Clinical trial NCT04245969: Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain
Official title: Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Shoulder Pain
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated. Current studies show promising results in different musculoskeletal disorders, however further studies with proper designs and conclusive findings are necessary.

Detailed description: Shoulder pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers. Many factors have been proposed as the cause of pain, however it is still controversial and the same regarding the best treatment option.

Treatments throw different techniques have been investigated, showing a variety of results in terms of pain and sensitivity. However, the use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment is to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment, strength, pain, sensitivity and range of movement, when compared to traditional methods used like manual therapy and/or exercise.

The stimulus will be carried out on the shoulder region (suprascapular, axillar, subscapular, long thoracic or pectoralis nerves) and the thoracic region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

The outcome measures will be electromyography and dynamometry to measure strength and muscular activity. The movements required to the patient will be shoulder flexion, abduction, adduction, and extension.

To quantify sensitivity, pain pressure thresholds will be measured throw an algometer placed on the coracoid process, on the lateral area of the shoulder (two centimeters below the acromion and on the acromioclavicular joint).

To measure the range of movement, a goniometer will be used for both glenohumeral and scapular rotations.

To measure quality of life and psychological factors several questionnaires will be asked (Pain catastrophizing scale, Pain vigilance and awareness questionnaire, Self-efficacy, SPADI, Tampa Scale-11, McGill)

Eligibility criteria: Inclusion Criteria:

* To suffer from shoulder pain more than three months.
* Men or women aged between 18 to 65 years;
* Unilateral pain located in the anterior and/or lateral shoulder region;
* 2 out of 3 positive clinical tests (Hawkins-Kennedy; Jobe; Neer);
* Pain with normal activity ≥ 4/10 on a visual analogue scale;
* Nontraumatic onset of shoulder pain.

Exclusion Criteria:

* History of significant shoulder trauma, such as fracture or ultrasonography-clinically suspected full thickness cuff tear, following the classification of Wiener and Seitz
* Recent shoulder dislocation in the past two years
* Systemic illnesses such as rheumatoid arthritis
* Adhesive capsulitis of the shoulder
* Shoulder pain originating from the neck or if there was a neurological impairment, osteoporosis, hemophilia and/or malignancies.

Primary outcomes:
measure: Change from Baseline ultrasound imaging at 3 months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
measure: Change from Baseline ultrasound imaging at 3 months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Secondary outcomes:
measure: Electromyography
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
measure: Change from Baseline dynamometry at 3 months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
measure: Algometry
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
measure: Range of movement
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
measure: Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at three months
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
measure: Catastrophizing Scale questionnaire
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
measure: Heart rate variability (HRV)
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
measure: Autonomic Symptom Profile questionnaire (ASP)
timeFrame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Other outcomes:
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