NCT03402867

Brief Summary

This study evaluates the effectiveness of Deep dry needling of active myofascial trigger points present in muscles of the neck and shoulder region in orchestral musicians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_1

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 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

28 days

First QC Date

January 10, 2018

Last Update Submit

July 5, 2018

Conditions

Pain SyndromeMusculoskeletal PainTrigger Point Pain, Myofascial

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale for pain

    Pain measurement. 100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).

    2 weeks

Secondary Outcomes (3)

  • Pressure pain threshold

    2 weeks

  • Neck disability index (NDI)

    2 weeks

  • Shoulder pain disability index (SPADI)

    2 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Deep dry needling applied on active myofascial trigger points in the shoulder and neck regions

Procedure: Deep dry needling

Interventions

Deep dry needlingPROCEDURE

Insertion of a filiform needle in the active trigger point of musculoskeletal muscle

Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Orchestral musicians
  • Chronic neck or shoulder pain
  • Presence of active myofascial trigger points

You may not qualify if:

  • Fear of needles
  • Coagulation disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEU San Pablo University

Madrid, Madrid, 28668, Spain

Location

MeSH Terms

Conditions

Somatoform DisordersMusculoskeletal PainMyofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Mental DisordersMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Deep dry needling
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 18, 2018

Study Start

February 1, 2018

Primary Completion

March 1, 2018

Study Completion

March 5, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

ES(1)