNE) or to the unimodal treatment group (TE). At admission, an investigator blinded to treatment assignment will conduct data collection. The measurements will be the following outcomes: a) Pain Catastrophizing Scale; b) Tampa Scale for Kinesiophobia-11; c) Numerical Rating Scale (NRS); d) Boston Carpal Tunnel Questionnaire; e) Hospital Anxiety and Depression Scale; f) Quality of Life, using the EQ-5D instrument; g) Patient's global impression of change; h) Katz Diagram; These evaluations will be performed again at week 6 and 12.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Multimodal treatment, Unimodal treatment
- Keywords
- pain, disability, education, exercise
- Medical subject headings
- Carpal Tunnel Syndrome, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal treatmentOther
A multimodal telerehabilitation intervention will be conducted through Whatsapp video calls. The combined treatment includes: 1) One 30-minute session of education in neurosciences of pain, using audiovisual material with examples and metaphors to improve the patient's understanding. In addition, two sessions of reinforcement of key contents will be held every 15 days; 2) Therapeutic exercise program: active wrist and finger exercises, stretching, mobilization exercises of the median nerve, and aerobic exercise (brisk walking). Each exercise will be dosed on a personalized basis, with a perceived exertion of 4-5 on the Borg scale. Therapeutic exercise will be self-administered, 3 sessions per week for 6 weeks. Telerehabilitation sessions will be performed every 15 days to monitor adherence and adjust the exercise dose.
Unimodal treatmentOther
An unimodal telerehabilitation intervention will be performed through Whatsapp video calls. The treatment will include only a therapeutic exercise program: active wrist and finger exercises, stretching, mobilization exercises of the median nerve, and aerobic exercise (brisk walking). Each exercise will be dosed on a personalized basis, with a perceived exertion of 4-5 on the Borg scale. Therapeutic exercise will be self-administered, 3 sessions per week for 6 weeks. Telerehabilitation sessions will be performed every 15 days to monitor adherence and adjust the exercise dose.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal treatment | Experimental | Therapeutic Exercise plus Pain Neuroscience Education Receives: Other: Multimodal treatment |
| Unimodal treatment | Active comparator | Therapeutic Exercise Receives: Other: Unimodal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain Catastrophizing Scale (PCS) at 6 and 12 weeks
To assess catastrophic thinking as a response to pain through 13 statements with 4 possible options from 1 "not at all" to 4 "all the time". a higher score indicates a higher catastrophic thinking
Measured: Baseline (0 weeks), 6 weeks and 12 week
Change from Baseline Tampa Scale for Kinesiophobia-11 (TSK-11) at 6 and 12 weeks
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
Measured: Baseline (0 weeks), 6 weeks and 12 week
Change from Baseline Numerical rating scale (NRS) at 6 and 12 weeks
The patient must rate his or her pain on a defined scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline (0 weeks), 6 weeks and 12 week
Secondary outcomes (7)
Change from Baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 and 12 weeks
The BCTQ measures self-reported functional status (BCTQ-F) and severity (BCTQ-S). The BCTQ-S consists of 11 questions, each question provides 5 response choices, from 1 (no symptoms) to 5 (most severe/often). The BCTQ-F includes 8 questions assessing difficulty with daily tasks. These responses are also scored on a 5-point scale (1-5).
Measured: Baseline (0 weeks), 6 weeks and 12 week
Change from Baseline Hospital Anxiety and Depression Scale (HAD) at 6 and 12 weeks
Patient's emotional state will be evaluated by Hospital Anxiety and Depression Scale (HAD), which assess the level of anxiety and depression. Subscales and score range are Anxiety (0-21) and Depression (0-21). Scoring: items of each subscale are summed, indicating: 0-7 normality, 8-10 probably case, 11-21 anxiety or depression clinical case. Higher values represent a worse outcome.
Measured: Baseline (0 weeks), 6 weeks and 12 week
Change from Baseline EQ-5D at 6 and 12 weeks
The EQ-5D is a self-assessed health-related quality of life questionnaire. The EQ-5D consists essentially of 2 pages: the EQ-5D description system and the visual analog scale (EQ VAS).
Measured: Baseline (0 weeks), 6 weeks and 12 week
Hand diagrams
To define total area marked for pain and numbness. The areas of the hand are marked by the patient and the marked area is quantified in square centimeters.
Measured: Baseline (0 weeks)
Change from Baseline Muscular endurance at 6 and 12 weeks
Maximum number of repetitions of rapid opening and closing of the hand until fatigue.
Measured: Baseline (0 weeks), 6 weeks and 12 week
Patient Global Impression of Change Scale (PGICS)
The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1.205-207 And, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.
Measured: 6 weeks
Patient Global Impression of Change Scale (PGICS)
The PGICS consists of two subscales, one categorical and one quantitative. The categorical scale is a 7-point verbal scale with the options "I have improved a lot" = 7, "I have improved a lot" = 6, "I have improved a little" = 5, "I am the same" = 4, "I have gotten a little worse" = 3, "I have gotten a lot worse" = 2, "I have gotten a lot worse" = 1.205-207 And, the quantitative scale consists of a line from 0 to 10, where 0 = much better and 10 = much worse.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Jan 2022
- Primary completion6 Jul 2022
- Study completion6 Jul 2022
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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico La Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile, University of Valencia, Hospital San José, Hospital Provincia Cordillera
- Responsible party
- Principal investigator, Rodrigo Ignacio Nunez Cortes, Hospital Clínico La Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184413
- Sponsor's protocol ID
- RNCHLF0022020
- Status last verified
- Aug 2022
- First submitted
- 27 Nov 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nunez-Cortes R, Cruz-Montecinos C, Torreblanca-Vargas S, Tapia C, Gutierrez-Jimenez M, Torres-Gangas P, Calatayud J, Perez-Alenda S. Effectiveness of adding pain neuroscience education to telerehabilitation in patients with carpal tunnel syndrome: A randomized controlled trial. Musculoskelet Sci Pract. 2023 Oct;67:102835. doi: 10.1016/j.msksp.2023.102835. Epub 2023 Jul 28.
PubMed 37572618
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal Telerehabilitation Program Combining Pain Neuroscience Education and Therapeutic Exercise for Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05184413
- Acronym / sponsor ID
- RNCHLF0022020
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- pain, disability, education, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Clínico La FloridaUniversity, hospital or other
- Collaborators
- University of Chile, University of Valencia, Hospital San José, Hospital Provincia Cordillera
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 11 Jan 2022 (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.
Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy characterized by pain, tingling sensation and paresthesia in the territory of the median nerve. These symptoms cause significant functional impairment that affects patients' quality of life. Pain neuroscience education (PNE) combined with therapeutic exercise (TE) has shown good results in patients with chronic pain, but the effects of this multimodal treatment via telerehabilitation have not been studied in patients with CTS. Telerehabilitation has demonstrated clinical and functional outcomes as effective as face-to-face interventions, being a good alternative to improve accessibility to rehabilitation care in a context of pandemic and social distancing. The purpose of this study is to provide coordinated, patient-centered care by implementing a Telerehabilitation model for patients with severe CTS. The objective of this study was to compare the effectiveness of a multimodal therapy program (TE plus PNE) versus a unimodal treatment (TE) in patients with CTS.
A Randomized Controlled Trial, simple-blind and multicenter study will be conducted. Patients will be randomly assigned to the multimodal treatment group (TE plus PNE) or to the unimodal treatment group (TE). At admission, an investigator blinded to treatment assignment will conduct data collection. The measurements will be the following outcomes: a) Pain Catastrophizing Scale; b) Tampa Scale for Kinesiophobia-11; c) Numerical Rating Scale (NRS); d) Boston Carpal Tunnel Questionnaire; e) Hospital Anxiety and Depression Scale; f) Quality of Life, using the EQ-5D instrument; g) Patient's global impression of change; h) Katz Diagram; These evaluations will be performed again at week 6 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal treatment | Experimental | Other: Multimodal treatmentTherapeutic Exercise plus Pain Neuroscience Education |
| Unimodal treatment | Active comparator | Other: Unimodal treatmentTherapeutic Exercise |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 20 years of age, severe CTS medical diagnosis, duration of symptoms for more than three months, access to a smartphone with internet, and acceptance to participate in the study.
Key exclusion criteria (1 listed)
- Inability to understand instructions, non-controlled mental health pathology, cognitive problems and previous surgery in the upper limb.
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 |
|---|---|---|
| Multimodal treatmentA multimodal telerehabilitation intervention will be conducted through Whatsapp video calls. The combined treatment includes: 1) One 30-minute session of education in neurosciences of pain, using audiovisual material with examples and metaphors to improve the patient's understanding. In addition, two sessions of reinforcement of key contents will be held every 15 days; 2) Therapeutic exercise program: active wrist and finger exercises, stretching, mobilization exercises of the median nerve, and aerobic exercise (brisk walking). Each exercise will be dosed on a personalized basis, with a perceived exertion of 4-5 on the Borg scale. Therapeutic exercise will be self-administered, 3 sessions per week for 6 weeks. Telerehabilitation sessions will be performed every 15 days to monitor adherence and adjust the exercise dose. | Other | Multimodal treatment |
| Unimodal treatmentAn unimodal telerehabilitation intervention will be performed through Whatsapp video calls. The treatment will include only a therapeutic exercise program: active wrist and finger exercises, stretching, mobilization exercises of the median nerve, and aerobic exercise (brisk walking). Each exercise will be dosed on a personalized basis, with a perceived exertion of 4-5 on the Borg scale. Therapeutic exercise will be self-administered, 3 sessions per week for 6 weeks. Telerehabilitation sessions will be performed every 15 days to monitor adherence and adjust the exercise dose. | Other | Unimodal treatment |
Primary outcome
Change from Baseline Pain Catastrophizing Scale (PCS) at 6 and 12 weeks
Time frame: Baseline (0 weeks), 6 weeks and 12 week
To assess catastrophic thinking as a response to pain through 13 statements with 4 possible options from 1 "not at all" to 4 "all the time". a higher score indicates a higher catastrophic thinking
Change from Baseline Tampa Scale for Kinesiophobia-11 (TSK-11) at 6 and 12 weeks
Time frame: Baseline (0 weeks), 6 weeks and 12 week
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
Change from Baseline Numerical rating scale (NRS) at 6 and 12 weeks
Time frame: Baseline (0 weeks), 6 weeks and 12 week
The patient must rate his or her pain on a defined scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
7 secondary outcomes
Change from Baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 and 12 weeks
Time frame: Baseline (0 weeks), 6 weeks and 12 week
Change from Baseline Hospital Anxiety and Depression Scale (HAD) at 6 and 12 weeks
Time frame: Baseline (0 weeks), 6 weeks and 12 week
Change from Baseline EQ-5D at 6 and 12 weeks
Time frame: Baseline (0 weeks), 6 weeks and 12 week
Hand diagrams
Time frame: Baseline (0 weeks)
Change from Baseline Muscular endurance at 6 and 12 weeks
Time frame: Baseline (0 weeks), 6 weeks and 12 week
Patient Global Impression of Change Scale (PGICS)
Time frame: 6 weeks
Patient Global Impression of Change Scale (PGICS)
Time frame: 12 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 3 Aug 2022.
- Derived from this study: PubMed 37572618Nunez-Cortes R, Cruz-Montecinos C, Torreblanca-Vargas S, Tapia C, Gutierrez-Jimenez M, Torres-Gangas P, Calatayud J, Perez-Alenda S. Effectiveness of adding pain neuroscience education to telerehabilitation in patients with carpal tunnel syndrome: A randomized controlled trial. Musculoskelet Sci Pract. 2023 Oct;67:102835. doi: 10.1016/j.msksp.2023.102835. Epub 2023 Jul 28.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal treatment and Unimodal treatment in people with Carpal Tunnel Syndrome, run by Hospital Clínico La Florida at 1 site in Chile.
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 1 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 3 Aug 2022. 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 Chile. 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?
Change from Baseline Pain Catastrophizing Scale (PCS) at 6 and 12 weeks (time frame: Baseline (0 weeks), 6 weeks and 12 week). 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 NCT05184413, 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 Aug 2022.