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Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Preoperative Pain Neuroscience Education
Usual Care
Sponsored by
Hospital Clínico La Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring physical therapy, Pain, disability, kinesiophobia.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years of age
  • Medical diagnosis of Carpal Tunnel Syndrome waiting for surgery
  • Agree to participate in the study.

Exclusion Criteria:

  • Inability to understand instructions,
  • Illiteracy,
  • Previous participation in educational programs regarding pain,
  • Pathology of uncontrolled mental health,
  • Cognitive problems,
  • Previous surgeries in the operated extremity.

Sites / Locations

  • Hospital Clinico La Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pain Neuroscience Education

Usual Care

Arm Description

Single session of pain neuroscience education a week prior to surgery, of an individual character, lasting approximately 30 minutes, performed by a physiotherapist trained. The main contents addressed in the educational session were: neurophysiological aspects of pain, biopsychosocial aspects of pain, concept of peripheral and central sensitization, using audio-visual support, examples and metaphors for a better understanding by the patient, as reported in previous studies. This treatment was combined with a hand therapy session seven days after the surgery, verbal and written instruction was given to the patients to perform exercises at home of active sliding of the digital flexor tendon, active opposition of the thumb and active range of flexion and extension of the wrist.

Patients in the control group received "usual care", which consists of an educational session prior to surgery, based on medical, anatomical and pathological aspects of the syndrome. This treatment was combined with a hand therapy session seven days after the surgery, verbal and written instruction was given to the patients to perform exercises at home of active sliding of the digital flexor tendon, active opposition of the thumb and active range of flexion and extension of the wrist.

Outcomes

Primary Outcome Measures

Change of Disability in upper-limb
The Perception of patients of their disability in upper-limb evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH) Spanish version Outcome Measure is a 30-item scored 1-5. The assigned values for all completed responses are simply summed and averaged. Scoring: The assigned values for all completed responses are simply summed and averaged and higher values represent a worse Disability in upper-limb.

Secondary Outcome Measures

Change of Pain Interference: Kinesiophobia
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 of Emotional status: Hospital Anxiety and Depression Scale (HAD).
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 of Pain evaluation:
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome (0 is no pain and 10 the maximum pain experienced).

Full Information

First Posted
May 14, 2018
Last Updated
August 6, 2019
Sponsor
Hospital Clínico La Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03576196
Brief Title
Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome
Official Title
Preoperative Pain Neuroscience Education Combined With Therapeutic Exercise Post-surgery in Patients With Carpal Tunnel Syndrome. A Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clínico La Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study Design: A double-blind randomized controlled study. Background: Patients operated on for carpal tunnel release surgery may persist with pain after surgery, which could be modulated by psychosocial factors such as depression, catastrophic thinking and kinesiophobia. Objectives: To evaluate the efficacy of a preoperative session in pain neuroscience education combined with postoperative therapeutic exercise in the perception of pain, functionality and psychosocial variables in patients following carpal tunnel release. Methods: Thirty participants were randomly assigned to the pain neuroscience education group combined with postoperative therapeutic exercise (n = 15) or to the control group with preoperative usual care combined with postoperative therapeutic exercise (n = 15). Evaluations included the Visual Analogue Scale (VAS), Disability of Arm, Shoulder, and Hand Questionnaire (QuickDASH), pain Catastrophizing Scale (PCS), Tampa scale of kinesiophobia (TSK-11) and Hospital Anxiety and Depression Scale (HADS) . A basal, fourth and twelfth week measurement was made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
physical therapy, Pain, disability, kinesiophobia.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Neuroscience Education
Arm Type
Experimental
Arm Description
Single session of pain neuroscience education a week prior to surgery, of an individual character, lasting approximately 30 minutes, performed by a physiotherapist trained. The main contents addressed in the educational session were: neurophysiological aspects of pain, biopsychosocial aspects of pain, concept of peripheral and central sensitization, using audio-visual support, examples and metaphors for a better understanding by the patient, as reported in previous studies. This treatment was combined with a hand therapy session seven days after the surgery, verbal and written instruction was given to the patients to perform exercises at home of active sliding of the digital flexor tendon, active opposition of the thumb and active range of flexion and extension of the wrist.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Patients in the control group received "usual care", which consists of an educational session prior to surgery, based on medical, anatomical and pathological aspects of the syndrome. This treatment was combined with a hand therapy session seven days after the surgery, verbal and written instruction was given to the patients to perform exercises at home of active sliding of the digital flexor tendon, active opposition of the thumb and active range of flexion and extension of the wrist.
Intervention Type
Other
Intervention Name(s)
Preoperative Pain Neuroscience Education
Other Intervention Name(s)
Experimental
Intervention Description
Single session of pain neuroscience education a week prior to surgery, of an individual character, lasting approximately 30 minutes, performed by a physiotherapist trained. The main contents addressed in the educational session were: neurophysiological aspects of pain, biopsychosocial aspects of pain, concept of peripheral and central sensitization, using audio-visual support, examples and metaphors for a better understanding by the patient, as reported in previous studies. This treatment was combined with a hand therapy session seven days after the surgery, verbal and written instruction was given to the patients to perform exercises at home of active sliding of the digital flexor tendon, active opposition of the thumb and active range of flexion and extension of the wrist.
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Control
Intervention Description
This treatment was combined with a hand therapy session seven days after the surgery, verbal and written instruction was given to the patients to perform exercises at home of active sliding of the digital flexor tendon, active opposition of the thumb and active range of flexion and extension of the wrist.
Primary Outcome Measure Information:
Title
Change of Disability in upper-limb
Description
The Perception of patients of their disability in upper-limb evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH) Spanish version Outcome Measure is a 30-item scored 1-5. The assigned values for all completed responses are simply summed and averaged. Scoring: The assigned values for all completed responses are simply summed and averaged and higher values represent a worse Disability in upper-limb.
Time Frame
Change from Baseline Disability at fourth and twelfth week
Secondary Outcome Measure Information:
Title
Change of Pain Interference: Kinesiophobia
Description
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).
Time Frame
Change from Baseline Kinesiophobia at fourth and twelfth week
Title
Change of Emotional status: Hospital Anxiety and Depression Scale (HAD).
Description
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.
Time Frame
Change from Baseline emotional status at fourth and twelfth week
Title
Change of Pain evaluation:
Description
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome (0 is no pain and 10 the maximum pain experienced).
Time Frame
Change from Baseline Pain at fourth and twelfth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years of age Medical diagnosis of Carpal Tunnel Syndrome waiting for surgery Agree to participate in the study. Exclusion Criteria: Inability to understand instructions, Illiteracy, Previous participation in educational programs regarding pain, Pathology of uncontrolled mental health, Cognitive problems, Previous surgeries in the operated extremity.
Facility Information:
Facility Name
Hospital Clinico La Florida
City
Santiago
State/Province
RM
Country
Chile

12. IPD Sharing Statement

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Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome

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