Effects of Percutaneous Electrical Stimulation in Patients With Chronic Supraspinatus Tendinopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

EP + PENS + ET: Percutaneous Electrolysis (EP) + Percutaneous Electrical Nerve Stimulation (PENS) + Therapeutic Exercise (ET)

EP + PENS placebo + ET: Percutaneous Electrolysis (PE) + Percutaneous Electrical Nerve Stimulation (PENS - placebo) + Therapeutic Exercise (ET)

EP placebo + PENS + ET: Percutaneous Electrolysis (EP - placebo) + Percutaneous Electrical Nerve Stimulation (PENS) + Therapeutic Exercise (ET)

EP placebo + PENS placebo + ET: Percutaneous Electrolysis (EP - placebo) + Percutaneous Electrical Nerve Stimulation (PENS - placebo) + Therapeutic Exercise (ET)

Study summary

The aim of this clinical trial is to evaluate the effects of two percutaneous stimulation techniques-Percutaneous Electrical Stimulation (PENS) and Percutaneous Electrolysis (PE)-combined with a therapeutic exercise (TE) program for the shoulder joint complex, on pain and function in individuals with chronic supraspinatus tendinopathy.

The main question this study seeks to answer is: Would incorporating percutaneous electrical stimulation (PENS) of the axillary and suprascapular nerves and galvanic percutaneous stimulation (PE) of the supraspinatus tendon into a therapeutic exercise (TE) program for the shoulder joint complex improve therapeutic outcomes in terms of pain, function, and upper limb disability? Based on an exercise program in all groups, researchers will compare the efficacy of active PENS and PE, as well as placebo, in all their combinations.

Participants will undergo a 12-week exercise program, during which they will receive four sessions (one session per week) of active percutaneous electrical stimulation or a placebo during the first month.

Participants will:

* Visit the center on four separate occasions for results measurement.
* Keep a session log to verify adherence to the exercise program.

Eligibility

Primary outcome measure(s)

• Pain Intensity — - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)
  The Numerical Pain Rating Scale (NPRS) will be used to estimate pain intensity. This scale assigns a number between 0 (no pain) and 10 (worst possible pain) (Farrar et al., 2001). Using this instrument, the patient will rate the intensity of the pain they feel at the worst time of day and the average level of pain experienced over the past week. This easy-to-complete, quick, and simple scale has shown a Minimal Detectable Change (MDC) of 1.3 to 2.8 points in patients with musculoskeletal problems and 1.7 points in subacromial pain syndrome.
• Pressure Pain Threshold (PPT) — - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)
  The test will be performed using a mechanical pressure algometer at specific study points to determine the amount of pressure applied at which the sensation of pressure changes to pain. The patient will be seated in a comfortable and relaxed position. The procedure consists of applying the tip of the algometer perpendicular to the skin and maintaining a pressure that will be progressively increased until the pain threshold is reached. Subjects will be instructed to signal when this pressure pain threshold (PPT) is exceeded. The physiotherapist will take three measurements, with a 30-second rest period between each measurement, calculating the average value in kg.. Measurements will be taken on the affected side, in the subacromial space region (treatment area), in the upper trapezius muscle (midpoint between the neck and shoulder muscle fibers), in the ventral part of the middle head of the deltoid muscle (segmental area), and in the tibialis anterior muscle,
• Function — - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)
  The Constat-Murley (CM) questionnaire is a commonly used, specific instrument for assessing overall shoulder joint function (Roy et al., 2010). The maximum score is 100 points, with 90 to 100 considered excellent, 80 to 89 good, 70 to 79 fair, and below 70 poor, although scores may vary with age. This tool includes a subjective assessment of the patient's pain and ability to perform daily activities (35 points), and an objective assessment of mobility and strength through physical examination (65 points). Its use has been specifically validated in shoulder arthroplasty, rotator cuff repair, adhesive capsulitis, and proximal humerus fractures. This tool has shown a Minimal Detectable Change (MDC) of 11.6 points in patients with subacromial impingement.
• Disability — - Baseline (T0) - 4 initial weeks - (T1) - 12 initial weeks - (T2) - 24 initial weeks - (T3)
  The Shoulder Pain and Disability Index (SPADI) focuses on the degree of pain or disability caused by shoulder problems during the past week. It is a self-administered questionnaire consisting of two dimensions: one for pain and one for functional activities. The pain dimension comprises five questions about the severity of pain. Functional activities are assessed with eight questions, designed to measure the degree of difficulty a person has performing various activities of daily living that require the use of the upper extremities. The patient answers the questions using a visual analog scale (from 0 to 10), both in the pain dimension (0 equals no pain and 10 equals the worst pain imaginable) and in the disability dimension (0 equals no difficulty and 10 equals so difficult that help was required). In patients with subacromial pain syndrome, this questionnaire has shown a Minimal Detectable Change (MDC) of 20.5 points.

Trial sites (1)

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