Does Ultrasound-guided Suprascapular Nerve Block Provide Additional Benefit Over Traditional Rehabilitation Program for Patients With Chronic Shoulder Pain (2015/8/1)

Does Ultrasound-guided Suprascapular Nerve Block Provide Additional Benefit

This study was conducted to compare the efficacy of hydrodilatation with hyaluronic acid under ultrasonographic guidance plus physical therapy (PT) with that of PT alone for treating adhesive capsulitis

Study Overview

• Status: Unknown
• Conditions: Suprascapular Nerve Block
• Intervention / Treatment: Other: physical therapy; Drug: suprascapular nerve block

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veteran General Hospital
    • Contact: Jia chi Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. chronic shoulder pain with duration of complaints more than 3 months
2. diagnosis of frozen shoulder or rotator cuff disorder

Exclusion Criteria:

1. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
2. neurologic deficits affecting shoulder function in normal daily activities;
3. shoulder pain caused by cervical radiculopathy
4. a history of drug allergy to xylocaine
5. pregnancy or lactation;
6. received injection into the affected shoulder during the preceding 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: physical therapy and suprascapular nerve block; patient received ultrasound-guided suprascapular nerve block as well as physical therapy.	Other: physical therapy; patient received traditional physical therapy, including therapeutic exercise and stretch exercise; Other Names: rehabilitation; Drug: suprascapular nerve block; 4ml 2% xylocaine; Other Names: 4cc 2% xylocaine
Active Comparator: physical therapy only; patient received physical therapy only.	Other: physical therapy; patient received traditional physical therapy, including therapeutic exercise and stretch exercise; Other Names: rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in constant shoulder score	the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength	at 4, 12 wk

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Shoulder Pain And disability index	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.	at 6, 12 wk
change in pain intensity	pain intensity was measured by visual analog scale.	at 4, 12 wk
change in glenohumeral joint range of motion	Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.	at 4, 12 wk

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: suprascapular nerve block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2015-09-009C