Specific and shared mechanisms associated with treatment for chronic neck pain: study protocol for the SS-MECH trial.

BACKGROUND: Treatment mechanisms involve the steps or processes through which an intervention unfolds and produces change in an outcome variable. Treatment mechanisms can be specific to the intervention provided (i.e. pain modulation) or shared with other treatments (i.e. reduced fear of movement). Whether specific and shared treatment mechanisms are different across interventions and whether they lead to the outcomes seen in trials is largely unknown. The management of individuals with chronic neck pain routinely include manual therapy (MT) and resistance exercise (RE), as both approaches are included in clinical practice guidelines and both yield similar outcomes. OBJECTIVES: Our study plans to answer two research questions: 1) what are the specific mechanisms associated with MT versus interventions (and are these different), and 2) what are the shared mechanisms associated with these interventions, and do specific or shared mechanisms mediate clinical outcomes? METHODS: This study will involve a 2-group parallel (1:1) single-blinded randomized trial to compare the specific and potential shared treatment mechanisms between these two approaches. We will enroll individuals with a history of chronic neck pain and evaluate whether specific or shared mechanisms mediate clinical outcomes. RESULTS: We hypothesize that MT and RE approaches will both exhibit different specific treatment mechanisms, and that both approaches will exhibit shared treatment mechanisms, which will notably influence outcomes at both discharge and 6-months. CONCLUSIONS: This study is important because it will help identify what specific or shared treatment mechanisms are associated with different interventions and, how different treatment mechanisms influence clinical outcomes.

The effectiveness of spinal manipulative therapy procedures for spine pain: protocol for a systematic review and network meta-analysis.

BACKGROUND: Spinal manipulative therapy (SMT) is a guideline-recommended treatment option for spinal pain. The recommendation is based on multiple systematic reviews. However, these reviews fail to consider that clinical effects may depend on SMT "application procedures" (i.e., how and where SMT is applied). Using network meta-analyses, we aim to investigate which SMT "application procedures" have the greatest magnitude of clinical effectiveness for reducing pain and disability, for any spinal complaint, at short-term and long-term follow-up. We will compare application procedural parameters by classifying the thrust application technique and the application site (patient positioning, assisted, vertebral target, region target, Technique name, forces, and vectors, application site selection approach and rationale) against: 1. Waiting list/no treatment; 2. Sham interventions not resembling SMT (e.g., detuned ultrasound); 3. Sham interventions resembling SMT; 4. Other therapies not recommended in clinical practice guidelines; and 5. Other therapies recommended in clinical practice guidelines. Secondly, we will examine how contextual elements, including procedural fidelity (whether the SMT was delivered as planned) and clinical applicability (whether the SMT is similar to clinical practice) of the SMT. METHODS: We will include randomized controlled trials (RCT) found through three search strategies, (i) exploratory, (ii) systematic, and (iii) other known sources. We define SMT as a high-velocity low-amplitude thrust or grade V mobilization. Eligibility is any RCT assessing SMT against any other type of SMT, any other active or sham intervention, or no treatment control on adult patients with pain in any spinal region. The RCTs must report on continuous pain intensity and/or disability outcomes. Two authors will independently review title and abstract screening, full-text screening, and data extraction. Spinal manipulative therapy techniques will be classified according to the technique application and choice of application sites. We will conduct a network-meta analysis using a frequentist approach and multiple subgroup and sensitivity analyses. DISCUSSION: This will be the most extensive review of thrust SMT to date, and will allow us to estimate the importance of different SMT application procedures used in clinical practice and taught across educational settings. Thus, the results are applicable to clinical practice, educational settings, and research studies. PROSPERO registration: CRD42022375836.

Protocol for the development of a 'trustworthy' living systematic review and meta analyses of manual therapy interventions to treat neuromusculoskeletal impairments.

BACKGROUND: Preprocessed research resources are believed to be highly 'trustworthy' when translating research to clinical practice. However, the overall 'trustworthiness' is unknown if this evidence contains randomized clinical trials (RCTs) where prospective has not been/cannot be verified, has low confidence in estimated effects, and if they are not up to date. OBJECTIVES: This protocol will be used to create a baseline benchmark for a series of trustworthy living systematic reviews (SRs) regarding manual therapy interventions. METHODS: Data will originate from RCTs related to manual therapy neuromusculoskeletal interventions, indexed in 6 search engines in English from 1 January 2010, to the present. Two blinded reviewers will identify the RCTs and extract data using Covidence. The data will be synthesized based on consensus and analyzed using the Cochrane collaboration's Review Manager. EXPECTED OUTCOMES: It is expected that there will be a shortage of RCTs with at least a moderate confidence in estimated effects that will allow for strong practice recommendations. DISCUSSION: Identifying evidence that can be translated into strong practice recommendations is essential to identify beneficial and harmful interventions, decrease practice variability, and identify neuromusculoskeletal manual therapy interventions that require further disciplined methodological focus.

Do Short-Term Effects Predict Long-Term Improvements in Women Who Receive Manual Therapy or Surgery for Carpal Tunnel Syndrome? A Bayesian Network Analysis of a Randomized Clinical Trial.

OBJECTIVE: The purpose of this study was to develop a data-driven Bayesian network approach to understand the potential multivariate pathways of the effect of manual physical therapy in women with carpal tunnel syndrome (CTS). METHODS: Data from a randomized clinical trial (n = 104) were analyzed comparing manual therapy including desensitization maneuvers of the central nervous system versus surgery in women with CTS. All variables included in the original trial were included in a Bayesian network to explore its multivariate relationship. The model was used to quantify the direct and indirect pathways of the effect of physical therapy and surgery on short-term, mid-term, and long-term changes in the clinical variables of pain, related function, and symptom severity. RESULTS: Manual physical therapy improved function in women with CTS (between-groups difference: 0.09; 95% CI = 0.07 to 0.11). The Bayesian network showed that early improvements (at 1 month) in function and symptom severity led to long-term (at 12 months) changes in related disability both directly and via complex pathways involving baseline pain intensity and depression levels. Additionally, women with moderate CTS had 0.14-point (95% CI = 0.11 to 0.17 point) poorer function at 12 months than those with mild CTS and 0.12-point (95% CI = 0.09 to 0.15 point) poorer function at 12 months than those with severe CTS. CONCLUSION: Current findings suggest that short-term benefits in function and symptom severity observed after manual therapy/surgery were associated with long-term improvements in function, but mechanisms driving these effects interact with depression levels and severity as assessed using electromyography. Nevertheless, it should be noted that between-group differences depending on severity determined using electromyography were small, and the clinical relevance is elusive. Further data-driven analyses involving a broad range of biopsychosocial variables are recommended to fully understand the pathways underpinning CTS treatment effects. IMPACT: Short-term effects of physical manual therapy seem to be clinically relevant for obtaining long-term effects in women with CTS.

Manual Therapy in Preadolescent Children: A Delphi Investigation of Physical Therapists in the United States.

OBJECTIVE: Limited research has investigated the use of manual therapy to treat the preadolescent (0-12 years of age) population with musculoskeletal and neurological impairments. The purpose of this study was to identify the following among physical therapists holding advanced credentials in pediatrics, neurodevelopmental treatment, or manual therapy: (1) consensus regarding effective techniques in the preadolescent population, (2) differences in opinion, and (3) perceived decision-making barriers and factors regarding use of manual therapy techniques. METHODS: Credentialed physical therapists in the United States were recruited for a 3-round Delphi investigation. An electronic survey in Round 1 identified musculoskeletal and neurological impairments and the manual techniques considered effective to treat such conditions, in addition to factors and barriers. Responses were used to create the second round, during which a 4-point Likert scale was used to score each survey item. A third round of scoring established consensus. Descriptive statistics and composite scores were calculated for each manual technique by impairment. Between-group differences were calculated using the Mann-Whitney U test with Bonferroni correction. RESULTS: Consensus was determined for several concepts. First, neuromuscular techniques were considered effective across all impairments, and joint mobilizations (grades I-IV) were believed to be effective to treat joint and muscle and myofascial impairments. Second, visceral manipulation and craniosacral therapy were considered ineffective in treating most impairments. There was lack of consensus and clear differences of opinion regarding the use of grade V mobilizations and dry needling. Significant barriers to use of manual therapy were: lack of knowledge, lack of evidence, and fear of litigation and harming patients. CONCLUSION: This study is an initial step for developing manual therapy guidelines, research, and educational opportunities regarding manual therapy in pediatric physical therapy.

Factors associated with cervical arterial dysfunction: a survey of physical therapist educators in the United States.

Objectives: The purpose of this study was to identify the key constructs associated with symptom description and behavior, natural history of complaints, and previous medical history of cervical arterial dysfunction (CAD) according to a panel of physical therapist (PT) educators. Methods: An electronic survey was conducted of licensed PT educators currently involved in musculoskeletal physical therapy education within a credentialed program. Survey prompts queried educators to list the subjective and objective items associated with CAD, in open-text format. Responses were coded to identify unique themes (constructs). Principal axis factor analysis with Varimax rotation was performed to identify underlying constructs associated with CAD according to the panel of educators. Results: Seventy-two educators completed the survey (24.2% response rate) resulting in 50 identified unique items through thematic coding. Factor analysis (Kaiser-Meyer-Olkin measure of sampling adequacy = .679, Bartlett's test of sphericity (x2(351) = 1129.06. p < .001), resulted in a four-factor solution: '5Ds and 3 Ns,' 'Other Neurological Findings,' 'Signs & Symptoms in Rotation and/or Extension,' and 'General Health.' Discussion: According to the PT educators in this study, the factors associated with CAD appear to reflect the IFOMPT guidelines. The responses and subsequent factor analysis demonstrate the lack of any one clinical finding for the identification of CAD in a patient with neck pain. Level of Evidence: V.

Manual Therapy Cures Death: I Think I Read That Somewhere.

Predatory journals are compromising the scientific credibility of "published" research. Past concerns with predatory journals have included the lack of a peer-review process, lack of an editorial board, and little to no description of the publication's ethical standards. In this editorial, we describe the ease with which bogus information can be published in predatory journals, and outline 3 risks to credible science associated with published information and downstream referencing, which may occur through source amnesia bias. J Orthop Sports Phys Ther 2018;48(11):830-832. doi:10.2519/jospt.2018.0107.

Variables Describing Individuals With Improved Pain and Function With a Primary Complaint of Low Back Pain: A Secondary Analysis.

OBJECTIVES: The purpose of this study was to identify descriptive factors in individuals with a primary complaint of low back pain (LBP) associated with improved pain and function after receiving physical therapy for LBP with or without manual therapy and exercise directed at the femoroacetabular joints. METHODS: Participants were enrolled in a randomized clinical trial investigating physical therapy interventions for their LBP, with or without interventions directed at the femoroacetabular joints (hips). A participant was deemed recovered if all of the following were met: Numeric Pain Rating Scale (NPRS) score of ≤2 points, ≤10% on the modified Oswestry Disability Index at discharge, and a global rating of change score of +4 at both 2 weeks and discharge. Logistic regression modelling determined descriptor variables that best predicted treatment recovery. RESULTS: Data from 90 participants were included in the analysis, with 44% (n = 40) achieving recovery by discharge from physical therapy (average 7.95 [±4.68]) visits. The variables of concurrent hip problems, lower body mass index ≤25.4, an irritable condition, and a baseline NPRS score of 4 points or less were retained in the final model (R2 = .384). Having a concurrent hip problem had the highest odds of achieving recovery in the model (odds ratio: 5.34, 95 % confidence interval: 1.31-21.8). CONCLUSIONS: The findings for the patients in this study suggest that those with a concurrent hip problem, a lower body mass index, irritable symptoms, and a baseline NPRS score of 4 points or less were associated with greater odds of achieving recovery with multimodal physical therapy interventions. Further research should continue to investigate the interplay between the lumbar spine and hip joints.

Thrust and nonthrust manipulation for older adults with low back pain: an evaluation of pain and disability.

OBJECTIVE: The purpose of the study was to compare the effects of thrust manipulation (TM) and non-TM (NTM) on a sample of older subjects with low back pain. METHODS: This is a secondary data analysis of a randomized control trial. Forty-nine subjects aged 55 to 88 years participated in the trial, who received either a TM or NTM on at least 2 occasions during the course of care, and were extracted from the larger data set. The treatment program included a standardized home exercise program for the first 2 sessions, which could be modified by the therapist after those 2 sessions. Numeric pain rating scale and Oswestry Disability Index (ODI) were the outcomes for this study. RESULTS: Multivariate analysis revealed no significant between-group differences for treatment group (P=.99) without group×time interaction (P=.90). Significant within-group changes were observed for both groups for ODI and numeric pain rating scale (P<.001); the average self-report of recovery was 78.0% (SD, 19.8%). Age stratification of the older subset revealed between-group differences in ODI change scores for the oldest subjects (>70 years) compared with 60 to 69 years (P=.02). CONCLUSIONS: This study showed that outcomes for both TM and NTM improved in older adults with low back pain.

Clinical tests for screening and diagnosis of cervical spine myelopathy: a systematic review.

OBJECTIVE: The purpose of this review was to investigate the diagnostic accuracy for screening and confirmation of clinical tests for cervical spine myelopathy (CSM) and to investigate the quality of the studies that have investigated these values. METHODS: This study was a systematic review that used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Search terms for PubMed included myelopathy; diagnosis, differential; sensitivity and specificity; and physical examination. Search terms for Cumulative Index to Nursing and Allied Health Literature were limited to myelopathy and sensitivity and specificity. Qualitative assessment included report of diagnostic accuracy metrics (sensitivity, specificity, and positive and negative likelihood ratios) and quality scores using the Quality Assessment of Diagnostic Accuracy Studies tool. Scores were created for single tests and clustered test findings. RESULTS: After evaluation, 12 full-text articles were selected, scored, and tabulated. Nearly all of the 18 tests demonstrated high levels of specificity and low levels of sensitivity, suggesting that they are poor screening tools. Only one study was scored as high quality. One study involved clustering of test findings but was considered low quality. CONCLUSION: Nearly all of the clinical tests for CSM seem to be poor screening tools, which implies that manually oriented clinicians may perform treatment methods in a situation of doubt or uncertainly. More high-quality studies are needed, and manual therapists need to be cognizant that the current clinical tests for CSM lack strong diagnostic accuracy measures that are necessary for clinical decision making.

Factor structure and concurrent/convergent validity of the modified somatic perception questionnaire and pain beliefs instrument.

OBJECTIVE: Our goal was to create a parsimonious combination of the Modified Somatic Perception Questionnaire (MSPQ) and the Pain Beliefs Screening Instrument (PBSI) through factorial structural analysis and to investigate the associations of the new scale (if unique) to disability, health condition, and quality of life report in patients with neck and low back pain scheduled for spine fusion surgery. METHODS: Factor analysis was used to refine all items within the 2 scales to 4 distinct factors: (1) somatic complaints of the head/neck, (2) somatic complaints of the gastrointestinal symptom, (3) pain beliefs and fear, and (4) self perception of serious problems. Each factor was assessed for concurrent validity with other well-established tools including the Deyo comorbidity index, the Short Form (SF)-36 mental and physical component subscales, and the Oswestry and Neck Disability Indices (ODI/NDI). RESULTS: The PBSI was fairly to moderately correlated with assessment tools of quality of life (SF-36) and disability assessment (ODI/NDI). Some of the items in the factor 1 from the MSPQ were slightly associated with the Deyo comorbidity index but not with the ODI/NDI. CONCLUSIONS: The items from the MSPQ failed to associate with measures of quality of life and disability and thus may provide only marginal value when assessing the multidimensional aspects associated with neck and low back pain. The PBSI has moderate correlation with disability assessments. Neither tool was found to strongly correlate with disability measures or with SF-36 scales (mental and physical component subscales). Additional tools may be needed to further identify the dimensions associated with chronic pain patients.

Effects of spinal manipulation on trunk proprioception in subjects with chronic low back pain during symptom remission.

OBJECTIVE: The purpose of this study was to examine the immediate effects of spinal manipulative therapy (SMT) on trunk proprioception in subjects with asymptomatic chronic low back pain (CLBP) and determine if those effects lasted 1 week. METHODS: This unbalanced randomized controlled crossover design examined 33 subjects with CLBP. Proprioception was tested via joint position sense, threshold to detect passive motion (TTDPM), direction of motion (DM), and force reproduction. Each subject received lumbar manipulation or a sham procedure followed by proprioception retest. This procedure was repeated 1 week later using the opposing treatment. Subjects receiving SMT in the second session returned a third time receiving the sham procedure again. RESULTS: Spinal manipulative therapy produced an effect for TTDPM in the manipulation first group (P = .008), the sham procedure produced an effect for joint position sense in the sham first group (P = .005). Spinal manipulative therapy had a 1-week effect for the manipulation first group (P = .006). No effect was noted for either DM or force reproduction. CONCLUSIONS: Results suggest SMT had minimal immediate effect on trunk proprioception. The effects noted occurred in session 1, implicating learning as a potential source. Learning, from repetitive proprioception training, may enhance neuromuscular control in subjects with CLBP before the use of therapeutic exercise. Subjects showed smaller deficits than previously reported for TTDPM or DM, suggesting proprioception deficits may correlate with pain level.

Dimensionality, internal consistency, and item analysis of the National Health and Nutrition Examination Surveys activities of daily living instrument among patients with report of low back pain.

OBJECTIVE: To measure selected psychometric properties of individual item responses from the National Health and Nutrition Examination Surveys (NHANES) activities of daily living (ADL) instrument among a population of patients with low back pain (LBP). METHODS: The study group consisted of 926 individual attendees of a traditional medical appointment. All subjects had self-reported LBP and completed questions within the NHANES ADL instrument, a 16-item questionnaire designed to represent the internal latent construct of ADL. Data analyses included exploratory factor analysis, internal consistency measures, and polytomous (graded) item response theory. RESULTS: The NHANES ADL instrument is a unidimensional and internally consistent measure of ADL. Graded item response theory analyses indicated that although some variability exists, all 16 single items were sensitive measures of the latent construct of ADL. Most item responses demonstrated high discrimination. CONCLUSION: Individual use of selected items of the NHANES ADL instrument may further improve the capacity of the health care provider in measuring and recording dysfunction associated with LBP.