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

NCT06149442 | Active Not Recruiting

• 1 other identifier: CEIM/2022/1/008
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neck Pain

Keywords

dry needling; myofascial trigger point

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disability (Neck disability index)

  Change From Baseline in Pain Scores on the Visual Analog Scale at one month.

• Pain catastrophizing

  Change From Baseline in Pain Scores on the Visual Analog Scale at one month.

• kinesiophobia

  Change From Baseline in Pain Scores on the Visual Analog Scale at one month.

• The Global Rating of Change (GRoC)

  Change From Baseline in Pain Scores on the Visual Analog Scale at one month.

Study Arms (3)

Dose of five muscle incisions

EXPERIMENTAL

Subjects treated in this group will receive an in-out technique with a dosage of five incisions in the myofascial trigger point of the levator scapulae muscle.

Other: Dose of five-incisions dry needling technique

Dose of ten muscle incisions

EXPERIMENTAL

Subjects treated in this group will receive an in-out technique with a dosage of ten incisions in the myofascial trigger point of the levator scapulae muscle.

Other: Dose of ten-incisions dry needling technique

Dose of fifteen muscle incisions

EXPERIMENTAL

Subjects treated in this group will receive an in-out technique with a dosage of fifteen incisions in the myofascial trigger point of the levator scapulae muscle.

Other: Dose of fifteen-incisions dry needling technique

Interventions

Dose of ten-incisions dry needling technique OTHER

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 ten muscle incisions

Dose of fifteen-incisions dry needling technique OTHER

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).

Dose of fifteen muscle incisions

Dose of five-incisions dry needling technique OTHER

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 five muscle incisions

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (2)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Location

Physiotherapy and Pain Institute

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Pecos-Martin, PhD

  Alcalá University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: December 4, 2023
• Primary Completion: January 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

ES (2)