NCT02435966

Brief Summary

The investigators study the efficacy of a combination of dry needling plus manual therapy against sham dry needling plus manual therapy in the treatment of chronic neck pain. The investigators identify the most active trigger point in the upper trapezius and levator scapulae and administer two treatments, with an interval of 7 days, with a follow up 30 days after the first intervention. The primary outcome is the Visual Analogue Scale of Pain. Secondary outcomes ar pressure pain threshold, Neck Disability Index (NDI) questionnaire and range of motion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 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

May 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

September 7, 2015

Completed
Last Updated

September 7, 2015

Status Verified

August 1, 2015

Enrollment Period

1.1 years

First QC Date

March 27, 2015

Results QC Date

August 8, 2015

Last Update Submit

August 8, 2015

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days

    The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS

    Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)

Secondary Outcomes (3)

  • Change in the Pressure Pain Threshold Measured by Algometer

    Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)

  • Change in the Cervical Range of Motion Measured by Goniometer

    Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)

  • Change in the Neck Disability Index Questionnaire

    Pre-intervention (Day 1); after 2nd intervention (7 days)

Study Arms (3)

Manual therapy + Dry needling

EXPERIMENTAL

Manual therapy + Dry needling: 2 sessions, after a 7 days interval

Device: Dry needlingOther: Manual therapy

Manual therapy + Sham Dry needling

OTHER

Manual therapy + Sham Dry needling: after a 7 days interval

Device: Sham Dry needlingOther: Manual therapy

Untreated control

NO INTERVENTION

Natural history of the condition

Interventions

Dry needlingDEVICE

Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)

Manual therapy + Dry needling
Sham Dry needlingDEVICE

Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae

Manual therapy + Sham Dry needling
Manual therapyOTHER

Standard manual therapy in the upper trapezius or the levator scapulae

Manual therapy + Dry needlingManual therapy + Sham Dry needling

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Neck pain for at least three months (or more)
  • An active trigger point in either the upper trapezius or the levator scapulae

You may not qualify if:

  • Treatment for neck pain within the previous six months
  • Neck Whiplash
  • Fibromyalgia
  • Infection in the area under treatment
  • Pharmacological treatment with anti-coagulants
  • Fear to needles
  • Degenerative conditions
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gallego-Sendarrubias GM, Rodriguez-Sanz D, Calvo-Lobo C, Martin JL. Efficacy of dry needling as an adjunct to manual therapy for patients with chronic mechanical neck pain: a randomised clinical trial. Acupunct Med. 2020 Aug;38(4):244-254. doi: 10.1136/acupmed-2018-011682. Epub 2020 Mar 23.

    PMID: 32202124DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Dry NeedlingMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Results Point of Contact

Title
Gracia M. Gallego, M.Sc.
Organization
Physios & Universidad Europea de Madrid
gracia.maria.gallego@gmail.com
+34 609036607

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Fisioterapeuta

Study Record Dates

First Submitted

March 27, 2015

First Posted

May 6, 2015

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

March 1, 2015

Last Updated

September 7, 2015

Results First Posted

September 7, 2015

Record last verified: 2015-08