Clinical trial NCT04058041: Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome
Official title: Effectiveness of Neural Mobilizations Exercises Versus Surgery in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Pain
Keywords: Neural mobilization
Surgery
Pain modulation
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physiological parameter
timeFrame: Change from Baseline Conditioned pain modulation at 6 months
Secondary outcomes:
measure: Neuropathic pain
timeFrame: Baseline and 6 months
measure: Pain intensity
timeFrame: Baseline and 6 months
measure: Pain expansion
timeFrame: Change from baseline and 6 months
measure: Pressure pain threshold
timeFrame: Baseline and 6 months
measure: Psychological factors_Anxiety
timeFrame: Baseline and 6 months
measure: Psychological factors_Depression
timeFrame: Baseline and 6 months
measure: Psychological factors_Kinesiophobia
timeFrame: Baseline and 6 months
measure: Psychological factors_catastrophizing
timeFrame: Baseline and 6 months
measure: Psychological factors_Fear avoidance
timeFrame: Baseline and 6 months
measure: Disability_DASH
timeFrame: Baseline and 6 months
measure: Disability_BOSTON
timeFrame: Baseline and 6 months
measure: Strength_grip
timeFrame: Baseline and 6 months
measure: Strength_pinch
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References: