Effectiveness of Focal Vibration in Shoulder Pathology

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBitlis Eren University

About this trial

We hypothesize that focal vibration therapy will reduce pain, increase the mobilization of the glenohumeral joint, and will improve functionality in patients with adhesive capsulitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged > 18 years

Unilateral adhesive capsulitis of the shoulder

The symptom duration > 3 months

Shoulder pain

Disqualifiers

Previous shoulder surgeries

Massive, minor, and major rotator cuff tears

Pain and muscle strength loss due to neurological causes

History or presence of malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Focal VibrationTherapy

    Device

    Myovolt delivers oscillatory mechanical vibration of focussed frequency and low amplitude to stimulate physiological benefits in soft tissues. Myovolt is non-aggressive and gentle to the body so can be safely targeted. Digitally tuned to transmit a discrete vibration frequency range between 30 - 100Hz for effective neuromuscular stimulation.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline Shoulder Pain at 4 weeks

Evaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" on the far left and "the most intense pain imaginable" on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.

Time frame
At 4 week
2

Change from 4 weeks Shoulder Pain at 6 weeks

Evaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" on the far left and "the most intense pain imaginable" on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.

Time frame
At 6 week

Secondary outcomes

1

Change from Baseline Range of Motion of Shoulder Joint at 4 weeks

The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.

Time frame
At 4 weeks
2

Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks

The joint movements of the affected shoulder was measured using a digital electrogoniometer. A higher score indicates greater improvement.

Time frame
At 6 weeks
3

Change from Baseline Shoulder Function at 4 weeks

Function was assessed using the self-administered Shoulder Pain and Disability Index.The Shoulder Pain and Disability Index contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, higher score indicating greater impairment or disability.

Time frame
At 4 weeks
4

Change from 4 weeks Shoulder Function at 6 weeks

Function was assessed using the self-administered Shoulder Pain and Disability Index.The Shoulder Pain and Disability Index contains 13 items that assess two domains; a 5-item sub-scale that measures pain and an 8-item sub-scale that measures disability. Each sub-scale is summed and transformed to a score out of 100. A mean is taken of the two sub-scales to give a total score out of 100, higher score indicating greater impairment or disability.

Time frame
At 6 weeks

Other outcomes

1

Change from baseline Shoulder Muscle Tone at 6 weeks

The muscle tone which is a biomechanical property of the shoulder muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph.

Time frame
At 6 weeks

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