Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome

• ClinicalTrials.gov Identifier: NCT03576196
• Recruitment Status: Completed
• First Posted: July 3, 2018
• Last Update Posted: August 7, 2019
• Sponsor: Hospital Clínico La Florida
• Information provided by (Responsible Party): Hospital Clínico La Florida

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.

Condition or disease	Intervention/treatment	Phase
Carpal Tunnel Syndrome	Other: Preoperative Pain Neuroscience Education; Other: Usual Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Preoperative Pain Neuroscience Education Combined With Therapeutic Exercise Post-surgery in Patients With Carpal Tunnel Syndrome. A Double-blind Randomized Controlled Trial
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: November 30, 2017
• Actual Study Completion Date: May 30, 2018

Arms and Interventions

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 Name: Experimental
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 Name: Control

Outcome Measures

Primary Outcome Measures :

1. Change of Disability in upper-limb [ Time Frame: Change from Baseline Disability at fourth and twelfth week ]
   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 :

1. Change of Pain Interference: Kinesiophobia [ Time Frame: Change from Baseline Kinesiophobia at fourth and twelfth week ]
   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).
2. Change of Emotional status: Hospital Anxiety and Depression Scale (HAD). [ Time Frame: Change from Baseline emotional status at fourth and twelfth week ]
   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.
3. Change of Pain evaluation: [ Time Frame: Change from Baseline Pain at fourth and twelfth week ]
   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).

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Chile

Hospital Clinico La Florida

Santiago, RM, Chile

Sponsors and Collaborators

Hospital Clínico La Florida

More Information

• Responsible Party: Hospital Clínico La Florida
• ClinicalTrials.gov Identifier: NCT03576196
• Other Study ID Numbers: RNC-001
• First Posted: July 3, 2018
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Clínico La Florida:

physical therapy; Pain; disability; kinesiophobia.

Additional relevant MeSH terms:

Carpal Tunnel Syndrome; Syndrome; Disease; Pathologic Processes; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries