Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576196
• Other study ID #: RNC-001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: August 2019
• Source: Hospital Clínico La Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 30, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Chile	Hospital Clinico La Florida	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clínico La Florida

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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