Frozen Shoulder
Conditions
Keywords
MMP-1, TIMP-1, Prolotherapy, Functional Outcome, Frozen Shoulder
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 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
Interventions
A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
DRUGNormal 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)
Sponsors
Bumi Herman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Intervention model description
This study involves two arms assigned randomly for receiving different treatments. One arm for Prolotherapy and Normal Saline in the comparison group.
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Matrix Metalloproteinase 1 in Blood | changes of Matrix Metalloproteinase 1 value from baseline to week 6 | 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 | changes of Tissue Inhibitor Metalloproteinase 1 value from baseline to week 6 | Tissue Inhibitor Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Outcome of the Shoulder | changes of Functional Outcome value from baseline to week 6 | 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 |
Countries
Indonesia
Outcome results
None listed