NCT04695548

Brief Summary

Dry needling is a minimally invasive technique which generates good results and neuromuscular benefits. Its application involves a highly prevalent effect called post-needling soreness. It is defined as a residual pain, located in the incision area, with a self-limiting period of 24-72 hours, as a result of a physiological process generated by the technique. So far, different clinical trials have been carried out to measure the effectiveness of several techniques for reducing post-needling soreness, reaching positive results. However, no studies have been found with the aim of distinguish which method is more effective for this goal; therefore, it is clear the need to continue investigating on the subject and comparing these techniques among them.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 19, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

January 2, 2021

Last Update Submit

July 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-needling soreness intensity

    The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.

    Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.

Secondary Outcomes (3)

  • Pain Catastrophizing

    Change from Baseline Pain Catastrophizing at 72 hours.

  • Fear of Pain.

    Change from Baseline Fear of Pain at 72 hours.

  • Pain Anxiety Symptoms

    Change from Baseline Pain Anxiety at 72 hours.

Study Arms (4)

Concentric contraction exercise

EXPERIMENTAL

After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds

Other: Concentric contraction exercise

Isometric contraction exercise

EXPERIMENTAL

After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds

Other: Isometric contraction exercise

Eccentric contraction exercise

EXPERIMENTAL

After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds

Other: Eccentric contraction exercise

Analytic passive stretching.

EXPERIMENTAL

After applying the dry needling technique to the upper trapezius muscle, the patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds.

Other: Analytic passive stretching

Interventions

The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds

Also known as: Muscle concentric contraction
Concentric contraction exercise

The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds

Also known as: Muscle isometric contraction
Isometric contraction exercise

The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of asking the participant to lower their shoulder, against the resistance of the elastic band, in a slow and controlled manner for 5 seconds.

Also known as: Muscle eccentric contraction
Eccentric contraction exercise

The patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds.

Also known as: Muscle passive stretching
Analytic passive stretching.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years;
  • Cervical pain.
  • Presence of an active PGM in the upper trapezius muscle.

You may not qualify if:

  • Traumatic history in the cervical region;
  • Inability to understand or perform the required exercises;
  • Pregnancy in the first trimester;
  • Altered state of coagulation;
  • Immunosuppression status;
  • State of alteration of sensitivity (e.g. central sensitization processes, fibromyalgia, etc.);
  • Unavoidable fear of needles;
  • Lack of knowledge about the use of the WhatsApp or Telegram messaging platform

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical University Physiotherapy and pain

Alcalá de Henares, Madrid, 2805, Spain

Location

MeSH Terms

Conditions

MyalgiaMyofascial Pain Syndromes

Interventions

Isometric Contraction

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Muscle ContractionMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Daniel Pecos-Martin, PhD

    Alcala University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 2, 2021

First Posted

January 5, 2021

Study Start

February 23, 2021

Primary Completion

April 25, 2021

Study Completion

June 30, 2021

Last Updated

July 19, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations