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The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder

Primary Purpose

Frozen Shoulder, Hydrodilatation, Joint Mobilization

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Comb group
PT group
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring frozen shoulder, hydrodilatation, joint mobilization, corticosteroid injection, physical therapy, rehabilitation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. . age between 20 to 80 years old;
  2. . chronic shoulder pain for ≥ 3 months;
  3. . > 30% loss of passive range of motion (ROM) of the affected shoulder in either external rotation or abduction, comparing with the sound side;
  4. . visual analog scale for pain on maximal passive external rotation or abduction > 4.

Exclusion Criteria:

  1. . Severe systemic disorders including cancer, stroke, or cardiopulmonary diseases;
  2. . Uncontrolled DM;
  3. . Rotator cuff tear or calcification of the affected shoulder;
  4. . Fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders;
  5. . a history of drug allergy to local anesthetics or corticosteroids;
  6. . receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Comb group

PT group

Arm Description

Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks. The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, a21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.

The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.

Outcomes

Primary Outcome Measures

Shoulder Pain and Disability Index(SPADI)

Secondary Outcome Measures

Visual analog scale(VAS)
The VAS for pain is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain. The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of VAS for pain is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.
Range of motion(ROM)
All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction.
Shoulder Disability Questionnaire(SDQ)
The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated 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 possible condition).
The 36-item Short Form Health Survey(SF-36)
The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health.

Full Information

First Posted
July 13, 2020
Last Updated
October 27, 2022
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04474145
Brief Title
The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder
Official Title
The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The effect of combination of hydrodilatation, corticosteroid injection, and joint mobilization for treatment of frozen shoulder, compared with general physical therapy.
Detailed Description
Frozen shoulder (FS) is a common clinical problem which induces pain, loss of passive and active range of motion (ROM) of glenohumeral joint, and leads to disability, functional limitation, and decreasing quality of life. FS is usually treated with conservative treatments, which include medications, physiotherapy, joint mobilization, hydrodilatation, intra-articular steroid injection, etc.. The short-term effect of each treatment is variable, and the long-term effect is not established. Clinically combination of each treatment is common, but types of combination, and the effect of combination is still not well studied. We aim to combine hydrodilatation (with corticosteroid injection), joint mobilization, and general physiotherapy to treat frozen shoulder and compare the long-term effect with general physical therapy alone. This is a prospective single-blind randomized controlled trial. 70 participants will be recruited from the outpatient clinic of the department of Physical Medicine and Rehabilitation of Shin Kong Wu Ho-Su Memorial Hospital and randomly divided into COMB group and PT group. Each subject in the COMB group will receive 2 times of ultrasound-guided hydrodilatation injection (10mg triamcilonone, 2cc 1% xylocain, and 17cc normal saline) through both anterior and posterior shoulder joint in a two-weekly interval. In addition, joint mobilization and general physiotherapy (stretch exercise and physical modalities) will also be given, 2 times a week, for 8 weeks. The PT group will receive general physical therapy, 2 times a week, for 8 weeks. Outcome measures include the Shoulder Pain and Disability Index (SPADI), the Shoulder Disability Questionnaire (SDQ), and active and passive range of motion (ROM) of the affected shoulder, the 36-item Short Form Health Survey (SF-36), and patients' self evaluation. Evaluation will be performed at baseline and at 2, 4, 6 months after the beginning of the treatment. Statistics will be performed after completing the patients' treatment and evaluations. We expect that the COMB group will recover sooner and better than the PT group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder, Hydrodilatation, Joint Mobilization, Corticosteroid Injection, Physical Therapy, Rehabilitation
Keywords
frozen shoulder, hydrodilatation, joint mobilization, corticosteroid injection, physical therapy, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comb group
Arm Type
Active Comparator
Arm Description
Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks. The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, a21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.
Arm Title
PT group
Arm Type
Active Comparator
Arm Description
The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.
Intervention Type
Procedure
Intervention Name(s)
Comb group
Intervention Description
Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks. The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, a21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection.
Intervention Type
Procedure
Intervention Name(s)
PT group
Intervention Description
The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index(SPADI)
Time Frame
change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Secondary Outcome Measure Information:
Title
Visual analog scale(VAS)
Description
The VAS for pain is obtained using a 100-mm-long horizontal line, with 0 mm on the left, indicating no pain, and 100 mm on the right, indicating very severe pain. The pain at rest is defined as rest pain, and pain on maximal abduction of the affected shoulder is defined as activity pain. The reliability of VAS for pain is 0.94, but in the absence of a criterion standard for pain, criterion validity cannot be evaluated.
Time Frame
change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Title
Range of motion(ROM)
Description
All the 4 planes of ROM will be measured. It includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0° of abduction.
Time Frame
change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Title
Shoulder Disability Questionnaire(SDQ)
Description
The SDQ is a pain-related questionnaire that contains 16 items describing common situations that may induce symptoms in patients with shoulder disorders. The response options are "yes," "no," and "not applicable." The final score is calculated 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 possible condition).
Time Frame
change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.
Title
The 36-item Short Form Health Survey(SF-36)
Description
The SF-36 is a generic measure of quality of life and is composed of 8 subscales related to the following components: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale generates a score from 0 to 100, and higher scores indicate better health.
Time Frame
change between baseline and at 2 months, 4 months, 6 months after the beginning of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: . age between 20 to 80 years old; . chronic shoulder pain for ≥ 3 months; . > 30% loss of passive range of motion (ROM) of the affected shoulder in either external rotation or abduction, comparing with the sound side; . visual analog scale for pain on maximal passive external rotation or abduction > 4. Exclusion Criteria: . Severe systemic disorders including cancer, stroke, or cardiopulmonary diseases; . Uncontrolled DM; . Rotator cuff tear or calcification of the affected shoulder; . Fracture, dislocation, or arthritis of the shoulder due to rheumatic disorders; . a history of drug allergy to local anesthetics or corticosteroids; . receiving corticosteroid or hyaluronic acid joint or bursa injection of the affected shoulder during the preceding three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Effect of Combined Hydrodilatation, Corticosteroid Injection, and Joint Mobilization for Treament of Frozen Shoulder

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