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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400486
• Other study ID #: 58624422.3.0000.5511
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2022
• Est. completion date: July 25, 2025

Study information

• Verified date: November 2023
• Source: University of Nove de Julho
• Contact: Cid Gomes, Phd
• Phone: +5511970941936
• Email: cid.andre[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 25, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain

Intervention

Other:
• Therapeutic exercise
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
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
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).

Locations

Country	Name	City	State
Brazil	University of Nove de Julho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional disability	The NDI will be used to verify the degree of disability due to neck pain.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Primary	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 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Catastrophic Thoughts about Pain Scale	The Catastrophic Thoughts About Pain Scale will be used to assess pain-related catastrophizing.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Kinesiophobia Tampa Scale	Tampa Kinesiophobia Scale will be used to assess fear of movement and injury recurrence.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	The Copenhagen Neck Functional Disability Scale (CNFDS)	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.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary	Global Perception of Change Scale	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.	Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.