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

Myofascial Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710735
• Other study ID #: Muscle and needling
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: October 18, 2012
• Start date: April 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 46 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Shoulder Pain

Intervention

Procedure:
• Dry needling
Insertion of acupuncture needle into a myofascial trigger point.

Locations

Country	Name	City	State
Denmark	Univ. of Southern Denmark	Odense	Funen

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern Denmark	Dansk Kiropraktor Fond, IMK Almene Fond, Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle contractility	Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)	30 minutes	No
Secondary	pressure-pain threshold	Algometer measurement of pressure-pain perception	60 seconds	No
Secondary	NRS-101	Self-reported pain	60 seconds	No