Roland-Morris Disability Score Research Articles

Impact of Musculoskeletal Pain on Health-Related Quality of Life Among Adults in Saudi Arabia.

Background Musculoskeletal pain (MSP) is widely recognized as a prevalent public health issue that affects individuals of various genders and age groups. The aim of this study is to assess the influence of musculoskeletal pain on the quality of life (QoL)of adult individuals living in Saudi Arabia. Method This is a cross-sectional study using an online-administered questionnaire that was distributed via online platforms in Saudi Arabia for the duration between January and August 2023. Three questionnaire instruments were used in this study. The 36-item Short Form Health Survey questionnaire (SF-36), The 5-level EQ-5D version (EQ-5D-5L), and Roland-Morris Disability Questionnaire. Binary logistic regression analysis was used to identify predictors of better QoL and having mild to moderate disability. Results A total of 8359 participants were involved in this study. The most commonly reported sites of musculoskeletal pain were the lower back, neck, and shoulder, accounting for 36.8% (n= 3072), 30.5% (n= 2549), and 30.1% (n= 2514), respectively. The mean pain score for the study participants was 4.3 (SD: 2.3), which indicates mild degree of pain. The median EQ-5D-5L index value for the study participants was 0.827 (0.756-1.00), which demonstrates a high quality of life. The mean SF-36 score for the study participants was 63.11 (17.4), which demonstrates moderate quality of life. The median Roland-Morris Disability score for the study participants was 1.00 (0.00-7.00), which demonstrates a low level of pain-related disability. Male gender, younger age (30-39 years), having higher education attainment, having higher monthly income (more than SAR 20000), and having lower BMI (less than 25.8 kg/cm2) were predictors of better QoL (p<0.05). Conclusion Musculoskeletal pain is a multifactorial condition influenced by structural, physical, psychological, social, lifestyle, and comorbid health elements. It ranges from acute to chronic pain and, despite rarely being fatal, has a significant impact on QoL. Musculoskeletal discomfort varies in terms of intensity, affected regions, and demographic and lifestyle factors. This study sheds light on the multifaceted nature of MSP, its impact on QoL, and the significance of early intervention and individualized management strategies to improve the QoLof those affected.

Thoracolumbar fascia mobility and chronic low back pain: Phase 2 of a pilot and feasibility study including multimodal chiropractic care

BackgroundThoracolumbar fascia mobility observed with ultrasound imaging and calculated as shear strain is lower in persons with chronic low back pain. This pilot and feasibility trial assessed thoracolumbar shear strain in persons with chronic low back pain following spinal manipulation and over an 8-week course of multimodal chiropractic care.MethodsAdults self-reporting chronic low back pain ≥ 1 year participated between September 2019 and April 2021 in a trial using ultrasound imaging to measure thoracolumbar shear strain. Ultrasound imaging occurred 2–3 cm lateral to L2-3 while participants relaxed prone on an automated table moving the lower extremities downward 15 degrees, for 5 cycles at 0.5 Hz. Pain intensity on an 11-point numerical rating scale, disability, pain interference, and global improvement were also collected. Participants received 8-weeks of twice-weekly chiropractic care including spinal manipulation, education, exercise, self-management advice and myofascial therapies. Shear strain was computed using 2 methods. The highest shear strain from movement cycles 2, 3, or 4 was averaged over right and left sides for each participant. Alternately, the highest shear strain from movement cycle 3 was used. All data were analyzed over time using mixed-effects models. Estimated mean changes are reported.ResultsOf 20 participants completing 8-weeks of chiropractic care (female n = 11), mean (SD) age was 41 years (12.6); mean BMI was 28.5 (6.2). All clinical outcomes improved at 8-weeks. Mean (95% confidence interval) pain intensity decreased 2.7 points (− 4.1 to − 1.4) for females and 2.1 points (− 3.7 to 0.4) for males. Mean Roland–Morris disability score decreased by 5 points (− 7.2 to − 2.8) for females, 2.3 points (− 4.9 to 0.2) for males. Mean PROMIS pain interference T-score decreased by 8.7 points (− 11.8 to − 5.5) for females, 5.6 points (− 9.5 to − 1.6) for males. Mean shear strain at 8-weeks increased in females 5.4% (− 9.9 to 20.8) or 15% (− 0.5 to 30.6), decreasing in males 6.0% (− 24.2 to 12.2) or 2% (− 21.0 to 16.8) depending on computational method.ConclusionSpinal manipulation does not likely disrupt adhesions or relax paraspinal muscles enough to immediately affect shear strain. Clinical outcomes improved in both groups, however, shear strain only increased in females following 8-weeks of multimodal chiropractic care.Trial registration ClinicalTrials.gov registration is NCT03916705.

A Regenerative Interventional Approach to the Management of Degenerative Low Back Pain

Objective: Low back pain has been strongly related to the degenerative process of the spine, especially the degeneration of the intervertebral disc and facet joints. The main procedures for the management of low back pain are no intended to slow down or reverse the degenerative process. Platelet Rich Plasma (PRP), an orthobiologic product, has been the subject of several studies in the management of low back pain. Methods: A prospective case series study presenting the clinical results of 23 patients treated with PRP injections performed following clinical a interventionist protocol called PerMuTIS – Personalized Multi Target Biologic Injection of the Spine. The method to obtain the platelet concentrate was the Simple Double Spin technique, a low-cost double spin that produces Leucocyte Rich PRP. Baseline scores of pain and disability using the Visual Analog Scale (VAS) and Roland-Morris Disability Questionnaire (RMDQ) were recorded. Results: Mean VAS pain score across the cohort decreased by approximately 62%, while the Roland-Morris disability score decreased by about 60% at 52 weeks. There was no report of adverse events. The Leucocite and Monocite Rich PRP product showed concentration of 4.3X above baseline, with monocites concentration of 3.2X baseline. Conclusion: The concept of application in multiple targets using a simple and low-cost preparation technique proved to be feasible and without reports of serious side effects that compromise its indication. The PerMuTIS – Personalized Multi Target Biologic Injection in the Spine Technique using Simple Double Spin protocol demonstrated safety and feasibility in this prospective study of patients with low back pain who failed conservative treatments. Large scale, multicenter randomized clinical trial will provide an appropriate level of evidence to assist in clinical practice.

Outcomes of minimally invasive spine decompression in lumbar spinal stenosis and intervertebral disc prolapse: A prospective study

Introduction: Lumbar spinal stenosis and intervertebral disc prolapse are the most common cause of back pain and sciatica. Both conditions are traditionally treated by a midline lumbar incision, after which the paraspinous muscles are elevated from the spinous processes and lamina and retracted laterally and extensively. Minimally invasive lumbar decompression is a procedure designed to debulk hypertrophied ligamentum flavum and removal of the herniated disc with a goal of relieving neural compression. Our study aimed to assess the outcome in terms of improvement in neurology, extent of pain relief in the postoperative period and complications in patients undergoing minimally invasive spine decompression.Methodology: The present study was conducted in a tertiary care hospital. A total of 16 patients who satisfied both the inclusion and exclusion criteria and gave informed consent were recruited for the study from January 2020 to March 2021. All patients underwent minimally invasive spine decompression by tubular retractors. Outcome measures used are Visual analog score for leg pain and back pain, Modified Oswestry Disability Index (MODI), Roland Morris Disability Questionnaire (RMDQ) and neurological examination preoperatively and postoperatively at 6 weeks, 3 months and 6 months.Results: Out of 16 patients, ten patients had intervertebral disc prolapse and six had lumbar spinal stenosis. L4L5 was the most common level seen in our patients. Mean pre-operative VAS score was 6.88 and 4.44 for leg pain and back pain, there was significant reduction at the end of 6 months. Mean preoperative MODI score was 66.38, preoperatively 13 patients (81%) had crippling back pain, 3 patients (18.75%) had severe disability. At the end of 6 months, all 16 patients had less than minimal disability. Mean preoperative roland morris disability score was 11.31+ 0.61. There was a significant mean improvement at 6 months postoperatively from the preoperative baseline score. Nine patients (43.8%) had a motor deficit of which 4 patients had a significant motor power improvement. Two patient had complications, one patient had CSF leak intraoperatively and the other patient developed a superficial wound infection.Conclusion: Minimally invasive spine surgery is an excellent surgical option in patients with lumbar spinal stenosis and prolapsed intervertebral disc. Patients who underwent minimally invasive spine decompression had satisfactory functional outcome in terms of pain relief, minimal hospital stay and early return to day to day activities.

Comparison of an Iranian Traditional Massage (Fateh Method) with Physiotherapy and Acupuncture for Patients with Chronic Low Back Pain: a Randomized Controlled Trial.

Low back pain (LBP) is currently a major reason for disability worldwide. Therapeutic massage is one of the most popular non-pharmacological methods for managing chronic LBP (CLBP), and the Fateh method is a massage technique based on Iranian Traditional Medicine. The current study aimed to compare the effects of Fateh massage with those of acupuncture and physiotherapy on relieving pain and disability in CLBP. Eighty-four patients with CLBP were categorized into groups that received Fateh massage, acupuncture, or physiotherapy. Each group included 28 randomly assigned patients who completed 10 sessions of therapy. Visual analogue scale (VAS) scores and Roland-Morris disability scores were evaluated at baseline, after intervention, and four weeks later. The findings were analyzed with SPSS software. The baseline VAS and Roland-Morris scores of the three study groups did not indicate significant differences (p > 0.05). All three groups showed significant pre-post improvements in both scores (p < 0.05). At the end of the treatment sessions, the three groups showed no significant difference in the reductions in pain intensity and disability score (p > 0.05). Improvements in disability and pain between the first and third time points were significant in all three groups (p < 0.05 for each group). In addition, the results of massage, physiotherapy, and acupuncture groups were not significantly different (p > 0.05). No adverse events occurred in the patients. The effects of Fateh massage were comparable to those of acupuncture and physiotherapy in reducing pain and disability in patients with CLBP.

Patients With Persistent Low Back Pain and Nerve Root Involvement: To Operate, or Not to Operate, That Is the Question.

Prospective cohort study. The aims of this study were to evaluate the outcome of surgical and nonsurgical treatment for patients with lumbar herniated disc (LHD) or lumbar spinal stenosis (LSS) after 2 years and to identify predictors for nonsuccess. Studies regarding the clinician's ability to identify patients with a poor prognosis are not in concurrence and further studies are warranted. This study included 390 patients with LHD or LSS referred for surgical evaluation after unsuccessful conservative treatment. Nonsuccess was defined as a Roland-Morris Disability score above 4 (0-23) or a Numeric Rating Scale back and leg pain score above 20 (0-60). Uni- and multivariate logistic regression analyses were used to investigate potential predictive factors including sociodemographic characteristics, history findings, levels of pain and disability, and magnetic resonance imaging findings. Rates of nonsuccess at 2 years were approximately 30% in surgically treated patients with LHD, approximately about 60% in patients with LSS for disability, and 30% and 40%, respectively for pain. For the main outcome variable, disability, in the final multiple logistic regression model, nonsuccess after surgery was associated with male sex (odds ratio [OR] 2.04, 95% confidence interval [CI]: 1.02-4.11, P = 0.04), low level of education (OR 2.60, 95% CI: 1.28-5.29, P = 0.01), high pain intensity (OR 3.06, 95% CI: 1.51-6.21, P < 0.01), and widespread pain (OR 3.59, 95% CI: 1.36-9.46, P = 0.01). The results indicate that the prognosis for patients referred for surgery with persistent LHD or LSS and unsuccessful conservative treatment is substantially better when surgery is performed as opposed to not performed. The predictive value of the variables male sex, low level of education, high pain intensity, and widespread pain location found in our study are partly in accordance with results of previous studies. Thus, our results warrant further investigation until firm conclusions can be made. 3.

Persian manual therapy method for chronic low-back pain with lumbar radiculopathy; a randomized controlled trial

BackgroundManual therapy is a non-surgical approach for management of musculoskeletal symptoms. This study investigated safety and efficacy of a Persian manual therapy method (Fateh technique) for management of chronic low-back pain (LBP) and radiculopathy. MethodsIn this controlled trial, 52 eligible patients with chronic LBP and lumbar radiculopathy were randomly assigned into two intervention groups; one received a 16-min soft tissue manipulation for four weekly sessions and did two daily home active exercises. The other group only did the two daily exercises for four weeks. Roland-Morris disability score, Visual Analogue Scale scores of LBP, radiculopathy and paresthesia, and finger-to-floor test result were assessed at the baseline, and in fourth and eighth weeks of trial. ResultsData of 48 participants was analyzed. Distributions of age, sex, and duration of symptoms in two groups were the same. Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36–5.19], 3.85 [2.67–5.03], 1.32 [0.37–2.27], and 4.58 [3.23–5.93] units, and increased body flexibility by 35.42 [6.91–63.92] millimeters. Compared with home exercise, Fateh technique was associated with greater changes in all outcomes. No adverse event has occurred. ConclusionsFateh technique is safe and effective for management of LBP and radiculopathy in patients without severe progressive symptoms.

Low back pain among health workers

Introduction. Back pain is often present among health workers. The aim of the study was to determine the impact of gender and years of work experience on the incidence of low back pain. Material and Methods. A prospective cross-sectional study included 67 subjects of both genders, and it was conducted in the period between June 1 and 15, 2020, in two health centers in Serbia. The impact of gender, age, years of work experience on the incidence of low back pain was analyzed, measured by the Roland-Morris disability questionnaire. Results. In the examined sample (n = 67), the majority were females (55, 82.1%). The average age of the respondents was 45.5 ? 12.2 years, with an average work experience of 20.62 ? 12.03 years. Low back pain was present in 35 subjects (52.2%). There was no statistically significant difference between male and female subjects regarding the Roland-Morris disability score (3.83 ? 4.50 vs. 4.96 ? 4.53; p &gt; 0.05). There was a statistically significant positive correlation between the age of subjects and the Roland-Morris disability score (r = 0.407; p &lt; 0.01). Subjects with more years of work experience presented with a higher Roland-Morris disability score (r = 0.371; p &lt; 0.01). Conclusion. Low back pain is common in older health workers with longer work experience, regardless of the level of formal education. Additional education of health workers on the application of protective attitudes, movements, and exercise, is needed in order to prevent the development of low back pain in the work environment.

Utilization of the directional balloon technique to improve the effectiveness of percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fractures and reduction of bone cement leakage.

Background:This article evaluates the effectiveness of a new directional balloon technique in the treatment of osteoporotic vertebral compression fractures (OVCFs).Methods:From September 2015 to April 2017, 100 patients with single-segment OVCFs treated using percutaneous kyphoplasty were available for complete data assessment. Among these, 51 cases were treated with the traditional nondirectional balloon technique (group 1) and 49 cases were treated with the directional balloon technique (group 2). Operative time, blood loss, and X-ray exposure time were compared between the 2 groups. The visual analogue score (VAS), Oswestry disability index (ODI), and Roland Morris disability (RMD) scores, and wedge-shaped and kyphosis angles were measured at 3 days and 1, 3, 6, and 12 months, respectively, after surgery.Results:There were no significant differences in blood loss or the amount of bone cement injected between the 2 groups; however, operative times, X-ray exposure times, and leakage rates of bone cement, especially type C in group 2, were significantly lower in group 2 than those in group 1. VAS, ODI, and RMD scores, and wedge-shaped and kyphosis angles at each time point after surgery were significantly higher than those before surgery. However, the improvement in VAS, ODI, and RMD scores in group 2 was only significantly better than those in group 1 at 3 days after surgery.Conclusion:The utilization of the directional balloon technique in the treatment of OVCFs using percutaneous kyphoplasty can not only reduce the operation time, the radiation, and the bone cement leakage, but also improve the early curative effect.

Treatment of patients with acute and subacute dorsalgia

Objective: to investigate the efficiency of treatment for acute and subacute dorsalgia, by providing information to patients and by using nonsteroidal anti-inflammatory drugs (NSAIDs) without conducting physical therapy, reflexotherapy, and manual therapy. Patients and methods. A total of 140 patients (87 women and 53 men; mean age 50.7±17.6 years) with acute and subacute back pain were followed up. Out of them 127 (91%) patients were found to have nonspecific (musculoskeletal) pain; 13 (9%) had discogenic radiculopathy. All the patients were informed of the benign nature of the disease, the high probability of its rapid resolution, the feasibility of abandoning prolonged bedrest, and the lack of need for physical therapy, reflexotherapy, massage, and manual therapy. To reduce pain, the patients received meloxicam 15 mg/day orally or intramuscularly or first 15 mg/day intramuscularly and then orally. The investigators assessed pain intensity with the numerical rating scale and functional activity restrictions with the Roland-Morris disability (RMD) questionnaire. Results. After treatment, the visual analogue scale pain intensity scores decreased from an average of 6.4 to 1.0; the RMD scores dropped from 6.8 to 1.4 (p&lt;0.001). The duration of treatment averaged 11.0±4.4 days. Comparison of different meloxicam dosage regimens showed no significant differences; a positive result was noted in all cases. No adverse events were observed during treatment. Conclusion. The investigation has shown the high efficiency of management in patients with acute and subacute dorsalgia, by providing information to patients (an education conversation), by using meloxicam, and by applying a personalized approach (treatment for concomitant diseases and conditions). Refusing physiotherapy, massage, acupuncture, and manual therapy substantially reduces the cost of treatment in patients with acute dorsalgia.

Treatment of Chronic Lower Back Pain: Study Protocol of a Comparative Effectiveness Study on Yoga, Eurythmy Therapy, and Physiotherapeutic Exercises

Background: We aim to compare the effectiveness of 3 active interventions, i.e., yoga, eurythmy therapy, and physiotherapeutic exercise, on chronic lower back pain. Methods: In this randomized controlled trial over 16 weeks (8 weeks of intervention, 8 weeks of follow-up), data of individuals with chronic lower back pain will be analyzed. Interventions are implemented as group sessions (75 min) once per week. Participants receive a manual for home-based practice and are assessed before and at the end of the 8-week intervention period, and at the end of an 8-week follow-up period. Standardized questionnaires are: the Roland-Morris Disability Score, visual analog scales measuring intensity of pain, the Brief Multidimensional Life Satisfaction Scale, the Perceived Stress Scale, the Inner Correspondence with the Practices questionnaire, the Freiburg Mindfulness Questionnaire, the General Self-Efficacy Scale, a self-regulation questionnaire, the Internal Coherence Scale, a pain diary (registering the need of analgesic medication), and a questionnaire on the patients' expectation that the interventions will be effective in reducing pain and how strong this reduction might be (2 single items), etc. Discussion: This large multicenter study will provide evidence on the effectiveness of 3 contrasting movement-orientated treatments that share some similarities but differ in essential details: yoga, eurythmy therapy, and physiotherapeutic exercises. It will provide important data on non-pharmacological options to treat lower back pain in a large group of affected individuals.

Therapeutic efficacy of nonsteroidal anti-inflammatory drug therapy versus exercise therapy in patients with chronic nonspecific low back pain: a prospective study.

Therapy for chronic, nonspecific low back pain is mainly conservative: medication and/or exercise. Pharmacotherapy, however, has side effects, and the quantities of concomitant drugs in older persons require attention. Although exercise promises improved function, its use to alleviate pain is controversial. Thus, we compared the efficacy of pharmacotherapy versus exercise for treating chronic nonspecific low back pain. The pharmacotherapy group (n=18: 8 men, 10 women) were prescribed celecoxib monotherapy. The exercise group (n=22: 10 men, 12 women) undertook stretching exercises. Because of drop-outs, the NSAID group (n=15: 7 men, 8 women) and the exercise group (n =18: 8 men, 10 women) were finally analyzed. We applied a visual analog scale, Roland-Morris disability scores, and the 36-Item Short Form Health Survey. We used a paired t-test for within-group analyses and an unpaired t-test for between-group analyses. Pain relief was achieved after 3 months of pharmacotherapy or exercise. Quality of life improved only in the exercise group. Recovery outcomes for the two groups were not significantly different. Efficacy of exercise therapy for strictly defined low back pain was almost equivalent to that of pharmacotherapy and provided better quality of life.

A prospective randomized controlled study comparing the pain relief in patients with osteoporotic vertebral compression fractures with the use of vertebroplasty or facet blocking.

To compare the clinical and radiological outcomes of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing facet blocking (FB) for severe pain due to osteoporotic vertebral compression fractures (OVCFs). Two hundred and six patients who had OVCFs on spine radiography and intractable back pain for ≤8weeks were recruited between January 2009 and January 2013 (165 females and 41 males, age ≥55years). Patients were randomly assigned to the PVP group (100 patients) or the FB group (106 patients). VAS, ODI, Roland Morris disability (RMD) scores, scores on the Standardized Physical Component of the SF-36 form (SPC) and scores on the Standardized Mental Component of the SF-36 form (SMC) were determined preoperatively and at each follow-up time (1day, 1week, 1, 3, 6, and 12months). In addition, plain radiographs were obtained at 3, 6, and 12months postoperatively to detect new fractures. Significantly lower VAS, ODI, and RMD scores for patients in the PVP group compared to those in the FB group were observed at follow-up of 1day and 1week (p<0.05). However, differences in the VAS, ODI, RMD and SPC/MCS (SF-36) scores between the two groups at follow-ups of more than 1month were statistically insignificant (p>0.05). Difference in numbers of new fractures in the two groups at the follow-up of 12months was also statistically insignificant. PVP produced better pain relief than FB in the short term (≤1week). However, the difference in pain-relief between these two techniques was insignificant in the long term (follow-up between 1 month and 12months).

Steroid injections added to the usual treatment of lumbar radicular syndrome: a pragmatic randomized controlled trial in general practice.

BackgroundLumbosacral radicular syndrome (LRS) is a self-limiting, benign, painful and impairing condition caused by lumbar disc herniation and inflammatory processes around the nerve root. Segmental epidural steroid injections (SESIs) are helpful to reduce radicular pain on a short-term basis. It is unknown whether SESIs are an effective addition to usual pain treatment of LRS in general practice. In our study, we assessed the effectiveness of SESIs on pain and disability as an addition to usual care for acute LRS in general practice.MethodsA pragmatic, single-blinded, randomized controlled trial in Dutch general practice was conducted. Circumstances of daily practice were closely followed. Care as usual (CAU) was compared to care as usual combined with an additional SESI in 63 patients in the acute phase of LRS. To detect a minimal clinically important difference of 1.2 points on a numerical rating scale for back pain and a common within-group standard deviation of 1.7 with a two-tailed alpha of 0.05 and a power of 0.80, we needed 33 subjects in each group. Statistical analysis was carried out using mixed models.ResultsA small significant effect in favour of the intervention, corrected for age, sex and baseline values, was found for back pain, impairment and Roland-Morris disability score. The differences, though statistically significant, were too small to be considered clinically relevant. Patients from the intervention group were significantly more satisfied with the received treatment than patients from the control group.ConclusionWe found a small, statistically significant, but not clinically relevant positive effect of SESIs on back pain, impairment and disability in acute LRS. We do not recommend implementing SESIs as an additional regular treatment option in general practice.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2474-15-341) contains supplementary material, which is available to authorized users.

Appropriateness Criteria for Surgery Improve Clinical Outcomes in Patients With Low Back Pain and/or Sciatica

Prospective, controlled, observational outcome study using clinical, radiographic, and patient/physician-based questionnaire data, with patient outcomes at 12 months follow-up. To validate appropriateness criteria for low back surgery. Most surgical treatment failures are attributed to poor patient selection, but no widely accepted consensus exists on detailed indications for appropriate surgery. Appropriateness criteria for low back surgery have been developed by a multispecialty panel using the RAND appropriateness method. Based on panel criteria, a prospective study compared outcomes of patients appropriately and inappropriately treated at a single institution with 12 months follow-up assessment. Included were patients with low back pain and/or sciatica referred to the neurosurgical department. Information about symptoms, neurologic signs, the health-related quality of life (SF-36), disability status (Roland-Morris), and pain intensity (VAS) was assessed at baseline, at 6 months, and at 12 months follow-up. The appropriateness criteria were administered prospectively to each clinical situation and outside of the clinical setting, with the surgeon and patients blinded to the results of the panel decision. The patients were further stratified into 2 groups: appropriate treatment group (ATG) and inappropriate treatment group (ITG). Overall, 398 patients completed all forms at 12 months. Treatment was considered appropriate for 365 participants and inappropriate for 33 participants. The mean improvement in the SF-36 physical component score at 12 months was significantly higher in the ATG (mean: 12.3 points) than in the ITG (mean: 6.8 points) (P = 0.01), as well as the mean improvement in the SF-36 mental component score (ATG mean: 5.0 points; ITG mean: -0.5 points) (P = 0.02). Improvement was also significantly higher in the ATG for the mean VAS back pain (ATG mean: 2.3 points; ITG mean: 0.8 points; P = 0.02) and Roland-Morris disability score (ATG mean: 7.7 points; ITG mean: 4.2 points; P = 0.004). The ATG also had a higher improvement in mean VAS for sciatica (4.0 points) than the ITG (2.8 points), but the difference was not significant (P = 0.08). The SF-36 General Health score declined in both groups after 12 months, however, the decline was worse in the ITG (mean decline: 8.2 points) than in the ATG (mean decline: 1.2 points) (P = 0.04). Overall, in comparison to ITG patients, ATG patients had significantly higher improvement at 12 months, both statistically and clinically. In comparison to previously reported literature, our study is the first to assess the utility of appropriateness criteria for low back surgery at 1-year follow-up with multiple outcome dimensions. Our results confirm the hypothesis that application of appropriateness criteria can significantly improve patient outcomes.

34. Balloon Kyphoplasty Improves Roland-Morris Disability Scores and Bone Pain Among Cancer Patients with Vertebral Compression Fractures: Interim Analysis from a Phase IV Randomized Trial

BACKGROUND CONTEXT: Destructive vertebral lesions are a common source of morbidity among patients with cancer. Kyphoplasty is a minimally invasive surgical procedure performed for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability and improving quality of life.

777 REPRODUCIBILITY OF DYNAMOMETRIC AND NON-DYNAMOMETRIC TRUNK EXTENSOR MUSCLE TESTS IN PATIENTS WITH CHRONIC LOW BACK PAIN

44 patients (22 men, 22 women; age range: 30-60 years) with CLBP (mean Roland-Morris disability scores reaching 6 ± 3.4) were randomized into two groups attending two assessment sessions. Group 1 (12 men and 12 women) underwent two tests (i.e. a maximal strength test (Figure 1) and a static endurance test requiring to maintain as long as possible a torque of 50 percent of maximal strength previously determined (Figure 2)) performed on a specific trunk extensor dynamometer (David Back). Group 2 (10 men and 10 women) was submitted to the non-dynamometric Sorensen test (lifting the upper trunk and maintaining the horizontal position) (Figure 3).

The Short Form 36 health survey in spine disease—validation against condition-specific measures

Health-Related Quality of Life (HRQoL) assessments in spinal disease offer the potential of outcome measures that better represent patients' disability and response to treatment. The Short Form 36 Health Survey (SF-36) is a generic HRQoL questionnaire that has been extensively used in primary and secondary care, but before it can be routinely applied in patients with spinal disease must be validated against traditional specific measures of physical and mental morbidity. Patients with lumbar disc prolapse, lumbar canal stenosis, and cervical spondylotic radiculomyelopathy were identified from a prospectively maintained database. Visual Analogue Scales (VAS) and condition-specific questionnaires including the Roland Morris Disability Score (RMDS), Myelopathy Disability Index (MDI), and Hospital Anxiety and Depression Scales (HADS), were completed alongside the SF-36 survey at baseline and following surgery. Convergent, discriminant, and predictive validity were assessed by computing correlations between the specific and generic scores. In addition, responsiveness (Standardised Response Mean, SRM) and floor and ceiling effects were examined. Data from 1623 assessments of 620 patients were available. Convergent validity was shown by strong correlations between condition-specific physical scores (MDI or RMDS) and the Physical Function and Bodily Pain domains of SF-36 (ρ = -0.52 to -0.76, all p < 0.01). VAS for leg or arm pain were also strongly correlated with Bodily Pain domain scores (ρ = -0.54 to -0.77, all p < 0.01). Discriminant validity was confirmed by non-significant partial correlations between Physical Function and Mental Health SF-36 domains when controlled for HADS scores (r = −0.01 to 0.02, p > 0.05). Predictive validity was demonstrated by similar correlations between pre- and post-operative scores for specific and generic instruments. Physical Function, Bodily Pain, and Mental Health domains were all free of significant floor or ceiling effects and showed moderate to good responsiveness (SRM 0.54-1.72). SF-36 domain scores are valid for measuring morbidity and surgical outcomes in common spinal disorders.

Balloon Kyphoplasty Improves Both Roland-Morris Disability Scores and Bone Pain among Cancer Patients with Vertebral Compression Fractures: Interim Analysis of Results from a Phase IV Random Trial

Destructive vertebral lesions are a common source of morbidity among patients with cancer. Balloon kyphoplasty is a minimally invasive surgical procedure performed for patients with painful vertebral compression fractures (VCFs) with the goal of reducing pain and disability and improving quality of life. We report the results of the first randomized trial among cancer patients with VCFs to assess the efficacy and safety of this procedure. Twenty-one sites in Europe, the United States, Canada and Australia enrolled 134 patients after consent and ethical review board approval. Adult patients diagnosed with a variety of cancers and ≤ 3 painful VCFs (VAS ≥ 4) were randomly assigned to immediate kyphoplasty (N=70) or nonsurgical supportive care (N=64). Patients with primary bone tumors, osteoblastic tumors or solitary plasmacytoma at the fracture site were excluded as well as patients with spinal cord compression. The primary objective was to determine the change in the Roland-Morris Disability questionnaire, a 0- (no disability) to 24-point (maximum disability) instrument validated for assessing back-specific physical functioning, at one month. Back pain was also assessed using a validated 0- (no pain) to 10-point (worst pain imaginable) numerical rating scale. Data from a preplanned interim analysis of this ongoing study are now reported. For pain and function, patients with complete data that has been evaluated through one month are included whereas all enrolled patients were analyzed for safety. Mean patient age was 64 years (range 37 to 88), 58% were female, and tumor types included multiple myeloma (36%), cancers of the breast (20%), lung (8%), prostate (6%) and other sites (30%). At study enrollment, 23% of patients were on daily corticosteroids and 48% had received bisphosphonates within 12 months of study entry. Prior to randomization, single VCFs were identified by the local investigators in 43% of patients; an equal proportion (29%) of patients had 2 or 3 fractures. Among the kyphoplasty and nonsurgical cohorts, 59 and 56 subjects, respectively were evaluable for the efficacy analysis. At baseline, average Roland-Morris scores were similar between the groups; 17.7 and 18.3 points for kyphoplasty and non-surgical-treated patients, respectively. However, at one month, there were marked differences between the two groups with a mean improvement for patients randomized to kyphoplasty of −8.3 points (95% CI −6.2 to −10.5) whereas those receiving non-surgical care showed no significant change (−0.1 points, 95% CI 0.9 to −1.0; p<0.0001 for difference). Mean baseline pain scores were also not different between the two groups (7.2 and 7.3 points for the kyphoplasty and nonsurgical groups, respectively). At one week, kyphoplasty-treated patients showed significant improvement in their back pain (−3.6 points, 95%CI, −2.8 to −4.4) whereas those patients treated non-surgically had no change in their pain (−0.3 points, 95%CI, 0.1 to −0.8; p<0.0001 for difference). Similar results for pain were obtained at one month; kyphoplasty resulted in a −4.1 point change (95%CI, −3.2 to −4.9) and those patients treated non-surgically had no change in their pain (−0.5 points; 95%CI, 0.04 to −1.0; p<0.0001 for difference). There was no significant difference in the number of patients with serious adverse events between the kyphoplasty (16) and nonsurgical (10) groups at one month. None of the serious adverse events in the kyphoplasty group were related to the devices used, including bone cement extravasation; one serious adverse event in the form of an intra-operative non-Q-wave myocardial infarction resolved and was attributed to anesthesia. This randomized study shows, at a pre-planned interim analysis time point, that patients with cancer-related VCFs treated with immediate balloon kyphoplasty show a marked reduction in back disability and pain at one month compared to non-surgical treatment. Pain reduction was also statistically significantly improved within one week postoperatively. Importantly, minimally clinically important differences for the Roland-Morris and pain scales used in this trial have been determined from previous studies and are estimated to be approximately 2.5 and 2.0 points, respectively. Thus, these improvements in disability and pain with balloon kyphoplasty were both statistically and clinically significant and achieved without an increase in adverse events.

Physiotherapy added to GP care results in long-term improvements for sciatica

In acute sciatica, does the addition of physiotherapy to general practitioner (GP) care improve patients’ global perceived effect of treatment? Randomised controlled trial with block randomisation and concealed allocation. The statistician was blinded to group allocation but participants, physiotherapists, and GPs were not. Eighty-six percent of participants were followed up at one year. Both per protocol and intention-to-treat analyses were performed. Community-based study involving 112 GPs and 33 physiotherapists in Rotterdam, The Netherlands. 135 adults with acute sciatica (lumbosacral radicular syndrome) were included. Those with a history of back surgery in the past 3 years or current indications for surgery were excluded. Participants in both groups were treated by their GP according to the Dutch College of General Practitioners’ 1996 clinical guideline for lumbosacral radicular syndrome. The intervention group additionally received advice, education, and exercise therapy from a physiotherapist. Participants in both groups received a maximum of nine individual consultations over a 6-week period. The primary outcome was Global Perceived Effect (GPE), measured on a 7-point scale ranging from 1 = completely recovered to 7 = vastly worsened. Results were dichotomised such that ‘completely recovered’ and ‘much improved’ were categorised as ‘improved’. Secondary outcomes assessed included: back and leg pain severity (11-point numerical rating scale), self-reported disability (0–24 Roland-Morris Disability questionnaire for sciatica), health status (Short-Form 36 and the Euroqol-5D) and fear of movement (Tampa scale for kinesiophobia). Outcomes were measured at 3, 6, 12, and 52 weeks after randomisation. At 12 weeks follow-up, 70% of the intervention group and 62% of the control group reported improvement (absolute risk reduction [ARR] 8%, 95% CI –4 to 20, number needed to treat [NNT] 12.) At 52 weeks follow-up, 79% of the intervention group and 56% of the control group reported improvement (ARR 23%, 95% CI 11 to 35, NNT 4.) The secondary outcomes did not differ between groups significantly. Sub-group analysis indicated that physiotherapy resulted in clinically and statistically significant treatment effects among those with higher disability (Roland-Morris Disability score ≥ 17 at baseline) at both 12 and 52 weeks. This study demonstrates that physiotherapy added to GP care for sciatica results in clinically worthwhile improvements in the long-term, particularly for those who present with more severe disability.