Effect of Ultrasound-guided Suprascapular Nerve Block Versus Intra-articular Corticosteroid Injection for Frozen Shoulder

Frozen Shoulder Clinical Trial

Official title:

Effect of Ultrasound-guided Suprascapular Nerve Block Versus Intra-articular Corticosteroid Injection for Frozen Shoulder: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515278
• Other study ID #: 20170915R
• Secondary ID: 2018SKHADR029
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim to compare the effect of ultrasound-guided suprascapular nerve block and intra-articular corticosteroid injection for frozen shoulder in pain control, improvement of range of motion, quality of life, and function.

Description:

The inclusion criteria is: 1. unilateral side involvement; 2. ≥50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side;

3. duration of symptoms ≥3 months. 4. age≥ 20year old.

The exclusion criteria include: 1. ever received manipulation of the affected shoulder with/without anesthesia; 2. systemic disease, severe degeneration, or trauma involving the shoulder (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.); 3. neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder; 4.pain or disorders of the cervical spine, elbow, wrist, or hand; 5.a history of drug allergy to local or corticosteroids; 6. Pregnancy or lactation; and 7. Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks 70 participants will be randomly divided to SCNB group and IACI group. Each subject in either group will receive 2 times of injection in a two-weekly interval. After injection, each subject in either group will receive the same protocol of physiotherapy program for 2 months. Outcome measures include the SPADI, the SDQ, active and passive ROM of the affected shoulder, and SF-36. Evaluation will be performed at baseline and at 4 weeks and 12 weeks after the beginning of the treatment. Statistics will be performed after completing the patients' treatment and evaluations.

A Shapiro-Wilk test will be applied to ensure that all the calculated variables followed a normal distribution. Subsequently, a 2-by-3, 2-way mixed-model analysis of variance, which has 1 between-subject factor (group: SCNB and IACI) and 1 within-subject factor (evaluation time: pretreatment, 4 weeks after beginning treatment, and 12 weeks after the beginning of the treatment), will be performed. Pair-wise comparisons between groups will be performed using an independent t test when a significant interaction is found; otherwise, the main effects are reported. When a time effect is found, a post hoc analysis will be performed using a polynomial test to determine the trend (linear or quadratic). All significance levels are set at alpha=.05, and SPSS version 15.0a will be used for all the statistical analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. unilateral side involvement.

2. =50% loss of passive ROM (external rotation or abduction) in the glenohumeral joint comparing to the unaffected side.

3. duration of symptoms =3 months.

4. age= 20year old.

Exclusion Criteria:

1. ever received manipulation of the affected shoulder with/without anesthesia.

2. systemic disease, severe degeneration, or trauma involving the shoulder. (ie, rheumatoid arthritis, osteoarthritis, history of injury to the labrum or articular cartilage or malignancies in the shoulder region, etc.)

3. neurologic diseases such as stroke or peripheral nerve neuropathy that have already affect the activity of shoulder.

4. pain or disorders of the cervical spine, elbow, wrist, or hand.

5. a history of drug allergy to local or corticosteroids.

6. Pregnancy or lactation.

7. Received corticosteroids, or hyaluronic acid intra-articular injection into the affected shoulder during the preceding 4 weeks.

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Procedure:
• SCNB group
IACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy.
• IACI group
SCNB is a new choice for treatment of frozen shoulder.As radiology techniques advance, ultrasound-guided SCNB becomes more popular. It provides a cost and time-effective way to infiltrate the nerve accurately without injury to the nerves or vessels.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of scores of the Shoulder Pain and Disability Index (SPADI)	The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.	baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Secondary	the active ROM	The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.	baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Secondary	Change of the Shoulder Disability Questionnaire (SDQ)	The SDQ is a symptoms-related questionnaire containing 16 items describing common situations that may induce symptoms in patients with shoulder disorders. By responding 'yes', 'no', or 'not applicable', the final score is obtained by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst situation).	baseline and at 4 weeks and 12 weeks after the beginning of the treatment.
Secondary	Change of 36-item Short-Form Health Survey (SF-36)	The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5).	baseline and at 4 weeks and 12 weeks after the beginning of the treatment.