Global Perceived Effect Scale Research Articles

A Stratified Approach for Managing Patients With Low Back Pain in Primary Care (SPLIT Program): A Before-and-After Study.

To determine the effects of stratified primary care for low back pain (SPLIT program) in decreasing back-related disability for patients with low back pain (LBP) in primary care. We conducted a before-and-after study. We compared health-related outcomes for 2 sequential, independent cohorts of patients with LBP recruited at 7 primary care units in Portugal. The first prospective cohort study characterized usual care (UC) and collected data from February to September 2018. The second was performed when the SPLIT program was implemented and collected data from November 2018 to October 2021. Between cohorts, physical therapists were trained in the implementation of the SPLIT program, which used the STarT Back Screening Tool to categorize patients for matched treatment. We compared back-related disability (Roland-Morris Disability Questionnaire, 0-24 points), pain (Numeric Pain Rating Scale, 0-10 points), perceived effect of treatment (Global Perceived Effect Scale, -5 to +5 points), and health-related quality of life (EuroQoL 5 dimensions 3 levels index, 0-1 points). We enrolled a total of 447 patients: 115 in the UC cohort (mostly treated with pharmacologic treatment) and 332 in the SPLIT cohort (all referred for a physical therapy intervention program). Over the study period of 6 months, patients in the SPLIT program showed significantly greater improvements in back-related disability (ß, -2.94; 95% CI, -3.63 to -2.24; P ≤ .001), pain (ß, -0.88; 95% CI, -1.18 to -0.57; P ≤ .001), perceived effect of treatment (ß, 1.40; 95% CI, 0.97 to 1.82; P ≤ .001), and health-related quality of life (ß, 0.11; 95% CI, 0.08 to 0.14; P ≤ .001) compared with UC. Patients in the SPLIT program for LBP showed greater benefits regarding health-related outcomes than those receiving UC.

Patient Characteristics Associated With Worsening of Neck Pain-Related Disability After Surgery for Degenerative Cervical Myelopathy: A Nationwide Study of 1508 Patients.

Functional status, pain, and quality of life usually improve after surgery for degenerative cervical myelopathy (DCM), but a subset of patients report worsening. The objective was to define cutoff values for worsening on the Neck Disability Index (NDI) and identify prognostic factors associated with worsening of pain-related disability 12 months after DCM surgery. In this prognostic study based on prospectively collected data from the Norwegian Registry for Spine Surgery, the NDI was the primary outcome. Receiver operating characteristics curve analyses were used to obtain cutoff values, using the global perceived effect scale as an external anchor. Univariable and multivariable analyses were performed using mixed logistic regression to evaluate the relationship between potential prognostic factors and the NDI. Among the 1508 patients undergoing surgery for myelopathy, 1248 (82.7%) were followed for either 3 or 12 months. Of these, 317 (25.4%) were classified to belong to the worsening group according to the mean NDI percentage change cutoff of 3.3. Multivariable analyses showed that smoking (odds ratio [OR] 3.4: 95% CI 1.2-9.5: P < .001), low educational level (OR 2.5: 95% CI 1.0-6.5: P < .001), and American Society of Anesthesiologists grade >II (OR 2.2: 95% CI 0.7-5.6: P = .004) were associated with worsening. Patients with more severe neck pain (OR 0.8: 95% CI 0.7-1.0: P = .003) and arm pain (OR 0.8: 95% CI 0.7-1.0; P = .007) at baseline were less likely to report worsening. We defined a cutoff value of 3.3 for worsening after DCM surgery using the mean NDI percentage change. The independent prognostic factors associated with worsening of pain-related disability were smoking, low educational level, and American Society of Anesthesiologists grade >II. Patients with more severe neck and arm pain at baseline were less likely to report worsening at 12 months.

Does the Keele STarT MSK tool predict the risk of poor outcome in non-specific shoulder complaints in primary care in a Dutch population?

ObjectivesThe Keele STarT MSK tool is a questionnaire to identify the prognostic factors for musculoskeletal conditions, such as shoulder complaints, developed by Keele University, UK. This study assessed whether the Keele STarT MSK tool can predict the risk of poor outcome in non-specific shoulder complaints in a Dutch population. DesignMulticentre prospective cohort study. SettingFourteen primary care physiotherapy clinics in the Netherlands participated in this study. ParticipantsIn total, 180 patients with non-specific shoulder complaints with complete data from the Keele STarT MSK tool (baseline), Short-Form 12 Health Survey (SF-12), Shoulder Pain and Disability Index (SPADI), Numeric Pain Rating Score (NPRS) and Global Perceived Effect (GPE) scale at week 6, week 12 or endpoint were included. Data were collected from January 2019 to January 2020. Of these, 180 patients were eligible for the study. Of these, 139 completed the study and were included in the analysis. Main outcome measuresPoor outcome was defined as: SF-12 score ≤33 (physical health), SPADI score ≥30% (disability in activity), NPRS score ≥3 (pain intensity) and GPE scale score ≥3 (patient-reported recovery). ResultsThe area under the receiver operating characteristic curves for prediction of outcome were excellent for the SF-12, acceptable for the SPADI and NPRS, and showed no discrimination for the GPE scale. The optimal cut-off value for the Keele STarT MSK score to discriminate between low and medium/high risk groups was ≥5. ConclusionsThe Keele STarT MSK tool is able to predict the risk of poor outcome in patients with non-specific shoulder complaints in primary care physiotherapy clinics. Further research is needed to establish whether stratified care (subgrouping and targeted treatment) is more efficient. Contribution of paper•The results of this study confirm the applicability of the Keele STarT MSK tool in patients with non-specific shoulder complaints in the Netherlands.•The optimal cut-off value for this target group was determined and corresponds to the previous results described by Van den Broek et al.[20].•By applying the Keele Start MSK tool, the patient with shoulder complaints is better screened for his complaints. This allows the patient to be referred to the right healthcare provider to receive the right care.

Global perceived improvement and health-related quality of life after physical therapy in Lebanese patients with chronic non-specific low back pain.

The effectiveness of physical therapy (PT) in patients with chronic non-specific low back pain (CNSLBP) is mainly evaluated through pain, disability, and health-related quality of life (HRQOL). However, recent studies have recommended the consideration of improvement from patients' perspectives. This study aimed to investigate the relationship between the global perception of improvement in Lebanese patients with CNSLBP who have undergone PT, the HRQOL levels, as well as pain intensity. 132 patients with CNSLBP who have undergone PT completed a questionnaire consisting of sociodemographic and CNSLBP characteristics questions, pain intensity numeric scale (NRS), 12-Item Short-Form Health Survey (SF-12), and the Global Perceived Effect scale (GPE). Binary logistic regressions and Pearson correlation coefficient were used for analyses. Global perceived improvement of PT varies according to HRQOL levels. A significant correlation was found between pain intensity after PT, perceived improvement from PT, and HRQOL. Educational level and pain irradiation have been shown to be predictive factors of perceived improvement after PT. Pain and HRQOL are interrelated and contributed to elucidating the global perception of improvement after PT in patients with CNSLBP. The findings suggest that patients' global perception of improvement should be considered in evaluating the benefits of physical therapy in addition to pain and HRQOL.

Long-Term Results After Surgery for Degenerative Cervical Myelopathy.

Degenerative cervical myelopathy (DCM) is a frequent cause of spinal cord dysfunction, and surgical treatment is considered safe and effective. Long-term results after surgery are limited. This study investigated long-term clinical outcomes through data from the Norwegian registry for spine surgery. Patients operated at the university hospitals serving Central and Northern Norway were approached for long-term follow-up after 3 to 8 years. The primary outcome was change in the Neck Disability Index, and the secondary outcomes were changes in the European Myelopathy Scale score, quality of life (EuroQoL EQ-5D); numeric rating scales (NRS) for headache, neck pain, and arm pain; and perceived benefit of surgery assessed by the Global Perceived Effect scale from 1 year to long-term follow-up. We included 144 patients operated between January 2013 and June 2018. In total, 123 participants (85.4%) provided patient-reported outcome measures (PROMs) at long-term follow-up. There was no significant change in PROMs from 1 year to long-term follow-up, including Neck Disability Index (mean 1.0, 95% CI -2.1-4.1, P = .53), European Myelopathy Scale score (mean -0.3, 95% CI -0.7-0.1, P = .09), EQ-5D index score (mean -0.02, 95% CI -0.09-0.05, P = .51), NRS neck pain (mean 0.3 95% CI -0.2-0.9, P = .22), NRS arm pain (mean -0.1, 95% CI -0.8-0.5, P = .70), and NRS headache (mean 0.4, 95% CI -0.1-0.9, P = .11). According to Global Perceived Effect assessments, 106/121 patients (87.6%) reported to be stable or improved ("complete recovery," "much better," "slightly better," or "unchanged") at long-term follow-up compared with 88.1% at 1 year. Dichotomizing the outcome data based on severity of DCM did not demonstrate significant changes either. Long-term follow-up of patients undergoing surgery for DCM demonstrates persistence of statistically significant and clinically meaningful improvement across a wide range of PROMs.

Potential effect modifiers for treatment with chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7–14 years: development of and results from a secondary analysis of a randomised clinical trial

BackgroundA recent randomized controlled trial (RCT) investigating the effect of chiropractic manipulation in 199 children aged 7–14 years with recurrent headaches demonstrated a significant reduction of number of days with headache and a better global perceived effect (GPE) in the chiropractic manipulation group compared to a sham manipulation group. However, potential modifiers for the effectiveness of chiropractic manipulation of children with recurrent headaches have never been identified. The present study is a secondary analysis of data from that RCT and will investigate potential effect modifiers for the benefit of chiropractic manipulation for children with headache.MethodsSixteen potential effect modifiers were identified from the literature and a summary index was prespecified based on clinical experience. Relevant variables were extracted from baseline questionnaires, and outcomes were obtained by means of short text messages. The modifying effect of the candidate variables was assessed by fitting interaction models to the data of the RCT. In addition, an attempt to define a new summary index was made.ResultsThe prespecified index showed no modifying effect. Four single variables demonstrated a treatment effect difference of more than 1 day with headache per week between the lower and the upper end of the spectrum: intensity of headache (p = 0.122), Frequency of headache (p = 0.031), sleep duration (p = 0.243), and Socioeconomic status (p = 0.082). Five variables had a treatment effect difference of more than 0.7 points on the GPE scale between the lower and the upper end of the spectrum: Frequency of headache (p = 0.056), Sport activity (p = 0.110), Sleep duration (p = 0.080), History of neck pain (p = 0.011), and Headache in the family (0.050). A new summary index could be constructed giving highest weight to History of neck pain and Headache in the family and Frequency of headache. The index suggests a difference of about 1 point in GPE between low and high values of the index.ConclusionChiropractic manipulation offers a moderate benefit for a broad spectrum of children. However, it cannot be excluded that specific headache characteristics, family factors, or a history of neck pain may modify the effect. This question must be addressed in future studies.Trial registration: ClinicalTrials.gov (Albers et al in Curr Pain Headache Rep 19:3–4, 2015), identifier NCT02684916, registered 02/18/2016—retrospectively registered.

Prospects of returning to work after lumbar spine surgery for patients considering disability pension: a nationwide study based on data from the Norwegian Registry for Spine Surgery

ObjectivesTo assess the odds for not returning to work (non-RTW) 1 year after treatment among patients who had applied for or were planning to apply for disability pension (DP-applicant) prior...

Impact of the number of previous lumbar operations on patient-reported outcomes after surgery for lumbar spinal stenosis or lumbar disc herniation.

Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort. This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS. The proportion reaching a PASS decreased from 66.0% (95% confidence interval (CI) 65.4 to 66.7) in cases with no previous operation to 22.0% (95% CI 15.2 to 30.3) in cases with four or more previous operations (p < 0.001). The odds of not reaching a PASS were 2.1 (95% CI 1.9 to 2.2) in cases with one previous operation, 2.6 (95% CI 2.3 to 3.0) in cases with two, 4.4 (95% CI 3.4 to 5.5) in cases with three, and 6.9 (95% CI 4.5 to 10.5) in cases with four or more previous operations. The ODI raw and change scores and the secondary outcomes showed similar trends. We found a dose-response relationship between increasing number of previous operations and inferior outcomes among patients operated for degenerative conditions in the lumbar spine. This information should be considered in the shared decision-making process prior to elective spine surgery.

Victorian Institute of Sport Assessment—Achilles thresholds for minimal important change and return to presymptom activity level in active soldiers with mid-portion Achilles tendinopathy

IntroductionMid-portion Achilles tendinopathy (mid-AT) is common in soldiers, significantly impacting activity levels and operational readiness. Currently, Victorian Institute of Sport Assessment—Achilles (VISA-A) represents the gold standard to evaluate pain and...

Postoperative Pain Management and Patient Satisfaction in an Indian Tertiary Care Centre-A Prospective Observational Study

Introduction: Despite various advancements over last two decades in pain medicine, post-operative pain remains inadequately addressed, even in a tertiary medical center. There are very limited studies addressing post-operative pain management in India. Few published studies have assessed post-operative pain, but only at 24 hours intervals, and utilising tools focusing on any one parameter of pain. Hence, a holistic assessment using four different pain assessment tools should be done to get a wider overview of the condition. Aim: To assess the intensity and severity of post-operative pain at 6, 12, 24 &amp; 48 hours postoperatively for patients undergoing surgery for orthopaedics, gastrointestinal, general surgery, obstetrics &amp; gynaecological ailments and patient satisfaction at 24 hours postoperatively. Materials and Methods: A prospective observational survey was conducted at a tertiary care centre of New Delhi from October 2020 to October 2021. Three scales were used to determine the status of post-operative pain at 6,12,24 and 48 hours followup. The three different pain scales were Numerical Pain Rating Scale (NRS-pain) static and dynamic, Global Perceived Effect (GPE) and Neuropathic Pain System Inventory (NPSI). Results: Total of 400 patients, with mean age of the study population was 43.26±4.98 years. Majority were males, 250 (60%) and of ASA Grade I, 208 (52%). Significant improvement was observed in the NRS pain score at each follow-up among those undergoing orthopaedic surgery, general surgery, and gynaecological procedures. Improvement in the mean GPE scale was only seen for orthopaedic surgeries. There was a significant neuropathic pain component observed in all the surgeries except gynaecological surgeries. Majority 321 (80.25%) had received information about their pain treatment but only 174 (43.5%) were satisfied with their pain treatment. Conclusion: A majority of the patients undergoing orthopaedic or general surgery, and gynaecological procedures had improvement in pain. This survey highlights the need for investigating future post-operative pain management protocols so that the intensity of post-operative pain, incidence of chronic persistent pain &amp; resulting suffering, as well as disability, can be minimised to a large extent.

Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial

BackgroundPlantar fasciopathy is the most common reason for complaints of plantar heel pain and one of the most prevalent musculoskeletal conditions with a reported lifetime incidence of 10%. The condition is normally considered self-limiting with persistent symptoms that often last for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. Heavy-slow resistance training and radiofrequency microtenotomy for the treatment of plantar fasciopathy have shown potentially positive effects on short- and long-term outcomes (> 3 months). However, the effect of heavy-slow resistance training compared with a radiofrequency microtenotomy treatment is currently unknown. This trial compares the efficacy of heavy-slow resistance training and radiofrequency microtenotomy treatment with supplemental standardized patient education and heel inserts in improving the Foot Health Status Questionnaire pain score after 6 months in patients with plantar fasciopathy.MethodsIn this randomized superiority trial, we will recruit 70 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of two groups: (1) heavy-slow resistance training, patient education and a heel insert (n = 35), and (2) radiofrequency microtenotomy treatment, patient education and a heel insert (n = 35). All participants will be followed for 1 year, with the 6-month follow-up considered the primary endpoint. The primary outcome is the Foot Health Status Questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a Global Perceived Effect scale, the physical activity level, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment.DiscussionBy comparing the two treatment options, we should be able to answer if radiofrequency microtenotomy compared with heavy-slow resistance training is superior in patients with plantar fasciopathy.Trial registrationClinicalTrials.gov NCT03854682. Prospectively registered on February 26, 2019.

Cross-Cultural Adaptation and Clinimetric Testing of Functional Rating Index (FRI) Outcome Measure into the Arabic Language.

Background The Functional Rating Index (FRI) is a self-report scale widely used to determine the level of disability in low back pain (LBP) populations. Objectives This study was aimed at conducting the cross-cultural adaptation of the FRI-Arabic version (FRI-Ar) and testing the clinometric properties of FRI-Ar. Methods The cross-cultural adaptation process was used to develop the FRI-Ar. This study included acute and subacute LBP patients. Each patient was asked to complete the questionnaires at three time points: baseline, 24-hour follow-up, and two-week follow-up. The questionnaires used were FRI-Ar, Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), Numerical Pain Rating Scale (NPRS), Global Perceived Effect Scale (GPE), and Patient-Specific Functional Scale (PSFS). Statistical analysis was carried out to measure the instrument's reliability, validity, and responsiveness. Results The FRI was cross-culturally adapted to the Arabic language, and the adapted version was validated. Two hundred patients completed the questionnaires at the baseline; however, 120 patients completed the questionnaires at 24-hour and two-week follow-up. Cronbach's alpha, interclass correlation coefficient (ICC2,1), standard error of measurement (SEM), and minimal detectable change (MDC95%) for the FRI-Ar were observed as 0.85, 0.85, 1.17 (2.9%), and 3.24, respectively. The FRI-Ar showed a moderate positive correlation only with the RMDQ, ODI, and NPRS (p < 0.05). Also, it showed the responsiveness with a small effect size (ES = 0.29) and standardized response mean (SRM = 0.44). Conclusion The FRI-Ar was developed, and it showed good reliability and validity. However, it revealed the responsiveness with the small change. It can evaluate both pain and functional limitations in acute and subacute LBP patients. Before using it in the Arabic population with acute and subacute LBP, it is recommended to conduct further research to test internal and external responsiveness using an external criterion with a more extended follow-up period and suitable interventions.

Traditional acupuncture and laser acupuncture in chronic nonspecific neck pain: study protocol for a randomized controlled trial

BackgroundNonspecific neck pain is a multifactorial and very common condition in adult individuals, traditional acupuncture (TA) and laser acupuncture (LA) may be treatment options for certain individuals in such a condition. However, no reports were found in the literature comparing the effectiveness of TA and LA in cases of chronic nonspecific neck pain. Therefore, the aim of the present study is to investigate the effectiveness of TA and LA therapies in individuals with chronic nonspecific neck pain, noting which one is more efficient for this condition. The result of this research will have direct implications for pain management and, consequently, may benefit individuals suffering from nonspecific chronic neck pain.Methods/designThis will be a controlled and randomized clinical trial. Eighty-four individuals will be recruited and distributed equally and randomly into 3 groups: TA (which will receive the acupuncture treatment with needles), LA (which will receive the laser acupuncture treatment), and Sham (who will receive the placebo intervention). The acupuncture points (Tianzhu, Fengchi, Jianjing, and Jianzhongshu) will be stimulated bilaterally. The primary outcome will be pain intensity, determined using the Numerical Rating Scale. The secondary outcomes will be pressure pain threshold, temporal summation of pain, conditioned pain modulation, use of analgesic medicines after treatment, and the global perceived effect scale. The assessments will be performed immediately before and after the treatment, which will be a single session, at the follow-up and 1 month after the end of the treatments; evaluation will be made of the pain intensity and the global perceived effect. Statistical analysis of the data obtained will consider a significance level of p < 0.05.DiscussionThis study will provide evidence concerning the effects of LA treatment, in comparison with TA and sham intervention, leading to benefits for individuals suffering from chronic nonspecific neck pain.Trial registrationBrazilian Registry of Clinical Trials - ReBEC RBR-7vbw5gd. Date of registration: August 06th, 2021.

Hip abductor versus adductor strengthening for clinical outcomes in knee symptomatic osteoarthritis: A randomized controlled trial

BackgroundHip adductors and abductors are weak in patients with knee osteoarthritis (KOA). However, most studies have not investigated selective adductor strengthening. ObjectiveTo compare the effects of adding selective hip abductors versus adductors strengthening to lower limb multimodal exercise program for pain, self-reported function, knee-related quality of life, medication ingested and performance-based tests in patients with symptomatic KOA. DesingRandomized controlled trial. MethodsSixty-six patients with KOA were randomly assigned to two treatment groups: hip abductor group (HABG) or hip adductor group (HADG). Both groups performed a lower limb multimodal exercise program. HABG and HADG groups added three hip abduction and three hip adduction exercises, respectively. Intensity of pain through numeric pain scale, Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales, Lequesne questionnaire, global perceived effect scale, medication ingested, performance-based tests were assessed at baseline, after 6 weeks, and 6 months. ResultsNo significant between-group differences were found in primary outcomes: pain intensity (mean difference = −1.15, 95%CI −2.44 – 0.12, P = 0.07), KOOS-pain (mean difference = 1.64, 95%CI −6.79 – 10.07, P = 0.70) and KOOS-function in daily living (mean difference = −0.12, 95%CI, −8.78 – 8.54, P = 0.97) in 6 weeks. Groups did not differ in any secondary outcome after 6 weeks or after 6 months (P > 0.05). ConclusionsThere is no difference between adding hip abductors or adductors strengthening to lower limb multimodal exercise program in improving pain, self-reported function, quality of life, medication ingested and performance-based tests in patients with KOA.

Clinical improvement after surgery for degenerative cervical myelopathy; A comparison of Patient-Reported Outcome Measures during 12-month follow-up.

Although many patients report clinical improvement after surgery due to degenerative cervical myelopathy, the aim of intervention is to stop progression of spinal cord dysfunction. We wanted to provide estimates and assess achievement rates of Minimal Clinically Important Difference (MCID) at 3- and 12-month follow-up for Neck Disability Index (NDI), Numeric Rating Scale for arm pain (NRS-AP) and neck pain (NRS-NP), Euro-Qol (EQ-5D-3L), and European Myelopathy Score (EMS). 614 degenerative cervical myelopathy patients undergoing surgery responded to Patient-Reported Outcome Measures (PROMs) prior to, 3 and 12 months after surgery. External criterion was the Global Perceived Effect Scale (1-7), defining MCID as "slightly better", "much better" and "completely recovered". MCID estimates with highest sensitivity and specificity were calculated by Receiver Operating Curves for change and percentage change scores in the whole sample and in anterior and posterior procedural groups. The NDI and NRS-NP percentage change scores were the most accurate PROMs with a MCID of 16%. The change score for NDI and percentage change scores for NDI, NRS-AP and NRS-NP were slightly higher in the anterior procedure group compared to the posterior procedure group, while remaining PROM estimates were similar across procedure type. The MCID achievement rates at 12-month follow-up ranged from 51% in EMS to 62% in NRS-NP. The NDI and NRS-NP percentage change scores were the most accurate PROMs to measure clinical improvement after surgery for degenerative cervical myelopathy. We recommend using different cut-off estimates for anterior and posterior approach procedures. A MCID achievement rate of 60% or less must be interpreted in the perspective that the main goal of surgery for degenerative cervical myelopathy is to prevent worsening of the condition.

Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial

BackgroundThe effectiveness of blood flow restriction training (BFR) in elderly with knee osteoarthritis (OA) is comparable to performing high-intensity protocols (70 to 80% of 1 RM [repetition maximum]) that are known to be effective for improving the muscle strength of knee extensors, with the advantage of generating less particular rating of perceived exertion and pain immediately after training. However, despite being a promising alternative, little is known about the best way to apply the BFR, such as level of pressure and combination or not with other therapeutic modalities. The purpose of this study is to evaluate whether different levels of blood flow restriction with low load (BFR + LL) and no load (BFR + rest) are non-inferior to high-intensity resistance exercise (HIRE+BFRplacebo) for pain reduction in patients with knee OA.Methods/designThis clinical trial is a non-inferiority, five-arm, randomized, active-controlled, single trial which will be carried out in 165 patients of both sexes with knee OA, aged 50 years and older. Participants will be randomly allocated into 5 exercise groups (40% of BFR + LL; 80% of BFR + LL; 40% of BFR + rest; 80% BFR + rest, and HIRE+BFR placebo). A mixed linear model will be used to examine the effect of group-by-time interaction on pain intensity on the WOMAC subscale (primary outcome) and on disease severity, physical functional data, balance data, quality of life, global perceived effect scale, and muscle strength (secondary outcomes). Participants will be analyzed for intention-to-treat, and the statistical assessor blinded to the groups. The collection of outcomes 72 h after completion of the 16 weeks of interventions will be the primary measurement point. Follow-up secondary timepoints will be collected at 20, 28, 40, 52, and 64 weeks after the end of interventions, except for pain during the training, which will be measured immediately at the end of each session. Only the comparison of the primary outcome between the HIRE group with each BFR group will be analyzed in the non-inferiority framework, the other comparisons between the BFR groups for the primary outcome, and all secondary outcomes will be interpreted in the superiority framework.DiscussionThe results of this clinical trial can point out more clearly to ways to optimize the BFR training with the minimum of pain immediately after training, which will allow the offer of an effective and more adherent strengthening training to patients with knee OA.Trial registrationRegistro Brasileiro de Ensaios Clínicos, RBR-93rx9q. Registered on 23 July 2020. Version 1.0.

Development of a clinical prediction model to inform clinical decision making for classification of patients with sciatica, based on their clinical characteristics, in the Greek health system: protocol for a prospective predictive exploratory study

IntroductionSciatica is one of the most common reasons for seeking healthcare for musculoskeletal pain. Sciatica is primarily considered as neuropathic in nature when neural tissue in the low back is...

Surgery for Degenerative Cervical Myelopathy: A Nationwide Registry-Based Observational Study With Patient-Reported Outcomes.

BACKGROUNDIndications and optimal timing for surgical treatment of degenerative cervical myelopathy (DCM) remain unclear, and data from daily clinical practice are warranted.OBJECTIVETo investigate clinical outcomes following decompressive surgery for DCM.METHODSData were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in the neck disability index (NDI) 1 yr after surgery. Secondary endpoints were the European myelopathy score (EMS), quality of life (EuroQoL 5D [EQ-5D]), numeric rating scales (NRS) for headache, neck pain, and arm pain, complications, and perceived benefit of surgery assessed by the Global Perceived Effect (GPE) scale.RESULTSWe included 905 patients operated between January 2012 and June 2018. There were significant improvements in all patient-reported outcome measures (PROMs) including NDI (mean −10.0, 95% CI −11.5 to −8.4, P < .001), EMS (mean 1.0, 95% CI 0.8-1.1, P < .001), EQ-5D index score (mean 0.16, 95% CI 0.13-0.19, P < .001), EQ-5D visual analogue scale (mean 13.8, 95% CI 11.7-15.9, P < .001), headache NRS (mean −1.1, 95% CI −1.4 to −0.8, P < .001), neck pain NRS (mean −1.8, 95% CI −2.0 to −1.5, P < .001), and arm pain NRS (mean −1.7, 95% CI −1.9 to −1.4, P < .001). According to GPE scale assessments, 229/513 patients (44.6%) experienced “complete recovery” or felt “much better” at 1 yr. There were significant improvements in all PROMs for both mild and moderate-to-severe DCM. A total of 251 patients (27.7%) experienced adverse effects within 3 mo.CONCLUSIONSurgery for DCM is associated with significant and clinically meaningful improvement across a wide range of PROMs.

Validity and Reliability of the Thai Version of the International Hip Outcome Tool in Young to Middle-Aged Physically Active Adults With Hip Disorders.

Background:The International Hip Outcome Tool (iHOT-33), which is a self-administered questionnaire that contains 33 questions, was developed to evaluate young to middle-aged physically active adults with hip pathology.Purpose:To translate and cross-culturally adapt the iHOT-33 to create a Thai version of the iHOT-33 (TH-iHOT-33) and to determine the validity and reliability of the TH-iHOT-33.Study Design:Cohort study (diagnosis); Level of evidence, 3.Methods:Translation and cross-cultural adaptation of the iHOT-33 were performed according to international guidelines. Patients aged 18 to 60 years with hip disorders who had a score ≥4 on a modified version of the Tegner activity scale completed the TH-iHOT-33 twice, 2 weeks apart. The Thai versions of the HOOS (Hip disability and Osteoarthritis Outcome Score) and EQ-5D-5L (European Quality of Life–5 Dimensions–5 Levels) were also completed at baseline. At 2 weeks, the Global Perceived Effect scale was completed in addition to the TH-iHOT-33. The statistical testing for validity included construct validity and hypotheses testing. Internal consistency, test-retest reliability, and measurement error were analyzed to determine reliability.Results:The iHOT-33 was successfully translated and cross-culturally adapted to create the TH-iHOT-33. Seventy-two patients with various hip disorders participated in this study. Of the predefined hypotheses used for construct validity, 86% were confirmed. A Cronbach alpha of 0.98 (95% CI, 0.97-0.99) demonstrated excellent internal consistency. Test-retest reliability was high, with an intraclass correlation coefficient of 0.83 (95% CI, 0.73-0.90). The standard error of measurement was 5.1 points. The smallest detectable change was 14.2 points at the individual level and 1.9 points at the group level. The minimal important change was 10.9 points. The TH-iHOT-33 had no observable floor or ceiling effects.Conclusion:The TH-iHOT-33 is a valid and reliable instrument for assessing the functional status and health-related quality of life of young to middle-aged physically active Thai adults with hip disorders.

Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain–Related Disability

Lower back pain (LBP) is a prevalent and challenging condition in primary care. The effectiveness of an individually tailored self-management support tool delivered via a smartphone app has not been rigorously tested. To investigate the effectiveness of selfBACK, an evidence-based, individually tailored self-management support system delivered through an app as an adjunct to usual care for adults with LBP-related disability. This randomized clinical trial with an intention-to-treat data analysis enrolled eligible individuals who sought care for LBP in a primary care or an outpatient spine clinic in Denmark and Norway from March 8 to December 14, 2019. Participants were 18 years or older, had nonspecific LBP, scored 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ), and had a smartphone and access to email. The selfBACK app provided weekly recommendations for physical activity, strength and flexibility exercises, and daily educational messages. Self-management recommendations were tailored to participant characteristics and symptoms. Usual care included advice or treatment offered to participants by their clinician. Primary outcome was the mean difference in RMDQ scores between the intervention group and control group at 3 months. Secondary outcomes included average and worst LBP intensity levels in the preceding week as measured on the numerical rating scale, ability to cope as assessed with the Pain Self-Efficacy Questionnaire, fear-avoidance belief as assessed by the Fear-Avoidance Beliefs Questionnaire, cognitive and emotional representations of illness as assessed by the Brief Illness Perception Questionnaire, health-related quality of life as assessed by the EuroQol-5 Dimension questionnaire, physical activity level as assessed by the Saltin-Grimby Physical Activity Level Scale, and overall improvement as assessed by the Global Perceived Effect scale. Outcomes were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months. A total of 461 participants were included in the analysis; the population had a mean [SD] age of 47.5 [14.7] years and included 255 women (55%). Of these participants, 232 were randomized to the intervention group and 229 to the control group. By the 3-month follow-up, 399 participants (87%) had completed the trial. The adjusted mean difference in RMDQ score between the 2 groups at 3 months was 0.79 (95% CI, 0.06-1.51; P = .03), favoring the selfBACK intervention. The percentage of participants who reported a score improvement of at least 4 points on the RMDQ was 52% in the intervention group vs 39% in the control group (adjusted odds ratio, 1.76; 95% CI, 1.15-2.70; P = .01). Among adults who sought care for LBP in a primary care or an outpatient spine clinic, those who used the selfBACK system as an adjunct to usual care had reduced pain-related disability at 3 months. The improvement in pain-related disability was small and of uncertain clinical significance. Process evaluation may provide insights into refining the selfBACK app to increase its effectiveness. ClinicalTrials.gov Identifier: NCT03798288.