NCT04725825

Brief Summary

An experimental study will be conducted to evaluate the effect of a single dry needling session, compared to a sham needling session, on pain intensity, local and peripheral hyperalgesia, and conditioned pain modulation in patients with chronic idiopathic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

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

September 24, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

September 24, 2020

Last Update Submit

February 8, 2022

Conditions

Keywords

Dry NeedlingSham NeedlingMyofascial Pain SyndromeCentral Pain Modulatory Effects

Outcome Measures

Primary Outcomes (1)

  • Change in distant Pressure Pain Threshold

    A distant standardised PPT will be assessed using a digital handheld pressure algometer (FDX; Wagner Instruments) at the quadriceps muscle of the dominant painful side to measure distant hyperalgesia. To measure the PPT, the researcher will apply the digital algometer to each of the indicated points with a round rubber end of 1 cm² and an increasing pressure of circa 1 N/s. As soon as the sensation of the subject shifts from a comfortable pressure to an altered, unpleasant feeling, the participant reports this and the test will be finished. Each point will be measured twice with a 30-second interval in between and all measurements will be performed by one researcher in the same standardised position for each point and will be executed in a randomised order per patient.

    Baseline and immediately after the intervention

Secondary Outcomes (3)

  • Numeric Rating Scale (NRS)

    Baseline and immediately after the intervention

  • Change in Conditioned Pain Modulation

    baseline and immediately after the intervention

  • Change in local Pressure Pain Threshold

    Baseline and immediately after the intervention

Study Arms (2)

Dry needling

EXPERIMENTAL

A single dry needling session will be performed on the dominant painful trapezius muscle, with the patient lying in prone position. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into skin surface, fascia, into the muscle tissue at the MTrP location, and will move the needle up and down (fast-in, fast-out technique) in three different directions. In case local twitch responses are elicited, this will be repeated until the local twitch responses are extinct.

Other: Dry needling

Sham needling

SHAM COMPARATOR

A single sham needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into the skin surface at the MTrP location. The fascia and muscle tissue will not be penetrated.

Other: Sham needling

Interventions

Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.

Dry needling

During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.

Sham needling

Eligibility Criteria

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

You may qualify if:

  • Chronic neck pain (symptom duration \>3 months)
  • Mean NRS score \>3/10
  • The presentation of a clinically relevant myofascial triggerpoint in the upper trapezius muscle.

You may not qualify if:

  • Specific neck pain (eg.structural pathology like a cervical discus hernia, cervical nerve root compression, factures...)
  • Major depression or psychiatric illness
  • Cardiovascular, neurological, life threatening, systemic and metabolic diseases
  • Other transferable diseases (HIV, hepatitis...)
  • Coagulation disorders or use of coagulation medication
  • Pregnancy or given birth the last year
  • Traumatic injuries/surgery to neck and upper limb region
  • Diagnosis of fibromyalgia/chronic fatigue syndrome
  • BMI \> 30 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Neck PainMyofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Mira Meeus

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 24, 2020

First Posted

January 27, 2021

Study Start

February 1, 2021

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

February 9, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations