Hypertonic Dextrose Injection and Physical Therapy for Frozen Shoulder

NCT06165926 | Unknown

• 1 other identifier: A202305063
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our study is to investigate whether the combination of hypertonic dextrose injection and shoulder joint hydrodilation, in conjunction with physical therapy, can effectively enhance shoulder joint pain relief, improve range of motion, and enhance daily life functionality in patients with frozen shoulder.

Conditions

Frozen Shoulder

Keywords

Frozen Shoulder; hypertonic dextrose injection; hydrodilation

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.

  the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months

Secondary Outcomes (2)

• Range of Motion (ROM)

  the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months

• Shoulder Pain and Disability Index (SPADI)

  the change from baseline, post-intervention 2, 4, 8, 12 weeks and 6 months

Study Arms (2)

15% hypertonic dextrose and physical therapy

EXPERIMENTAL

The patient receives a single ultrasound-guided injection of 15% hypertonic dextrose into the shoulder joint (3 ml of 50% Dextrose + 1 ml of 2% xylocaine + 6 ml of normal saline). Subsequent evaluations occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection treatment, totally two sessions. Simultaneously, the patient undergoes an 8-week physical therapy program, attending sessions twice a week. Each session, lasting approximately 30 minutes, includes joint activities, stretching, and muscle-strengthening exercises under the guidance and supervision of a physical therapist.

Drug: 15% hypertonic dextrose; Other: physical therapy

normal saline and physical therapy

PLACEBO COMPARATOR

The patient undergoes a single ultrasound-guided normal saline injection for shoulder joint distension (1 ml of 2% xylocaine + 9 ml of normal saline). Subsequent assessments occur at the second and fourth weeks, followed by a second round of ultrasound-guided shoulder joint injection treatment, totally two sessions. Simultaneously, the patient is undergoing an 8-week physical therapy program, with sessions held twice a week. Each session, lasting approximately 30 minutes, includes joint activities, stretching, and muscle-strengthening exercises under the guidance and supervision of a physical therapist.

Drug: Normal saline; Other: physical therapy

Interventions

15% hypertonic dextrose DRUG

The solution is prepared with 3 ml of 50% Dextrose, 1 ml of 2% xylocaine, and 6 ml of normal saline. The ultrasound-guided injection of 15% hypertonic dextrose is performed at the first week. Subsequent ultrasound-guided shoulder joint injection treatment with hypertonic dextrose is performed at the fourth weeks. A total of 2 sessions of hypertonic dextrose injections are performed.

15% hypertonic dextrose and physical therapy

Normal saline DRUG

The solution is prepared with 1 ml of 2% xylocaine + 9 ml of normal saline. The ultrasound-guided injection of Normal saline(0.9%) is performed at the first week. Subsequent ultrasound-guided shoulder joint injection treatment with Normal saline is performed at the fourth weeks. A total of 2 sessions of Normal saline injections are performed.

normal saline and physical therapy

physical therapy OTHER

Under the guidance and supervision of a physical therapist, the patient undergoes physical therapy sessions twice a week for a total duration of 8 weeks. Each session lasts approximately 30 minutes and includes joint activities, stretching, and muscle-strengthening exercises.

15% hypertonic dextrose and physical therapy; normal saline and physical therapy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Frozen shoulder is diagnosed by physicians based on the patient's medical history, physical examination, X-ray, and ultrasound reports.
• The symptoms persist for more than 3 months.
• There is a reduction of at least 30 degrees in at least two of the affected shoulder joint angles compared to the angles of the healthy side: shoulder flexion, abduction, and external rotation.

You may not qualify if:

• Ultrasound of the shoulder muscles reveals a complete tear or massive tear of the rotator cuff tendon or calcific tendinitis.
• Systemic rheumatic disease.
• Previous shoulder fracture or surgical intervention.
• Recent shoulder joint injections within the last 3 months.
• Acute cervical nerve root compression.
• Current pregnancy or breastfeeding.
• Poorly controlled diabetes (intravenous glucose injection may cause temporary blood sugar elevation).
• Patients with cancer.
• Cognitive impairment, inability to follow simple instructions, or inability to cooperate with the study procedures.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

MeSH Terms

Conditions

Bursitis

Interventions

Saline Solution; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Therapeutics; Rehabilitation

Central Study Contacts

Chih-Ya Chang, MD

CONTACT

886-2-87923311; gradesboy@gmail.com

Chia-Ying Lai, MD

CONTACT

886-2-87923311; pokerface165@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12