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Frozen ShoulderPhase 4NCT05131269

Prolotherapy Intervention in Patient With Frozen Shoulder

A Phase 4 study testing Dextrose 15 % in Water and Normal Saline 20 mL Injection in people with Frozen Shoulder, run by Bumi Herman at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 70 years
Conditions the study is for
Frozen Shoulder
What is being tested?
Dextrose 15 % in Water and Normal Saline 20 mL Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteIndonesia
Study dates
1 Dec 2021to 30 Nov 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion Criteria
  2. Age 35-70
  3. Diagnosed with frozen shoulder
  4. At least showing symptoms more than 3 months
  5. Exclusion Criteria
  6. Receiving other intraarticular injection
  7. Taking Nonsteroid Antiinflammation drugs 1 week prior to intervention
  8. Skin disorder around the injection site
  9. Septic arthritis

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Hasanuddin University, Faculty of Medicine

    Makassar, South Sulawesi, 90245

Other trials in Indonesia

About this study

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

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.

Read more

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

Read the 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

  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
Frozen Shoulder
Being tested
Dextrose 15 % in Water, Normal Saline 20 mL Injection
Keywords
MMP-1, TIMP-1, Prolotherapy, Functional Outcome, Frozen Shoulder
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dextrose 15 % in WaterDrug

    Also called Prolotherapy

    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 InjectionDrug

    Also called Comparator

    A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)

Study groups in NCT05131269
Study groupRoleWhat they receive
ProlotherapyExperimentalA 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
Receives: Drug: Dextrose 15 % in Water
Normal Saline 0.9%Placebo comparatorA 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
Receives: Drug: Normal Saline 20 mL Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Matrix Metalloproteinase 1 in Blood

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

    Measured: changes of Matrix Metalloproteinase 1 value from baseline to week 6

  2. 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

    Measured: changes of Tissue Inhibitor Metalloproteinase 1 value from baseline to week 6

Secondary outcomes (1)

  1. 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

    Measured: changes of Functional Outcome value from baseline to week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start1 Dec 2021
  3. Primary completion31 May 2022
  4. Study completion30 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05131269
Sponsor's protocol ID
0411211741
Status last verified
Dec 2022
First submitted
4 Nov 2021
Last updated
22 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data will be shared accordingly

Publications

  • 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.

    PubMed 32990454

  • 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.

    PubMed 29992159

  • 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.

    PubMed 21703585

  • 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.

    PubMed 23604641

  • 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.

    PubMed 28027657

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dextrose 15 % in Water and Normal Saline 20 mL Injection in people with Frozen Shoulder, run by Bumi Herman at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Matrix Metalloproteinase 1 in Blood (time frame: changes of Matrix Metalloproteinase 1 value from baseline to week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05131269, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.

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