The Effects of Dry Needling on the Superficial Neck Musculature

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060004
• Other study ID #: 1.0 14/12/2018
• Status: Completed
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: May 27, 2021

Study information

• Verified date: July 2023
• Source: University of Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 27, 2021
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Dry needling
Dry needling is a technique used by physiotherapists.
• Sham dry needling
Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.
• Electrotherapy + therapeutic exercise
Standard care of neck pain.

Locations

Country	Name	City	State
Spain	Facultad de Fisioterapia, Universidad de Valladolid	Soria

Sponsors (1)

Lead Sponsor	Collaborator
University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck pain	The investigators measure the neck pain with Visual Analogue Scale (VAS) at baseline.	Baseline.
Primary	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.
Primary	Cervical disability	The investigators measure the cervical disability with Neck Disability Index (NDI) at baseline.	Baseline.
Primary	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.
Primary	Motor control	The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at baseline.	Baseline.
Primary	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	Neck range of motion	The investigators measure the neck range of motion with an inclinometer at baseline.	Baseline.
Secondary	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.
Secondary	Pressure pain threshold	The investigators measure the pressure pain threshold with a digital algometer at baseline.	Baseline.
Secondary	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.
Secondary	Kinesiophobia	The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at baseline.	Baseline.
Secondary	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.
Secondary	Pain catastrophism	The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at baseline.	Baseline.
Secondary	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.
Secondary	Anxiety and depression	The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at baseline.	Baseline.
Secondary	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.