Efficacy of Dry Needling With the Fascial Winding Technique in the Carpal Tunnel Syndrome

NCT03907956 | Completed

• 1 other identifier: JGascon-Garcia
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

So far there are studies that report the benefits of physiotherapy treatment in carpal tunnel syndrome, but none on the treatment of dry needling. Recently, an ultrasound validation study has been published in which the results indicate that the application of dry needling with "fascial winding technique" in the carpal tunnel, following the "four-pole carpal dry needling" model, is valid for reaching and traction of the transverse carpal ligament. Stretching over this ligament could lead to new therapeutic possibilities for dry needling at this level. The objective of this project is to demonstrate the clinical efficacy of this technique in patients affected by carpal tunnel syndrome, determining the proportion of patients who can be avoided surgery, and quantifying the improvement in the clinic related to pain, strength and functionality of the hand and the median nerve. The study is a randomized clinical trial on a sample of 86 patients diagnosed with carpal tunnel syndrome, who have been prescribed surgery at this level. The degree of involvement of the median nerve will be mild or moderate, according to electromyographic results. The dry needling with fascial winding technique will be applied to the intervention group following the model of "four-pole carpal dry needling" during a period of 6 weeks, at the rate of one weekly session. The control group will remain within the normal course of their waiting list status for STC surgery, without receiving any extraordinary treatment to what is normally practiced in this situation. The main variables contemplated are: need for surgery at the end of the study, level of involvement of the median nerve (according to electromyographic result), transverse area of the median nerve at the entrance of the carpal tunnel and relationship between the area of the median nerve at the wrist and the forearm (both recorded by ultrasound study), pain intensity (using visual analog scale), symptom intensity, functional capacity and quality of life (according to the Boston Carpal Tunnel Questionnaire), and degree of muscular strength to the grip manual and digital.

Conditions

Carpal Tunnel Syndrome

Keywords

physiotherapy; carpal tunnel syndrome; myofascial pain syndrome; dry needling

Outcome Measures

Primary Outcomes (1)

• The need to continue performing surgery for carpal tunnel syndrome.

  According to the tests carried out and under medical criteria, at the end of the study will be assessed the need to continue performing surgery at this level for each of the individuals who participated in the study.

  Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study

Secondary Outcomes (9)

• Level of involvement of the median nerve, registered by EMG.

  Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study

• Cross sectional area of the median nerve at the wrist tunnel (CSA-M)

  Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study

• Wrist-forearm relationship (WF-R)

  Before the start of treatment (week 0) and after 6 weeks of the end of treatment (week 12), in all the subjects participating in the study

• Intensity of pain, collected and measured with a Visual Analogue Scale (VAS).

  For Intervention group: Before the start of treatment (week 0), every two weeks (weeks 2, 4, 6 and 8) and after 6 weeks of the end of treatment (week 12). For Control group: week 0, week 6 and wek 12

• Boston Carpal Tunnel Questionare (BCTQ)

  For Intervention group: Before the start of treatment (week 0), every two weeks (weeks 2, 4, 6 and 8) and after 6 weeks of the end of treatment (week 12). For Control group: week 0, week 6 and wek 12

Other Outcomes (8)

• Age

  Before the start of treatment (week 0)

• Sex

  Before the start of treatment (week 0)

• Profession

  Before the start of treatment (week 0)

Study Arms (2)

INTERVENTION

EXPERIMENTAL

The subjects included in the intervention group will be treated with Dry Needling with Fascial Winding Technique according to the original Four-Pole Carpal Dry Needling approach, which has already been validated recently by means of a first ultrasound study.

Other: Dry Needling with Fascial Winding Technique

CONTROL

NO INTERVENTION

The individuals of the control group will remain within the normal course of their waiting list status for CTS surgery, without receiving any extraordinary treatment to what is normally practiced in this situation.

Interventions

Dry Needling with Fascial Winding Technique OTHER

For placement of Dry Needling (DN) needles with Fascial Winding Technique (FWT) according to the Four-pole Carpal Dry Needling (FCDN) approach model, only anatomical references are used, in all cases from a carpal ventral approach. The needles used are the Chinese type with silver handle and guide tube, measuring 25x0.30 mm., Agupunt® brand. Four needles are placed, at the level of the bones: scaphoid, pisiform, trapezius and hamate. The four needles follow an oblique direction, always on the back and looking for the midline of the center of the carpal tunnel, with an inclination of approximately 45º, both in the cranio-caudal and medial-lateral directions. In each of the needles, it deepens until it reaches a firm elastic stop, attributable to the Transverse Carpal Ligament. Next, the FWT is applied to each of the needles, consisting of rotating them in the same direction until you feel the final stop of the "needle grasp".

INTERVENTION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The study population are individuals with a clinical and electromyographic diagnosis of CTS, and levels of mild median nerve involvement (focal demyelination without axonal degeneration) or moderate (focal demyelination with sensory but non-motor axonal degeneration) according to electromyogram (EMG).

You may not qualify if:

• Will not be included those subjects with previous surgery in the CT, to whom the involvement of the median nerve is attributable to another type of neuropathy (diabetic, uraemic, deficiency, ...), to those who present a previous pain in the region, attributable to arthritis and not to CTS, to individuals suffering from fibromyalgia and/or chronic pain syndrome, to those who suffer from aversion or phobia to needles, to pregnant patients, to those with intellectual disability to understand the procedure, methodology and object of the study (mental, psychiatric disorders, low level of IQ, ...), and/or those patients who show little collaboration to the correct performance of the study.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Hospital Universitari de Bellvitge: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08967, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Jordi Gascon-Garcia

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Assignment to groups. To the extent that the sample is recruited, subjects will be randomly distributed into two groups (intervention and control) using a software-generated randomization system. Each subject will be assigned a numbered, sealed and opaque envelope where their inclusion in the intervention or control group will be specified. The evaluating staff will be blinded to the assignment to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is a randomized single-blind clinical trial (RCT).

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 9, 2019
• Study Start: April 1, 2019
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

ES (1)