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Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs

Primary Purpose

Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dry needling
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myofascial Pain Syndrome focused on measuring TP, Myofascial pain

Eligibility Criteria

20 Years - 46 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Univ. of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling (deep)

Dry needling (superficial)

Arm Description

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

Insertion of dry needle less than 1cm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pressure-pain threshold
Algometer measurement of pressure-pain perception
NRS-101
Self-reported pain

Full Information

First Posted
October 17, 2012
Last Updated
October 18, 2012
Sponsor
University of Southern Denmark
Collaborators
Lundbeck Foundation, Dansk Kiropraktor Fond, IMK Almene Fond
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1. Study Identification

Unique Protocol Identification Number
NCT01710735
Brief Title
Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Lundbeck Foundation, Dansk Kiropraktor Fond, IMK Almene Fond

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
TP, Myofascial pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling (deep)
Arm Type
Experimental
Arm Description
Subjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius.
Arm Title
Dry needling (superficial)
Arm Type
Active Comparator
Arm Description
Insertion of dry needle less than 1cm.
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Other Intervention Name(s)
Acupuncture
Intervention Description
Insertion of acupuncture needle into a myofascial trigger point.
Primary Outcome Measure Information:
Title
muscle contractility
Description
Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
pressure-pain threshold
Description
Algometer measurement of pressure-pain perception
Time Frame
60 seconds
Title
NRS-101
Description
Self-reported pain
Time Frame
60 seconds

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hartvigsen Hartvigsen, PhD
Organizational Affiliation
Univ. of Southern Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Per Aagaard, PhD
Organizational Affiliation
Univ. of Southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Univ. of Southern Denmark
City
Odense
State/Province
Funen
ZIP/Postal Code
5230
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23176709
Citation
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.
Results Reference
derived
PubMed Identifier
23116179
Citation
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.
Results Reference
derived

Learn more about this trial

Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs

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