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Prolotherapy Intervention in Patient With Frozen Shoulder

Primary Purpose

Frozen Shoulder

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Dextrose 15 % in Water
Normal Saline 20 mL Injection
Sponsored by
Bumi Herman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring MMP-1, TIMP-1, Prolotherapy, Functional Outcome, Frozen Shoulder

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  1. Inclusion Criteria

    1. Age 35-70
    2. Diagnosed with frozen shoulder
    3. At least showing symptoms more than 3 months
  2. Exclusion Criteria

    1. Receiving other intraarticular injection
    2. Taking Nonsteroid Antiinflammation drugs 1 week prior to intervention
    3. Skin disorder around the injection site
    4. Septic arthritis

Sites / Locations

  • Hasanuddin University, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prolotherapy

Normal Saline 0.9%

Arm Description

A solution of 7.5 ml of 15% dextrose with 2 ml of 40% lidocaine and 10.5 water is given to these shoulder segments as follows. Supraspinatus muscle 2-4 ml Infraspinatus muscle 2-4 ml Teres minor muscle 2-3 ml, Subscapularis muscle 2-3 ml. Intraarticular glenohumeral joint 5 ml Bursa sub acromial 1-2 ml, Long head tendon biceps 1-2 ml Acromioclavicular joint 1 ml

A solution of 20 ml normal saline 0.9% is given to these shoulder segments as follows. Supraspinatus muscle 2-4 ml Infraspinatus muscle 2-4 ml Teres minor muscle 2-3 ml, Subscapularis muscle 2-3 ml. Intraarticular glenohumeral joint 5 ml Bursa sub acromial 1-2 ml, Long head tendon biceps 1-2 ml Acromioclavicular joint 1 ml

Outcomes

Primary Outcome Measures

Matrix Metalloproteinase 1 in Blood
Matrix Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
Tissue Inhibitor Metalloproteinase 1 in Blood
Tissue Inhibitor Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed

Secondary Outcome Measures

The Functional Outcome of the Shoulder
The functional outcome is measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire where the patient were asked to do simple task involving the arm, shoulder and hand and also the assessment of additional symptoms and impact to daily life. Higher score indicates disabilities

Full Information

First Posted
November 4, 2021
Last Updated
December 20, 2022
Sponsor
Bumi Herman
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1. Study Identification

Unique Protocol Identification Number
NCT05131269
Brief Title
Prolotherapy Intervention in Patient With Frozen Shoulder
Official Title
The Level of Matrix Metalloproteinase-1 (MMP-1), Tissue Inhibitor Matrix Metalloproteinase-1 (TIMP-1) After Prolotherapy Intervention and The Functional Outcome in Patient With Frozen Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bumi Herman

4. Oversight

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

5. Study Description

Brief Summary
Introduction : Prolotherapy is regenerative tissue therapy that is considered to be efficacious in reducing symptoms and morbidity of frozen shoulder, but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Matrix Metalloproteinase- I (MMP-1), Tissue Inhibitor Matrix Metalloproteinase (TIMP-1), as the biomarkers of cartilage repair. Objective: To determine the effect of prolotherapy on MMP-1, TIMP-1, and functional outcomes in frozen shoulder patients Method: a double-blind randomized controlled trial study involving participants who had been diagnosed with Frozen Shoulder. History taking, functional outcome assessment, MMP-1, and TIMP-1 were measured. The prolotherapy via intraarticular and extraarticular was performed four times, followed by the evaluation of functional outcome, MMP-1, and TIMP-1 at week 12 Alternative Hypothesis : Prolotherapy will increase the MMP-1, TIMP-1 levels, and improve functional outcome among Frozen Shoulder patients
Detailed Description
Design : Double-blind randomized trial Randomization : Simple Randomization generated by an online randomizer Sample Size : Difference between two means of primary outcome where mean difference (μ 1 - μ 2 ) = 0.47 pool variance = 0.09 Z 1-α/2 = 1.95 with type 1 error 5% 1-β = 1.282 with power 90%. Yielding 16 patients for each arm Detailed Intervention Intervention group: Prolotherapy is given four times (Week 0, Week 2, Week 4, and Week 6) Comparison group: Normal Saline is given four times with a timeframe similar to the intervention group Injection location Rotator Cuff muscles Intraarticular glenohumeral joint Subacromial bursa long-heap of the biceps tendon Acromioclavicular joint Statistical analysis : Descriptive statistic to elaborate baseline characteristic Assuming the baseline characteristic between groups are similar, the independent t-test will be conducted to see the differences between group, whereas Mann Whitney will be performed for nonparametric data Difference within-group (baseline and last day) will be measured by paired-t-test or Wilcoxon for non parametric scenario

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
MMP-1, TIMP-1, Prolotherapy, Functional Outcome, Frozen Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This study involves two arms assigned randomly for receiving different treatments. One arm for Prolotherapy and Normal Saline in the comparison group.
Masking
None (Open Label)
Masking Description
A sealed envelope of the randomized sequence was given to the investigator and care provider, and participants were recruited consecutively according to the permutation sequence. Participants were masked from the therapy by receiving treatment individually in different rooms and occasions. On the day of the assessment, the physician and laboratory technicians were blinded from group allocation
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolotherapy
Arm Type
Experimental
Arm Description
A solution of 7.5 ml of 15% dextrose with 2 ml of 40% lidocaine and 10.5 water is given to these shoulder segments as follows. Supraspinatus muscle 2-4 ml Infraspinatus muscle 2-4 ml Teres minor muscle 2-3 ml, Subscapularis muscle 2-3 ml. Intraarticular glenohumeral joint 5 ml Bursa sub acromial 1-2 ml, Long head tendon biceps 1-2 ml Acromioclavicular joint 1 ml
Arm Title
Normal Saline 0.9%
Arm Type
Placebo Comparator
Arm Description
A solution of 20 ml normal saline 0.9% is given to these shoulder segments as follows. Supraspinatus muscle 2-4 ml Infraspinatus muscle 2-4 ml Teres minor muscle 2-3 ml, Subscapularis muscle 2-3 ml. Intraarticular glenohumeral joint 5 ml Bursa sub acromial 1-2 ml, Long head tendon biceps 1-2 ml Acromioclavicular joint 1 ml
Intervention Type
Drug
Intervention Name(s)
Dextrose 15 % in Water
Other Intervention Name(s)
Prolotherapy
Intervention Description
A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Intervention Type
Drug
Intervention Name(s)
Normal Saline 20 mL Injection
Other Intervention Name(s)
Comparator
Intervention Description
A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Primary Outcome Measure Information:
Title
Matrix Metalloproteinase 1 in Blood
Description
Matrix Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
Time Frame
changes of Matrix Metalloproteinase 1 value from baseline to week 6
Title
Tissue Inhibitor Metalloproteinase 1 in Blood
Description
Tissue Inhibitor Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
Time Frame
changes of Tissue Inhibitor Metalloproteinase 1 value from baseline to week 6
Secondary Outcome Measure Information:
Title
The Functional Outcome of the Shoulder
Description
The functional outcome is measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire where the patient were asked to do simple task involving the arm, shoulder and hand and also the assessment of additional symptoms and impact to daily life. Higher score indicates disabilities
Time Frame
changes of Functional Outcome value from baseline to week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age 35-70 Diagnosed with frozen shoulder At least showing symptoms more than 3 months Exclusion Criteria Receiving other intraarticular injection Taking Nonsteroid Antiinflammation drugs 1 week prior to intervention Skin disorder around the injection site Septic arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuralam Sarif, MD
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Irawan Yusuf, PhD
Organizational Affiliation
Hasanuddin University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Endy Adnan, PhD
Organizational Affiliation
Hasanuddin University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Irfan Idris, PhD
Organizational Affiliation
Hasanuddin University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasanuddin University, Faculty of Medicine
City
Makassar
State/Province
South Sulawesi
ZIP/Postal Code
90245
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data will be shared accordingly
Citations:
PubMed Identifier
32990454
Citation
Akcay S, Gurel Kandemir N, Kaya T, Dogan N, Eren M. Dextrose Prolotherapy Versus Normal Saline Injection for the Treatment of Lateral Epicondylopathy: A Randomized Controlled Trial. J Altern Complement Med. 2020 Dec;26(12):1159-1168. doi: 10.1089/acm.2020.0286. Epub 2020 Sep 28.
Results Reference
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PubMed Identifier
29992159
Citation
Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.
Results Reference
background
PubMed Identifier
21703585
Citation
Distel LM, Best TM. Prolotherapy: a clinical review of its role in treating chronic musculoskeletal pain. PM R. 2011 Jun;3(6 Suppl 1):S78-81. doi: 10.1016/j.pmrj.2011.04.003.
Results Reference
background
PubMed Identifier
23604641
Citation
Lubis AM, Lubis VK. Matrix metalloproteinase, tissue inhibitor of metalloproteinase and transforming growth factor-beta 1 in frozen shoulder, and their changes as response to intensive stretching and supervised neglect exercise. J Orthop Sci. 2013 Jul;18(4):519-27. doi: 10.1007/s00776-013-0387-0. Epub 2013 Apr 19.
Results Reference
background
PubMed Identifier
28027657
Citation
Saltzman BM, Leroux T, Meyer MA, Basques BA, Chahal J, Bach BR Jr, Yanke AB, Cole BJ. The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies. Am J Sports Med. 2017 Sep;45(11):2647-2653. doi: 10.1177/0363546516680607. Epub 2016 Dec 27.
Results Reference
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Prolotherapy Intervention in Patient With Frozen Shoulder

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