Dual Task During Exercise for Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

— DTCTR  

Official title:

Effects of Dual Task on Hand Performance, Pain, Function and Psychosocial Factors in Patients With Carpal Tunnel Release

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05593952
• Other study ID #: ID0004
• Status: Completed
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: February 23, 2024

Study information

• Verified date: March 2024
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 23, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Other:
• Dual task
exercise with dual task + usual treatment
• Single task
exercise without dual task + usual treatment.

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscular endurance assessed by the maximum number of possible repetitions of exercise with elastic resistance	The maximum number of possible repetitions of exercise with elastic resistance in each of the conditions shall be counted (to a perceived effort of BORG 3/10)	Baseline (0 weeks)
Primary	Muscular endurance assessed by the maximum number of possible repetitions of exercise with elastic resistance	The maximum number of possible repetitions of exercise with elastic resistance in each of the conditions shall be counted (to a perceived effort of BORG 3/10)	Change from Baseline at 4 weeks
Secondary	Kinesiophobia assessed by the TSK-11	Kinesiophobia will be assessed using the Spanish version of the Tampa Kinesiophobia Scale (TSK-11) in a self-recorded manner. This instrument has shown adequate reliability (showing an internal consistency of a=0.79). The total score ranges from 11 to 44 points, with higher levels of kinesiophobia occurring the higher the score on the scale [17]. In addition, kinesiophobia specific to the type of exercise performed will be assessed, with a self-perceived scale from 0 to 10, where patients will indicate the fear of performing all possible repetitions during a strength exercise. This questionnaire will be carried out pre- and post-intervention	Baseline (0 weeks)
Secondary	Catastrophizing assessed by thePCS	The level of Catastrophism will be assessed through the self-recorded Pain Catastrophism Scale (PCS), which consists of 13 items describing different thoughts and feelings associated with pain. The scale has 5 grades, being 0 not at all, 1 a little, 2 moderately, 3 a lot and 4 all the time. The subject has to mark his or her situation in each case. The scale consists of 13 items in total (0-52 points). Higher scores indicate higher levels of pain catastrophism. This questionnaire has a minimum detectable change of 10.45 points and has shown excellent psychometric reliability data (a=0.94). The cut-off point for early detection of people with a tendency towards pain catastrophizing is 11 points. This questionnaire will be administered pre- and post-intervention	Baseline (0 weeks)
Secondary	Self-efficacy assessed by the Perceived Chronic Pain Self-Efficacy questionnaire	The Perceived Chronic Pain Self-Efficacy questionnaire contains 19 items and assesses 3 domains with good psychometric reliability values: self-efficacy for pain management (a=0.72), physical functioning (a=0.98) and symptom management (a=0.85). Each item is scored from 0-10, with 0 being "not at all able" and 10 being "fully able". The main objective of this questionnaire is to assess the perceived self-efficacy and ability to cope with the consequences of pain in patients with chronic pain. Furthermore, this questionnaire has a criterion (concurrent) validity value of r=0.75. This questionnaire will be administered pre- and post-intervention (baseline and after 4 weeks).	Baseline (0 weeks)
Secondary	Severity of symptoms and function assessed by the BCTS	Boston carpal tunnel questionare (BCTS) subscales: 1) The Symptom Severity Questionnaire consists of 11 questions, each offering 5 response options, from 1 (no symptoms) to 5 (most severe/frequent). 2) The Functionality Questionnaire includes 8 questions assessing difficulty in performing everyday tasks (opening a new or very tight bottle, writing, turning a key, preparing food, etc.). The score for each subscale is weighted to obtain an average ranging from 1 to 5 points. This questionnaire will be administered pre- and post-intervention.	Baseline (0 weeks)
Secondary	Pain assessed by the VAS	The visual analogue scale (VAS) is a 100 millimetre (mm) line used to assess self-perceived pain intensity in research. At the left end of the line is a small text indicating "no pain" and at the right end of the line is a small text stating "maximum bearable pain". The patient marks a point on the scale and then the clinician or researcher quantifies the number of mm marked by the patient. Thus, the range of self-perceived pain intensity travels from 0-100 mm. VAS is the most widely used in research to date to assess pain intensity. This variable will be measured on 3 occasions: pre-, immediate post-exercise and after 10 min, in the first two sessions (familiarisation week and acute effects analysis) and after 4 weeks of intervention.	Baseline (0 weeks)
Secondary	Pressure Pain assessed by the PPT	Pressure Pain Thresholds (PPT): The Algometer (Wagner Instruments, Greenwich, CT, USA), will be used in this study. It consists of a round rubber disc (1 cm2 surface area) attached to a pressure (force) gauge. The gauge displays values in kilograms, but as the surface area of the rubber tip is 1 cm2, the readings are expressed in kg/cm2. The range of values of the pressure algometer is from 0 to 10 kg, in 0.1 kg intervals. Pressure is applied at a rate of 0.31 kg/s or 1 kg every 3 seconds. Previous studies have reported that the intra-examiner reliability of this procedure ranges between 0.6 and 0.97, while the inter-examiner reliability ranges between 0.4 and 0.98. Pressure pain thresholds will be carried out bilaterally (affected and unaffected side) on the carpal tunnel (distal to the scar) and lateral epicondyle on the unaffected limb. This variable will be measured on 3 occasions: pre, immediate post-exercise and immediate post-exercise.	Baseline (0 weeks)
Secondary	Kinesiophobia assessed by the TSK-11	Kinesiophobia will be assessed using the Spanish version of the Tampa Kinesiophobia Scale (TSK-11) in a self-recorded manner. This instrument has shown adequate reliability (showing an internal consistency of a=0.79). The total score ranges from 11 to 44 points, with higher levels of kinesiophobia occurring the higher the score on the scale [17]. In addition, kinesiophobia specific to the type of exercise performed will be assessed, with a self-perceived scale from 0 to 10, where patients will indicate the fear of performing all possible repetitions during a strength exercise. This questionnaire will be carried out pre- and post-intervention	Change from Baseline at 4 weeks
Secondary	Catastrophizing assessed by the PCS	The level of Catastrophism will be assessed through the self-recorded Pain Catastrophism Scale (PCS), which consists of 13 items describing different thoughts and feelings associated with pain. The scale has 5 grades, being 0 not at all, 1 a little, 2 moderately, 3 a lot and 4 all the time. The subject has to mark his or her situation in each case. The scale consists of 13 items in total (0-52 points). Higher scores indicate higher levels of pain catastrophism. This questionnaire has a minimum detectable change of 10.45 points and has shown excellent psychometric reliability data (a=0.94). The cut-off point for early detection of people with a tendency towards pain catastrophizing is 11 points. This questionnaire will be administered pre- and post-intervention	Change from Baseline at 4 weeks
Secondary	Self-efficacy assessed by the Perceived Chronic Pain Self-Efficacy questionnaire	The Perceived Chronic Pain Self-Efficacy questionnaire contains 19 items and assesses 3 domains with good psychometric reliability values: self-efficacy for pain management (a=0.72), physical functioning (a=0.98) and symptom management (a=0.85). Each item is scored from 0-10, with 0 being "not at all able" and 10 being "fully able". The main objective of this questionnaire is to assess the perceived self-efficacy and ability to cope with the consequences of pain in patients with chronic pain. Furthermore, this questionnaire has a criterion (concurrent) validity value of r=0.75. This questionnaire will be administered pre- and post-intervention (baseline and after 4 weeks).	Change from Baseline at 4 weeks
Secondary	Severity of symptoms and function assessed by the BCTS	Boston carpal tunnel questionare (BCTS) subscales: 1) The Symptom Severity Questionnaire consists of 11 questions, each offering 5 response options, from 1 (no symptoms) to 5 (most severe/frequent). 2) The Functionality Questionnaire includes 8 questions assessing difficulty in performing everyday tasks (opening a new or very tight bottle, writing, turning a key, preparing food, etc.). The score for each subscale is weighted to obtain an average ranging from 1 to 5 points. This questionnaire will be administered pre- and post-intervention.	Change from Baseline at 4 weeks
Secondary	Pain assessed by the VAS	The visual analogue scale (VAS) is a 100 millimetre (mm) line used to assess self-perceived pain intensity in research. At the left end of the line is a small text indicating "no pain" and at the right end of the line is a small text stating "maximum bearable pain". The patient marks a point on the scale and then the clinician or researcher quantifies the number of mm marked by the patient. Thus, the range of self-perceived pain intensity travels from 0-100 mm. VAS is the most widely used in research to date to assess pain intensity. This variable will be measured on 3 occasions: pre-, immediate post-exercise and after 10 min, in the first two sessions (familiarisation week and acute effects analysis) and after 4 weeks of intervention.	Change from Baseline at 4 weeks
Secondary	Pressure Pain assessed by the PPT	Pressure Pain Thresholds (PPT): The Algometer (Wagner Instruments, Greenwich, CT, USA), will be used in this study. It consists of a round rubber disc (1 cm2 surface area) attached to a pressure (force) gauge. The gauge displays values in kilograms, but as the surface area of the rubber tip is 1 cm2, the readings are expressed in kg/cm2. The range of values of the pressure algometer is from 0 to 10 kg, in 0.1 kg intervals. Pressure is applied at a rate of 0.31 kg/s or 1 kg every 3 seconds. Previous studies have reported that the intra-examiner reliability of this procedure ranges between 0.6 and 0.97, while the inter-examiner reliability ranges between 0.4 and 0.98. Pressure pain thresholds will be carried out bilaterally (affected and unaffected side) on the carpal tunnel (distal to the scar) and lateral epicondyle on the unaffected limb. This variable will be measured on 3 occasions: pre, immediate post-exercise and immediate post-exercise.	Change from Baseline at 4 weeks