Prolotherapy Intervention in Patient With Frozen Shoulder
NCT ID: NCT05131269
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2021-12-01
2022-11-30
Brief Summary
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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
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Double-blind randomized trial
Randomization :
Simple Randomization generated by an online randomizer
Sample Size :
Difference between two means of primary outcome where
1. mean difference (μ 1 - μ 2 ) = 0.47
2. pool variance = 0.09
3. Z 1-α/2 = 1.95 with type 1 error 5%
4. 1-β = 1.282 with power 90%. Yielding 16 patients for each arm
Detailed Intervention
1. Intervention group: Prolotherapy is given four times (Week 0, Week 2, Week 4, and Week 6)
2. Comparison group: Normal Saline is given four times with a timeframe similar to the intervention group
Injection location
1. Rotator Cuff muscles
2. Intraarticular glenohumeral joint
3. Subacromial bursa
4. long-heap of the biceps tendon
5. Acromioclavicular joint
Statistical analysis :
1. Descriptive statistic to elaborate baseline characteristic
2. 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
3. Difference within-group (baseline and last day) will be measured by paired-t-test or Wilcoxon for non parametric scenario
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prolotherapy
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.
1. Supraspinatus muscle 2-4 ml
2. Infraspinatus muscle 2-4 ml
3. Teres minor muscle 2-3 ml,
4. Subscapularis muscle 2-3 ml.
5. Intraarticular glenohumeral joint 5 ml
6. Bursa sub acromial 1-2 ml,
7. Long head tendon biceps 1-2 ml
8. Acromioclavicular joint 1 ml
Dextrose 15 % in Water
A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Normal Saline 0.9%
A solution of 20 ml normal saline 0.9% is given to these shoulder segments as follows.
1. Supraspinatus muscle 2-4 ml
2. Infraspinatus muscle 2-4 ml
3. Teres minor muscle 2-3 ml,
4. Subscapularis muscle 2-3 ml.
5. Intraarticular glenohumeral joint 5 ml
6. Bursa sub acromial 1-2 ml,
7. Long head tendon biceps 1-2 ml
8. Acromioclavicular joint 1 ml
Normal Saline 20 mL Injection
A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Interventions
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Dextrose 15 % in Water
A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Normal Saline 20 mL Injection
A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with frozen shoulder
3. At least showing symptoms more than 3 months
Exclusion Criteria
2. Taking Nonsteroid Antiinflammation drugs 1 week prior to intervention
3. Skin disorder around the injection site
4. Septic arthritis
35 Years
70 Years
ALL
No
Sponsors
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Bumi Herman
OTHER
Responsible Party
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Bumi Herman
Assistant Lecturer
Principal Investigators
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Nuralam Sarif, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Irawan Yusuf, PhD
Role: STUDY_CHAIR
Hasanuddin University
Endy Adnan, PhD
Role: STUDY_CHAIR
Hasanuddin University
Irfan Idris, PhD
Role: STUDY_CHAIR
Hasanuddin University
Locations
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Hasanuddin University, Faculty of Medicine
Makassar, South Sulawesi, Indonesia
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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0411211741
Identifier Type: -
Identifier Source: org_study_id