Central Pain Modulatory Effects of Dry-Needling in Patients With Non-Specific Neck Pain

NCT ID: NCT04725825

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-07-15

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.

Conditions

Neck Pain, Posterior; Trapezius Muscle Strain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Dry needling

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.

Group Type: EXPERIMENTAL

Dry needling

Intervention Type: OTHER

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.

Sham needling

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.

Group Type: SHAM_COMPARATOR

Sham needling

Intervention Type: OTHER

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.

Interventions

Dry needling

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.

Intervention Type: OTHER

Sham 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

VakgroepRevalidatiewetenschappen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mira Meeus

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Ghent University

Ghent, Oost-Vlaanderen, Belgium

Countries

Belgium

Other Identifiers

BC-05419

Identifier Type: -

Identifier Source: org_study_id