Central Pain Modulatory Effects of Dry-Needling in Patients With Non-Specific Neck Pain
1 other identifier
interventional
54
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2021
CompletedFebruary 9, 2022
February 1, 2022
5 months
September 24, 2020
February 8, 2022
Conditions
Keywords
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
EXPERIMENTALA 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.
Sham needling
SHAM COMPARATORA 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.
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.
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.
Eligibility Criteria
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
- University Ghentlead
Study Sites (1)
Ghent University
Ghent, Oost-Vlaanderen, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mira Meeus
University Ghent
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