Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

Effectiveness of Neural Mobilizations Exercises Versus Surgery in Patients With Carpal Tunnel Syndrome

neural exercise in patients with carpal tunnel syndrome

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain
• Intervention / Treatment: Procedure: Surgery; Procedure: Surgery and neural mobilization; Procedure: Neural Mobilization

Detailed Description

OBJECTIVE: The aim objective is to compare the neurophysiological effects of the surgery versus neural mobilization exercises added to surgery versus only neural mobilization exercises on temporal summation and noxious inhibitory pain system and their relationship with the improve of symptoms, with pain and disability in patients with Carpal tunnel syndrome.

STUDY DESIGN: Randomized parallel-group trial. BACKGROUND: Carpal tunnel syndrome (CTS) such as a neuropathic pain condition with altered pain modulation and wind-up, but there is a clack of knowledge if some therapies could have a positive effect.

METHODS: In the Humans study, 54 patients with CTS will be randomly allocated to either a surgery group (n=18) or Surgery with neural exercises group (n=18) or neural exercise group (n=18), the groups with neural exercise will received 10 sessions. The primary outcome will be conditioned pain modulation, temporal summation, pain intensity,. Secondary outcomes will be hand disability assessed with the Boston Carpal Tunnel Questionnaire, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire, neuropathic pain questionnaire (DN4), psychological questionnaires (anxiety, catastrophizing, kinesiophobia depression and fear avoid questionnaires), and pressure pain threshold. Patients will be assessed baseline and post-treatment, 1, 3 and 6 months after the last treatment by an assessor unaware of group assignment Patients were assessed at. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josué Fernández, PhD; Phone Number: 34914888949; Email: josue.fernandez@urjc.es
• Study Contact Backup: Name: Luis Matesanz; Phone Number: 675042482; Email: luis.matesanzgarcia@gmail.com

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Recruiting
      • Universidad Rey Juan Carlos
      • Contact: Josué Fernández, PhD; Phone Number: 34914888949; Email: josue.fernandez@urjc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Tinel and Phalen positive 4/10 in VAS Scale Increase symptoms at night 12 months of symptomatology Sensorial and motor dysfunction in the conduction of the median nerve

Exclusion Criteria:

Previous surgery Wrist fractures Rheumatoid Arthritis or Fibromyalgia Systemic disease Pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neural mobilization; passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand	Procedure: Surgery; open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome; Procedure: Surgery and neural mobilization; following the surgery patients will be treat with neural mobilization exercises.
Active Comparator: Surgery; the surgeon will release the median nerve in the tunnel carpal. After that the therapist will teach home exercises (no neural exercises) to the patients.	Procedure: Surgery and neural mobilization; following the surgery patients will be treat with neural mobilization exercises.; Procedure: Neural Mobilization; neural exercise Will be performed in the patients
Active Comparator: Surgery and Neural mobilization; the surgeon will release the median nerve in the tunnel carpal. After that the therapist will perform mobilizations of the median nerve just like the experimental group.	Procedure: Surgery; open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome; Procedure: Neural Mobilization; neural exercise Will be performed in the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameter	Conditioned pain modulation: Diffuse noxious inhibitory control system will be measure with tourniquet test	Change from Baseline Conditioned pain modulation at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain	Neuropathic pain Questionnaire DN4	Baseline and 6 months
Pain intensity	Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).	Baseline and 6 months
Pain expansion	Body pain maps	Change from baseline and 6 months
Pressure pain threshold	Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.	Baseline and 6 months
Psychological factors_Anxiety	State Trait Anxiety Inventory (STAI-T)	Baseline and 6 months
Psychological factors_Depression	Beck Depression Inventory (BDI-II)	Baseline and 6 months
Psychological factors_Kinesiophobia	Tampa Scale for Kinesiophobia.. The score goes from 11 to 44. A higher value indicates a worse outcome.	Baseline and 6 months
Psychological factors_catastrophizing	Pain Catastrophizing Scale. The scores goes from 0 to 52. A higher value indicates a worse outcome.	Baseline and 6 months
Psychological factors_Fear avoidance	Fear Avoidance Belief Questionnaire (FABQ)	Baseline and 6 months
Disability_DASH	Disabilities of Arm, Shoulder and Hand (DASH)	Baseline and 6 months
Disability_BOSTON	Boston Carpal Tunnel Questionnaire	Baseline and 6 months
Strength_grip	grip strength without pain	Baseline and 6 months
Strength_pinch	pinch strength	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Anticipated): February 12, 2020
• Study Completion (Anticipated): September 20, 2020

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Surgery; Pain modulation; Neural mobilization
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome; Neuralgia
• Other Study ID Numbers: CPMP/ICH/135/95

Drug and device information, study documents

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