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. 2019 Mar 5;3(1):33–48. doi: 10.1080/24740527.2019.1574536

Table 2.

Characteristics of studies included in the systematic review: Outcomes including analgesic benefits and adverse effects.

Study, year, number of patients, type of study Newer SCS mode Follow-up time points after implantation Outcomes assessed Important results Adverse effects of paresthesia-free SCS Comments
Case reports/series
Al-Kaisy et al.12 2015 (n = 15) CS (R) HF-10 1, 3, and 6 months NRS pain
BPI
PCS
EQ-5D
painDETECT
At 6 months:
NRS pain reduced by 59%
BPI reduced by 45%
PCS reduced by 75%
EQ-5D increased by 101%
Excellent or good satisfaction for 10/11 patients
No adverse effects related to paresthesia-free SCS 11/15 had successful trials but 3 of the 4 patients who had no benefit had CRPS of the foot; all 3 patients with CRPS of the hand responded
Kriek et al.18 2015(n = 1) CR (R) Burst 24 months NRS pain
Medication intake
Vasomotor and sudomotor symptoms
ROM
NRS pain decreased by 75%
Lower medication intake
No worsening in vasomotor and sudomotor symptoms or ROM
Burst stimulation provides analgesia when tolerance develops to conventional SCS
Reddy et al.19 2016 (n = 2) CS (P) HF-10 0.5 days VAS pain
Discomfort
Feedback from patients
NRS pain reduced by 30%–50%
Patients preference: HF
  0.5-day trial of HF-SCS during weeklong conventional trial; possibility of carryover effects
Smith et al.20 2015 (n = 1) CR (R) HF (1.15 kHz) 6 months NRS pain
QoL
Medication intake
Quality of sleep
NRS pain reduced by 50%
Reduction of medication intake
Paresthesia-free (high-frequency) SCS mode used by patient to avoid intolerable paresthesias
Tate21 2017(n = 1) CR (R) HF-10 4 months NRS pain
QoL
Vasomotor and sudomotor symptoms
Anxiety
ROM
Medication intake
100% pain relief with resolution of phantom limb pain, anxiety, and improved QoL
Improvement in vasomotor and sudomotor symptoms
ROM: improved gait
Medication intake: opiate-free
Wille et al.13 2017(n = 3) CS (R) HD 1, 6, and 12 months after switch from conventional to HD SCS NRS pain Significant and progressive decrease (7.9 to 3.1) in NRS pain scores following implementation of HD mode for 12 months in 2 patients on HD for this duration
One patient with CRPS requested reprogramming to conventional SCS due to preference to PB-SCS (although effect of PF-SCS)
Possibility of a dose-related response between the amount of energy delivered to the spinal cord and clinical effect
Abstracts
Amirdelfan et al.22 2017 (n = 6) CS (R) HF-10 4 to 15 months VAS pain
Medication usage
Physical activity
Vasomotor signs
Decrease in VAS pain scores by 83% ± 3.0% and medication usage
Improvement in activity and vasomotor signs
All 6 patients responded
Santarelli et al.23 2016 (n = 7) CS (P) HF-10 3, 6, 9, and 12 months VAS pain scores
Medication usage
Quality of life (SF-36)
CES-D scores
PGIC
Functional status (6-min walking test or hand grip test)
Follow-up ongoing at time of publication of abstract: long-term results not available for every patient
At 3 months (n = 4): decrease in VAS pain scores (by 25%–100%) and in CES-D scores; improved ROM and PGIC scores
At 12 months (n = 1): decrease in VAS pain scores to 0 at 12 months and decrease in CES-D scores by 66% with improvement in physical function
5 patients had positive trials and 1 patient had direct implant (due to diabetes)
Smet and Van Buyten24 2016 (n = 1) CR (R) HF-10 12 months NRS pain
ROM wrist
Medication intake
NRS pain reduced to 0/10
ROM in wrist improved
Discontinuation of all analgesic medications
Gulve et al.25 2015 (n = 1) CR (R) HF-10 18 months NRS pain
EQ-5D score
Medications
Functional improvement
NRS pain: 80% reduction
EQ-5D score increased from 0.2 to 0.8
Discontinuation of all analgesic medications and able to resume pre-injury activities
  No postural variation in analgesic effect and no sensory symptoms
Wohak26 2013 (n = 3) CS (R) HF-10 4 to 8 months NRS pain
ROM
Medication intake
Vasomotor signs
NRS pain and hyperalgesia decreased by 80%–100%
ROM: improvement
 
Randomized clinical trial
Kriek et al.27 2017 (n = 29) RCT Three groups: 500 Hz, 1200 Hz, Burst At the end of 2 weeks with each of the fove modes
At the end of 3 months with the preferred stimulation mode
VAS for pain
MPQ
GPE
Preference of type of stimulation
VAS pain: All PF-SCS settings were equi-analgesic and significantly better with higher GPE scores than placebo
VAS pain scores were lower with preferred stimulation
52% of patients preferred nonstandard stimulation
No serious adverse effects Various reasons for patients preferring particular modes:
Amount of pain reduction
Lack of paresthesia
User-friendliness
comfort
Recharging time

SCS = spinal cord stimulation; CS (R/P) = case series (retrospective/prospective); HF-10 = high-frequency stimulation at 10 kHz; NRS = numerical rating scale; BPI = Brief Pain Inventory; PCS = Pain Catastrophizing Scale; EQ-5D = EuroQol–five dimensions; CR = case report; ROM = range of motion; HF = high-frequency stimulation; VAS = visual analog scale; QoL = quality of life; HD = high-density stimulation; CRPS = complex regional pain syndrome; PB-SCS = paresthesia-based spinal cord stimulation; PF-SCS = parasthesia-free spinal cord stimulation; SF-36 = Short Form 36; CES-D = Center for Epidemiological Studies–Depression Scale; PGIC = Patient Global Impression of Change; RCT = randomized controlled trial.