Comparing the effectiveness of nonsurgical treatments for lumbar spinal stenosis in reducing pain and increasing walking ability
The primary outcome measures were self-reported pain/function measured by the Swiss Spinal Stenosis (SSS) questionnaire and walking performance measured by the Self-paced Walking Test (SPWT). The secondary outcome measure was daily physical activity measured by accelerometry. We took outcome measure...
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| Format: | eBook |
| Language: | English |
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[Washington, D.C.]
Patient-Centered Outcomes Research Institute (PCORI)
[2019], 2019
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| Series: | Final research report
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | The primary outcome measures were self-reported pain/function measured by the Swiss Spinal Stenosis (SSS) questionnaire and walking performance measured by the Self-paced Walking Test (SPWT). The secondary outcome measure was daily physical activity measured by accelerometry. We took outcome measures at baseline as well as 2 months and 6 months from baseline. The primary end point was at 2 months. The primary analysis used linear mixed models to compare changes in each outcome measure between the groups. The secondary analysis was a comparison of the proportion of responders (≥30% change) in each outcome measure by group, using the chi-square test. RESULTS: No serious adverse events were reported in any of the groups. At 2 months, there was a statistically significantly greater reduction in adjusted mean SSS score (range, 12-55) in the MTE group compared with MC (2.1; 95% CI, 0.3-3.9) or GE (2.4; 95% CI, 0.6-4.3). BACKGROUND: Lumbar spinal stenosis (LSS) is a highly prevalent condition among older adults and the most frequent indication for spinal surgery in patients older than the age of 65. In this past decade the fastest growth in lumbar surgery in the United States has occurred in older adults with LSS, and the rate of complex fusion procedures has significantly increased. These operations are associated with significant health care costs, risks, complications, and rehospitalization rates. Yet, evidence is lacking for the effectiveness of the various nonsurgical treatment options offered to patients with LSS. This study was designed to help bridge this evidence gap. OBJECTIVE: Compare the clinical effectiveness of 3 common nonsurgical approaches to the management of patients with LSS: (1) medical care (MC) provided by a physiatrist; (2) nonspecific group exercise (GE) classes provided by certified exercise instructors; or (3) a combination of manual therapy and individualized exercises (MTE) provided by chiropractors and physical therapists. METHODS: Randomized controlled clinical trial of 259 patients with LSS. Patients were community-dwelling older adults (≥60 years of age) recruited from the Pittsburgh metro area. We confirmed diagnosis of LSS by both diagnostic imaging (MRI or CT) and symptoms of neurogenic claudication. Participants were randomized into 1 of the 3 groups described above and treated for a total of 6 weeks. Participants in the GE and MTE groups had a total of 12 treatment sessions; those in the MC group had a total of 3 treatment sessions. The minimum clinically important difference (MCID) for the SSS is 3.02 points; therefore the between-group SSS differences were not clinically significant. The adjusted mean differences in SPWT scores at 2 months favored MTE compared with MC (135.1; 95% CI, −17.2 to 287.4) or GE (46.2; 95% CI, −110.9 to 203.4), but these between-group SPWT differences were not statistically significant. GE showed significantly greater improvement in adjusted mean physical activity at 2 months compared with MC (30.5; 95% CI, 3.1-57.9), but clinical significance is unknown due to the lack of an established MCID for physical activity. The MTE group had significantly more SSS (20%) and SPWT (65.3%) responders at 2 months compared with MC (7.6%; 48.7%) or GE (3%; 46.2%) (P = .002 and P = .04, respectively). We prespecified responders as those participants who showed ≥30% improvement from baseline on the measured outcome. At 6 months, there were no longer significant between-group differences on any outcome measures. There was a general trend toward short-term improvement in SSS and physical activity that was not sustained over time; however, all groups maintained their improvements in walking performance (SPWT) at 6 months. STUDY LIMITATIONS: There were a greater of proportion of GE dropouts immediately after randomization and a potential attention bias due to the greater amount of individualized attention given to the MTE group. CONCLUSIONS: The combination of manual therapy and individualized exercise led to significantly greater improvement in SSS and SPWT at 2 months, whereas GE led to significantly greater improvement in physical activity at 2 months. The clinical significance of these short-term improvements is unknown |
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| Physical Description: | 1 PDF file (89 pages) illustrations |