Neuropathic Pain
Conditions
Keywords
Neural mobilization, Surgery, Pain modulation
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.
Interventions
PROCEDURENeural Mobilization
neural exercise Will be performed in the patients
PROCEDURESurgery
open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome
PROCEDURESurgery and neural mobilization
following the surgery patients will be treat with neural mobilization exercises.
Sponsors
Universidad Rey Juan Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Baseline and 6 months | Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain). |
| 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. |
| Neuropathic pain | Baseline and 6 months | Neuropathic pain Questionnaire DN4 |
| Psychological factors_Fear avoidance | Baseline and 6 months | Fear Avoidance Belief Questionnaire (FABQ) |
| Disability_DASH | Baseline and 6 months | Disabilities of Arm, Shoulder and Hand (DASH) |
| Disability_BOSTON | Baseline and 6 months | Boston Carpal Tunnel Questionnaire |
| Strength_grip | Baseline and 6 months | grip strength without pain |
| Strength_pinch | Baseline and 6 months | pinch strength |
| Psychological factors_catastrophizing | Baseline and 6 months | Pain Catastrophizing Scale. The scores goes from 0 to 52. A higher value indicates a worse outcome. |
Countries
Spain
Contacts
Primary ContactJosué Fernández, PhD
Backup ContactLuis Matesanz
Outcome results
None listed