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Dry Needling and Pain Education in the Treatment of Chronic Neck Pain

Primary Purpose

Pain, Neck

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Dry needling

Pain neuroscience education

Conventional treatment

About this trial

This is an interventional treatment trial for Pain, Neck

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Mechanical neck pain for at least 12 weeks
10% or higher on the Neck Disability Index questionnaire
20mm or higher on the Visual Analogue Scale (VAS) of neck pain
Presence of at least one active myofascial trigger point

Exclusion Criteria:

Neck pain associated with whiplash injuries
Medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis)
Neck pain with cervical radiculopathy
Neck pain associated with externalized cervical disc herniation
Fibromyalgia syndrome
Previous neck surgery
Neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches

Sites / Locations

Hospital Universitario Infanta Sofia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Dry needling

Conventional treatment

Dry needling and pain neuroscience education

Arm Description

Received Dry needling in the neck muscles.

the participants received the conventional treatment for non-specific neck pain.

Received the same treatment as dry needling group and pain education.

Outcomes

Primary Outcome Measures

Pain using Visual Analogue Scale

Visual Analogue Scale: consists of a line of 100mm which represents the "no pain" on the left side of the same and the "worst pain imaginable" on the right side

Secondary Outcome Measures

Medication intake

Medication use: number of pills

Disability using Neck Disability Index

Neck disability index: patients ability to function in daily life activities.

Kinesiophobia using Tampa Scale of Kinesiophobia

Tampa Scale of Kinesiophobia: participants pain-related fear of movement and (re)injury

Catastrophizing using Pain Catastrophizing Scale

Pain Catastrophizing Scale: propensity to catastrophize about pain

Pain anxiety using Pain Anxiety Symptoms Scale

Pain Anxiety Symptoms Scale: The anxiety behaviors associated with pain

Beck Depression Inventory-II

Self-report measure to assess the severity of depressive symptoms

Full Information

NCT ID

NCT03095365

First Posted

March 14, 2017

Last Updated

September 5, 2017

Sponsor

Universidad Rey Juan Carlos

1. Study Identification

Unique Protocol Identification Number

NCT03095365

Brief Title

Dry Needling and Pain Education in the Treatment of Chronic Neck Pain

Official Title

Dry Needling and Pain Neuroscience Education in Chronic Pain Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

March 14, 2017 (Actual)

Primary Completion Date

September 1, 2017 (Actual)

Study Completion Date

September 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

to compare the effects on pain, disability and psychological factors of the combination of MTrP dry needling and pain neuroscience education to MTrPs dry needing alone and control electrotherapy usual care in patients with chronic neck pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dry needling

Arm Type

Active Comparator

Arm Description

Received Dry needling in the neck muscles.

Arm Title

Conventional treatment

Arm Type

Active Comparator

Arm Description

the participants received the conventional treatment for non-specific neck pain.

Arm Title

Dry needling and pain neuroscience education

Arm Type

Experimental

Arm Description

Received the same treatment as dry needling group and pain education.

Intervention Type

Other

Intervention Name(s)

Dry needling

Intervention Description

Insertion of solid filament needles in the muscle

Intervention Type

Other

Intervention Name(s)

Pain neuroscience education

Intervention Description

Explanation of the functioning of the central nervous system, the differences between acute pain and chronic pain and the importance of thoughts and beliefs in the processing and chronification of pain

Intervention Type

Other

Intervention Name(s)

Conventional treatment

Intervention Description

Electrotherapy: Transcutaneous electrical nerve stimulation and microwaves

Primary Outcome Measure Information:

Title

Pain using Visual Analogue Scale

Description

Visual Analogue Scale: consists of a line of 100mm which represents the "no pain" on the left side of the same and the "worst pain imaginable" on the right side

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Medication intake

Description

Medication use: number of pills

Time Frame

3 months

Title

Disability using Neck Disability Index

Description

Neck disability index: patients ability to function in daily life activities.

Time Frame

3 months

Title

Kinesiophobia using Tampa Scale of Kinesiophobia

Description

Tampa Scale of Kinesiophobia: participants pain-related fear of movement and (re)injury

Time Frame

3 months

Title

Catastrophizing using Pain Catastrophizing Scale

Description

Pain Catastrophizing Scale: propensity to catastrophize about pain

Time Frame

3 months

Title

Pain anxiety using Pain Anxiety Symptoms Scale

Description

Pain Anxiety Symptoms Scale: The anxiety behaviors associated with pain

Time Frame

3 months

Title

Beck Depression Inventory-II

Description

Self-report measure to assess the severity of depressive symptoms

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Mechanical neck pain for at least 12 weeks 10% or higher on the Neck Disability Index questionnaire 20mm or higher on the Visual Analogue Scale (VAS) of neck pain Presence of at least one active myofascial trigger point Exclusion Criteria: Neck pain associated with whiplash injuries Medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis) Neck pain with cervical radiculopathy Neck pain associated with externalized cervical disc herniation Fibromyalgia syndrome Previous neck surgery Neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josue Fernandez-Carnero, PhD

Organizational Affiliation

Universidad Rey Juan Carlos

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Universitario Infanta Sofia

City

San Sebastián de los Reyes

State/Province

Madrid

ZIP/Postal Code

28702

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

32370545

Citation

Valiente-Castrillo P, Martin-Pintado-Zugasti A, Calvo-Lobo C, Beltran-Alacreu H, Fernandez-Carnero J. Effects of pain neuroscience education and dry needling for the management of patients with chronic myofascial neck pain: a randomized clinical trial. Acupunct Med. 2021 Apr;39(2):91-105. doi: 10.1177/0964528420920300. Epub 2020 May 5.

Results Reference

derived

Learn more about this trial

Dry Needling and Pain Education in the Treatment of Chronic Neck Pain

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