Clinical trial NCT04060004: The Effects of Dry Needling on the Superficial Neck Musculature
Official title: The Effects of Dry Needling on the Superficial Neck Musculature in Patients With Chronic Myofascial Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: physical therapy
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The term myofascial pain refers to the existence of myofascial trigger points (MTP), which are defined as hypersensitive points in a tense band of skeletal muscle, which can cause referred pain or autonomous phenomena.

To address the treatment of myofascial trigger points, conservative and invasive techniques have been proposed. Dry needling is one of the invasive techniques that have been shown to be effective in improving pain and function in patients with myofascial trigger points.

This trial aims to analyse the effectiveness of dry needling in patients with myofascial neck pain.

Detailed description: The main objective of the study is to analyze the effects of dry needling on the superficial neck musculature in patients with chronic myofascial neck pain in terms of pain, functional capacity, mobility, psychosocial variables and motor control compared with both sham dry needling group and control group.

In addition, a secondary objective is to analyze the relationships between the psychosocial variables and the results obtained in the variables analyzed in the patients belonging to the three groups.

For this purpose the investigators conduct a randomized controlled trial double-blind. Patients included are randomized into 3 groups. One receives dry needling, another one receives sham dry needling, and the last one is a control group.

The hypothesis of this study is that patients in the real dry needling group will improve more compared to patients in the sham dry needling group and the control group.

Eligibility criteria: Inclusion Criteria:

* Patients with myofascial neck pain
* Presence of at least one active myofascial trigger point on the superficial neck musculature
* Neck pain of at least 3 months
* Age 18-70
* Pain intensity between 20 and 100 mm in the Analog Visual Scale
* Neck disability index (NDI) greater than or equal to 15 points
* Spanish speakers
* Patients who do not present contraindications for the use of dry needling (anticoagulants, nickel allergy or belenophobia)
* Patients who have not received physiotherapy or pharmacological treatment for neck pain for the last three months

Exclusion Criteria:

* History of cervical trauma
* Cervical spine surgery
* Vertebral fracture
* Cervical pain associated with whiplash
* Red flags (tumor, metabolic disorders or rheumatoid arthritis)
* Inflammatory lesion in the neck region
* Pregnancy
* Fibromyalgia diagnosis
* Neck pain associated with radiculopathy
* Patients pending legal litigation
* Psychiatric pathology diagnosis

Primary outcomes:
measure: Neck pain
timeFrame: Baseline.
measure: Neck pain
timeFrame: Through study completion, an average of 11 days.
measure: Cervical disability
timeFrame: Baseline.
measure: Cervical disability
timeFrame: Through study completion, an average 11 days.
measure: Motor control
timeFrame: Baseline.
measure: Motor control
timeFrame: Through study completion, an average 11 days.
Secondary outcomes:
measure: Neck range of motion
timeFrame: Baseline.
measure: Neck range of motion
timeFrame: Through study completion, an average 11 days.
measure: Pressure pain threshold
timeFrame: Baseline.
measure: Pressure pain threshold
timeFrame: Through study completion, an average 11 days.
measure: Kinesiophobia
timeFrame: Baseline.
measure: Kinesiophobia
timeFrame: Through study completion, an average 11 days.
measure: Pain catastrophism
timeFrame: Baseline.
measure: Pain catastrophism
timeFrame: Through study completion, an average 11 days.
measure: Anxiety and depression
timeFrame: Baseline.
measure: Anxiety and depression
timeFrame: Through study completion, an average 11 days.
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Facultad de Fisioterapia, Universidad de Valladolid
Study officials:
References: