Prolotherapy Intervention in Patient With Frozen Shoulder

NCT05131269 | Completed Phase 4

• 1 other identifier: 0411211741
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Frozen Shoulder

Keywords

MMP-1; TIMP-1; Prolotherapy; Functional Outcome; Frozen Shoulder

Outcome Measures

Primary Outcomes (2)

• Matrix Metalloproteinase 1 in Blood

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

  changes of Matrix Metalloproteinase 1 value from baseline to week 6

• 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

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

Secondary Outcomes (1)

• The Functional Outcome of the Shoulder

  changes of Functional Outcome value from baseline to week 6

Study Arms (2)

Prolotherapy

EXPERIMENTAL

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

Drug: Dextrose 15 % in Water

Normal Saline 0.9%

PLACEBO COMPARATOR

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

Drug: Normal Saline 20 mL Injection

Interventions

Dextrose 15 % in Water DRUG

A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)

Also known as: Prolotherapy

Prolotherapy

Normal Saline 20 mL Injection DRUG

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

Also known as: Comparator

Normal Saline 0.9%

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35-70
• Diagnosed with frozen shoulder
• At least showing symptoms more than 3 months

You may not qualify if:

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

Sponsors & Collaborators

• Bumi Herman: lead

Study Sites (1)

Hasanuddin University, Faculty of Medicine

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (5)

• 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.

  PMID: 32990454 BACKGROUND

• 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.

  PMID: 29992159 BACKGROUND

• 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.

  PMID: 21703585 BACKGROUND

• 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.

  PMID: 23604641 BACKGROUND

• 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.

  PMID: 28027657 BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Glucose; Water; Prolotherapy; Saline Solution; Injections

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Complementary Therapies; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy

Study Officials

• Nuralam Sarif, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Irawan Yusuf, PhD

  Hasanuddin University

  STUDY CHAIR

• Endy Adnan, PhD

  Hasanuddin University

  STUDY CHAIR

• Irfan Idris, PhD

  Hasanuddin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: This study involves two arms assigned randomly for receiving different treatments. One arm for Prolotherapy and Normal Saline in the comparison group.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 23, 2021
• Study Start: December 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: November 30, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)