Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

doi:10.1016/j.math.2014.10.003

Manual Therapy

Volume 20, Issue 2, April 2015, Pages 335-341

https://doi.org/10.1016/j.math.2014.10.003 Get rights and content

Abstract

Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making.

This paper provides a detailed report of AE experienced by elderly participants in a randomized comparative effectiveness trial of SMT and exercise for chronic NP.

AE data, consistent with CONSORT recommendations, were collected on elderly participants who received 12 weeks of SMT with home exercise, supervised plus home exercise, or home exercise alone. Standardized questions were asked at each treatment; participants were additionally encouraged to report AE as they occurred. Qualitative interviews documented participants' experiences with AE. Descriptive statistics and content analysis were used to categorize and report these data.

Compliance was high among the 241 randomized participants. Non-serious AE were reported by 130/194 participants. AE were reported by three times as many participants in supervised plus home exercise, and nearly twice as many as in SMT with home exercise, as in home exercise alone. The majority of AE were musculoskeletal in nature; several participants associated AE with specific exercises. One incapacitating AE occurred when a participant fell during supervised exercise session and fractured their arm. One serious adverse event of unknown relationship occurred to an individual who died from an aneurysm while at home. Eight serious, non-related AE also occurred.

Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP. As such, they should be expected and discussed when developing care plans.

Section snippets

Background

Neck pain is common and a growing public health concern among seniors (Vaupel et al., 1998, Hartvigsen et al., 2003, Hartvigsen et al., 2004). Spinal manipulative therapy (SMT) and exercise are two non-pharmacological therapies with demonstrated effectiveness for neck pain in the general population (Hurwitz et al., 2008, Miller et al., 2010, Kay et al., 2012) including the elderly (Maiers et al., 2013). When considering the clinical utility of any intervention, it is essential to weigh the

Methods

An RCT was conducted to determine the relative short- and long-term effectiveness of spinal manipulative therapy with home exercise (SMT with home exercise), supervised rehabilitative exercise and home exercise (supervised plus home exercise), and home exercise alone for seniors with neck pain (Maiers et al., 2007). Participants needed to have a primary complaint of weekly, mechanical neck pain with an average rating of ≥3 (0–10) over the previous two weeks. Additional inclusion criteria

Results

A total of 241 individuals were enrolled in the study, with comparable baseline demographic and clinical characteristics across groups (Table 1). Results showed statistically significant between-group differences in favor of SMT with home exercise after 12 weeks of treatment, compared to both supervised plus home exercise, and home exercise alone. Compliance, defined as attending 80% of the recommended sessions, was generally high in all three intervention groups. The average number of SMT

Discussion

The AE identified in this study were primarily musculoskeletal or pain related and non-serious. This is consistent with other literature on SMT and exercise (Thiel et al., 2007, Rubinstein et al., 2008, Liu and Latham, 2010, Eriksen et al., 2011, Evans et al., 2012, Walker et al., 2013). Moreover, musculoskeletal AE were so common among study participants that these may be considered normal reactions to SMT and exercise therapies in this population and should be expected. The multimodal

Conclusions

Non-serious musculoskeletal AE were common among elderly study participants receiving SMT and exercise interventions for chronic neck pain. In light of their high occurrence, these AE may be regarded as normal reactions to SMT and exercise and should be anticipated and discussed by care providers with their patients.

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Characterization of thoracic spinal manipulation and mobilization forces in older adults
2021, Clinical Biomechanics
Citation Excerpt :
The magnitude of SMT forces has been suggested to be a potential contributor to adverse events observed following thoracic SMT including in older adults (Puentedura and O'Grady, 2015; To et al., 2020). Specifically, although most adverse events experienced by older adults following SMT are mild and transient (e.g., increased stiffness and pain), more severe events, such as spinal cord injuries and rib fractures, have also been reported and are suggested to be related to the use of high SMT forces (Hondras et al., 2009; Maiers et al., 2015; Puentedura and O'Grady, 2015; To et al., 2020). To focus on rib fractures, previous cadaveric biomechanical studies have reported failure tolerances for the ribs of older adults (61–99 years old) ranging between 16 N–165 N in a frontal motor vehicle collision (Agnew et al., 2015; Kang et al., 2020).
Spinal mobilization and spinal manipulation are common interventions used by manual therapists to treat musculoskeletal conditions in older adults. Their force-time characteristics applied to older adults' thoracic spine are important considerations for effectiveness and safety but remain unknown. This study aimed to describe the force-time characteristics of posterior-to-anterior spinal mobilization and manipulation delivered to older adults' thoracic spine.
Twenty-one older adults (≥65 years) with no thoracic pain received posterior-to-anterior thoracic spinal mobilization and/or manipulation with the force characteristics a chiropractor deemed appropriate. Six-degree-of-freedom load cells and an instrumented treatment table recorded the force characteristics of both interventions at the clinician-participant and participant-table interfaces, respectively. Preload force, total peak force, time to peak and loading rate were analyzed descriptively.
Based on data from 18 adults (56% female; average: 70 years old), mean resultant spinal mobilization forces at the clinician-participant interface were: 220 ± 51 N during preload, 323 ± 67 N total peak force, and 312 ± 38 ms time to peak. At the participant-table interface, mobilization forces were 201 ± 50 N during preload, 296 ± 63 N total peak force, and 308 ± 44 ms time to peak. Mean resultant spinal manipulation forces at the clinician-participant interface were: 260 ± 41 N during preload, 470 ± 46 N total peak force, and 165 ± 28 ms time to peak. At the participant table interface, spinal manipulation forces were 236 ± 47 N during preload, 463 ± 57 N total peak force, and 169 ± 28 ms time to peak.
Results suggest older adults experience unique, but comparable force-time characteristics during spinal mobilization and manipulation delivered to their thoracic spine compared to the ones delivered to younger adults described in the literature.
Prevalence and profile of Australian osteopaths treating older people
2019, Complementary Therapies in Medicine
To explore the characteristics of the Australian osteopathy workforce who participate in the management of older patients with musculoskeletal complaints.
Secondary analysis of a cross-sectional survey of osteopaths.
The Osteopathy Research and Innovation Network (ORION), an Australian practice-based research network.
The demographic, practice and treatment characteristics of osteopaths who identify as ‘always’or ‘often’ treating patients aged 65 years or over.
Over half (58%) of total participants (n = 992) indicated often treating older people and this was associated with referral patterns with other health professionals and a non-urban practice location. Osteopaths providing care to older people were more likely to discuss diet/nutrition and medications, and provide pain counselling. Osteopaths who treated older adults were more likely to treat shoulder musculoskeletal disorders, degenerative spine disorders, chronic or persistent pain, and tendinopathies.
A substantial proportion of Australian osteopaths treat older adults frequently. The potential value and impact of osteopathy in managing the health needs of an ageing population warrants close examination from both researchers and policy makers.
Manual therapy, exercise therapy or combined treatment in the management of adult neck pain – A systematic review and meta-analysis
2017, Musculoskeletal Science and Practice
Neck pain is a common and often disabling musculoskeletal condition. Two therapies frequently prescribed for its management are manual therapy (MT) and exercise therapy (ET), and combining these treatment approaches are common.
To assess whether or not combined treatment consisting of MT and ET is more effective than either therapy alone in relieving pain and improving function in adult patients with grade I-II neck pain.
Systematic review with meta-analysis.
A systematic search on EMBASE, MEDLINE, AMED, CENTRAL and PEDro were performed until June 2017. Randomized controlled trials with adult grade I-II neck pain patients were included if they investigated the combined effect of MT and ET to the same ET or MT alone, and reported pain intensity or disability on numerical scales. Quality of life was assessed as a secondary outcome. Quality of the included trials was assessed with the PEDro scale, and the quality of evidence was assessed with GRADE.
1169 articles were screened, and 7 studies were included, all of which investigated the addition of ET to MT. Only very small and non-significant between group differences was found on pain intensity at rest, neck disability, and quality of life at immediate post-treatment, 6 months, and 12 months follow-up. The quality of evidence was moderate for pain-at-rest outcomes and moderate too low for neck disability and quality of life outcomes.
Combined treatment consisting of MT and ET does not seem to be more effective in reducing neck pain intensity at rest, neck disability or improving quality of life in adult patients with grade I-II neck pain, than ET alone.
Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs
2017, Musculoskeletal Science and Practice
Citation Excerpt :
Headache was reported as a common AE (mean 10.3%; 95% CI 10.2–10.4), which is likely because previous studies primarily investigated neck pain and not headache (Cagnie et al., 2004; Walker et al., 2013; Hurwitz et al., 2004; Thiel et al., 2007; Rubinstein et al., 2007; Eriksen et al., 2011; Maiers et al., 2015). The comparable study reported mild and transient local tenderness (38%), muscle soreness (13%) and headache (11%), although tiredness was not recorded as an AE (Maiers et al., 2015). Few severe and transient AEs were reported in four RCTs (mean 16.4%; 95% CI 15.6–17.2) (Cagnie et al., 2004; Walker et al., 2013; Hurwitz et al., 2004; Maiers et al., 2015), and no serious AEs were reported in the previous CSMT studies (Cagnie et al., 2004; Walker et al., 2013; Hurwitz et al., 2004; Thiel et al., 2007; Rubinstein et al., 2007; Eriksen et al., 2011; Maiers et al., 2015).
Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverse events (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal.
To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT) RCT.
A prospective 3-armed, single-blinded, placebo, RCT.
Seventy migraineurs were randomized to the CSMT or a placebo, with 12 intervention sessions over three months. The recommendations by CONSORT and the International Headache Society's Task Force on AEs in migraine RCTs were followed. A standardized reporting scheme designed for pharmacological RCTs was used, and the AEs were described as frequencies and percentages within each group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of AEs in each group were calculated when possible. Attributable risk (%) and relative risk were calculated with the corresponding 95% CIs.
AEs were assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the CSMT group and the placebo group, respectively, and tiredness on the intervention day was reported by 8.5% and 1.4% of CSMT group and the placebo group, respectively. The highest attributable risk was for tiredness on the treatment day, 7.0% (CI 3.9–10.2%) which presented a relative risk of 5.9 (CI 2.3–15.0).
AEs were mild and transient, and severe or serious AEs were not observed.
Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain
2016, Spine Journal
Chronic neck pain is a prevalent and disabling condition among older adults. Despite the large burden of neck pain, little is known regarding the cost-effectiveness of commonly used treatments.
This study aimed to estimate the cost-effectiveness of home exercise and advice (HEA), spinal manipulative therapy (SMT) plus HEA, and supervised rehabilitative exercise (SRE) plus HEA.
Cost-effectiveness analysis conducted alongside a randomized clinical trial (RCT) was performed.
A total of 241 older adults (≥65 years) with chronic mechanical neck pain comprised the patient sample.
The outcome measures were direct and indirect costs, neck pain, neck disability, SF-6D-derived quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 1-year time horizon.
This work was supported by grants from the National Center for Complementary and Integrative Health (#F32AT007507), National Institute of Arthritis and Musculoskeletal and Skin Diseases (#P60AR062799), and Health Resources and Services Administration (#R18HP01425). The RCT is registered at ClinicalTrials.gov (#NCT00269308). A societal perspective was adopted for the primary analysis. A healthcare perspective was adopted as a sensitivity analysis. Cost-effectivenesswas a secondary aim of the RCT which was not powered for differences in costs or QALYs. Differences in costs and clinical outcomes were estimated using generalized estimating equations and linear mixed models, respectively. Cost-effectiveness acceptability curves were calculated to assess the uncertainty surrounding cost-effectiveness estimates.
Total costs for SMT+HEA were 5% lower than HEA (mean difference: −$111; 95% confidence interval [CI] −$1,354 to $899) and 47% lower than SRE+HEA (mean difference: −$1,932; 95% CI −$2,796 to −$1,097). SMT+HEA also resulted in a greater reduction of neck pain over the year relative to HEA (0.57; 95% CI 0.23 to 0.92) and SRE+HEA (0.41; 95% CI 0.05 to 0.76). Differences in disability and QALYs favored SMT+HEA. The probability that adding SMT to HEA is cost-effective at willingness to pay thresholds of $50,000 to $200,000 per QALY gained ranges from 0.75 to 0.81. If adopting a health-care perspective, costs for SMT+HEA were 66% higher than HEA (mean difference: $515; 95% CI $225 to $1,094), resulting in an ICER of $55,975 per QALY gained.
On average, SMT+HEA resulted in better clinical outcomes and lower total societal costs relative to SRE+HEA and HEA alone, with a 0.75 to 0.81 probability of cost-effectiveness for willingness to pay thresholds of $50,000 to $200,000 per QALY.
The reporting of adverse events following spinal manipulation in randomized clinical trials—a systematic review
2016, Spine Journal
Citation Excerpt :
Although the recent publication of two RCTs directly investigating adverse events associated with SMT is timely, their results must be interpreted with caution as both trials do not report data concerning the effectiveness of the SMT provided and as such do not permit formulation of an informed risk-benefit analysis [53,54]. In contrast, manuscripts published as secondary analyses of large clinical trial data sets specifically reporting adverse events data should be promoted as they included benefit data from the primary analysis [55,56]. This provided the reader with adequate information to inform a balanced risk-benefit analysis [57,58].
Spinal manipulative therapy (SMT) is commonly used to treat spinal disorders. Although clinical practice guidelines recommend the use of SMT in the treatment of neck and back disorders, concerns exist about the nature and incidence of adverse events associated with the intervention. Comprehensive reporting of adverse events in clinical trials could allow for accurate incidence estimates through meta-analysis. However, it is not clear if randomized clinical trials (RCTs) that involve SMT are currently reporting adverse events adequately.
This study aimed to describe the extent of adverse events reporting in published RCTs involving SMT, and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement.
This is a systematic literature review.
The Physiotherapy Evidence Database (PEDro) and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analyzed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analyzed using tests for equality of proportions with continuity correction. There was no funding obtained for this study. The authors declare no conflict of interest.
Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events reported (0.3%). Only 22 articles (15.7%) reported on adverse events in the abstract. There were no differences in reporting of adverse events post-CONSORT for any of the chosen parameters.
Although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable. We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.

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Original articleAdverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

Abstract

Section snippets

Background

Methods

Results

Discussion

Conclusions

Man Ther

Man Ther

J Psychiatr Res

J Manip Physiol Ther

Man Ther

Arch Phys Med Rehabil

Man Ther

Rheum Dis Clin North Am

Man Ther

Guidance on the management of pain in older people

Age Ageing

Management of pain induced by exercise and mobilization during physical therapy programs: views of patients and care providers

BMC Musculoskelet Disord

Exercise prescription for older adults with osteoarthritis pain: consensus practice recommendations

JAGS

Triggers of subarachnoid hemorrhage: role of physical exertion, smoking, and alcohol in the Australasian Cooperative Research on Subarachnoid Hemorrhage Study (ACROSS)

Stroke

Cervical arterial dissections and association with cervical manipulative therapy: a statement for healthcare professionals from the American heart association/American stroke association

Stroke

High-intensity interval training in stroke rehabilitation

Top Stroke Rehabil

Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial

Ann Intern Med

Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover study

Spine

How much physical activity do older adults need?

The role of chiropractic care in older adults

Chiropr Man Therap

Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: a prospective, multicenter, cohort study

BMC Musculoskelet Disord

Life-threatening complications of spinal manipulation

Stroke

Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995–2001

Med J Aust

Supervised exercise with and without spinal manipulation perform similarly and better than home exercise for chronic neck pain: a randomized controlled trial

Spine

Management of chronic arthritis pain in the elderly

Drugs Aging

Manipulation or mobilisation for neck pain

Cochrane Database Syst Rev

Spinal manipulative therapy. A status report

Clin Orthop Relat Res

Arterial dissections following cervical manipulation: the chiropractic experience

CMAJ

Original article
Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial