Electrical Dry Needling and Therapeutic Exercise Versus Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain

NCT06522893 | Completed

• 1 other identifier: AP-0429-2023-C4-F2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness of electrical dry needling combined with therapeutic exercise versus therapeutic exercise alone in patients with nonspecific chronic mechanical neck pain.

Conditions

Neck Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Neck disability index

  The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache.

  At baseline, at 6 weeks and at 2 months

Secondary Outcomes (10)

• Pain (Visual Analog Scale)

  At baseline, at 6 weeks and at 2 months

• McGill Pain Questionnaire

  At baseline, at 6 weeks and at 2 months

• Quality of Life (SF-36 quality of life questionnaire)

  At baseline, at 6 weeks and at 2 months

• Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)

  At baseline, at 6 weeks and at 2 months

• Tampa scale for kinesiophobia

  At baseline, at 6 weeks and at 2 months

Study Arms (2)

Electrical Dry Needling and Therapeutic exercise

EXPERIMENTAL

The group receiving dry needling combined with therapeutic exercise (n=35) will receive up to 6 sessions of stimulation at the active trigger points in the cervical region, according to Travell and Simons: occipitofrontalis, sternocleidomastoid, splenius capitis, anterior, middle, and posterior scalene muscles, upper, middle, and lower trapezius, and multifidus at the C6 level. Using ultrasound guidance, 0.25 mm x 25 mm needles will be inserted into the active. The needles will be connected to a TENS (transcutaneous electrical nerve stimulation) device (TensMed S82-Enraf Nonius), applying an asymmetric biphasic square wave current, low frequency (8 Hz), pulse duration of 250 μs, with an intensity perceived as mild to moderate, for 30 minutes. In addition, this group will undergo a protocol of specific therapeutic exercises for the cervical spine during the same electropuncture session and immediately afterward.

Other: Electrical Dry Needling and Therapeutic exercise

Therapeutic Exercise

ACTIVE COMPARATOR

The therapeutic exercise group (n=35) will perform progressive exercises for the cervical flexor and extensor muscles, once a week for 6 weeks (6 sessions in total, with each session lasting 30 minutes). The protocol includes activation and recruitment of the deep cervical flexor muscles, isometric co-contraction exercises for both deep and superficial flexors, and eccentric and isokinetic exercises for both flexors and extensors. Each week's session will include the exercises for that week, along with the exercises from previous weeks, as detailed in the specific cervical spine exercise table, which indicates sets, repetitions, contraction time, and rest periods.

Other: Therapeutic exercise

Interventions

Therapeutic exercise OTHER

The therapeutic exercise group (n=35) will perform progressive exercises for the cervical flexor and extensor muscles, once a week for 6 weeks (12 sessions in total). The protocol includes activation and recruitment of the deep cervical flexor muscles, isometric co-contraction exercises for both deep and superficial flexors, and eccentric and isokinetic exercises for both flexors and extensors. Each week's session will include the exercises for that week, along with the exercises from previous weeks, as detailed in the specific cervical spine exercise table, which indicates sets, repetitions, contraction time, and rest periods.

Therapeutic Exercise

Electrical Dry Needling and Therapeutic exercise OTHER

The group receiving dry needling combined with therapeutic exercise (n=35) will receive up to 6 sessions of stimulation at the active trigger points in the cervical region, according to Travell and Simons: occipitofrontalis, sternocleidomastoid, splenius capitis, anterior, middle, and posterior scalene muscles, upper, middle, and lower trapezius, and multifidus at the C6 level, bilaterally, once a week for 3 weeks. Using ultrasound guidance, 0.25 mm x 25 mm needles will be inserted into the active trigger points. The needles will be connected to a TENS (transcutaneous electrical nerve stimulation) device (TensMed S82-Enraf Nonius), applying an asymmetric biphasic square wave current, low frequency (2 Hz), pulse duration of 250 μs, for 30 minutes. In addition, this group will perform a protocol of specific therapeutic exercises for the cervical spine during the same electropuncture session and immediately afterward.

Electrical Dry Needling and Therapeutic exercise

Eligibility Criteria

• Age: 30 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged between 30 and 65 years with chronic cervical pain lasting 3 months or more and not receiving any other type of physiotherapy treatment.

You may not qualify if:

• Patients with sensory and/or coagulation disorders, history of spine surgery, cardiac complications, severe concurrent central or peripheral nervous system disease, epilepsy, needle phobia, disc pathology, or serious pathologies that may be the primary cause of chronic cervical pain (e.g., tumors, Arnold Chiari disease, vertigo syndrome, etc.) will be excluded, as they are contraindicated for transcutaneous electrical nerve stimulation (TENS).

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Adelaida María Castro Sánchez

Almería, Almeria, 04120, Spain

Location

Related Publications (18)

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MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

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: PhD

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 26, 2024
• Study Start: November 15, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 15, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)