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Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

U

Universidad Rey Juan Carlos

Status

Unknown

Conditions

Neuropathic Pain

Treatments

Procedure: Surgery and neural mobilization
Procedure: Neural Mobilization
Procedure: Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04058041
CPMP/ICH/135/95

Details and patient eligibility

About

neural exercise in patients with carpal tunnel syndrome

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 3 patient groups

Neural mobilization
Experimental group
Description:
passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand
Treatment:
Procedure: Surgery
Procedure: Surgery and neural mobilization
Surgery
Active Comparator group
Description:
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.
Treatment:
Procedure: Surgery and neural mobilization
Procedure: Neural Mobilization
Surgery and Neural mobilization
Active Comparator group
Description:
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.
Treatment:
Procedure: Surgery
Procedure: Neural Mobilization

Trial contacts and locations

1

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Central trial contact

Luis Matesanz; Josué Fernández, PhD

Data sourced from clinicaltrials.gov

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