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Completed

NCT Number: NCT04255186

Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

The purpose of this study is to assess the effectiveness of 448 kHz capacitive resistive monopolar radiofrequency in the treatment of subacromial syndrome.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

About this study

Shoulder pain has a high prevalence in our society, several studies estimate an annual prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain, particularly in third place, after the low back pain and neck pain.

Symptoms of pathologies of subacromial syndrome, where, regardless of origin, pain is the number one symptom for the patient, which emanates functional impairment and the impact on quality of life.

Among the non-pharmacological treatments of subacromial syndrome, a systematic review concludes that the first line of intervention should be a therapeutic exercise program. In many cases, this is usually accompanied by the application of electrophysical agents (short wave, laser, etc.). A recent study has shown that the application of Short Wave Radio Frequency improved pain in people with subacromial syndrome. The current frequency that is applied in the short wave is 27.12 MHz, however, there are other relatively new forms of radiofrequency in which a frequency less than 1 MHz is used. These are beginning to be used in clinical practice and recently have shown positive results related to pain and functionality of musculoskeletal pathologies such as knee osteoarthritis. In these two clinical trials, what is called Resistive Capacitive Monopolar Radio Frequency (RFCR) was used, the frequency of which was 448 KHz and 485KHz respectively, much lower than the frequency used in Shortwave. The RFCR has a potential advantage since it is applied with electrodes directly on the skin and is not transmitted in the air unlike the Short Wave.

Based on the few clinical trials in people with pathology and the physiological effects evidenced in healthy people and in vitro preclinical studies, it is considered pertinent to carry out the present investigation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients between 18 and 70 years years old with diagnosis of subacromial syndrome
  • Visual Analogue Scale (VAS) less than or equal to 7.
  • Positive Neer and Hawkins test.

Exclusion criteria

  • Clinical examination compatible with complete rotator cuff tear (Drop-arm positive test)
  • Fibromyalgia
  • Adhesive capsulitis
  • Be receiving physiotherapeutic treatment or have received it previously for this pathology one month before the start of treatment.
  • Patients with alterations of thermal sensitivity.
  • Derived from the absolute and relative contraindications of CRMRF:
  • Pacemaker
  • Thrombophlebitis
  • Pregnancy
  • Skin disorders (recent wounds or burns)

Treatment and study plan

Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency

Device

Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method

Other names: CRMRF

Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency

Device

Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method

Sham stimulation

Device

a simulated stimulation protocol so that the device does not emit current

Primary outcomes

  1. Visual Analogue Scale

    Time frame: Baseline

    minimun 0 - maximun10. Higher scores mean a worse outcome

  2. Visual Analogue Scale

    Time frame: After 3 weeks

    minimun 0 - maximun10. Higher scores mean a worse outcome

  3. Visual Analogue Scale

    Time frame: 1 month after the end of the intervention

    minimun 0 - maximun10. Higher scores mean a worse outcome

  4. Visual Analogue Scale

    Time frame: 3 months after the end of the intervention

    minimun 0 - maximun10. Higher scores mean a worse outcome

  5. SPADI

    Time frame: Baseline

    Shoulder Pain and Disabilty Index

  6. SPADI

    Time frame: After 3 weeks

    Shoulder Pain and Disabilty Index

  7. SPADI

    Time frame: 1 month after the end of the intervention

    Shoulder Pain and Disabilty Index

  8. SPADI

    Time frame: 3 months after the end of the intervention

    Shoulder Pain and Disabilty Index

Secondary outcomes

  1. Quick DASH

    Time frame: Baseline

    Abbreviated

  2. Quick DASH

    Time frame: After 3 weeks

    Abbreviated

  3. Quick DASH

    Time frame: 1 month after the end of the intervention

    Abbreviated

  4. Quick DASH

    Time frame: 3 months after the end of the intervention

    Abbreviated

  5. PPT

    Time frame: Baseline

    Pressure Pain Threshold in subacromial area

  6. PPT

    Time frame: After 3 weeks

    Pressure Pain Threshold in subacromial area

  7. European Quality ol life - 5 dimensions (EQ-5D)

    Time frame: Baseline

    Higher scores mean a better outcome

  8. European Quality ol life - 5 dimensions (EQ-5D)

    Time frame: After 3 weeks

    Higher scores mean a better outcome

  9. European Quality ol life - 5 dimensions (EQ-5D)

    Time frame: 1 month after the end of the intervention

    Higher scores mean a better outcome

  10. European Quality ol life - 5 dimensions (EQ-5D)

    Time frame: 3 months after the end of the intervention

    Higher scores mean a better outcome

Other outcomes

  1. Medication intake

    Time frame: Baseline

    Analgesic ladder for chronic pain. Higher scores mean a worse outcome

  2. Medication intake

    Time frame: After 3 weeks

    Analgesic ladder for chronic pain. Higher scores mean a worse outcome

  3. Medication intake

    Time frame: 1 month after the end of the intervention

    Analgesic ladder for chronic pain. Higher scores mean a worse outcome

  4. Medication intake

    Time frame: 3 months after the end of the intervention

    Analgesic ladder for chronic pain. Higher scores mean a worse outcome

  5. Blinding assesment

    Time frame: After three weeks

    The patient, the external evaluator, the therapist who applies radiofrequency and the kinesitherapist physiotherapist will be asked about the patient's group of belonging.

  6. Blinding assesment

    Time frame: 3 months after the end of the intervention

    The patient, the external evaluator, the therapist who applies radiofrequency and the kinesitherapist physiotherapist will be asked about the patient's group of belonging.

  7. Total number of sessions of the exercise protocol for discharge

    Time frame: 3 months after the end of the intervention

    After the first 3 weeks, if the patient has not met the criteria for discharge, more sessions will continue performing the same exercise protocol according to medical criteria. This total number of sessions will be recorded.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Castilla-La Mancha Health Service
  • Hospital General Nuestra Señora del Prado
  • Indiba S.A.

Registry information

Official study title

Treatment Using 448 kHz Capacitive Resistive Monopolar Radiofrequency in Patients With Subacromial Syndrome. A Randomised Controlled Trial.

Acronym: CRMRF

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Sep 30, 2021

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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