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Completed

NCT Number: NCT02495818

Suprascapular Nerve Block Guided by Ultrasound

The purpose of this study is to evaluate the effect of suprascapular nerve block guided by ultrasound combined with home exercises compared with placebo. Pain intensity, function, pressure pain threshold and goniometry were designed to be assessed in all patients.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Medicina Fisica e Reabilitacao HCFMUSP

São Paulo, 05716-150, Brazil

About this study

The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since June 2013. The investigators are including patients with clinical diagnosis of supraspinatus tendinitis based on the Lateral Jobe Test.

The patients are being randomized in two arms: Active (2% 5ml lidocaine for suprascapular nerve block and home exercises) and placebo control (saline solution as the nerve block and home exercises). The randomization is being performed in blocks of 4 and 6.

The investigator, the raters, the MD who makes the procedure and the patients are blind to treatment.

4 visits are being performed. Screening and initial evaluation visit, procedure visit, follow up 1 week after intervention and follow up 12 weeks after intervention.

The sample size was estimated to be 54 in each arm.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of supraspinatus tendonitis, based on Jobe's lateral test;
  • Pain longer than 1 month prior to screening visit;
  • BMI between 20 and 30 kg/m²;
  • VAS of 4 or higher in screening visit;
  • Ability to understand the questionaires and instructions for home exercises;
  • Signed Informed Consent Form;

Exclusion criteria

  • History of:
  • Shoulder surgery;
  • Athletic activities;
  • Severe shoulder arthrosis;
  • Diagnosis of total rupture of supraspinatus tendon
  • Autoimmune disease;
  • Fracture of humerus, acromion and clavicle
  • Luxation and subluxation of shoulder.
  • Diseases that cause spasticity, such as stroke or spinal cord injury;
  • Systemic alterations that can lead to peripheral neuropathy;
  • Uncontrolled Diabetes or thyroidopathy;
  • Diagnosis of cervical spinal cord injury that results in motor alterations;
  • Allergy or hypersensibility for local or systemic anaesthetics;
  • Coagulopathy;
  • Fibromyalgia according to the 1990 American School of Rheumatology;
  • Uncontrolled psychiatric diseases or controlled psychiatric diseases that need more than two medicines;
  • Acute of chronic renal failure;
  • Pulmonary diseases that presents hypoxemia such as Gold IV Chronic Obstructive Pulmonary Disease or pulmonary fibrosis.
  • Arrhythmia (except isolated supraventricular extrasystoles), coronary failure or functional class 2 or higher heart failure
  • Pregnancy;
  • Use of oral or subcutaneous anticoagulation agent;
  • Patients who fail to comply with the proposed treatment.

Treatment and study plan

Lidocaine

Procedure

Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.

Saline solution

Procedure

Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution

Homemade exercises

Other

Codman and Hughston exercises.

Primary outcomes

  1. Change from baseline in the score of pain and function as assessed by Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline and one week after intervention

    Scale for assessing pain and shoulder function.

Secondary outcomes

  1. Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).

    Time frame: Baseline and one week after intervention.

    Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain)

  2. Change from baseline in pain Intensity assessed by Visual Analogue Scale (VAS).

    Time frame: Baseline and twelve weeks after intervention.

    Self rated pain scale from 0 (no pain) to 10 (the maximum possible pain)

  3. Change from baseline in the score of pain and function as assessed by SPADI

    Time frame: Baseline and 12 weeks after intervention

    Scale for assessing pain and shoulder function.

  4. Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry

    Time frame: Baseline and one week after intervention

    Measurement of pain under pressure of the structures of dermatome, myotome and sclerotome corresponding to levels C5 and C6 of spinal cord.

  5. Change from baseline in Pain Pressure Threshold (PPT) as assessed by Algometry

    Time frame: Baseline and twelve weeks after intervention

    Measurement of pain under pressure of the structures of dermatome, myotome and sclerotome corresponding to levels C5 and C6 of spinal cord.

  6. Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry

    Time frame: Baseline and one week after intervention

    Goniometry for active movements for flexion and abduction of the shoulder

  7. Change from baseline in Active Range of Motion (AROM) as assessed by Goniometry

    Time frame: Baseline and twelve weeks after intervention

    Goniometry for active movements for flexion and abduction of the shoulder

  8. Safety as assessed by the number of Adverse Events

    Time frame: 1 week and 12 weeks after intervention

    Assessment of possible Adverse Events after the intervention

Sponsors and collaborators

Lead sponsor

Marta Imamura

Other

Registry information

Official study title

Suprascapular Nerve Block Guided by Ultrasound in the Rehabilitation of the Supraspinatus Tendonitis - A Randomized Double Blind Controlled Trial

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2015
Registry last updated
May 16, 2018

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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