Carpal Tunnel Syndrome
Conditions
Keywords
pain, disability, education, exercise
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.
Interventions
OTHERMultimodal treatment
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.
OTHERUnimodal treatment
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.
Sponsors
University of Chile
University of Valencia
Hospital San José
Hospital Provincia Cordillera
Hospital Clínico La Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The investigator at each center responsible for conducting the study evaluations will be blinded to group assignment. A second investigator will be responsible for generating randomization, sequencing, enrolling participants, and assigning participants to treatment. Patients will be blinded to the assigned group
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Pain Catastrophizing Scale (PCS) at 6 and 12 weeks | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand diagrams | Baseline (0 weeks) | 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. |
| Change from Baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 and 12 weeks | Baseline (0 weeks), 6 weeks and 12 week | 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). |
| Patient Global Impression of Change Scale (PGICS) | 6 weeks | 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. |
| Change from Baseline Muscular endurance at 6 and 12 weeks | Baseline (0 weeks), 6 weeks and 12 week | Maximum number of repetitions of rapid opening and closing of the hand until fatigue. |
| Change from Baseline Hospital Anxiety and Depression Scale (HAD) at 6 and 12 weeks | Baseline (0 weeks), 6 weeks and 12 week | 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. |
| Change from Baseline EQ-5D at 6 and 12 weeks | Baseline (0 weeks), 6 weeks and 12 week | 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). |
Countries
Chile
Outcome results
None listed