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

U

University of Nove de Julho

Status

Completed

Conditions

Chronic Pain
Neck Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05400486
58624422.3.0000.5511

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 3 patient groups

Therapeutic exercise group
Active Comparator group
Description:
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.
Treatment:
Other: Therapeutic exercise
Therapeutic exercise group + high frequency TENS
Experimental group
Description:
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.
Treatment:
Other: Therapeutic exercise group + high frequency TENS
Other: Therapeutic exercise
Therapeutic exercise group + Interferential
Experimental group
Description:
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).
Treatment:
Other: Therapeutic exercise
Other: Therapeutic exercise group + Interferential

Trial contacts and locations

1

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Central trial contact

Cid Gomes, Phd

Data sourced from clinicaltrials.gov

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