Dry Needling, Manual Therapy and Exercise for Neck Pain Management

NCT ID: NCT05607459

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: 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

Therapeutic Exercise

Intervention Type: BEHAVIORAL

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

Manual Therapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Therapeutic Exercise

Intervention Type: BEHAVIORAL

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

Manual Therapy

Intervention Type: 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.

Sham Dry Needling

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

Therapeutic Exercise

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Camilo Jose Cela University

OTHER

Sponsor Role: lead

Responsible Party

José Manuel Pérez Ortiz

Vice-dean of research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Antonio Valera Calero, PhD

Role: PRINCIPAL_INVESTIGATOR

Camilo José Cela University

Locations

Juan Antonio Valera-Calero

Alcorcón, Madrid, Spain

Countries

Spain

Other Identifiers

PhD-MML

Identifier Type: -

Identifier Source: org_study_id