Clinical trial NCT05184413: Telerehabilitation in Carpal Tunnel Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: pain
disability
education
exercise
Lead sponsor: Hospital Clínico La Florida
Sponsor class: OTHER
Collaborators: name: University of Chile
name: University of Valencia
name: Hospital San José
name: Hospital Provincia Cordillera
First posted: 2022-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Inability to understand instructions, non-controlled mental health pathology, cognitive problems and previous surgery in the upper limb.

Primary outcomes:
measure: Change from Baseline Pain Catastrophizing Scale (PCS) at 6 and 12 weeks
timeFrame: Baseline (0 weeks), 6 weeks and 12 week
measure: Change from Baseline Tampa Scale for Kinesiophobia-11 (TSK-11) at 6 and 12 weeks
timeFrame: Baseline (0 weeks), 6 weeks and 12 week
measure: Change from Baseline Numerical rating scale (NRS) at 6 and 12 weeks
timeFrame: Baseline (0 weeks), 6 weeks and 12 week
Secondary outcomes:
measure: Change from Baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 and 12 weeks
timeFrame: Baseline (0 weeks), 6 weeks and 12 week
measure: Change from Baseline Hospital Anxiety and Depression Scale (HAD) at 6 and 12 weeks
timeFrame: Baseline (0 weeks), 6 weeks and 12 week
measure: Change from Baseline EQ-5D at 6 and 12 weeks
timeFrame: Baseline (0 weeks), 6 weeks and 12 week
measure: Hand diagrams
timeFrame: Baseline (0 weeks)
measure: Change from Baseline Muscular endurance at 6 and 12 weeks
timeFrame: Baseline (0 weeks), 6 weeks and 12 week
measure: Patient Global Impression of Change Scale (PGICS)
timeFrame: 6 weeks
measure: Patient Global Impression of Change Scale (PGICS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital la Florida
Study officials:
References: