An interventional study of Preoperative Pain Neuroscience Education and Usual Care in Carpal Tunnel Syndrome, sponsored by Hospital Clínico La Florida. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Hospital Clínico La Florida · Not applicable, Interventional, and Treatment
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's enrollment of 2 is below the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Hospital Clínico La Florida is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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.
Time frame: Change from Baseline Disability at fourth and twelfth week
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).
Time frame: 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.
Time frame: 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).
Time frame: Change from Baseline Pain at fourth and twelfth week
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Clínico La Florida