Dry Needling, Manual Therapy and Exercise for Neck Pain Management

Efficacy of Adding Dry Needling to a Manual Therapy and Therapeutic Exercise Interventions for Managing Neck Pain Populations: A Randomized Controlled Trial

Since neck pain is the fourth highest disabling condition (with an estimated point prevalence of 20%, lifetime prevalence up to 70% and high recurrence rates), dry needling targeting myofascial trigger points in neck muscles has been proposed as an effective treatment for reducing pain and disability in patients with chronic neck pain.

A recent meta-analysis reported whether dry needling could be recommended for this population. Low to moderate evidence suggests that dry needling can be effective at the short-term, but its effects on pressure pain sensitivity or cervical range of motion are limited.

Study Overview

• Status: Recruiting
• Conditions: Neck Pain, Posterior
• Intervention / Treatment: Other: Dry Needling; Behavioral: Therapeutic Exercise; Other: Manual Therapy; Other: Sham Dry Needling

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Antonio Valera-Calero, PhD; Phone Number: 653 766 841; Email: javalera@ucjc.edu

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Recruiting
      • Juan Antonio Valera-Calero
      • Contact: Juan Antonio Valera-Calero, PhD; Phone Number: +34653766841; Email: javalera@ucjc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• To be between 18 and 65 years old
• To have been experiencing unilateral neck pain for at least 3 months
• To have a Neck Disability Index (NDI) score >8
• To have a Visual Analogue Scale (VAS) score >3
• To have at least one active MTrP located in the upper trapezius or cervical multifidus muscles

Exclusion Criteria:

• History of whiplash injury
• Previous cervical surgery
• Cervical radiculopathy or myelopathy
• Diagnosis of fibromyalgia
• Additional analgesic treatments during the study (e.g. physiotherapy or drugs)
• Psychiatric disorders
• Any contraindication to the interventions proposed (e.g. fear of needles or anticoagulants)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling Group; This group will receive dry needling, manual therapy (consisting of a manual compression over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus) and therapeutic exercise interventions	Other: Dry Needling; Dry needling consists of a skilled intervention which uses a thin filiform needle (as those used in acupuncture) to penetrate the skin and stimulate underlying myofascial trigger points (defined as "a hyperirritable spot in skeletal muscle that is associated with a hypersensitive palpable nodule in a taut band which is painful on manual compression and can give rise to characteristic referred pain, referred tenderness, motor dysfunction and autonomic phenomena.") This intervention will be performed targeting the upper trapezius and cervical multifidus muscles; Behavioral: Therapeutic Exercise; Patients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles.; Other: Manual Therapy; Patients will receive a manual compression (30 seconds) over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus muscle.
Active Comparator: Sham Dry Needling Group; This group will receive manual therapy (consisting of a manual compression over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus), therapeutic exercise interventions and a previously described sham dry needling intervention.	Behavioral: Therapeutic Exercise; Patients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles.; Other: Manual Therapy; Patients will receive a manual compression (30 seconds) over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus muscle.; Other: Sham Dry Needling; For the sham DN intervention, a similar approach will be used, but the skin will be not pierced since the material used will be a telescopic Park's sham device. The guide tube will be pressed against the skin mark and the sham needle will be allowed to drop. The handle will be tapped briskly, but the (blunted) needle tip will not not break the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)	Baseline
Visual Analogue Scale	A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)	One month follow-up
Visual Analogue Scale	A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)	Three months follow-up
Visual Analogue Scale	A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)	Six months follow-up
Visual Analogue Scale	A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable)	Twelve months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburg Sleeping Quality Index	This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)	Baseline
Pittsburg Sleeping Quality Index	This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)	One month follow-up
Pittsburg Sleeping Quality Index	This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)	Three months follow-up
Pittsburg Sleeping Quality Index	This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)	Six months follow-up
Pittsburg Sleeping Quality Index	This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality)	Twelve months follow-up
Hospital Anxiety and Depression Scale	This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.	Baseline
Hospital Anxiety and Depression Scale	This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.	One month follow-up
Hospital Anxiety and Depression Scale	This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.	Three months follow-up
Hospital Anxiety and Depression Scale	This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.	Six months follow-up
Hospital Anxiety and Depression Scale	This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels.	Twelve months follow-up
Neck Disability Index	This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).	Baseline
Neck Disability Index	This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).	One month follow-up
Neck Disability Index	This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).	Three months follow-up
Neck Disability Index	This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).	Six months follow-up
Neck Disability Index	This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability).	Twelve months follow-up
Tampa Scale for Kinesiophobia	The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.	Baseline
Tampa Scale for Kinesiophobia	The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.	One month follow-up
Tampa Scale for Kinesiophobia	The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.	Three months follow-up
Tampa Scale for Kinesiophobia	The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.	Six months follow-up
Tampa Scale for Kinesiophobia	The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 "complete disagreement" and 4 "complete agreement" (total score from 0 to 44), where higher scores indicate greater kinesiophobia.	Twelve months follow-up

Collaborators and Investigators

• Sponsor: Camilo Jose Cela University
• Collaborators: Universidad Rey Juan Carlos
• Investigators: Principal Investigator: Juan Antonio Valera Calero, PhD, Camilo Jose Cela University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Dry Needling
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: PhD-MML

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No