NASHA hyaluronic acid for the treatment of shoulder osteoarthritis: a prospective, single-arm clinical trial

Figures & data

Table 1 Patient demographics and baseline characteristics (safety set, N=41)

Characteristic	Mean (SD) or n (%)
Age (years)	65.4 (9.5)
Male gender	29 (70.7%)
Body weight (kg)	83.4 (17.7)
Body mass index (kg/m^2)	28.4 (4.8)

Figure 1 Shoulder pain on movement (SPOM) visual analog scale (VAS) results: mean score and mean percentage change from baseline. Error bars represent standard deviation (SD).

Table 2 Primary and secondary efficacy results in the full analysis set (N=40)

Variable	Baseline (n=40)	Week 6 (n=39)	Week 12 (n=30)	Week 18 (n=19)	Week 26 (n=24)
SPOM VAS score  - Mean (SD)  - LSMean (SE)	70.9 (13.7)	50.7 (24.6) 48.5 (3.4)	44.1 (26.0) 47.4 (3.2)	46.4 (27.9) 49.0 (3.4)	50.0 (26.8) 50.1 (3.4)
SPAN VAS score  - Mean (SD)  - LSMean (SE)	70.1 (20.5)	50.7 (26.4) 49.3 (4.1)	46.2 (27.8) 49.6 (3.9)	43.8 (23.9) 50.0 (3.7)	49.5 (31.8) 51.1 (3.9)
Patient global assessment VAS score  - Mean (SD)  - LSMean (SE)	40.7 (22.3)	55.1 (25.2) 58.9 (3.9)	60.2 (21.3) 59.4 (3.2)	68.6 (19.5) 61.2 (3.1)	53.3 (25.6) 57.8 (3.3)
ASES patient self-evaluation SSI score  - Mean (SD)  - LSMean (SE)	55.2 (19.2)	62.9 (20.9) 65.2 (3.7)	65.6 (14.9) 65.8 (3.2)	58.8 (14.0) 63.5 (3.1)	60.2 (19.9) 62.0 (3.0)
Use of rescue medication since the previous clinic visit  - number of patients, n/N (%)  - weekly dose [mg], mean (SD)*	5/32 (15.6) 6000 (NE)	19/39 (48.7) 3150 (4175)	12/32 (37.5) 1888 (1843)	12/25 (48.0) 1916 (1754)	9/23 (39.1) 3254 (2619)

Notes: *Not every patient who reported taking rescue medication reported the dose; at baseline, only one patient reported a dose.

Abbreviations: ASES, American shoulder and elbow surgeons; LSMean, least square mean; NE, not evaluable; SD, standard deviation; SE, standard error; SPAN, shoulder pain at night; SPOM, shoulder pain on movement; SSI, shoulder score index; VAS, visual analog scale.

Table 3 Adverse events occurring in more than one patient (safety set, N=41)

Adverse event	Number of patients (%)
Any	17 (41.5)
Headache	6 (14.6)
Musculoskeletal pain	3 (7.3)
Arthralgia	3 (7.3)
Pain in extremity	2 (4.9)
Viral upper respiratory tract infection	2 (4.9)