Single Ultrasound-Guided Dextrose Prolotherapy Plus Therapeutic Exercise for Subacromial-Subdeltoid Bursitis: A Pilot Double-Blind Randomized Controlled Trial.

OBJECTIVE

To determine whether a single ultrasound-guided dextrose prolotherapy (DPT) injection added to supervised therapeutic exercise improves outcomes versus saline injection plus the same program in adults with subacromial-subdeltoid (SASD) bursitis.

DESIGN

Pilot double-blind randomized controlled trial with 13-week follow-up.

SETTING

Tertiary referral hospital in XXXXX.

PARTICIPANTS

Adults aged ≥20 years with ultrasound-confirmed SASD bursitis and shoulder pain ≤3 months were randomized (n=46; 23 per group); 42 completed 13-week follow-up.

INTERVENTIONS: Participants received one ultrasound-guided SASD bursal injection of 10 mL 20% dextrose or 10 mL normal saline, followed by a standardized 12-week therapeutic exercise program delivered 3 times weekly.

MAIN OUTCOME MEASURES: The primary outcome was Shoulder Pain and Disability Index (SPADI) total score. Secondary outcomes included SPADI subscales, Disabilities of the Arm, Shoulder and Hand (DASH), visual analog scale (VAS) pain, shoulder range of motion (ROM), and World Health Organization Quality of Life-Brief (WHOQOL-BREF). Treatment effects were assessed by sex- and baseline-adjusted repeated-measures analysis of covariance using the group × time interaction.

RESULTS

SPADI total score showed a more favorable longitudinal trajectory with DPT+exercise than saline+exercise (group × time p=.004). At 13 weeks, the observed unadjusted between-group difference was -6.40 points (95% CI, -8.72 to -4.08), below the prespecified 8-point minimal clinically important difference. Significant group × time interactions also favored DPT+exercise for SPADI pain (p=.002) and disability (p=.017), active abduction (p<.001) and external rotation (p=.012), passive external rotation (p=.002) and internal rotation (p=.016), and VAS pain (p=.001). DASH and WHOQOL-BREF showed no differential longitudinal effects.Four DPT participants reported transient postinjection soreness; no serious adverse events occurred.

CONCLUSIONS

Adding a single ultrasound-guided DPT injection to therapeutic exercise produced more favorable longitudinal changes in SPADI total score, selected ROM measures, and pain than saline injection plus exercise and was well tolerated. Larger trials with longer follow-up are warranted.