Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome

NCT03576196 | Completed DMC

• 1 other identifier: RNC-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

physical therapy; Pain; disability; kinesiophobia.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Pain Interference: Kinesiophobia

  Change from Baseline Kinesiophobia at fourth and twelfth week

• Change of Emotional status: Hospital Anxiety and Depression Scale (HAD).

  Change from Baseline emotional status at fourth and twelfth week

• Change of Pain evaluation:

  Change from Baseline Pain at fourth and twelfth week

Study Arms (2)

Pain Neuroscience Education

EXPERIMENTAL

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

Usual Care

OTHER

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

Interventions

Preoperative Pain Neuroscience Education OTHER

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.

Also known as: Experimental

Pain Neuroscience Education

Usual Care OTHER

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.

Also known as: Control

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clínico La Florida: lead

Study Sites (1)

Hospital Clinico La Florida

Santiago, RM, Chile

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: July 3, 2018
• Study Start: June 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: May 30, 2018
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

CL (1)