NCT02190890

Brief Summary

The purpose of this study are (1) to determine the effectiveness of different dry needling dosages in the treatment of myofascial trigger points in the upper trapezius muscle in patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and (3) evaluate the influence of psychological factors on the perception of postneedling soreness.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

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

September 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

July 4, 2014

Last Update Submit

December 5, 2017

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (2)

  • Pain

    Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).

    1 week

  • Postneedling soreness

    Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).

    1 week

Secondary Outcomes (8)

  • Pressure pain threshold

    1 week

  • Cervical range of motion

    1 week

  • Neck disability

    1 week

  • Pain in cervical range of motion

    1 week

  • Psychological factors

    Pre-intervention

  • +3 more secondary outcomes

Study Arms (4)

Dry needling: 4 local twitch responses

EXPERIMENTAL

Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 4 local twitch responses were elicited.

Procedure: Dry needling

Dry needling: 6 local twitch responses

EXPERIMENTAL

Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 6 local twitch responses were elicited.

Procedure: Dry needling

Dry needling: Until no more local twitch responses elicited

EXPERIMENTAL

Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until no more local twitch responses were elicited.

Procedure: Dry needling

Control

ACTIVE COMPARATOR

The needle was inserted 1.5 cm away from the trigger point in the trapezius muscle and withdrawn without any consecutive insertion.

Procedure: Control

Interventions

Dry needlingPROCEDURE
Dry needling: 4 local twitch responsesDry needling: 6 local twitch responsesDry needling: Until no more local twitch responses elicited
ControlPROCEDURE
Control

Eligibility Criteria

Age18 Years - 53 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of an active myofascial trigger point. Neck pain: Superior to 3 cm in VAS

You may not qualify if:

  • Neck area: Fracture, radiculopathy, previous surgery, previous needling treatment in the last 6 months, previous analgesic medication (24 hours), psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Martin-Pintado-Zugasti A, Fernandez-Carnero J, Leon-Hernandez JV, Calvo-Lobo C, Beltran-Alacreu H, Alguacil-Diego I, Gallego-Izquierdo T, Pecos-Martin D. Postneedling Soreness and Tenderness After Different Dosages of Dry Needling of an Active Myofascial Trigger Point in Patients With Neck Pain: A Randomized Controlled Trial. PM R. 2018 Dec;10(12):1311-1320. doi: 10.1016/j.pmrj.2018.05.015. Epub 2018 May 29.

    PMID: 29857165DERIVED

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 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

July 4, 2014

First Posted

July 15, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2015

Last Updated

December 6, 2017

Record last verified: 2017-12