The Importance of the Number of Incisions in the Effectiveness of Dry Needling

Neck Pain Clinical Trial

Official title:

Effectiveness of the Dry Needling Technique According to the Number of Incisions in the Treatment of Neck Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149442
• Other study ID #: CEIM/2022/1/008
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: January 20, 2025

Study information

• Verified date: April 2024
• Source: University of Alcala
• Contact: Grupo Fisioterapia y dolor
• Phone: +34 918855142
• Email: gifyd[@]uah.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The dry needling technique is a procedure increasingly used by health professionals.

Dry needling consists of the use of a filiform needle to treat musculoskeletal pain. Currently, the mechanisms by which it is an effective technique are not well understood. One of the aspects not yet evaluated is the best dose in terms of the number of times it is necessary to insert the needle into the patient to achieve the best result.

This research work aims to assess which treatment obtains the best results in the management of patients with chronic neck pain.

Description:

With the objective of demonstrating how the dose used during the application of the dry needling technique is related to the effectiveness of the treatment, we have designed a study where three different doses of the dry needling technique for the treatment of myofascial trigger points will be compared in the upper trapezius muscle in participants with neck pain.

Randomly, the participants will be distributed to each of the treatment groups and we will measure how the effectiveness of each of the applied doses determines the result of the application of the dry needling technique in the treatment of neck pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 20, 2025
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Nonspecific mechanical neck pain for more than 3 months.

• Neck pain of at least VAS 5/10.

• Reproduction of pain and symptoms subjects on palpation.

• Pain on passive stretching of the muscle.

Exclusion Criteria:

• Subjects with previous surgical intervention.

• Subjects undergoing other intervention (rehabilitation/medication).

• Positive findings that raise suspicion of cervical radiculopathy:

• Subjects diagnosed: degenerative arthropathies, inflammatory, systemic conditions (fibromyalgia).

• Cardiovascular diseases.

• Whiplash or whiplash.

• Belenophobia.

• Dizziness and vertigo.

• Pregnant.

• Thyroid disorders.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Dose of five-incisions dry needling technique
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (five incisions).
• Dose of ten-incisions dry needling technique
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (ten incisions).
• Dose of fifteen-incisions dry needling technique
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (fifteen incisions).

Locations

Country	Name	City	State
Spain	Centro Investigación Fisioterapia y Dolor	Alcalá De Henares	Madrid
Spain	Physiotherapy and Pain Institute	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck pain	Visual Analog Scale (VAS). VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. It is a straight horizontal line of fixed length, usually 100 mm where 0 is no pain and 10 is the worst possible pain.	Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
Secondary	Disability (Neck disability index)	This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. It´s value ranges from 0 to 10 to 50 points, where 0 is the absence of disability and 50 is the highest degree of disability.	Change From Baseline in Pain Scores on the Visual Analog Scale at one month.
Secondary	Pain pressure Threshold	Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation.	Change From Baseline in Pain Scores on the Visual Analog Scale at one month.