Telerehabilitation in Carpal Tunnel Syndrome

NCT05184413 | Completed

• 1 other identifier: RNCHLF0022020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

pain; disability; education; exercise

Outcome Measures

Primary Outcomes (3)

• 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

  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).

  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.

  Baseline (0 weeks), 6 weeks and 12 week

Secondary Outcomes (7)

• Change from Baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 and 12 weeks

  Baseline (0 weeks), 6 weeks and 12 week

• Change from Baseline Hospital Anxiety and Depression Scale (HAD) at 6 and 12 weeks

  Baseline (0 weeks), 6 weeks and 12 week

• Change from Baseline EQ-5D at 6 and 12 weeks

  Baseline (0 weeks), 6 weeks and 12 week

• Hand diagrams

  Baseline (0 weeks)

• Change from Baseline Muscular endurance at 6 and 12 weeks

  Baseline (0 weeks), 6 weeks and 12 week

Study Arms (2)

Multimodal treatment

EXPERIMENTAL

Therapeutic Exercise plus Pain Neuroscience Education

Other: Multimodal treatment

Unimodal treatment

ACTIVE COMPARATOR

Therapeutic Exercise

Other: Unimodal treatment

Interventions

Multimodal treatment OTHER

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.

Multimodal treatment

Unimodal treatment OTHER

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.

Unimodal treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clínico La Florida: lead
• University of Chile: collaborator
• University of Valencia: collaborator
• Hospital San José: collaborator
• Hospital Provincia Cordillera: collaborator

Study Sites (1)

Hospital la Florida

Santiago, Chile

Location

Related Publications (1)

• 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.

  PMID: 37572618 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain; Motor Activity

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: January 11, 2022
• Study Start: January 15, 2022
• Primary Completion: July 6, 2022
• Study Completion: July 6, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

CL (1)