Comparison of the Additional Effects of Using TENS and Interferential Currents for the Treatment of Individuals With Chronic Nonspecific Neck Pain.

NCT05400486 | Completed DMC

• 1 other identifier: 58624422.3.0000.5511
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

In the current clinical and scientific reality, conservative treatment is the most coherent clinical management with a view to the proper rehabilitation of patients with chronic neck pain, with a trend towards the use of therapeutic exercise. However, some uncertainty about the effectiveness of therapeutic exercises still remains, requiring further studies with high methodological rigor, especially with regard to multimodal treatment, such as the combination of therapeutic exercises with photobiomodulation. Thus, the objective of this project is to evaluate the effects of adding photobiomodulation to a program of specific therapeutic exercises for the treatment of individuals with chronic non-specific neck pain. To this end, 60 participants will be randomized into three groups: therapeutic exercise group + photobiomodulation (n = 20), and therapeutic exercise group. There will be 8 treatment sessions and participants will be evaluated before, after the 8 sessions, and 4 weeks after the end of treatment using the Numerical Pain Scale, Neck Disability Index, Catastrophic Thoughts about Pain Scale, and Tampa Kinesiophobia Scale. In the statistical analysis, a linear mixed model will be applied, considering the interaction between the time and group factors. Finally, the addition of photobiomodulation to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain.

Conditions

Neck Pain; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Functional disability

  The NDI will be used to verify the degree of disability due to neck pain.

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.]

• Numerical Pain Scale

  The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.]

Secondary Outcomes (4)

• Catastrophic Thoughts about Pain Scale

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.]

• Kinesiophobia Tampa Scale

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.]

• The Copenhagen Neck Functional Disability Scale (CNFDS)

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.]

• Global Perception of Change Scale

  Change from Baseline after 8 weeks of intervention and 4 weeks after the end of the intervention.]

Study Arms (3)

Therapeutic exercise group

ACTIVE COMPARATOR

1.Movements of flexion, extension, inclinations, and rotations of the cervical region at maximum amplitude and without load. 2.Neural mobilization of the cervical nerve roots. 3.Contraction of the deep muscles of the flexors, extensors, and rotators of the cervical region without performing spinal movements, using the movement of the eyes to aid in the accomplishment of these exercises. 4.Isometric contraction of the flexor muscles, inclinators, and rotators against manual resistance of the physiotherapist. 5.Isometric contraction of the cervical extensors of the cervical region against gravity. 6.Contraction of the flexor muscles, extensors, and incliners of the cervical region against the resistance of elastic bands.

Other: Therapeutic exercise

Therapeutic exercise group + high frequency TENS

EXPERIMENTAL

This group will consist of 25 participants. Initially, TENS (Endophasys® - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda) will be applied to the cervical region through 4 silicon-carbon electrodes measuring 4 x 4 cm, with a water-based gel to reduce impedance at the skin-electrode interface. Thus, TENS will be applied with a rectangular, biphasic, and symmetrical pulse, with a pulse width of 100 µm, a frequency of 100 Hz, at the maximum tolerated sensitive threshold, for 30 minutes (VANCE et al., 2012). After the application of TENS, the same program of therapeutic exercises applied in the first group will be applied, in the same sequence, evolution, times, and repetitions.

Other: Therapeutic exercise; Other: Therapeutic exercise group + high frequency TENS

Therapeutic exercise group + Interferential

EXPERIMENTAL

This group will consist of 25 participants. Initially, the protocol of exercises performed in the therapeutic exercise group will be applied. In sequence, the interferential current will be applied. Through the Endophasys® device - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda). Four electrodes (8x5 cm), two upper and two lower (forming a square) will be positioned around the center of the neck. The electrodes will be positioned crosswise, following the parameters: 4KHz (carrier frequency), 1/1 second (Sweep Mode), 60 Hz Amplitude of frequency modulation (AMF), 30 Hz (Delta AMF), automatic vector mode, with intensity at the motor threshold of sensation, lasting 30 minutes (Albornoz-Cabello et al., 2019).

Other: Therapeutic exercise; Other: Therapeutic exercise group + Interferential

Interventions

Therapeutic exercise OTHER

1.Movements of flexion, extension, inclinations, and rotations of the cervical region at maximum amplitude and without load. 2.Neural mobilization of the cervical nerve roots. 3.Contraction of the deep muscles of the flexors, extensors, and rotators of the cervical region without performing spinal movements, using the movement of the eyes to aid in the accomplishment of these exercises. 4.Isometric contraction of the flexor muscles, inclinators, and rotators against manual resistance of the physiotherapist. 5.Isometric contraction of the cervical extensors of the cervical region against gravity. 6.Contraction of the flexor muscles, extensors, and incliners of the cervical region against the resistance of elastic bands.

Therapeutic exercise group; Therapeutic exercise group + Interferential; Therapeutic exercise group + high frequency TENS

Therapeutic exercise group + high frequency TENS OTHER

TENS (Endophasys® - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda) will be applied to the cervical region through 4 silicon-carbon electrodes measuring 4 x 4 cm, with a water-based gel to reduce the impedance at the interface electrode skin. Thus, TENS will be applied with a rectangular, biphasic, and symmetrical pulse, with a pulse width of 100 µm, and a frequency of 100 Hz, at the maximum tolerated sensitive threshold, for 30 minutes (VANCE et al., 2012).

Therapeutic exercise group + high frequency TENS

Therapeutic exercise group + Interferential OTHER

In sequence, the interferential current will be applied. Through the Endophasys® device - NMS-0501, KLD Biosistemas® Equipamentos Eletrônicos Ltda). Four electrodes (8x5 cm), two upper and two lower (forming a square) will be positioned around the center of the neck. The electrodes will be positioned crosswise, following the parameters: 4KHz (carrier frequency), 1/1 second (Sweep Mode), 60 Hz Amplitude of frequency modulation (AMF), 30 Hz (Delta AMF), automatic vector mode, with intensity at the motor threshold of sensation, lasting 30 minutes (Albornoz-Cabello et al., 2019).

Therapeutic exercise group + Interferential

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• With chronic neck pain (for more than 90 days)
• Identified according to the following criteria: NDI score ≥ 5
• Numerical Pain Scale (END) score ≥ 3 at rest or during active neck movement

You may not qualify if:

• Individuals who had a history of cervical trauma; head, face, or cervical surgery
• Degenerative diseases of the spine
• Pain radiating to the upper limbs
• Having been submitted to physiotherapeutic treatment for the cervical region in the last three months
• Use of analgesics, anti-inflammatory drugs, or muscle relaxants in the last week; the presence of systemic diseases
• medical diagnosis of fibromyalgia.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, 01504-001, Brazil

Location

Related Publications (1)

• de Santana GN, da Silva ACB, Dos Santos PG, Girasol CE, de Oliveira AR, Dibai-Filho AV, de Paula Gomes CAF. Does Adding Electroanalgesic Modalities to a Multimodal Therapeutic Program Improve Clinical Outcomes in Individuals With Chronic Nonspecific Neck Pain? A Randomised Controlled Trial. Eur J Pain. 2025 Oct;29(9):e70121. doi: 10.1002/ejp.70121.

  PMID: 40910433 DERIVED

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 Officials

• Cid Gomes, Phd

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigator will not be part of any assessment or treatment process. Two researchers will be solely responsible for evaluating the outcomes. These will not participate in any other process. And they did not know the allocation of participants in their respective groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, professor

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: July 30, 2022
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

BR (1)