Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

Not Applicable

• Conditions: Neuropathic Pain
• Interventions: Procedure: Neural Mobilization; Procedure: Surgery; Procedure: Surgery and neural mobilization

• Registration Number: NCT04058041
• Lead Sponsor: Universidad Rey Juan Carlos

Brief Summary

neural exercise in patients with carpal tunnel syndrome

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 Timeline

• Study First Submitted: 2018-02-13
• Study Start: 2018-03-12
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-14
• Last Update Submitted: 2019-08-14
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-15
• Primary Completion: 2020-02-12
• Study Completion: 2020-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery and Neural mobilization	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.
Neural mobilization	Surgery	passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand
Surgery and Neural mobilization	Surgery	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.
Neural mobilization	Surgery and neural mobilization	passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand
Surgery	Neural Mobilization	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.
Surgery	Surgery and neural mobilization	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain intensity	Baseline and 6 months	Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Neuropathic pain	Baseline and 6 months	Neuropathic pain Questionnaire DN4
Pain expansion	Change from baseline and 6 months	Body pain maps
Pressure pain threshold	Baseline and 6 months	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.
Psychological factors_Anxiety	Baseline and 6 months	State Trait Anxiety Inventory (STAI-T)
Psychological factors_Depression	Baseline and 6 months	Beck Depression Inventory (BDI-II)
Psychological factors_Kinesiophobia	Baseline and 6 months	Tampa Scale for Kinesiophobia.. The score goes from 11 to 44. A higher value indicates a worse outcome.
Psychological factors_catastrophizing	Baseline and 6 months	Pain Catastrophizing Scale. The scores goes from 0 to 52. A higher value indicates a worse outcome.
Psychological factors_Fear avoidance	Baseline and 6 months	Fear Avoidance Belief Questionnaire (FABQ)
Strength_grip	Baseline and 6 months	grip strength without pain
Disability_DASH	Baseline and 6 months	Disabilities of Arm, Shoulder and Hand (DASH)
Disability_BOSTON	Baseline and 6 months	Boston Carpal Tunnel Questionnaire
Strength_pinch	Baseline and 6 months	pinch strength

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Alcorcón, Madrid, Spain