Dry Needling, Manual Therapy and Exercise for Neck Pain Management

NCT05607459 | Completed DMC

• 1 other identifier: PhD-MML
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain, Posterior

Keywords

Dry Needling

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (20)

• Pittsburg Sleeping Quality Index

  Baseline

• Pittsburg Sleeping Quality Index

  One month follow-up

• Pittsburg Sleeping Quality Index

  Three months follow-up

• Pittsburg Sleeping Quality Index

  Six months follow-up

• Pittsburg Sleeping Quality Index

  Twelve months follow-up

Study Arms (2)

Dry Needling Group

EXPERIMENTAL

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; Behavioral: Therapeutic Exercise; Other: Manual Therapy

Sham Dry Needling Group

ACTIVE COMPARATOR

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; Other: Manual Therapy; Other: Sham Dry Needling

Interventions

Dry Needling OTHER

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

Dry Needling Group

Therapeutic Exercise BEHAVIORAL

Patients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles.

Dry Needling Group; Sham Dry Needling Group

Manual Therapy OTHER

Patients will receive a manual compression (30 seconds) over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus muscle.

Dry Needling Group; Sham Dry Needling Group

Sham Dry Needling OTHER

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.

Sham Dry Needling Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Camilo Jose Cela University: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Juan Antonio Valera-Calero

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling; Exercise Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Juan Antonio Valera Calero, PhD

  Camilo José Cela University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-dean of research

Model Details: Randomized, parallel, controlled and single-blinded clinical trial

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 7, 2022
• Study Start: November 1, 2022
• Primary Completion: March 28, 2025
• Study Completion: March 30, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)