Back to resultsComparison of the Additional Effects of Using TENS and Interferential Currents for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
Primary Purpose
Neck Pain, Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Therapeutic exercise
Therapeutic exercise group + high frequency TENS
Therapeutic exercise group + Interferential
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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.
Sites / Locations
- University of Nove de JulhoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Therapeutic exercise group
Therapeutic exercise group + high frequency TENS
Therapeutic exercise group + Interferential
Arm 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.
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.
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).
Outcomes
Primary Outcome Measures
Functional disability
The NDI will be used to verify the degree of disability due to neck pain.
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'.
Secondary Outcome Measures
Catastrophic Thoughts about Pain Scale
The Catastrophic Thoughts About Pain Scale will be used to assess pain-related catastrophizing.
Kinesiophobia Tampa Scale
Tampa Kinesiophobia Scale will be used to assess fear of movement and injury recurrence.
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.
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.
Full Information
NCT ID
NCT05400486
First Posted
May 27, 2022
Last Updated
February 27, 2023
Sponsor
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT05400486
Brief Title
Comparison of the Additional Effects of Using TENS and Interferential Currents for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
Official Title
Comparison of the Additional Effects of Using TENS and Interferential Currents for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
October 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic exercise group
Arm Type
Active Comparator
Arm 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.
Arm Title
Therapeutic exercise group + high frequency TENS
Arm Type
Experimental
Arm 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.
Arm Title
Therapeutic exercise group + Interferential
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise group + high frequency TENS
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise group + Interferential
Intervention Description
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 Outcome Measure Information:
Title
Functional disability
Description
The NDI will be used to verify the degree of disability due to neck pain.
Time Frame
Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Title
Numerical Pain Scale
Description
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'.
Time Frame
Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Secondary Outcome Measure Information:
Title
Catastrophic Thoughts about Pain Scale
Description
The Catastrophic Thoughts About Pain Scale will be used to assess pain-related catastrophizing.
Time Frame
Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Title
Kinesiophobia Tampa Scale
Description
Tampa Kinesiophobia Scale will be used to assess fear of movement and injury recurrence.
Time Frame
Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Title
The Copenhagen Neck Functional Disability Scale (CNFDS)
Description
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.
Time Frame
Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
Title
Global Perception of Change Scale
Description
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.
Time Frame
Change from Baseline, after 5 weeks of intervention and 4 weeks after the end of the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cid Gomes, Phd
Phone
+5511970941936
Email
cid.andre@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cid Gomes, Phd
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cid Gomes, Phd
Phone
+5511970941936
Email
cid.andre@gmail.com
First Name & Middle Initial & Last Name & Degree
Cid Gomes, MSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Make data available remotely in digital cloud storage.
Learn more about this trial
Comparison of the Additional Effects of Using TENS and Interferential Currents for the Treatment of Individuals With Chronic Nonspecific Neck Pain.
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