NCT01290653

Brief Summary

This study investigates the effect of two different techniques (dry needling and Strain-counterstrain manual technique) on the upper trapezius myofascial trigger point (MTP). Subjects with active or latent MTP in this location of the muscle will be identified and will be randomly assigned to one out of three groups: dry needling, strain-counterstrain or placebo manual technique. Pain pressure threshold, provoked pain, pain at rest, neck disability and electromyography (EMG) activity of the upper trapezius will be registered before and after six sessions of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

5 months

First QC Date

February 4, 2011

Last Update Submit

May 13, 2014

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Pressure Threshold

    Amount of pressure (Kg/cm2) applied at the myofascial trigger point site that elicit pain for the patient will be reported. Analogy pressure algometer(Wagner, FPK 20) will be used.

    6 sessions

Secondary Outcomes (3)

  • Pain at rest

    6 sessions

  • Neck Disability

    6 sessions

  • Electromyographic activity of the upper trapezius

    6 sessions

Study Arms (3)

Dry Needling of trigger point

EXPERIMENTAL

Deep dry needling will be applied on the upper trapezius myofascial trigger point

Other: Dry needling

Strain-counterstraing technique

EXPERIMENTAL

This manual technique will be applied at the upper trapezius.

Other: Strain-counterstrain technique

Placebo manual technique

PLACEBO COMPARATOR

A technique simulating strain-counterstrain, but without any therapeutic manoeuvre will be applied at the upper trapezius site.

Other: Placebo manual technique

Interventions

Dry needlingOTHER

Deep dry needling until achieving twitch response of the muscle

Dry Needling of trigger point
Strain-counterstrain techniqueOTHER

A manual technique to release tension of painful muscles.

Strain-counterstraing technique
Placebo manual techniqueOTHER

A placebo technique, consisting of manual contact of the therapist with the patient without any further therapeutic approach

Placebo manual technique

Eligibility Criteria

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

You may qualify if:

  • Active myofascial trigger point at the upper trapezius

You may not qualify if:

  • Diagnosed fibromyalgia
  • Cervical radiculopathy
  • Facial neuralgia
  • Coagulation alteration
  • Cancer
  • Allergy (included needles)
  • History of cervical or shoulder surgery
  • History of deep venous thrombosis
  • History of myopathy
  • History of infiltration at upper trapezius trigger point
  • Anticoagulant medication
  • Aspirin intake during the last 3 days
  • Drug intake (AINES, narcotics, antiepileptics, or any other analgesic medication)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

Related Publications (1)

  • Segura-Orti E, Prades-Vergara S, Manzaneda-Pina L, Valero-Martinez R, Polo-Traverso JA. Trigger point dry needling versus strain-counterstrain technique for upper trapezius myofascial trigger points: a randomised controlled trial. Acupunct Med. 2016 Jun;34(3):171-7. doi: 10.1136/acupmed-2015-010868. Epub 2016 Jan 8.

    PMID: 26746173DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Eva Segura-Ortí, PhD

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 4, 2011

First Posted

February 7, 2011

Study Start

February 1, 2011

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

ES(1)