Clinical trial NCT04725825: Central Pain Modulatory Effects of Dry-Needling in Patients With Non-Specific Neck Pain
Official title: Central Pain Modulatory Effects of Dry-Needling in Patients With Non-Specific Neck Pain: a Randomized Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain, Posterior
Trapezius Muscle Strain
Keywords: Dry Needling
Sham Needling
Myofascial Pain Syndrome
Central Pain Modulatory Effects
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Chronic idiopathic neck pain frequently has a myofascial origin. This cervical myofascial pain is caused by myofascial trigger points (MTrPs). Myofascial trigger points are defined as hyperirritable nodules in a contracture of skeletal muscle fibers, which can cause pain symptoms, motor symptoms as well as autonomic symptoms.

Many chronic pain populations (e.g. chronic whiplash associated disorders, fibromyalgia, chronic low back pain) show impaired pain processing and signs of central sensitisation. Central pain processing is defined as an increased responsivity of the nociceptive neurons in the central nerve system and is characterized by hyperalgesia (increased pain after a painful stimuli), allodynia (pain caused by a non-painful stimuli) and temporal summation (increased pain response after repeated stimuli with the same intensity). Hyperalgesia can be divided in local (increased sensitivity in the area of the complaints) and peripheral (increased sensitivity at remote area's). Furthermore, deficient inhibitory pain modulation can be present in this population. Conditioned pain modulation (CPM) can be measured by combining a painful conditioning stimuli (e.g. cold or heat) on a remote location, with a painful test stimuli.

Cervical myofascial pain is often treated by dry needling (DN). DN is a myofascial treatment technique, which has been gaining interest in recent years. During DN, a thin, solid filiform needle is inserted directly into the MTrP. During this treatment, local twitch responses can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increased local blood flow, recovery of the muscle metabolism and thus a reduction of pain and stiffness. By deactivation of the source of pain, chronification of the pain can be prevented.

Up to this moment, there are no studies that investigated the central effects of DN. The aim of this study is to compare the effects of DN with sham needling on pain intensity, local and peripheral hyperalgesia and CPM, in patients with chronic idiopathic neck pain. Therefore, 100 patients will be recruited. Participants are included based on online questionnaires, a clinical examination of neck and shoulder, and the identification of a MTrP in the upper trapezius muscle. All participants will receive information and have to sign an informed consent form. Participants will be subjected to baseline assessment, which involves measurements of pain scores, hyperalgesia (pressure pain thresholds (PPT) by algometry) and CPM (by combining immersion of the hand in hot water while repeating the PPT). Then, participants will be randomly allocated to either a dry needling group or a sham needling group. The dry needling group will receive a dry needling treatment at the identified trigger point location of the upper trapezius, whereas the sham needling group will receive an intervention in which the needle only penetrates the skin but not the fascia and muscle tissue. The one-time intervention of both groups will take approximately 15 minutes. After the treatment, the baseline measurements will be repeated.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in distant Pressure Pain Threshold
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Baseline and immediately after the intervention
measure: Change in Conditioned Pain Modulation
timeFrame: baseline and immediately after the intervention
measure: Change in local Pressure Pain Threshold
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Mira Meeus
role: PRINCIPAL_INVESTIGATOR
References: