Table 1. Spasticity results.
| Author(s) Study Design | Methods | Outcome |
| Gianino et al27 Pre-post intervention and qualitative study |
Population: 25 (40% males) subjects diagnosed with intractable spasticity of the spine, including subjects with MS (15), SCI (7), and neurological diseases (3); mean age 39.4 yrs (range, 21-70 yrs) | There were no significant changes in the QLI-SCI total or subscale scores for the different time points. However, there was a trend toward improvement for the health and function subscales. |
| Objective: To explore the effect from intrathecal baclofen on spasticity and QOL | There were significant differences between MS and SCI participants with respect to the SIP total score (P = .0358) as well as the physical (P = .0026) and psychological (P = .0037) SIP subscores. | |
| QOL outcome measures:QLI-SCI, SIP, Ashworth Scale | After 3 months treatment with intrathecal baclofen, subjects reported less spasticity, improved ability to perform daily activities, greater mobility, and reduced pain. | |
| Westgren & Levi42 Cross-sectional survey |
Population: 320 persons (261 men) with SCI; mean age 42 yrs (range, 17-78 yrs); YPI ≤ 4 yrs and ≥ 4 yrs | Spasticity was associated with lower QOL. Problematic spasticity yielded significant medium effect sizes in all of the SF-36 subscales. |
| Objective: To determine associations between major outcome variables after SCI and QOL | ||
| QOL outcome measures: SF-36 | ||
| Noonan et al39 Cross-sectional survey |
Population: 70 persons (81% male) with SCI; mean age at injury, 45 ± 18 (13-91 yrs); mean age at follow-up, 51 ± 18 (19-95 yrs) | Spasticity was significantly related to the physical functioning subscore of the SF-36 in the first 2 stages of analysis, but became nonsignificant once all confounding variables were controlled for. |
| Objective: To determine the effect of associated SCI conditions on health status and QOL | ||
| QOL outcome measures: SF-36; Numeric QOL Rating | ||
| Loubser et al34 Pre-post intervention study |
Population: 9 males with SCI and spasticity; mean age, 45.6 ± 12.35 (22-63 yrs) | All but one patient benefited markedly in terms of gaining independence, of reducing time and effort for care required by caregivers, or both. |
| Objective: To explore the effect from intrathecal baclofen on spasticity | Persons with paraplegia and lower level tetraplegia gained independence in mobility and self-care. | |
| QOL outcome measures: Occupational Therapy Evaluation of Personal Independence | Persons with paraplegia with severe spasticity gained independence in driving. Although persons with high tetraplegia remained dependent in ADLs, caregiver time and effort for daily care decreased markedly. | |
| Fleuren et al9 Cross-sectional survey |
Population: 26 patients 920 males) with SCI; mean age 41.0 ± 10.6 yrs; mean mos post injury 100.9 ± 76.5 mos. | 57.7% of patients found the perceived spasticity problematic, mostly due to decreasing function (73.3%) rather than pain. Spasticity impacted ability to change position (22.0%), make a transfer (20.7%), be active (17.1%), maintain a stable body position (12.2%), as well as ADLs (17.1%). |
| Objective: To study the manifestation of spasticity in daily life of patients with SCI, their perception of spasticity, and spasticity-related discomfort | ||
| QOL outcome measures: Nonstandardized study-specific questionnaire | Findings confirm that the impact of spasticity on daily life is related to the context in which it occurs. Positive effects include helping to get dressed and prevention of pressure sores and muscle atrophy. Negative effects include initial shame regarding spasms and initial time taken to understand the new body signals. | |
| Adams et al 38 Cross-sectional survey |
Population: Study 1: 9 persons (8 males) with SCI; mean age 37.6 ± 11.5 yrs; mean YPI 13.6 ± 11.5 yrs; Study 2: 19 persons (15 males) with SCI; mean age 45.7 ± 13.9 yrs; mean YPI 13.6 ± 11.5 yrs; Study 3: 61 persons (45 males) with SCI; mean age 41.9 ± 12.6 yrs, mean YPI 10.2 ± 8.6 yrs | SCI-SET showed significant (P <.001) moderate to strong associations with self-assessed spasticity severity, self-assessed spasticity impact, QLI-SCI, and the PSFS. With regard to test-retest reliability, the intra-class correlation coefficients for SCI-SET was .91, and above the recommended minimum reliability values. |
| Objective: To develop and assess the reliability and validity of a new scale designed to measure the impact of spasticity on daily life in people with SCI | The mean SCI-SET score indicated an overall negative impact of spasticity on daily life despite perceptions of some benefits. | |
| QOL outcome measures: SCI-SET; QLI-SCI health and functioning subscale (satisfaction) | ||
| Adams & Hicks36 Random cross-over, pre-post intervention study |
Population: 7 persons (6 males) with chronic SCI; mean age 37.1 ± 7.7 yrs; mean YPI 5.0 ± 4.4 yrs. | Participation in 12 sessions of BWSTT or TTS did not result in group changes in scores on the SCI-SET. The 12 sessions of BWSTT resulted in a medium effect size (0.5) on QOL. |
| Objective: To determine the effects of body-weight-supported treadmill training (BWSTT) and tilt-table standing (TTS) on spasticity, motor neuron excitability, and related constructs in individuals with chronic SCI | ||
| QOL outcome measures: SCI-SET; QLI-SCI | ||
| Boutilier et al35 Pilot prospective pre- and post-intervention study |
Population: 8 persons (7 males) with SCI, mean age 44.12 yrs, YPI range 4 to 29 yrs, who could stand with or without the assistance of bracing or supports | Although self-evaluations of spasticity using the SCI-SET showed improvement from the initial visit (-0.91) to midway (-0.63) to the final visit (-0.57), differences were not statistically significant. |
| Objective: To determine whether a dynamic standing program using the Segway Personal Transporter results in any measurable physiological effects in individuals with SCI | ||
| QOL outcome measures: SCI-SET | ||
| Anson et al45 Cross-sectional and longitudinal survey |
Population: 125 persons with SCI; ≥18 yrs; and YPI > 1 yr | Spasticity was weakly and negatively associated with giving advice and social support (P < .05). |
| Objective: (1) To investigate relationships among social support, adjustment, and secondary complications in persons with SCI; (2) to explore potential effects of persons’ perceived contribution to the social support of others and reception of social support from others | ||
| QOL outcome measures: QLI-SCI, RSS | ||
| Lundqvist et al41 | Population: 98 (81 males) subjects with SCI; mean age 33.5 yrs (16-72 yrs); 2.3 YPI (.1-22.7 yrs) | Patients with spasticity problems scored significantly worse on the ambulation and feeding issues. |
| Cross-sectional survey | Objective: To define the QOL of SCI patients – their physical, psychological, and social functioning | |
| QOL outcome measures: SIP | ||
| Jagatsinh32 | Population: 98 (81 males) subjects with SCI; mean age 33.5 yrs (16-72 yrs), 2.3 YPI (.1-22.7 yrs) | Patients demonstrated improvements in ADLs such as feeding ability (10), self-care (10), indoor and outdoor mobility (19), and driving (4). |
| Pre-post intervention study | Objective: To assess the effects of intrathecal baclofen on symptoms of spasticity and ADLs | |
| QOL outcome measures: Modified scale comprised of items from the Barthel Index, FIM, and SCIM | ||
| Kogel et al33 Pre-post intervention study – case approach |
Population: 5 male subjects with tetraplegia | Emotionally, all participants showed decreases in vigor. Test data also showed slight to significant increases in at least one dysphoric mood for each patient, although results were extremely variable. Consequently, dronabinol seems to produce a heightened emotionality, but in an extremely individualized manner. |
| Objective: To assess the effects of dronabinol, a THC derivative, for the treatment of spasticity | ||
| QOL outcome measures: POMS | ||
| Jones et al37 Pre-post intervention study with a qualitative component |
Population: 7 males with SCI (AIS A or B); mean age 36.7 yrs (25-45 yrs); with positive bulbocavernous reflex | Participants reported perceived improvement in spasticity severity and overall healthrelated QOL. |
| Objective: To document changes in perceived sexual function and spasticity after implant of a baclofen pump | ||
| QOL outcome measures: SF- 36; Schwartz et al’s performance scale items for perception of spasticity severity | ||
| Westerkam et al43 Cross-sectional survey |
Population: 1,549 participants with SCI; mean age 45.1 yrs; YPI <1. | Three aspects of spasticity (daily activities, positive impact, and spasticity at its worst) were negatively correlated with home life satisfaction, global satisfaction, and overall QOL. The daily activities scale and the spasticity at its worst rating were negatively correlated with vocational satisfaction. Spasticity is negatively associated with QOL after SCI, and this should be an important consideration throughout patient treatment and rehabilitation. |
| Objective: To identify the relationship between spasticity and life satisfaction among participants with SCI | ||
| QOL outcome measures: Home life satisfaction, global satisfaction, vocational satisfaction, overall QOL, 3 subscales of the PRISM | ||
| Craven et al44 Cross-sectional telephone survey |
Population: 357 (218 males) community-dwelling persons with chronic traumatic and non-traumatic SCI; mean age 54 yrs; mean YPI 19.3 (onset range, 2-65 yrs) | HUI-Mark III scores were lower (P < .001) in high impact groups for spasms compared to low/no impact groups. |
| Objective: To describe the relationships between secondary health conditions and health preference in a cohort of adults with chronic SCI | ||
| QOL Outcome Measures: HUI-Mark III; SCS-M | ||
| Cook et al40 Cross-sectional survey |
Population: 180 persons (162 males) with SCI; mean age 52.12 ± 11 yrs; YPI range, 2 mos to 56 yrs | The intraclass correlation coefficient values for the PRISM’s 7 subscales were all high (.82 to .91), and internal consistency was the lowest for the need for intervention scale (α =.74) and highest for social avoidance/anxiety scale (α = .96). |
| Objective: To develop an instrument that measures the impact of spasticity on QOL | The a priori hypotheses regarding abnormal and involuntary muscle movement were partially confirmed, and thus provided some content validity for the PRISM. | |
| QOL outcome measures: PRISM |
Note: ADLs = activities of daily living; AIS = American Spinal Injury Association Impairment Scale; BWSTT = body-weight-supported treadmill training; HUI-Mark III = Health Utilities Index-Mark III; mos = months: MS = multiple sclerosis; POMS = Profile of Mood States; PRISM = Patient Reported Impact of Spasticity Measure; PSFS = Penn Spasm Frequency Scale; QLI-SCI = Ferrans and Powers Quality of Life Index-SCI Version III; QOL = quality of life; RSS = Reciprocal Social Support; SCI = spinal cord injury; SCIM = Spinal Cord Independence Measure; SCI-SET = Spinal Cord Injury Spasticity Evaluation Tool; SCS-M = SCI Secondary Conditions Scale-Modified; SIP = Sickness Impact Profile; TTS = tilt-table standing; YPI = years post injury.