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The Effects of Dry Needling on the Superficial Neck Musculature

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sham dry needling
Electrotherapy + therapeutic exercise
Sponsored by
University of Valladolid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring physical therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Facultad de Fisioterapia, Universidad de Valladolid

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Placebo Comparator

Arm Label

Control group

Experimental group 1

Experimental group 2

Arm Description

Electrotherapy + therapeutic exercise

Electrotherapy + therapeutic exercise + dry needling

Electrotherapy + therapeutic exercise + sham dry needling

Outcomes

Primary Outcome Measures

Neck pain
The investigators measure the neck pain with Visual Analogue Scale (VAS) at 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).
Cervical disability
The investigators measure the cervical disability with Neck Disability Index (NDI) at 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).
Motor control
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at 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).

Secondary Outcome Measures

Neck range of motion
The investigators measure the neck range of motion with an inclinometer at 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).
Pressure pain threshold
The investigators measure the pressure pain threshold with a digital algometer at 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).
Kinesiophobia
The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at 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).
Pain catastrophism
The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at 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).
Anxiety and depression
The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at 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).

Full Information

First Posted
August 15, 2019
Last Updated
July 18, 2023
Sponsor
University of Valladolid
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1. Study Identification

Unique Protocol Identification Number
NCT04060004
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
May 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valladolid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Electrotherapy + therapeutic exercise
Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
Electrotherapy + therapeutic exercise + dry needling
Arm Title
Experimental group 2
Arm Type
Placebo Comparator
Arm Description
Electrotherapy + therapeutic exercise + sham dry needling
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Dry needling is a technique used by physiotherapists.
Intervention Type
Other
Intervention Name(s)
Sham dry needling
Intervention Description
Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.
Intervention Type
Other
Intervention Name(s)
Electrotherapy + therapeutic exercise
Intervention Description
Standard care of neck pain.
Primary Outcome Measure Information:
Title
Neck pain
Description
The investigators measure the neck pain with Visual Analogue Scale (VAS) at baseline.
Time Frame
Baseline.
Title
Neck pain
Description
The investigators measure the neck pain with Visual Analogue Scale (VAS) at the end of the intervention (through study completion, an average 11 days).
Time Frame
Through study completion, an average of 11 days.
Title
Cervical disability
Description
The investigators measure the cervical disability with Neck Disability Index (NDI) at baseline.
Time Frame
Baseline.
Title
Cervical disability
Description
The investigators measure the cervical disability with Neck Disability Index (NDI) at the end of the intervention (through study completion, an average 11 days).
Time Frame
Through study completion, an average 11 days.
Title
Motor control
Description
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at baseline.
Time Frame
Baseline.
Title
Motor control
Description
The investigators measure the motor control with Craniocervical Flexion Test (CCFT) at the end of the intervention (through study completion, an average 11 days).
Time Frame
Through study completion, an average 11 days.
Secondary Outcome Measure Information:
Title
Neck range of motion
Description
The investigators measure the neck range of motion with an inclinometer at baseline.
Time Frame
Baseline.
Title
Neck range of motion
Description
The investigators measure the neck range of motion with an inclinometer at the end of the intervention (through study completion, an average 11 days).
Time Frame
Through study completion, an average 11 days.
Title
Pressure pain threshold
Description
The investigators measure the pressure pain threshold with a digital algometer at baseline.
Time Frame
Baseline.
Title
Pressure pain threshold
Description
The investigators measure the pressure pain threshold with a digital algometer at the end of the intervention (through study completion, an average 11 days).
Time Frame
Through study completion, an average 11 days.
Title
Kinesiophobia
Description
The investigators measure the kinesiophobia with Tampa Scale for Kinesiophobia (TSK-11) at baseline.
Time Frame
Baseline.
Title
Kinesiophobia
Description
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).
Time Frame
Through study completion, an average 11 days.
Title
Pain catastrophism
Description
The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at baseline.
Time Frame
Baseline.
Title
Pain catastrophism
Description
The investigators measure the pain catastrophism with the Pain Catastrophizing Scale (PCS) at the end of intervention (through study completion, an average 11 days).
Time Frame
Through study completion, an average 11 days.
Title
Anxiety and depression
Description
The investigators measure the anxiety and depression with the Hospital Anxiety and Depression Scale (HADS) at baseline.
Time Frame
Baseline.
Title
Anxiety and depression
Description
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).
Time Frame
Through study completion, an average 11 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Facultad de Fisioterapia, Universidad de Valladolid
City
Soria
ZIP/Postal Code
42004
Country
Spain

12. IPD Sharing Statement

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The Effects of Dry Needling on the Superficial Neck Musculature

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