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Trial registered on ANZCTR


Registration number
ACTRN12625000090415
Ethics application status
Approved
Date submitted
11/11/2024
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of therapeutic exercise plus capacitive-resistive radiofrequency therapy and percutaneous ultrasound-guided neuromodulation on non-specific chronic neck pain.
Scientific title
Effects of therapeutic exercise plus capacitive-resistive radiofrequency therapy and percutaneous ultrasound-guided neuromodulation on non-specific chronic neck pain.
Secondary ID [1] 313752 0
ninguno
Universal Trial Number (UTN)
U1111-1314-4263
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific chronic neck pain 335698 0
Condition category
Condition code
Musculoskeletal 332263 332263 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 332264 332264 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will only receive the assigned treatment; they may not combine treatment with medication or other physiotherapy treatment. Any interference with treatment will be grounds for exclusion.

Group 1. RESISTIVE-CAPACITIVE RADIOFREQUENCY THERAPY AND THERAPEUTIC EXERCISE.
The medical device to be used will be a Winback BACK1S. The data analysis will be independent of Winback and will be performed by Dr. Rodríguez Blanco, Cleofás. The device is a high frequency therapy device, registered and marketed exclusively by Winback, France and produced by Daeyang, South Korea, in accordance with 93/42/EEC under the number 1984-MDD-14- 108 314). The Back1S device used for the clinical study has 3 frequencies: 300KHz, 500KHz and 1MHz. Each frequency is supposed to allow targeting the depth of action: the lower the frequency, the deeper the action. Two frequencies (300 and 500 KHz) will be used during this study. The capacitive mode (CET) is an application mode that has a superficial action (2 to 3 cm) on soft tissues (high water content). The resistive (RET) is an application mode that allows to cross the total depth of the tissues and acts on all fibrous tissues (low water content). The dynamic function used within this protocol allows the device to automatically switch from 300 KHZ to 500 KHz frequency every 3 seconds. The device will be used with a power of 12 watts. The 60 mm diameter movable capacitive electrode and a 60 mm diameter movable resistive electrode will be used on the bilateral cervical paravertebral musculature from C0 to C7 and a planar electrode as a return electrode on the abdomen. The cream to be used is a conductive, conditioning and skin-preparing cream with no therapeutic effect. The dose to be used will be 5 ml which will be applied directly on the electrode and will then come into contact with the skin. The intervention will be administered by the principal investigator, a physiotherapist, and will be done as follows: with the patient in prone position; cream will be applied on the capacitive and resistive electrode and the electrical dose will be increased by moving the mobile electrode within the patient's tolerance level, while controlling the skin temperature tolerable for the patient. The therapy application time will be 10 minutes (5 minutes of application with the capacitive electrode and 5 minutes of application with the resistive electrode). The duration and frequency of administration of the capacitive-resistive radiofrequency therapy will be 10 minutes, one day a week during the 8 weeks of treatment. The administration of radiofrequency will be performed together with therapeutic exercises during the 8 weeks. Follow-up and adherence to treatment will be recorded in a Microsoft Excell template designed for the study. The day of treatment and the treatment performed will be noted. In the same way, a daily record will be kept in a Microsoft Excell template where the exercises performed by the patient will be noted and reported to us through the Whatsapp application.
GROUP 2. THERAPY BY MEANS OF PERCUTANEOUS NEUROMODULATION AND THERAPEUTIC EXERCISE.
The subjects in the second group will receive therapy by means of percutaneous ultrasound-guided percutaneous neuromodulation of the spinal nerve bilaterally. Using an Esaote Mylab Gamma ultrasound machine with a linear musculoskeletal probe and the patient in the supine position, the spinal nerve will be located in the anteroinferior area of the upper trapezius bilaterally. The intervention will be administered by the principal investigator, Physiotherapist. The physiotherapist will previously disinfect the area to be treated with chlorhexidine and the puncture will be performed with a 30X40mm acupuncture needle perpendicular to the right and left upper trapezius muscle, visualizing it in the ultrasound machine to avoid puncturing the pulmonary pleura. The needle tip will stop when it has contacted the epineurium of the accessory nerve. The needle will be the negative electrode. A second adhesive electrode will be placed 1 cm laterally to each of the negative electrodes. The parameters used will be set to low frequency (2 Hz) compensated symmetrical pulsed biphasic symmetrical pulsed current and a pulse width of 120 µs applied over a period of 10 minutes. The patient will be asked to indicate when the current intensity is tolerated and not painful. The administration of percutaneous neuromodulation therapy will be performed together with therapeutic exercises during the 8 weeks. The duration and frequency of administration of the percutaneous neuromodulation therapy will be 10 minutes, one day a week during the 8 weeks of treatment. Follow-up and adherence to treatment will be recorded in a Microsoft Excell template designed for the study. The day of treatment and the treatment performed will be noted. In the same way, a daily record will be kept in a Microsoft Excell template where the exercises performed by the patient will be noted and reported to us through the Whatsapp application.
THERAPEUTIC EXERCISE.
The three designated groups will perform the same TE sequence for 8 weeks. The physiotherapist will instruct the patient to perform them correctly. The first two weeks of therapeutic exercise will last 19 minutes, one session per week. The third and fourth week the duration will be 23 minutes, adding two more exercises, one session per week. From week 5 to week 8 the duration will be 25 minutes, when adding the last exercise, one session per week. It is detailed below.
1st and 2nd WEEK: exercises 1 and 2.
1. Craneocervical flexion (CCF) in supine position with a towel on the back of the neck, the patient is asked to push the towel (3 series, 10 repetitions, 8s of contraction each repetition and 8s of rest between repetitions, with 30 s of rest between series).
2. Sitting CCF (3 series, 10 repetitions, 8s of contraction each repetition and 8s of rest between repetitions, with 30s of rest between series).
3rd AND 4th WEEK: exercises 1, 2, 3 and 4.
3. Co-contraction of deep and superficial neck flexors in supine position (10 repetitions, 8 seconds of contraction with 8 seconds of rest between repetition).
4. Sitting. Flexors, rotators and co-contraction inclinations. The patient will perform craneal flexion, while the physiotherapist asks the patient to bend, turn and look to the same side while the same patient opposes a resistance with the hand (5 repetitions to the right and 5 repetitions to the leftalternatively, 8 seconds of contraction)
5th, 6th, 7th and 8th WEEK: exercises 1, 2, 3, 4 and 5.
5. Excentric for extensors. With the patient seated, he should perform a cervical extension, then he should perform a CCF and then finish doing a cervical flexion (10 repetitions, 8 seconds of contraction with 8 seconds of rest between repetition).

Individuals with CNNP will be recruited through a text message broadcast on social networks in the province of Almeria (Andalusia - Spain) and will be selected based on the eligibility criteria listed below. The study will be conducted at the Fisiosur Physiotherapy Clinic facilities in the town of Garrucha (Almeria).
Intervention code [1] 329928 0
Treatment: Devices
Intervention code [2] 329929 0
Treatment: Other
Intervention code [3] 329931 0
Rehabilitation
Comparator / control treatment
GROUP 3. THERAPEUTIC EXERCISE PLUS PLACEBO.
In this group the subjects will receive 10 minutes of RF using the same protocols of patient positioning and use of electrodes and return plate as in group 1. In this case the application will be performed as follows: with the patient in prone position; cream will be applied on the capacitive and resistive electrode when appropriate, performing 4 minutes with the mobile capacitive electrode and 4 minutes with the mobile resistive electrode, but without increasing the intensity, so the intensity that the patient will receive will be 0. The duration and frequency of administration of the capacitive-resistive radiofrequency placebo therapy will be 10 minutes, one day a week during the 8 weeks of treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 339838 0
Visual Analogue Scale (VAS) for pain.
Timepoint [1] 339838 0
The primary outcomes assessed will be obtained immediately before the study, the seconds outcomes assessed through the study (4 weeks), the third outcomes assessed at the end of the same (8weeks) and the last outcomes will be obtained 4 weeks after the end of the study (12 weeks after the start of the study).
Primary outcome [2] 339839 0
Cervical range of motion in the sagittal plane. The mobility in flexion-extension in sitting position will be evaluated.
Timepoint [2] 339839 0
The primary outcomes assessed will be obtained immediately before the study, the seconds outcomes assessed through the study (4 weeks), the third outcomes assessed at the end of the same (8weeks) and the last outcomes will be obtained 4 weeks after the end of the study (12 weeks after the start of the study).
Primary outcome [3] 339840 0
Cervical range of motion in the frontal plane. Lateral flexion mobility in sitting position will be evaluated.
Timepoint [3] 339840 0
The primary outcomes assessed will be obtained immediately before the study, the seconds outcomes assessed through the study (4 weeks), the third outcomes assessed at the end of the same (8weeks) and the last outcomes will be obtained 4 weeks after the end of the study (12 weeks after the start of the study).
Secondary outcome [1] 441607 0
Pain extent.
Timepoint [1] 441607 0
Immediately before the study, halfway through the study (4 weeks) at the end of the same (8 weeks) and 4 weeks after the end of the study (12 weeks after the start of the study).
Secondary outcome [2] 441608 0
Neck Disability Index (NDI).
Timepoint [2] 441608 0
Immediately before the study, halfway through the study (4 weeks) at the end of the same (8 weeks) and 4 weeks after the end of the study (12 weeks after the start of the study).
Secondary outcome [3] 441609 0
Pain Catastrophizing
Timepoint [3] 441609 0
Immediately before the study, halfway through the study (4 weeks) at the end of the same (8 weeks) and 4 weeks after the end of the study (12 weeks after the start of the study).
Secondary outcome [4] 443033 0
Kinesiophobia
Timepoint [4] 443033 0
The primary outcomes assessed will be obtained immediately before the study, the seconds outcomes assessed through the study (4 weeks), the third outcomes assessed at the end of the same (8weeks) and the last outcomes will be obtained 4 weeks after the end of the study (12 weeks after the start of the study).
Secondary outcome [5] 443034 0
Cervical range of motion in the transversal plane. Rotational mobility in the sitting position will be assessed. This outcome is primary.
Timepoint [5] 443034 0
The primary outcomes assessed will be obtained immediately before the study, the seconds outcomes assessed through the study (4 weeks), the third outcomes assessed at the end of the same (8weeks) and the last outcomes will be obtained 4 weeks after the end of the study (12 weeks after the start of the study).
Secondary outcome [6] 443037 0
Head posture in the sagittal plane. This outcome is primary.
Timepoint [6] 443037 0
The primary outcomes assessed will be obtained immediately before the study, the seconds outcomes assessed through the study (4 weeks), the third outcomes assessed at the end of the same (8weeks) and the last outcomes will be obtained 4 weeks after the end of the study (12 weeks after the start of the study).
Secondary outcome [7] 443038 0
Head posture in the frontal plane. This outcome is primary.
Timepoint [7] 443038 0
The primary outcomes assessed will be obtained immediately before the study, the seconds outcomes assessed through the study (4 weeks), the third outcomes assessed at the end of the same (8weeks) and the last outcomes will be obtained 4 weeks after the end of the study (12 weeks after the start of the study).

Eligibility
Key inclusion criteria
Age from 18 to 70 years.
Current neck pain.
Neck pain continued for at least the last 12 weeks.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neck pain radiating to upper limbs.
Neck pain associated with vertigo.
Osteoporosis.
Psychological disorders.
Vertebral fractures.
Tumors.
Metabolic diseases.
Anterior neck surgery.
Red flags (severe muscle spasm, involuntary weight loss).
Physiotherapy treatment in the last 3 months.
Pregnant women.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Randomisation performed with free software (htts://www.randomizer.org).
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment outside Australia
Country [1] 26717 0
Spain
State/province [1] 26717 0
Almería

Funding & Sponsors
Funding source category [1] 317790 0
Self funded/Unfunded
Name [1] 317790 0
Country [1] 317790 0
Primary sponsor type
Individual
Name
Josefa M López de Haro. Fisiosur. Physical Therapy Clinic
Address
Country
Spain
Secondary sponsor category [1] 320109 0
None
Name [1] 320109 0
Address [1] 320109 0
Country [1] 320109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316473 0
COMITÉ DE ÉTICA DE LA INVESTIGACIÓN BIOMÉDICA DE ANDALUCÍA
Ethics committee address [1] 316473 0
Consejería de Salud y Consumo. Secretaría General de Salud Pública e I+D+i en Salud. 1, Avenida de la Innovación, Edificio Arena. 41020- Sevilla (España)
Ethics committee country [1] 316473 0
Spain
Date submitted for ethics approval [1] 316473 0
18/06/2024
Approval date [1] 316473 0
12/07/2024
Ethics approval number [1] 316473 0

Summary
Brief summary
To compare the effects of adding capacitive-resistive radiofrequency (RF) therapy and percutaneous ultrasound-guided neuromodulation (PNM) to therapeutic exercise (TE) in chronic non-specific neck pain (CNNP). Performing TE in combination with PNM and FR produces more beneficial effects with respect to pain, posture and disability in patients with CNNP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138006 0
Dr Juan José González Gerez
Address 138006 0
Almería University . Sacramento Highway. 04120. La Cañada. Almería.
Country 138006 0
Spain
Phone 138006 0
+34 639616829
Fax 138006 0
Email 138006 0
[email protected]
Contact person for public queries
Name 138007 0
Juan José González Gerez
Address 138007 0
Almería University . Sacramento Highway. 04120. La Cañada. Almería.
Country 138007 0
Spain
Phone 138007 0
+34 639616829
Fax 138007 0
Email 138007 0
[email protected]
Contact person for scientific queries
Name 138008 0
Juan José González Gerez
Address 138008 0
Almería University . Sacramento Highway. 04120. La Cañada. Almería.
Country 138008 0
Spain
Phone 138008 0
+34 639616829
Fax 138008 0
Email 138008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive personal data


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.