The Effects of Dry Needling on the Superficial Neck Musculature

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Dry Needling on the Superficial Neck Musculature in Patients With Chronic Myofascial Pain: A Randomized Controlled Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Other: Dry needling
* Other: Sham dry needling
* Other: Electrotherapy + therapeutic exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Electrotherapy + therapeutic exercise | Other: Electrotherapy + therapeutic exercise<br>* Standard care of neck pain.<br>|
| Experimental: Experimental group 1<br>Electrotherapy + therapeutic exercise + dry needling | Other: Dry needling<br>* Dry needling is a technique used by physiotherapists.<br>Other: Electrotherapy + therapeutic exercise<br>* Standard care of neck pain.<br>|
| Placebo Comparator: Experimental group 2<br>Electrotherapy + therapeutic exercise + sham dry needling | Other: Sham dry needling<br>* Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.<br>Other: Electrotherapy + therapeutic exercise<br>* Standard care of neck pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck pain | The investigators measure the neck pain with Visual Analogue Scale (VAS) at baseline. | Baseline. | 
| Neck pain | The investigators measure the neck pain with Visual Analogue Scale (VAS) at the end of the intervention (through study completion, an average 11 days). | Through study completion, an average of 11 days. | 
| Cervical disability | The investigators measure the cervical disability with Neck Disability Index (NDI) at baseline. | Baseline. | 
| Cervical disability | The investigators measure the cervical disability with Neck Disability Index (NDI) at the end of the intervention (through study completion, an average 11 days). | Through study completion, an average 11 days. | 
| Motor control | The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at baseline. | Baseline. | 
| Motor control | The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at the end of the intervention (through study completion, an average 11 days). | Through study completion, an average 11 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck range of motion | The investigators measure the neck range of motion with an inclinometer at baseline. | Baseline. | 
| Neck range of motion | The investigators measure the neck range of motion with an inclinometer at the end of the intervention (through study completion, an average 11 days). | Through study completion, an average 11 days. | 
| Pressure pain threshold | The investigators measure the pressure pain threshold with a digital algometer at baseline. | Baseline. | 
| Pressure pain threshold | The investigators measure the pressure pain threshold with a digital algometer at the end of the intervention (through study completion, an average 11 days). | Through study completion, an average 11 days. | 
| Kinesiophobia | The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at baseline. | Baseline. | 
| Kinesiophobia | The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at the end of the intervention (through study completion, an average 11 days). | Through study completion, an average 11 days. | 
| Pain catastrophism | The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at baseline. | Baseline. | 
| Pain catastrophism | The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at the end of intervention (through study completion, an average 11 days). | Through study completion, an average 11 days. | 
| Anxiety and depression | The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at baseline. | Baseline. | 
| Anxiety and depression | The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at the end of intervention (through study completion, an average 11 days). | Through study completion, an average 11 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy