- OE M.I.N.D. contains data from 686 RCTs related to shoulder conditions with over 136,000 patients, and is a powerful and efficient tool to auto generate evidence reports regarding a clinical topic.
- Patients with rotator cuff tendinopathy who received prolotherapy with dextrose or glucose demonstrated superior outcomes in composite clinical outcomes and pain compared with those who received placebo solutions or care as usual with physical therapy in three follow-up durations: within 1 month, 1 to 6 months and beyond 6 months. The effects were statistically significant, but the 95% CI of both outcomes did not exceed the recommended minimally important difference.
- Corticosteroid injection is associated with small but significant improvement in composite clinical outcomes than prolotherapy within 6 months follow-up but not beyond 6 months follow-up. There was no significant difference between corticosteroid injection and prolotherapy in pain in short- or long-term follow-up.
- Prolotherapy appears to be safe for treatment of rotator cuff tendinopathy. No serious adverse events were reported post injection.
- There is 1 study aiming to recruit 60 patients currently ongoing studies that investigates effects of prolotherapy in treating rotator cuff tendinopathy using data from clinicaltrials.gov. There are 21 studies aiming to recruit 873 patients currently ongoing for an intervention of tendinopathy in the shoulder.
- In most published studies related to prolotherapy and shoulder, variables of age, visual analogue scale for pain and a follow-up of 3 months are reported.
Rotator cuff tendinopathy affects 1 in 5 people and is a common cause of shoulder pain and weakness (Bury et al., 2018; Yamamoto et al., 2010). The prevalence of rotator cuff tendinopathy increases with age (Yamamoto et al., 2010). Rotator cuff tendinopathy is a chronic degenerative condition and is associated with excessive use of rotator cuff tendons and muscles or a tear (Lewis, 2009). Conservetive strategies including patient education, exercise and physical therapy are recommended and mostly performed in management of rotator cuff tendinopathy (Tashjian, 2011; Bury et al., 2018).'
Prolotherapy is a regenerative injection of a solution to the painful and degenerated sites to promote local healing of injured tissues and has been found effective and safe in treatment for chronic musculoskeletal conditions including knee osteoarthritis (https://myorthoevidence.com/Blog/Show/124), nonsurgical sacroiliac pain, lateral epicondylosis, plantar fasciopathy and rotator cuff disorders ranging from tendinosis to small full-thickness or partial-thickness teas (Hauser et al., 2016; Reeves et al., 2016). Hypertonic/hyperosmolar dextrose [the dexter (right-handed) form of glucose] is the most commonly used solution in clinical practice. To ensure accuracy of injection, ultrasound-guided injection is usually performed (Hauser et al., 2016; Catapano et al., 2021).
In this OE Original, we present analytics using OE M.I.N.D. that include a scoping review of published studies, meta-analysis results and quality of evidence, cumulative evidence synthesized by time and a profile of ongoing trials for prolotherapy for rotator cuff tendinopathy. All of the data were extracted from randomized controlled trials (RCTs) by experienced medical literature reviewers. OE M.I.N.D. updates the data on a daily basis, with new trials and data being constantly added. The results in this OE Original were based on analyses performed on June 25, 2021.
2. OE M.I.N.D. Meta Analyzer --- Overview of the available evidence
Over 136,000 patients across 686 studies were reported for shoulder conditions. There are 47 treatments that were studied for rotator cuff tendinopathy, and 19 outcome measures were reported at various followup durations evaluating efficacy of prolotherapy in treating the condition (Figure 1).
Figure 1. Summary data of research topic according to anatomical region, condition and treatment
2. OE M.I.N.D. Meta Analyzer --- Effectiveness of treatments
We identified 9 RCTs investigating effectiveness of prolotherapy for rotator cuff tendinopathy. Of them, 6 studies compared injection of prolotherapy solution (mostly a mixture of dextrose or glucose and lidocaine or lignocaine hydrochloride) with a control of either injection of placebo (saline or solution without dextrose) or care as usual with physical therapy (Bertrand et al., 2016; Chang et al., 2021; George et al., 2018; Lin et al., 2019a; Mofrad et al., 2021; Seven et al., 2017). Two studies compared prolotherapy with injection of a corticosteroid (Amanollahi et al., 2019; Cole et al., 2018). One multi-arm study compared prolotherapy with both a corticosteroid and saline (Sari et al., 2020). The longest follow-up among the included RCTs was a mean of 17 months (Seven et al., 2017). The characteristics of the RCTs included in meta-analysis are presented in Table 1.
Table 1. Characteristics of RCTs included in meta-analysis
Number of patients
Amanollahi et al., 2019
Chronic rotator cuff tendinopathy
3 ml of 5% dextrose and 2 ml of 2% lidocaine; Subcutaneous; 3 injections at 1-week intervals.
20 mg (10 mg/ml) triamcinolone, 2 ml of acetonide, and 1% of 2 ml lidocaine; Subacromial; Ultrasound-guided; Single injection.
Bertrand et al., 2016
Painful rotator cuff tendinopathy
25% dextrose, 0.1% lidocaine and saline; Injection onto painful entheses; 3 injections at 1-month intervals.
0.1% lidocaine and saline; Injection onto painful entheses; 3 injections at 1-month intervals.
Chang et al., 2021
Rotator cuff disease and bursitis
4.5 mL of 15% dextrose and 0.5 mL of 1% xylocaine; Ultrasound-guidance bursal injection; 3 injections at 2-week intervals.
4.5 mL of normal saline and 0.5 mL of 1% xylocaine; Ultrasound-guidance bursal injection; 3 injections at 2-week intervals.
Cole et al., 2018
25% glucose prolotherapy solution (1mL of 50% glucose and 1mL of 1% lignocaine hydrochloride); Ultrasound-guided injection into the area of supraspinatus tendinopathy; Single injection.
1mL of 40 mg/mL methylprednisolone acetate and 1mL of 1% lignocaine hydrochloride; Ultrasound-guided injection into the area of supraspinatus tendinopathy; Single injection.
George et al., 2018
Focal supraspinatus tendinosis
0.5–1.0 ml of prolotherapy (12.5% dextrose and 0.5% lignocaine); Ultrasound-guided injection into the area of focal tendinosis; Single injection
Patients continued standard physiotherapy.
Lin et al., 2019a
Chronic supraspinatus tendinopathy
5 mL of 20% hypertonic dextrose prolotherapy (4.0 mL of 50% dextrose and 1.0 mL of normal saline); Ultrasound-guided injection at the supraspinatus enthesis site; Single injection.
5 mL of 5% normal saline; Ultrasound-guided injection at the supraspinatus enthesis site; Single injection.
Mofrad et al., 2021
Chronic rotator cuff tendinopathy
8 mL of 12.5% dextrose and 40 mg of 2% lidocaine; Ultrasound-guided injection at the tender points; 2 injections at 1-week intervals.
Superficial heat using a hot pack; transcutaneous electrical nerve stimulation; pulsed ultrasound; physical therapy and exercise for 3 weeks.
Sari et al., 2020
Rotator cuff tendon lesions
5 mL of prolotherapy solution (4 mL 20% dextrose and 1 mL lidocaine); Ultrasound-guided lateral subacromial injection; Single injection.
Same injection method.
The second arm: 3 mL 1% lidocaine and 2 mL saline.
The third arm: 2 mL 40 mg triamcinolone acetonide, 2 mL 1% lidocaine and 1 ml saline.
Seven et al., 2017
Chronic rotator cuff lesions and symptoms in form of tendinosis or partial tear of rotator cuff
A 4 mL of prolotherapy solution (3.6 mL of 25% dextrose and 0.4 mL lidocaine) was injected to the subacromial bursa; 20 mL dextrose solution (18 mL of 15% dextrose and 2 mL lidocaine) to supraspinatus, infraspinatus, teres minor insertions, pectoralis minor, coracobrachialis and biceps brachii insertions; Ultrasound-guided; 3 injections at 3-week intervals, and maximum 6 rounds of injections.
Patients continued exercises, 3 sessions per week for 12 weeks.
We are presenting the meta-analysis results of composite clinical outcomes, function and pain within three time frames of follow-up: within 1 month, 1 to 6 months, and equals to or more than 6 months post intervention as well as incidence of adverse events at the longest follow-up period.
2.1 Composite clinical outcomes (0 to 100, a higher score indicates better recovery)
2.1.2 Prolotherapy vs. Control
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Disability of Arm and Shoulder (DASH) score, and Shoulder Pain And Disability Index (SPADI) are normalized on a 0 to 100 scale to assess patient recovery (Velentgas et al., 2010).
In the current comparison of prolotherapy versus control for the composite clinical outcomes at 1 month, a total of 396 patients from 5 studies published between 2017 and 2021 are included in the analysis. The overall effect demonstrates that prolotherapy results in a significant improvement with patients experiencing, on average, a 6.89 [95% confidence interval (CI), 3.66 to 10.11] point improvement. The effect and 95% CI did not exceed the recommended minimally important difference (MID) of 10.2 points on the 0 to 100 DASH score (Hao et al., 2019). The certainty of the evidence by GRADE assessment was rated as low due to serious risk of bias and imprecision (Figure 2).
During 1 to 6 months follow-up, a total of 408 patients from 6 studies published between 2017 and 2021 are included in analysis. The overall effect demonstrates that prolotherapy results in a significant improvement with patients experiencing, on average, a 4.99 (95% CI, 2.89 to 7.1) point improvement, with low certainty of evidence (Figure 2).
Beyond 6 months post intervention, a total of 249 patients from 2 studies are included in the analysis. Prolotherapy demonstrates a significant improvement with patients experiencing, on average, a 16.9 (95% CI, 12.59 to 21.2) point improvement. The effect and 95% CI exceeded the recommended MID. We rated the certainty of evidence as moderate (Figure 2).
Figure 2. Forest plot of composite clinical outcomes on a 0-100 scale
(Prolotherapy vs. Control)
Notes: MID = minimally important difference; ROB = risk of bias; red circle with a cross mark = high risk of bias; yellow circle with an exclamation mark = have some concerns; green circle with a check mark = low risk of bias.
2.1.2 Prolotherapy vs. Corticosteroid Injection
One study enrolling 129 patients reported ASES for the comparison of prolotherapy versus ultrasound-guided corticosteroid injection (Sari et al., 2020). The results are in favour of corticosteroid at 1 month [mean difference (MD), 12.97; 95% CI, 7.22 to 18.72] and during 1 to 6 months post intervention (MD, 6.87; 95% CI, 2.15 to 11.59). Nevertheless, the effects and 95% CIs did not exceed the MID of 21.9 points on the 0 to 100 ASES score (Gagnier et al., 2018). We rated the certainty of evidence as moderate due to imprecision due to imprecision (Figure 3).
Beyond 6 months post intervention, there is no significant difference between prolotherapy and corticosteroid injection, with moderate certainty of evidence due to imprecision (Figure 3).
Figure 3. Forest plot of American Shoulder and Elbow Surgeons (ASES) score
(Prolotherapy vs. Corticosteroid injection)
Notes: MID = minimally important difference; ROB = risk of bias.
2.2 Pain score (0 to 100, a higher score indicates worse pain)
2.2.1 Prolotherapy vs. Control
Visual analogue scale (VAS) of pain, shoulder pain intensity on a 5-Likert scale and pain subscale of DASH are normalized on a 0 to 100 scale to assess pain post intervention.
In the comparison of prolotherapy versus control for pain, the overall effect demonstrates that prolotherapy results in a significant reduction in pain in all the 3 follow-up periods: within 1 month (396 patients from 5 studies; MD, -10.15; 95% CI, -12.87 to -7.44), 1 to 6 months (482 patients from 7 studies; MD, -5.3; 95% CI, -7.52 to -3.09) and beyond 6 months (323 patients from 3 studies; MD, -13.57; 95% CI, -16.66 to -10.48). Nevertheless, these effects and 95% CIs did not exceed MID of 1.5 points on the 0 to 10 pain VAS, i.e., 15 points on a 0 to 100 pain scale after conversion, for patients with shoulder condition (Hao et al., 2019). We rated the certainty of evidence as low due to risk of bias and imprecision (Figure 4).
Figure 4. Forest plot of pain on 0-100 score (Prolotherapy vs. Control)
Notes: MID = minimally important difference; ROB = risk of bias.
2.2.2 Prolotherapy vs. Corticosteroid Injection
There is no significant difference in the outcome of normalized pain scale between prolotherapy and ultrasound-guided corticosteroid injection in all the 3 follow-up periods: within 1 month (189 patients from 2 studies; MD, 1.11; 95% CI, -3.86 to 6.07), 1 to 6 months (165 patients from 2 studies; MD, 1.21; 95% CI, -2.35 to 4.76) and beyond 6 months (165 patients from 2 studies; MD, 3.51; 95% CI, -0.1 to 7.11), with low certainty of evidence (Figure 5).
Figure 5. Forest plot of pain on 0-100 score (Prolotherapy vs. Corticosteroid Injection)
2.3 Incidence of adverse events
2.3.1 Prolotherapy vs. Control
The reported adverse events were minor and included discomfort with injection, pain or soreness after injection, local anesthetic effect and hypotension (Bertrand et al., 2016; Chang et al., 2021; Lin et al., 2019a; Seven et al., 2017).
There was no significant difference in adverse events between prolotherapy and control at the longest follow-up [275 patients from 4 studies; relative risk (RR), 2.59; 95% CI, 0.63 to 10.63), with very low certainty of evidence due to risk of bias, imprecision and inconsistency (Figure 6).
Figure 6. Forest plot of adverse events (Prolotherapy vs. Control)
2.3.2 Prolotherapy vs. Corticosteroid Injection
In the comparison of prolotherapy versus ultrasound-guided corticosteroid injection, one study reported that no important adverse events occurred in either group.
We present a summary of the nine outcome measures at three follow-up durations in Table 2.
Table 2. Summary and certainty of the evidence
= 1 month
> 1 to < 6 months
= 6 months
Composite clinical outcomes, vs. Control
Composite clinical outcomes, vs. Corticosteroids
Pain, vs. Control
Pain, vs. Corticosteroids
Adverse events at the longest follow-up, vs. Control
(Very low certainty)
Adverse events at the longest follow-up, vs. Corticosteroids
(Meta-analysis was not performed)
3. OE M.I.N.D. Forecaster --- Sequential meta-analysis
The trends in treatment effects over time show that, when new RCTs are reported and more patients are included in the analysis, precision of effects increases for all the outcomes at their longest follow-up (narrower 95% CI over time) (Figures 7, 8).
3.1 Composite clinical outcomes
Compared with control, the overall effects were in favour of prolotherapy in composite clinical outcomes measured with ASES, DASH or SPADI over time. The effects were greater than the MID before 2019. From 2019 to 2021, smaller effects of prolotherapy were observed (were statistically significant but did not exceed the MID) (Figure 7).
We were not able to perform a sequential meta-analysis that compared prolotherapy with corticosteroid injection for composite clinical outcomes because only one study (Sari et al., 2020) reported the outcome of interest.
Figure 7. Sequential meta-analysis result for composite clinical outcomes
(Prolotherapy vs. Control)
Note: MID = minimally important difference.
3.2 Pain score
For the comparison of prolotherapy and control for pain, the overall effects were in favour of prolotherapy and the effects were small (difference was within the MID) over time (Figure 8, the upper figure).
For the comparison of prolotherapy and corticosteroid injection, the treatment effect stated with first reported study published in 2018 favouring corticosteroid, with patients experiencing, on average, a 7.5 point (95% CI, 3.37 to 11.63) improvement for pain, a small effect that was within the MID. After examining all the evidence over time up to 2020, the final treatment effect demonstrated no significant difference in pain between prolotherapy and corticosteroid injection (Figure 8, the lower figure).
Figure 8. Sequential meta-analysis result for pain
Note: MID = minimally important difference.
4. OE M.I.N.D Ongoing trials report
We found one registered, ongoing study that is investigating the effects of prolotherapy in treating tendinopathy in the shoulder. It is a single-center, interventional study being conducted in Egypt and aiming to recruit 60 patients.
For any treatment for tendinopathy in the shoulder, a total of 21 studies were found to be currently ongoing around the world, aiming to recruit 873 patients. Six of these 21 ongoing studies (28.6%) are being conducted in the United States. Three of them (10.3%) have an intervention of eccentric exercise and 2 of them (6.9%) have an intervention of an injection (Figure 9).
Figure 9. Ongoing trials of surgical intervention for rotator cuff repair
5. OE M.I.N.D. Research Planning Tool
The OE M.I.N.D. Research Planning Tool provides us with an overview of characteristics of prior RCTs. For studies related to prolotherapy and shoulder, the most frequently reported characteristics include: patient demographics, age (100% studies reported age); follow-up time point, 3 months (44.4% studies reported outcomes at 3 months’ follow-up); studies conducted at a single center (100%); VAS pain (55.6%); and the country, Iran (22.2%) (Figure 10).
Figure 10.The most frequently reported characteristics of relevant studies about prolotherapy and shoulder
In this OE Original, we identified 9 RCTs that investigated the efficacy and safety of prolotherapy (dextrose or glucose injection to the painful sites) in patients with rotator cuff tendinopathy. In our meta-analysis, low to moderate quality of evidence showed that prolotherapy was superior to control in composite clinical outcomes (ASES, DASH or SPADI) and pain improvement at short (within 1 month) or longer follow-up durations among patients with rotator cuff tendinopathy. The effects were statistically significant, but the 95% CI of the composite clinical outcomes or pain scale did not exceed the recommended MID when reporting treatment effects regarding shoulder condition.
In terms of composite clinical outcomes for the comparison of prolotherapy and corticosteroid injection, data was available from only 1 RCT (Sari et al., 2020). The result showed that corticosteroid injection was superior to prolotherapy in ASES within 1 month and during 1 to 6 months’ follow-up, with moderate level of certainty by GRADE. The effects and 95% CIs did not exceed the MID. Low to moderate evidence showed that there was no significant difference between prolotherapy and corticosteroid injection for ASES beyond 6 months post intervention, or for pain scores at any of the three follow-up periods.
No serious adverse events were reported after prolotherapy in all the eligible RCTs. Furthermore, prolotherapy is a relatively inexpensive therapy and uses an easy-to-prepare solution (Reeves et al., 2016).
The findings in this OE Original are consistent with previously published systematic reviews on the same topic that dextrose prolotherapy has potential effects and among the injection therapies for rotator cuff tendinopathy, corticosteroid is effective in the short-term but not in longer-term of over 24 weeks (Hauser et al., 2016; Catapano et al., 2020; Giovannetti de Sanctis et al., 2021; Lin et al., 2019b).
One of the major concerns during the evidence quality assessment was the imprecision issue. We rated down one level of GRADE assessment for imprecision regarding both outcomes. Although the CIs of the outcomes excluded the no effect line, their CIs crossed the recommended MID values and clinical decisions would differ if the upper boundary versus the lower boundary of the CIs represented the true effect, for patients to achieve a minimally important improvement (Guyatt et al., 2011a). For most outcomes except for composite clinical outcomes for prolotherapy versus corticosteroid injection, we also rated down one level of GRADE assessment for serious risk of bias due to lack of blinding to investigators and participants (Guyatt et al., 2011b).
Additional future research with larger sample sizes and with at least 6 months follow-up is needed to comprehensively evaluate the outcomes and associated cost, and verify the findings of the current meta-analysis results.
Meta-analysis of 7 RCTs showed that for patients with rotator cuff tendinopathy, prolotherapy with dextrose or glucose is associated with small benefits in composite clinical outcomes and pain than control in both short-term and longer-term (over 6 months) of follow-up. Meta-analysis of 3 RCTs showed that corticosteroid injection is associated with small benefits in composite clinical outcomes than prolotherapy within 6 months follow-up but not in >= 6 months follow-up. There was no significant difference between corticosteroid injection and prolotherapy in pain in short- or long-term follow-up. No serious adverse events were reported after prolotherapy.
Related ACE Reports:
Related OE Original:
Amanollahi A, Asheghan M, Hashemi SE. Subacromial corticosteroid injection versus subcutaneous 5% dextrose in patients with chronic rotator cuff tendinopathy: A short-term randomized clinical trial. Interventional Medicine and Applied Science. 2019 Nov 11:1-7.
Bertrand H, Reeves KD, Bennett CJ, Bicknell S, Cheng AL. Dextrose prolotherapy versus control injections in painful rotator cuff tendinopathy. Archives of physical medicine and rehabilitation. 2016 Jan 1;97(1):17-25.
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Chang YJ, Chang FH, Hou PH, Tseng KH, Lin YN. Effects of Hyperosmolar Dextrose Injection in Patients With Rotator Cuff Disease and Bursitis: A Randomized Controlled Trial. Archives of Physical Medicine and Rehabilitation. 2021 Feb 1;102(2):245-50.
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