Meaningful Improvements In Disability Research Articles

Effect of long-term cervical extensor exercise program on functional disability, pain intensity, range of motion, cervical muscle mass, and cervical curvature in young adult population with chronic non-specific neck pain: a randomized controlled trial

BackgroundThe prevalence of chronic non-specific neck pain (CNNP) is on the rise among the young adult population. We herein aimed to compare the effects of long-term specific cervical extensor training and stretching exercises on improving this chronic disorder in young adults.MethodsIn this prospective, randomized, controlled study, 70 participants aged 18–35 years with CNNP and cervical lordosis loss were included. The participants were assigned to undergo either specific cervical extensor training (observation group) or perform usual stretching exercises (control group). The exercise duration was set at 12 months, with 9 months at the clinic and 3 months at home. The outcome assessments included changes in the neck disability index, visual analog scale from baseline, cervical range of motion (CROM), cross-sectional areas (CSAs) of cervical extensors, and cervical curvature from baseline. The outcome measures were compared between groups at 3, 6, and 12 months of follow-up.ResultsAll 70 participants underwent randomization, and no significant differences in demographics and baseline data were found between the two groups. The observation group showed a greater improvement in neck disability index and visual analog scale scores at the 12-month follow-up than the control group. Additionally, a more substantial increase in CROM and CSAs of cervical extensors was observed in the observation group at the 6-month and 12-month follow-ups (P < 0.05). Although more participants in the observation group achieved cervical lordosis at the 12-month follow-up, the difference was marginally nonsignificant (9% in the control group vs. 28% in the observation group, P = 0.075).ConclusionsIn young adults with CNNP, long-term specific cervical extensor training was associated with a more significant clinically meaningful improvement in disability, pain, and CROM than stretching exercises. The increased CSAs of cervical extensors may potentially contribute to the restoration of cervical lordosis.Trial registration The study is registered at the Chinese domestic clinical trial (ChiCTR2000040009) at Chictr.org. The date of registration: November 18, 2020.

Hip-focused physical therapy versus spine-focused physical therapy for older adults with chronic low back pain at risk for mobility decline (MASH): a multicentre, single-masked, randomised controlled trial

Previously, we identified a population of older adults with chronic low back pain, hip pain, and hip muscle weakness who had worse 12-month low back pain and functional outcomes than age-matched adults with only low back pain, indicating an increased risk for future mobility decline. We sought to determine whether tailored, hip-focused physical therapy reduced pain and functional limitations in this high-risk population compared with non-tailored, spine-focused physical therapy. We did a multicentre, single-masked, randomised controlled trial at three research-based sites in the USA. We recruited older adults (aged 60-85 years) with hip pain and weakness who reported moderate low back pain intensity at least half the days in the last 6 months. Patients were randomly assigned to hip-focused physical therapy or spine-focused physical therapy using permuted blocks with random block size, stratified by site and sex (ie, male or female). The primary outcomes were self-reported disability using the Quebec Back Pain Disability Scale (QBPDS) and performance-based 10-Meter Walk Test (10MWT) at 8 weeks. All analyses were done in the intention-to-treat population. Adverse events were collected by study staff via a possible adverse event reporting form and then adjudicated by site investigators. This trial was registered with ClinicalTrials.gov, NCT04009837. Between Nov 1, 2019, and April 30, 2022, 184 participants were randomly assigned to receive hip-focused (n=91) or spine-focused physical therapy (n=93) interventions. The mean age was 70·7 (SD 6·2) years. 121 (66%) of 184 participants were women, 63 (34%) were men, and 149 (81%) were White. At 8 weeks, the mean between-group difference on the QBPDS was 4·0 (95% CI 0·5 to 7·5), favouring hip-focused physical therapy. Both groups had similar, clinically meaningful gait speed improvements (10MWT) at 8 weeks (mean difference 0·004 m/s [95% CI -0·044 to 0·052]). No serious adverse events were related to study participation. Tailored hip-focused physical therapy demonstrated greater improvements in low back pain-related disability at 8 weeks. However, both hip-focused physical therapy and spine-focused physical therapy produced clinically meaningful improvements in disability and function for this high-risk population at 6 months. These findings warrant further investigation before clinical implementation. US National Institute on Aging of the National Institutes of Health.

Beyond migraine headache day reduction: Clinically meaningful improvement in disability (MIDAS score) in the absence of greater than 50% reductions in monthly migraine days with galcanezumab (P10-12.008)

Beyond migraine headache day reduction: Clinically meaningful improvement in disability (MIDAS score) in the absence of greater than 50% reductions in monthly migraine days with galcanezumab (P10-12.008)

Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies

BackgroundMigraine is the second leading cause of disability worldwide. Although many preventive treatments reduce migraine frequency and severity, it is unclear whether these treatments reduce migraine-related disability in a clinically meaningful way. This pooled analysis evaluated the ability of fremanezumab to reduce migraine-related disability, based on responses and shifts in severity in patient-reported disability outcomes.MethodsThis pooled analysis included 3 double-blind phase 3 trials (HALO EM, HALO CM, FOCUS) in which patients with episodic or chronic migraine were randomly assigned 1:1:1 to quarterly or monthly fremanezumab or matched placebo for 12 weeks. Migraine-related disability was assessed using the 6-item Headache Impact Test (HIT-6) and Migraine Disability Assessment (MIDAS) questionnaires. A clinically meaningful improvement in disability was defined per American Headache Society guidelines: for HIT-6, a ≥ 5-point reduction; for MIDAS, a ≥ 5-point reduction when baseline score was 11 to 20 or ≥ 30% reduction when baseline score was > 20. Proportions of patients who demonstrated shifts in severity for each outcome were also evaluated.ResultsFor patients with baseline MIDAS scores of 11 to 20 (n = 234), significantly higher proportions achieved 5-point reductions from baseline in MIDAS scores with fremanezumab (quarterly, 71%; monthly, 70%) compared with placebo (49%; both P ≤ 0.01). For patients with baseline MIDAS scores of > 20 (n = 1266), proportions achieving ≥30% reduction from baseline in MIDAS scores were also significantly higher with fremanezumab (quarterly, 69%; monthly, 79%) compared with placebo (58%; both P < 0.001). For HIT-6 scores, proportions of patients achieving 5-point reductions from baseline were significantly higher with fremanezumab (quarterly, 53%; monthly, 55%) compared with placebo (39%; both P < 0.0001). Proportions of patients with shifts of 1 to 3 grades down in MIDAS or HIT-6 disability severity were significantly greater with quarterly and monthly fremanezumab compared with placebo (all P < 0.0001).ConclusionFremanezumab demonstrated clinically meaningful improvements in disability severity in this pooled analysis.Trial registrationsHALO CM, NCT02621931; HALO EM, NCT02629861; FOCUS, NCT03308968.

Quantifying the collective influence of social determinants of health using conditional and cluster modeling.

ObjectivesOur objective was to analyze the collective effect of social determinants of health (SDoH) on lumbar spine surgery outcomes utilizing two different statistical methods of combining variables.MethodsThis observational study analyzed data from the Quality Outcomes Database, a nationwide United States spine registry. Race/ethnicity, educational attainment, employment status, insurance payer, and gender were predictors of interest. We built two models to assess the collective influence of SDoH on outcomes following lumbar spine surgery—a stepwise model using each number of SDoH conditions present (0 of 5, 1 of 5, 2 of 5, etc) and a clustered subgroup model. Logistic regression analyses adjusted for age, multimorbidity, surgical indication, type of lumbar spine surgery, and surgical approach were performed to identify the odds of failing to demonstrate clinically meaningful improvements in disability, back pain, leg pain, quality of life, and patient satisfaction at 3- and 12-months following lumbar spine surgery.ResultsStepwise modeling outperformed individual SDoH when 4 of 5 SDoH were present. Cluster modeling revealed 4 distinct subgroups. Disparities between the younger, minority, lower socioeconomic status and the younger, white, higher socioeconomic status subgroups were substantially wider compared to individual SDoH.DiscussionCollective and cluster modeling of SDoH better predicted failure to demonstrate clinically meaningful improvements than individual SDoH in this cohort. Viewing social factors in aggregate rather than individually may offer more precise estimates of the impact of SDoH on outcomes.

Why futile recanalization matters

The efficacy of stroke thrombectomy is largely determined by patient selection. If clinical trial criteria are used, a strikingly low number-needed-to-treat (NNT) of 2.6 can be achieved as published by...

287. Early postoperative physical activity predicts clinical improvement in disability 1 year following spine surgery

BACKGROUND CONTEXT Walking at least 4,500 steps/day or engaging in at least 60 minutes of moderate-to-vigorous physical activity/week are known to provide multiple health benefits and prevent disability in adults with and without musculoskeletal pain. However, little is known about the impact of physical activity on outcomes following spine surgery. PURPOSE The primary objective of this study was to determine whether early postoperative physical activity is associated with clinically meaningful improvement in disability in patients undergoing spine surgery. A secondary objective was to investigate the physical activity threshold that best discriminates improvement in disability at one year following spine surgery. STUDY DESIGN/SETTING Secondary analysis of randomized controlled trial data. PATIENT SAMPLE A total of 248 participants undergoing elective surgery for a degenerative lumbar spine condition. OUTCOME MEASURES Clinically meaningful improvement in disability was considered a 30% reduction in Oswestry Disability Index (ODI) scores from baseline (6 weeks after surgery) to 1-year follow-up. METHODS Physical activity was measured using an accelerometer (Actigraph GT3X) worn for at least 10 hours/day for at least 3 days at 6-weeks following spine surgery. Physical activity was quantified as steps/day and time spent in moderate-to-vigorous physical activity (ie, at least 2,020 counts/minute). Multivariable logistic regression analysis was conducted to determine the association between steps/day at 6 weeks and clinically meaningful improvement in disability at 1 year, controlling for age, body mass index (BMI), education, race, sex, previous surgery, spinal procedure, baseline ODI score, and back and leg pain. Receiver operating characteristic curves were used to identify steps/day and moderate-to-vigorous physical activity/week that best discriminated the likelihood of achieving clinical improvement. RESULTS Of 248 participants, 216 participants (mean [SD]; age= 63[11] years, BMI= 32[7] kg/m2, 52% female) had physical activity for at least 3 valid days. Of 216 patients, 43% (n=93) achieved clinical improvement in ODI at 1-year following spine surgery. Each additional 1000 steps/day and additional 1 minute of moderate-to-vigorous physical activity/day were associated with 27% (OR=1.27, 95% CI=1.07, 1.51) and 4% (OR=1.04, 95% CI=1.01, 1.08) higher odds of achieving clinically meaningful improvement in ODI, respectively. At 6 weeks following spine surgery, walking less than 3000 steps/day (sensitivity = 68%, specificity = 52%) was associated with 66% (OR=0.34, 95% CI=0.16, 0.69) lower odds of achieving clinical improvement in disability compared to those who walked at least 3000 steps/day. In addition, engaging in less than 21 minutes of moderate-to-vigorous physical activity/week (sensitivity = 62%, specificity = 48%) was associated with a 46% (OR=0.54, 95% CI=0.29, 1.02) lower odds of achieving clinical improvement in disability at 1-year postoperative compared to those who engaged in at least 21 minutes of moderate-to-vigorous physical activity/week. CONCLUSIONS Walking at least 3,000 steps/day or engaging in at least 21 minutes of moderate-to-vigorous physical activity/week may serve as an initial recommendation for patients early after spine surgery. Results suggest that these early postoperative thresholds may optimize clinical improvement in disability at 1 year following spine surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Duration and Dosage of Opioids After Spine Surgery: Implications on Outcomes at 1 Year.

Longitudinal Cohort Study OBJECTIVE.: The aim of this study was to determine whether duration of postoperative opioids is associated with long-term outcomes, and if initial postoperative opioid dosage is associated with opioid cessation after spine surgery. Preoperative opioid use is associated with poor outcomes, but little evidence exists regarding the implications of opioid dosage and duration after spine surgery. Data from our state's prescription drug database was linked to our prospective clinical spine registry to analyze opioid dispensing and outcomes in elective surgical spine patients between 2010 and 2017. Patients were stratified based on preoperative chronic opioid use and multivariable regression was used to assess associations between duration of postoperative opioids and outcomes at one year, including satisfaction, chronic opioid use, and meaningful improvements in pain, disability, and quality of life. In a secondary aim, a Cox proportional hazards model was used to determine whether initial postoperative opioid dosage was associated with time to opioid cessation. Of 2172 patients included, 35% had preoperative chronic opioid use. In patients without preoperative chronic opioid use, a postoperative opioid duration of 31 to 60 days was associated with chronic opioid use at 1 year (adjusted odds ratio [aOR]: 4.1 [1.7-9.8]) and no meaningful improvement in extremity pain (aOR: 1.8 [1.3-2.6]) or axial pain (aOR: 1.6 [1.1-2.2]); cessation between 61 and 90 days was associated with no meaningful improvement in disability (aOR: 2 [1.3-3]) and dissatisfaction (aOR:1.8 [1-3.1]). In patients with preoperative chronic opioid use, postoperative opioids for ≥90 days was associated with dissatisfaction. Cox regression analyses showed lower initial postoperative opioid dosages were associated with faster opioid cessation in both groups. Our results suggest that a shorter duration of postoperative opioids may result in improved 1-year patient-reported outcomes, and that lower postoperative opioid dosages may lead to faster opioid cessation. 2.

Cognitively informed exercise and educational group in patients with persistent low back pain: a service evaluation

Purpose: Low Back Pain (LBP) is the largest cause of years lived with disability worldwide. UK guidelines recommend a combined physical and psychological programme (CPPP), preferably delivered in groups, as a treatment option. A CPPP based on the fear avoidance model of pain was evaluated in 2013, where just 36% of patients achieved a clinically meaningful improvement in disability. The programme was revised (2017) to include a focus on pain self-efficacy, the largest mediating factor in LBP-related disability. The aim of this service evaluation (SE) was to evaluate whether the revised programme improves LBP-related disability, with a secondary aim to evaluate the programme content.

Minimal Clinically Important Difference of the 6-Minute Walk Test in People With Stroke.

The 6-minute walk test (6MWT) is commonly used in people with stroke. The purpose of this study was to estimate the minimal clinically important difference (MCID) of the 6MWT 2 months poststroke. We performed a secondary analysis of data from a rehabilitation trial. Participants underwent physical therapy between 2 and 6 months poststroke and the 6MWT was measured before and after. Two anchors of important change were used: the modified Rankin Scale (mRS) and the Stroke Impact Scale (SIS). The MCID for the 6MWT was estimated using receiver operating characteristic curves for the entire sample and for 2 subgroups: initial gait speed (IGS) <0.40 m/s and ≥0.40 m/s. For the entire sample, the estimated MCID of the 6MWT was 71 m with the mRS as the anchor (area under the curve [AUC] = 0.66) and 65 m with the SIS as the anchor (AUC = 0.59). For participants with IGS <0.40 m/s, the estimated MCID was 44 m with the mRS as the anchor (AUC = 0.72) and 34 m with the SIS as the anchor (AUC = 0.62). For participants with IGS ≥0.40 m/s, the estimated MCID was 71 m with the mRS as the anchor (AUC = 0.59) and 130 m with the SIS as the anchor (AUC = 0.56). Between 2 and 6 months poststroke, people whose IGS is <0.40 m/s and experience a 44-m improvement in the 6MWT may exhibit meaningful improvement in disability. However, we were not able to estimate an accurate MCID for the 6MWT in people whose IGS was ≥0.40 m/s. MCID values should be estimated across different levels of function and anchors of importance.Video Abstract available for more insights from the authors (see Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A232).

Regional manual therapy and motor control exercise for chronic low back pain: a randomized clinical trial

ObjectivesClinical practice guidelines recommend a focus on regional interdependence for the management of chronic low back pain (CLBP). This study investigated the additive effect of regional manual therapy (RMT) when combined with standard physical therapy (SPT) in a subgroup with CLBP.MethodsForty-six participants with CLBP and movement coordination impairments were randomly assigned to receive SPT consisting of a motor control exercise program and lumbar spine manual therapy, or SPT with the addition of RMT to the hips, pelvis, and thoracic spine. Outcome measures included disability level, pain intensity, pain catastrophizing, fear avoidance beliefs, and perceived effect of treatment. Appropriate parametric and non-parametric testing was used for analysis.ResultsBoth groups demonstrated improvements in disability level, pain intensity, pain catastrophizing, and fear avoidance beliefs across time (P < 0.001). There was no difference between groups for any variable over 12 weeks, although a significantly greater proportion of participants in the RMT group exceeded the minimal clinically important difference (MCID) for disability. The perceived effect of treatment also was significantly higher in the group receiving RMT at two weeks and four weeks, but not 12 weeks.DiscussionSPT with or without RMT resulted in significant improvements in disability level, pain intensity, pain catastrophizing, and fear avoidance beliefs over 12 weeks in persons with CLBP and movement coordination impairments. RMT resulted in greater perceived effect of treatment, and a clinically meaningful improvement in disability, across four weeks compared to SPT alone.Level of Evidence: 1bClinical Trial Registration: ClinicalTrials.gov registration No. NCT02170753

Repetitive transcranial magnetic stimulation at 1Hz and 5Hz produces sustained improvement in motor function and disability after ischaemic stroke

Repetitive transcranial magnetic stimulation (rTMS) is a simple and non-invasive method of augmenting motor recovery after stroke, probably mediated by restoring inter-hemispheric activation balance. This placebo-controlled pilot study examined the possible benefit of stimulating the lesioned hemisphere (5-Hz rTMS) or inhibiting the contra-lesional hemisphere (1-Hz rTMS) on clinical recovery of motor function in patients with ischaemic stroke and assessed the sustainability of the response. Sixty patients with ischaemic stroke (>1 month from onset) with mild-to-moderate hemiparesis were randomized to receive 10 daily sessions of either sham rTMS, 5-Hz ipsi-lesional rTMS or 1-Hz contra-lesional rTMS, in addition to a standard physical therapy protocol. Serial assessments were made over a period of 12 weeks by the thumb-index finger tapping test (FT), Activity Index (AI) score and the modified Rankin Scale (mRS). In contrast to control patients, those receiving active rTMS as ipsi-lesional 5-Hz stimulation or 1-Hz contra-lesional stimulation showed statistically significant improvement on the FT test, AI scores and mRS score at 2 weeks, and the effect was sustained over the 12-week observation period. No significant adverse events were observed during treatment in either group. Repetitive TMS has beneficial effects on motor recovery that can be translated to clinically meaningful improvement in disability in patients with post-stroke hemiparesis, with a well-sustained effect. The similarity of inhibitory and stimulatory rTMS in producing these effects supports the inter-hemispheric balance hypothesis and encourages further research into their use in long-term neurorehabilitation programmes of patients with stroke.

Manual Physical Therapy Interventions and Exercise for Patients with Temporomandibular Disorders

The purpose of this study was to investigate the outcome of a series of consecutive patients with temporomandibular disorder (TMD) who were treated with manual physical therapy interventions and exercise. Consecutive patients with the clinical presentation of TMD completed several self-report measures and underwent a standardized historical and physical examination. Following the examination, patients received a multimodal treatment approach incorporating manual physical therapy and exercise. All self-report questionnaires were completed at a 2-week follow-up. Paired t-tests were performed between the baseline and 2-week follow-up scores. The mean TMD Disability Index scores were 32.1% (15.4%) at baseline and 18.3% (12.5%) at the 2-week follow-up, representing an improvement of 13.9% (CI: 8.2%, 19.5%) (p<0.05). Patient Specific Functional Scale (PSFS) scores improved 3.1 points (CI: 2.3, 3.9) (p<0.05). These results suggest that patients with TMD who are treated with a rehabilitation program including manual physical therapy interventions plus exercise, with or without iontophoresis with dexamethasone, can demonstrate clinically meaningful improvements in disability and overall perceived change in a relatively short period of time.

A non-surgical approach to the management of lumbar spinal stenosis: A prospective observational cohort study

BackgroundWhile it is widely held that non-surgical management should be the first line of approach in patients with lumbar spinal stenosis (LSS), little is known about the efficacy of non-surgical treatments for this condition. Data are needed to determine the most efficacious and safe non-surgical treatment options for patients with LSS. The purpose of this paper is to describe the clinical outcomes of a novel approach to patients with LSS that focuses on distraction manipulation (DM) and neural mobilization (NM).MethodsThis is a prospective consecutive case series with long term follow up (FU) of fifty-seven consecutive patients who were diagnosed with LSS. Two were excluded because of absence of baseline data or failure to remain in treatment to FU. Disability was measured using the Roland Morris Disability Questionnaire (RM) and pain intensity was measured using the Three Level Numerical Rating Scale (NRS). Patients were also asked to rate their perceived percentage improvement.ResultsThe mean patient-rated percentage improvement from baseline to the end to treatment was 65.1%. The mean improvement in disability from baseline to the end of treatment was 5.1 points. This was considered to be clinically meaningful. Clinically meaningful improvement in disability from baseline to the end of treatment was seen in 66.7% of patients. The mean improvement in "on average" pain intensity was 1.6 points. This did not reach the threshold for clinical meaningfulness. The mean improvement in "at worst" pain was 3.1 points. This was considered to be clinically meaningful.The mean duration of FU was 16.5 months. The mean patient-rated percentage improvement from baseline to long term FU was 75.6%. The mean improvement in disability was 5.2 points. This was considered to be clinically meaningful. Clinically meaningful improvement in disability was seen in 73.2% of patients. The mean improvement in "on average" pain intensity from baseline to long term FU was 3.0 points. This was considered to be clinically meaningful. The mean improvement in "at worst" pain was 4.2 points. This was considered to be clinically meaningful. Only two patients went on to require surgery.No major complications to treatment were noted.ConclusionA treatment approach focusing on DM and NM may be useful in bringing about clinically meaningful improvement in disability in patients with LSS.