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Completed

NCT Number: NCT05400486

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

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.

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Key information

Conditions

Neck Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nove de Julho

São Paulo, 01504-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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 + 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 + 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).

Primary outcomes

  1. Functional disability

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

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

  2. Numerical Pain Scale

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

    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'.

Secondary outcomes

  1. Catastrophic Thoughts about Pain Scale

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

    The Catastrophic Thoughts About Pain Scale will be used to assess pain-related catastrophizing.

  2. Kinesiophobia Tampa Scale

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

    Tampa Kinesiophobia Scale will be used to assess fear of movement and injury recurrence.

  3. The Copenhagen Neck Functional Disability Scale (CNFDS)

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

    The CNFDS is a one-dimensional self-report scale consisting of 15 items that assess the degree of disability in activities of daily living in patients diagnosed with neck pain. When calculating the CNFDS score, the following procedures should be considered: For items 1 to 5, the answer "yes" = 0, "sometimes" = 1 and "no" = 2; For items 6 to 15, the answer "yes" = 2, "sometimes" = 1 and "no" = 0. Thus, the total score ranges from 0 to 30, the higher the score, the greater the disability.

  4. Global Perception of Change Scale

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

    The perception of the global effect of the treatment by the research participant will be evaluated by the Global Perception of Change Scale. The Global Perception of Change Scale is a direct scale on the patient's self-perception when the intervention is performed. This scale is composed of 11 points, ranging from -5 (worse compared to the start of treatment), 0 (neutral) and +5 (improvement compared to the start of treatment), using the Portuguese version.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2022
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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