Shoulder Impingement Syndrome, Subacromial Impingement Syndrome
Conditions
Keywords
shoulder pain, shoulder impingement syndrome, radiofrequency treatment, electrophysical agents
Brief summary
The purpose of this study is to assess the effectiveness of 448 kHz capacitive resistive monopolar radiofrequency in the treatment of subacromial syndrome.
Detailed description
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.
Interventions
DEVICEThermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
DEVICESubthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
DEVICESham stimulation
a simulated stimulation protocol so that the device does not emit current
Sponsors
Hospital General Nuestra Señora del Prado
Castilla-La Mancha Health Service
Indiba S.A.
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | Baseline | minimun 0 - maximun10. Higher scores mean a worse outcome |
| SPADI | Baseline | Shoulder Pain and Disabilty Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PPT | Baseline | Pressure Pain Threshold in subacromial area |
| Quick DASH | Baseline | Abbreviated |
| European Quality ol life - 5 dimensions (EQ-5D) | Baseline | Higher scores mean a better outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blinding assesment | 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. |
| Total number of sessions of the exercise protocol for discharge | 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. |
| Medication intake | Baseline | Analgesic ladder for chronic pain. Higher scores mean a worse outcome |
Countries
Spain
Outcome results
None listed