NCT01710735

Brief Summary

In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
Last Updated

October 19, 2012

Status Verified

October 1, 2012

Enrollment Period

1.1 years

First QC Date

October 17, 2012

Last Update Submit

October 18, 2012

Conditions

Keywords

TPMyofascial pain

Outcome Measures

Primary Outcomes (1)

  • muscle contractility

    Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)

    30 minutes

Secondary Outcomes (2)

  • pressure-pain threshold

    60 seconds

  • NRS-101

    60 seconds

Study Arms (2)

Dry needling (deep)

EXPERIMENTAL

Subjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius.

Procedure: Dry needling

Dry needling (superficial)

ACTIVE COMPARATOR

Insertion of dry needle less than 1cm.

Procedure: Dry needling

Interventions

Dry needlingPROCEDURE

Insertion of acupuncture needle into a myofascial trigger point.

Also known as: Acupuncture
Dry needling (deep)Dry needling (superficial)

Eligibility Criteria

Age20 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A clinically relevant MFTrP of the upper Trapezius musculature
  • Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101).
  • BMI less than 31

You may not qualify if:

  • a history of chronic, systemic pathology (e.g. hemophilia)
  • pre-existing neck/shoulder pathology/surgical procedures,
  • clinical depression
  • health-related legal action
  • pregnant
  • anti-inflammatory and/or chronic pain medication
  • had received dry needling for a shoulder/neck disorder within 6 months prior to the study (to raise the level of patient naiveté) suffered from needle phobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ. of Southern Denmark

Odense, Funen, 5230, Denmark

Location

Related Publications (2)

  • Myburgh C, Hartvigsen J, Aagaard P, Holsgaard-Larsen A. Skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and upper Trapezius myofascial trigger points- a randomized intervention study. Chiropr Man Therap. 2012 Nov 25;20(1):36. doi: 10.1186/2045-709X-20-36.

  • Hofer KA, Ruonala R, Albert VA. The double-corolla phenotype in the Hawaiian lobelioid genus Clermontia involves ectopic expression of PISTILLATA B-function MADS box gene homologs. Evodevo. 2012 Nov 1;3(1):26. doi: 10.1186/2041-9139-3-26.

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry NeedlingAcupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Jan Hartvigsen Hartvigsen, PhD

    Univ. of Southern Denmark

    STUDY DIRECTOR
  • Per Aagaard, PhD

    Univ. of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 19, 2012

Study Start

April 1, 2011

Primary Completion

May 1, 2012

Study Completion

September 1, 2012

Last Updated

October 19, 2012

Record last verified: 2012-10

Locations