Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome

Preoperative Pain Neuroscience Education Combined With Therapeutic Exercise Post-surgery in Patients With Carpal Tunnel Syndrome. A Double-blind Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Preoperative Pain Neuroscience Education; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile
      • Hospital Clinico La Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain Neuroscience Education; 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.	Other: Preoperative Pain Neuroscience Education; 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.; Other Names: Experimental
Other: Usual Care; 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.	Other: Usual Care; 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.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline Disability at fourth and twelfth week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 from Baseline Kinesiophobia at fourth and twelfth week
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 from Baseline emotional status at fourth and twelfth week
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).	Change from Baseline Pain at fourth and twelfth week

Collaborators and Investigators

• Sponsor: Hospital Clínico La Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Pain; physical therapy; disability; kinesiophobia.
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: RNC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No