Clinical trial NCT05593952: Dual Task During Exercise for Carpal Tunnel Release
Official title: Effects of Dual Task on Hand Performance, Pain, Function and Psychosocial Factors in Patients With Carpal Tunnel Release
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to evaluate the effect of the dual task on hand motor performance, pain, functionality and psychosocial factors in patients with carpal tunnel syndrome undergoing surgery.

Men and women aged 20-60 years with a medical diagnosis of CTS according to international clinical guidelines will be candidates for the present study. Patients receiving rehabilitation following carpal tunnel release surgery will be potentially eligible.

After the familiarization week and the analysis of acute effects, subjects will be randomly distributed into two groups: 1) exercise with dual task + usual treatment; 2) exercise without dual task + usual treatment. The exercises performed will be the same as during the familiarization week, as well as the guidelines for performing them. Both groups will perform 4 weeks of intervention, for two days a week with two days of rest between sessions.

Detailed description: The aim of this study will be to evaluate the effect of the dual task on hand motor performance, pain, functionality and psychosocial factors in patients with carpal tunnel syndrome undergoing surgery.

Men and women aged 20-60 years with a medical diagnosis of CTS according to international clinical guidelines will be candidates for the present study. Patients receiving rehabilitation following carpal tunnel release surgery will be potentially eligible.

Patients will voluntarily participate in the study, which will be conducted at the Hospital Clínico Universitario de Valencia, during the months of November 2022 to January 2023. All participants will be informed of the aims and content of the research and written informed consent will be obtained. The study will conform to the Declaration of Helsinki and will be approved by the local ethics committee.

Exclusion criteria shall be as follows: Inability to understand instructions, uncontrolled mental health pathology, cognitive problems, previous surgery on the upper extremity, complex regional pain syndrome.

The experimental protocol begins with the assessment of self-perceived pain intensity and perceived exertion when using different intensities of elastic resistance, during wrist flexion and extension, at a controlled speed of 1.5sec/phase. To assess the intensity at which they will work, participants will perform 2 repetitions and will be allowed a rest of 60s between sets until they obtain a score of 3 on the Borg CR10 scale. For this purpose, 1.5 m long elastic bands, pre-stretched to approximately 25% of their initial length, in yellow, red, green, blue, black, silver and gold (TheraBand CLX, The Hygenic Corporation, Akron, OH, USA), will be progressively used starting from the lowest available elastic resistance (i.e. yellow). This intensity is selected because it appears to correspond to a resistance equivalent to 30% of 1RM and is considered a light intensity. Exercises should be performed with the subject's available ROM. Participants are asked to move their body and trunk as little as possible and to perform the exercise smoothly, without stopping or accelerating. The exercise will be performed in a seated position, with the back supported by the backrest and the forearm resting on a table, with the shoulders and elbows bent at 90º, leaving the wrist free, with the elastic bands held under the feet (stepping on them).

During the week of familiarisation and analysis of acute effects, subjects will attend 2 sessions, separated by 2 rest days in between, where they will perform 2 conditions/session (4 conditions in total at the end of the study), in a counterbalanced manner, with 10 minutes rest between each condition: 1) perform the highest number of wrist flexion repetitions with the appropriate resistance; 2) perform the highest number of wrist flexion repetitions with the appropriate band, and following a dual task; 3) perform the highest number of wrist extension repetitions with the appropriate band; 4) perform the highest number of wrist extension repetitions with the appropriate band, and following a dual task.

The dual task will be self-regulated and will consist of subtracting 3 by 3 from 100, and performing the maximum number of repetitions possible. The subject will perform the mathematical operation aloud, without being corrected, but if they get stuck on a number or operation, they will have to be told to continue subtracting from that number or from another, so that they do not stop performing the operations. At the end of each condition, the subject will be asked about the perceived difficulty of the self-regulated mathematical task (where 0 is not difficult at all and 10 is the maximum difficulty), and the maximum number of repetitions performed will be recorded. The pressure points and VAS will then be measured again.

After the familiarisation week and the analysis of acute effects, subjects will be randomly distributed into two groups: 1) exercise with dual task + usual treatment; 2) exercise without dual task + usual treatment. The exercises performed will be the same as during the familiarisation week, as well as the guidelines for performing them. Both groups will perform 4 weeks of intervention, for two days a week with two days of rest between sessions.

Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of CTS according to international clinical guidelines
* Patients referred for rehabilitation after carpal tunnel release surgery
* Agree to participate

Exclusion Criteria:

* Inability to understand instructions.
* Uncontrolled mental health pathology.
* Cognitive problems.
* Previous surgery on the upper extremity.
* Complex regional pain syndrome

Primary outcomes:
measure: Muscular endurance assessed by the maximum number of possible repetitions of exercise with elastic resistance
timeFrame: Baseline (0 weeks)
measure: Muscular endurance assessed by the maximum number of possible repetitions of exercise with elastic resistance
timeFrame: Change from Baseline at 4 weeks
Secondary outcomes:
measure: Kinesiophobia assessed by the TSK-11
timeFrame: Baseline (0 weeks)
measure: Catastrophizing assessed by thePCS
timeFrame: Baseline (0 weeks)
measure: Self-efficacy assessed by the Perceived Chronic Pain Self-Efficacy questionnaire
timeFrame: Baseline (0 weeks)
measure: Severity of symptoms and function assessed by the BCTS
timeFrame: Baseline (0 weeks)
measure: Pain assessed by the VAS
timeFrame: Baseline (0 weeks)
measure: Pressure Pain assessed by the PPT
timeFrame: Baseline (0 weeks)
measure: Kinesiophobia assessed by the TSK-11
timeFrame: Change from Baseline at 4 weeks
measure: Catastrophizing assessed by the PCS
timeFrame: Change from Baseline at 4 weeks
measure: Self-efficacy assessed by the Perceived Chronic Pain Self-Efficacy questionnaire
timeFrame: Change from Baseline at 4 weeks
measure: Severity of symptoms and function assessed by the BCTS
timeFrame: Change from Baseline at 4 weeks
measure: Pain assessed by the VAS
timeFrame: Change from Baseline at 4 weeks
measure: Pressure Pain assessed by the PPT
timeFrame: Change from Baseline at 4 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Laura López-Bueno, PhD
role: PRINCIPAL_INVESTIGATOR
References: