Clinical trial NCT05607459: Dry Needling, Manual Therapy and Exercise for Neck Pain Management
Official title: Efficacy of Adding Dry Needling to a Manual Therapy and Therapeutic Exercise Interventions for Managing Neck Pain Populations: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain, Posterior
Keywords: Dry Needling
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2022-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel, controlled and single-blinded clinical trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline
measure: Visual Analogue Scale
timeFrame: One month follow-up
measure: Visual Analogue Scale
timeFrame: Three months follow-up
measure: Visual Analogue Scale
timeFrame: Six months follow-up
measure: Visual Analogue Scale
timeFrame: Twelve months follow-up
Secondary outcomes:
measure: Pittsburg Sleeping Quality Index
timeFrame: Baseline
measure: Pittsburg Sleeping Quality Index
timeFrame: One month follow-up
measure: Pittsburg Sleeping Quality Index
timeFrame: Three months follow-up
measure: Pittsburg Sleeping Quality Index
timeFrame: Six months follow-up
measure: Pittsburg Sleeping Quality Index
timeFrame: Twelve months follow-up
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: One month follow-up
measure: Hospital Anxiety and Depression Scale
timeFrame: Three months follow-up
measure: Hospital Anxiety and Depression Scale
timeFrame: Six months follow-up
measure: Hospital Anxiety and Depression Scale
timeFrame: Twelve months follow-up
measure: Neck Disability Index
timeFrame: Baseline
measure: Neck Disability Index
timeFrame: One month follow-up
measure: Neck Disability Index
timeFrame: Three months follow-up
measure: Neck Disability Index
timeFrame: Six months follow-up
measure: Neck Disability Index
timeFrame: Twelve months follow-up
measure: Tampa Scale for Kinesiophobia
timeFrame: Baseline
measure: Tampa Scale for Kinesiophobia
timeFrame: One month follow-up
measure: Tampa Scale for Kinesiophobia
timeFrame: Three months follow-up
measure: Tampa Scale for Kinesiophobia
timeFrame: Six months follow-up
measure: Tampa Scale for Kinesiophobia
timeFrame: Twelve months follow-up
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Juan Antonio Valera-Calero
state: Madrid
Study officials:
affiliation: Camilo José Cela University
name: Juan Antonio Valera Calero, PhD
role: PRINCIPAL_INVESTIGATOR
References: