Musculoskeletal Pain Clinical Trials

The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth. Participation includes: quantitative sensory testing blood draw sleep assessment questionnaires Read Less

Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative treatment modality. Additionally, this modality may have reparative or regenerative potential, which could lead to the first treatment for osteoarthritis that treats the underlying disease as opposed to symptomatic control. Additionally, there are no acceptable non-surgical treatments for focal chondral defects of the knee. Surgical treatments that do exist have diminished outcomes if performed on patients older than age 30-40 years. If successful, intra-articular MSC injections into the knee would represent the first non-operative treatment for focal chondral defects and also represent a potential option for treatment in patients over the age of 30-40 years. This trial will be a prospective, single-center phase I pilot study to evaluate the safety and tolerability of a single intra-articular injection of autologous bone marrow-derived MSCs in 16 subjects, 8 who have knee osteoarthritis and 8 who have a focal chondral defect in the knee. Patients will undergo a bone marrow harvest procedure at the Dahms Clinical Research Unit (DCRU) of University Hospitals Cleveland Medical Center. MSCs will be isolated and expanded. After approximately 2-3 weeks, patients will return for an intra-articular injection of 50x106 MSCs Subsequent study visits will occur on post-injection day 7 and months 2, 6, 12, and 24. Safety of intra-articular injection of MSCs will be evaluated at study visits by interval history, physical examination and assessment of any adverse events that are observed/reported. Additionally, efficacy will be evaluated by having patients complete functional outcome measures including: Visual Analog Score (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Form, and Lysholm Knee Scale. These will be completed at the pre-treatment visit and then repeated at the 2, 6, 12, and 24-month follow-up visits. Lastly, T1 rho and T2 mapping on magnetic resonance imaging (MRI) will be used to assess for improved cartilage quality after intra-articular injection of MSCs. An MRI will be obtained at the pre-treatment visit. At the 12 and 24 month follow up visit, additional MRIs will be obtained and analyzed to compare the pre-treatment MRI to post-treatment MRIs. Read Less

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are: Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain? What are predictors of recovery from chronic pain? What brain systems are associated with the spread of pain? For this study participants will undergo: Functional Magnetic Resonance Imaging (fMRI) Quantitative Sensory Testing Psychological Assessments Read Less

Nearly 2 out of 10 women will sustain a distal forearm fracture throughout their lifespan.Recent longitudinal studies illustrate that as many as 1/3 of all persons who undergo closed reduction and casting for distal radius fractures (DRF) go on to develop type 1 complex regional pain syndrome (CRPS). Graded motor imagery (i.e., motor imagery and mirror therapy), a movement representation technique, is strongly supported in the literature as a treatment of CRPS and has recently been suggested as a potential strategy to prevent its onset. Other complications include disability, wrist/forearm tightness and sensorimotor changes. The investigators propose that an early intervention protocol which includes graded motor imagery (GMI) will improve the pain, functional and upper limb sensorimotor outcomes of persons following closed reduction and casting of DRF relative to a standard of care intervention. Read Less

To identify biological and phenotypic prognostic markers of recovery vs. persistence of pain and functional disability in adolescents with chronic musculoskeletal pain. Read Less

The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms. Read Less

The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise. Read Less

The purpose of this pilot study is to examine the feasibility and preliminary efficacy of Empowered Relief for Youth with chronic pain (ER-Y). ER-Y is a single-session pain management class for youth focused on pain science education and teaching self-regulatory skills for pain management based on the evidence-based adult ER class. Feasibility and acceptability of ER-Y will be assessed post-class. Preliminary efficacy will be assessed by administering surveys at baseline, 4-weeks, 8-weeks, and 12-weeks post class. Read Less

Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only. Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care. Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will include validated self-report measures that will take place at pre-treatment (baseline), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics. Read Less

This is a pilot study designed to evaluate the effectiveness of TENS as part of post-operative pain management. Subjects receiving a TENS unit as part of clinical practice will be approached for consent and followed for 12 months. Read Less

The proposed study will test the feasibility and acceptability of an 8-week home-based reciprocal peer support pain self-management intervention (CONNECT) for women Veterans with chronic musculoskeletal pain. The use of this format will improve the accessibility of treatment to women Veterans who experience logistical, healthcare delivery and psychosocial barriers to care. To address these barriers women Veterans who enroll in CONNECT will be paired and work together to learn/practice pain coping skills, set meaningful activity goals, and participate in a graduated walking program; they will exchange nightly text messages and engage in a weekly 20 minute phone call to reinforce each other and provide support for pain self-management efforts. This is a single-arm pilot project; all eligible and interested women with chronic musculoskeletal pain will receive CONNECT. The primary outcome will be post-treatment and long-term follow-up retention rates. Read Less

This project proposes to understand the sources of pain variability, and demonstrate that pain variability represents fluctuation in natural pain management. The project further proposes to determine if endogenous capacity to modulate pain can be trained to maximize their body's ability to manage pain, much as the way in which athletic performance can be trained. Read Less