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

Sponsor
University of Alcala (Other)
Overall Status
Recruiting
CT.gov ID
NCT06149442
Collaborator
(none)
90
2
3
6.5
45
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dose of five-incisions dry needling technique
  • Other: Dose of ten-incisions dry needling technique
  • Other: Dose of fifteen-incisions dry needling technique
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effectiveness of the Dry Needling Technique According to the Number of Incisions in the Treatment of Neck Pain
Actual Study Start Date :
Dec 4, 2023
Anticipated Primary Completion Date :
Mar 20, 2024
Anticipated Study Completion Date :
Jun 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose of five muscle incisions

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
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).

Experimental: Dose of ten muscle incisions

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
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).

Experimental: Dose of fifteen muscle incisions

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
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).

Outcome Measures

Primary Outcome Measures

  1. Neck pain [Change From Baseline in Pain Scores on the Visual Analog Scale at one month.]

    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.

Secondary Outcome Measures

  1. Disability (Neck disability index) [Change From Baseline in Pain Scores on the Visual Analog Scale at one month.]

    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.

  2. Pain pressure Threshold [Change From Baseline in Pain Scores on the Visual Analog Scale at one month.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro Investigación Fisioterapia y Dolor Alcalá De Henares Madrid Spain 28805
2 Physiotherapy and Pain Institute Alcalá de Henares Madrid Spain 28805

Sponsors and Collaborators

  • University of Alcala

Investigators

  • Study Director: Daniel Pecos-Martin, PhD, Alcalá University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Daniel Pecos Martín, Principal investigator, University of Alcala
ClinicalTrials.gov Identifier:
NCT06149442
Other Study ID Numbers:
  • CEIM/2022/1/008
First Posted:
Nov 29, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Dec 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Dr. Daniel Pecos Martín, Principal investigator, University of Alcala
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023