NCT03095365

Brief Summary

to compare the effects on pain, disability and psychological factors of the combination of MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control electrotherapy usual care in patients with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

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

First Submitted

Initial submission to the registry

March 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

March 14, 2017

Last Update Submit

September 5, 2017

Conditions

Pain, Neck

Outcome Measures

Primary Outcomes (1)

  • Pain using Visual Analogue Scale

    Visual Analogue Scale: consists of a line of 100mm which represents the "no pain" on the left side of the same and the "worst pain imaginable" on the right side

    3 months

Secondary Outcomes (6)

  • Medication intake

    3 months

  • Disability using Neck Disability Index

    3 months

  • Kinesiophobia using Tampa Scale of Kinesiophobia

    3 months

  • Catastrophizing using Pain Catastrophizing Scale

    3 months

  • Pain anxiety using Pain Anxiety Symptoms Scale

    3 months

  • +1 more secondary outcomes

Study Arms (3)

Dry needling

ACTIVE COMPARATOR

Received Dry needling in the neck muscles.

Other: Dry needling

Conventional treatment

ACTIVE COMPARATOR

the participants received the conventional treatment for non-specific neck pain.

Other: Conventional treatment

Dry needling and pain neuroscience education

EXPERIMENTAL

Received the same treatment as dry needling group and pain education.

Other: Dry needlingOther: Pain neuroscience education

Interventions

Pain neuroscience educationOTHER

Explanation of the functioning of the central nervous system, the differences between acute pain and chronic pain and the importance of thoughts and beliefs in the processing and chronification of pain

Dry needling and pain neuroscience education
Dry needlingOTHER

Insertion of solid filament needles in the muscle

Dry needlingDry needling and pain neuroscience education
Conventional treatmentOTHER

Electrotherapy: Transcutaneous electrical nerve stimulation and microwaves

Conventional treatment

Eligibility Criteria

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

You may qualify if:

  • Mechanical neck pain for at least 12 weeks
  • % or higher on the Neck Disability Index questionnaire
  • mm or higher on the Visual Analogue Scale (VAS) of neck pain
  • Presence of at least one active myofascial trigger point

You may not qualify if:

  • Neck pain associated with whiplash injuries
  • Medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis)
  • Neck pain with cervical radiculopathy
  • Neck pain associated with externalized cervical disc herniation
  • Fibromyalgia syndrome
  • Previous neck surgery
  • Neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Infanta Sofia

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Related Publications (1)

  • Valiente-Castrillo P, Martin-Pintado-Zugasti A, Calvo-Lobo C, Beltran-Alacreu H, Fernandez-Carnero J. Effects of pain neuroscience education and dry needling for the management of patients with chronic myofascial neck pain: a randomized clinical trial. Acupunct Med. 2021 Apr;39(2):91-105. doi: 10.1177/0964528420920300. Epub 2020 May 5.

    PMID: 32370545DERIVED

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

  • Josue Fernandez-Carnero, PhD

    Universidad Rey Juan Carlos

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 29, 2017

Study Start

March 14, 2017

Primary Completion

September 1, 2017

Study Completion

September 5, 2017

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

ES(1)