Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058041
• Other study ID #: CPMP/ICH/135/95
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: September 20, 2020

Study information

• Verified date: August 2019
• Source: Universidad Rey Juan Carlos
• Contact: Josué Fernández, PhD
• Phone: 34914888949
• Email: josue.fernandez[@]urjc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

neural exercise in patients with carpal tunnel syndrome

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: September 20, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Neuralgia
• Neuropathic Pain

Intervention

Procedure:
• Neural Mobilization
neural exercise Will be performed in the patients
• Surgery
open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome
• Surgery and neural mobilization
following the surgery patients will be treat with neural mobilization exercises.

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

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