32 Clinical Trials for Various Conditions
The aim of the research is to determine if participants who receive physical therapy (physiotherapy) including soft tissue mobilization, dry needling, Heavy slow load (eccentric-concentric) exercise (with hand weights specific to the biceps muscle) and a comprehensive rotator cuff and scapular stabilization program achieve greater reductions in pain and disability in the short (3-4 weeks) and long term (6 months) compared to those who receive soft tissue mobilization and a comprehensive rotator cuff and scapular stabilization program. Both treatment approaches are within the standard of care for physical therapists, the aim being to determine the most effective treatment approach. Study participants will be recruited form clinicians and flyers within the university/hospital organization where the study is taking place. Participants will be asked to attend 6 physical therapy visits and complete 6 surveys about their pain and disability.
The investigators hypothesize that TrueRelief will result in improved outcomes for patients with shoulder pain compared to those receiving the sham TrueRelief treatment. Also, it is likely that those with fewer medical comorbidities will experience the greatest improvement.
The purpose of this study is to explore the possible effects Kinesio Tape may have on proprioception in individuals with patellar tendonitis. A supportive knee application, a facilitative hip application, and a combination of the two will be applied and compared. Within and between group comparisons will be drawn. Participants will report for two research sessions with 24-36 hours between. Prior to arrival, they will complete a digital Victorian Institute of Sport Assessment for Patellar Tendonitis (VISA-P) and email it to the researcher. Participants must score less than 80 (out of a possible 100) to be considered for this study. If the individual meets the inclusion criteria, he/she will be scheduled for the 1st session. Upon arrival to the first session, informed consent will be obtained, the VISA-P will be reviewed, and intance of patellar tendonitis will be confirmed through palpation. Participants will then completed a Tampa Scale for Kinesiophobia (TSK) to measure fear of movement and a Visual Analog Scale (VAS) to measure overall pain. Height and weight measurments will be taken due to requirements of the Biodex Balance System (BBS), which will be used for balance measurements. Participants will take two, twenty-second practice tests, one with eyes open and one with eyes closed, followed by two minutes rest. Baseline testing will then be completed as follows: the participant will complete two tests with eyes open, and two tests with eyes closed on the injured leg, each with one minute rest between. The participant will then be taped with Kinesio Tape to either the hip, knee, or both the hip and knee according to the random group assignment. They will then rest for 15 minutes and complete a second round of balance testing with the same parameters as baseline testing. Participants will be scheduled for a second day no less that 24 hours and no more than 36 hours for re-test purposes. On the second day of testing, participants will be given $10 for their participation on Day 1. If they want to continue with testing procedures, they will participate in the same balance testing procedures as Day 1. The integrety of the tape application will be confirmed, and second TSK and VAS scale will be administered. A final round of balance testing will be completed, and the participant will receive an additional $10 if they choose to complete both days of testing. This research will allow us to compare results of the TSK, the VAS and the BBS testing both within subject and between group.
The purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection.
This is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. Numerous techniques of biceps tenodesis currently exist and are commonly performed. We will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.
The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.
The overall goal of this proposal is to correlate ultrasound elastography technique with more standard clinically based outcome measures within the setting of a small sample sized group of patients affected by moderate-to- severe, chronic (\>6months) midsubstance Achilles tendinopathy (AT).
This pilot study will evaluate the feasibility of pain-guided activity modification during rehabilitation for patellar tendinopathy. The information provided will be utilized to conduct a larger randomized clinical trial to determine if there is a difference in recovery from patellar tendinopathy during rehabilitation between individuals that use pain-guided activity modification and those that halt all painful activities. Recovery from patellar tendinopathy will be assessed using pain ratings, tendon-specific outcome measures, tendon structure, tendon mechanical properties, and muscle function.
The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.
ZetrOZ's Ultrasonic Diathermy device (sam(R) Professional System) is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and enhance tendon extensibility for individuals with tendinopathy over a 6 week time period.
The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.
The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.
The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff tendinopathy (RCT) is as effective as a single injection of platelet rich plasma (PRP) in reducing the symptoms of RCT.
This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.
Rotator cuff tendinopathy, one of the pathologies identified as part of the cluster of shoulder symptoms known as subacromial pain syndrome, is a common musculoskeletal shoulder condition. Resolution of pain and disability is poor despite treatment, with only about 50% reporting full recovery at 12 - 18 months. Prior studies suggest therapeutic exercise when used alone and with other interventions can have positive outcomes; however, not all patients with rotator cuff tendinopathy respond. Few studies have assessed the effects of exercise for individuals with chronic pain, especially brain driven mechanisms, thought to play a key role. In this study, we will use brain imaging to understand the mechanisms, identify predictors of a positive response to exercise, and the relationship to biomechanical and pain-related factors in patients with RC tendinopathy. The findings from this study will optimize the delivery and treatment response to exercise for individuals with shoulder pain.
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid. Specific Aim 1: Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies. The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid. Specific Aim 1: Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies. The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.
The primary objective of this study is to assess the overall safety and general tolerability of extended release triamcinolone acetate (TA-ER/FX006) in patient with rotator cuff disease. The study will enroll 65 patients, aged 40-75 years old, in a longitudinal case series level IV study using extended release triamcinolone to treat shoulder pain from rotator cuff disease. Inclusion criteria will be shoulder pain without a history of trauma and physical exam consistent with rotator cuff tendinitis, impingement syndrome or rotator cuff tear.
The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. This project will evaluate the efficacy of a novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS).
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
Sixty patients will be identified in the clinic with rotator cuff tendonitis or a low-grade partial-thickness tear of the rotator cuff that are either insulin-dependent or insulin-independent diabetics. Patients will be informed about the current prospective study and written consent will be obtained. Patient information about kidney function, current diabetic medication type, dose and frequency will be obtained in clinic. If there is a diagnosed kidney function abnormality, the patient will be excluded from the study. Patients will be asked about their most recent HbA1C. If HbA1C has not been checked within the past 3 months, the patient will have HbA1C checked in the lab either same day as the injection or the following day. Patients will be randomized into two patient groups: Toradol (Ketorolac) injection group (n=30) and or Steroid injection group (n=30). The randomization will be done using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm. Patients assigned to Toradol group will receive 60mg of Toradol (Ketorolac) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Those assigned to Steroid group will receive 80mg of Kenalog (Triamcinolone Acetonide) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000. Patients will be blinded to the kind of injection they receive, but the physicians who perform the injection will not be blinded for the medical record purposes. The injection will be done under ultrasound guidance to the subacromial space. Continuous blood glucose measurement will be started in an hour within the injection. An instructional session about continuous glucose monitoring will be given to the patients by our research team immediately following the injection. The blood glucose levels will be monitored for 1 week following the injection. The data will be collected on the patient's return to clinic in 2 weeks. Pain score based on a visual analog scale will be obtained prior to injection, 5 min, 3 days, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after injection. Shoulder range of motion, patient satisfaction, QuickDash score, and ASES survey score will be measured in clinic 4, 8, and 12 weeks after injection.
Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only option. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose of this study is to explore the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI.
The purpose of this study is to determine if dry needling both low back and extremity areas is more effective for reducing pain and improving strength, balance and functional performance among patients with chronic musculoskeletal conditions compared to dry needling of extremity areas only.
Shoulder pain is common in persons with spinal cord injury (SCI). It is most often caused by overuse injuries to the muscles and tendons that can occur during wheelchair propulsion, transfers, and other activities of daily living. Normally, shoulder pain resolves with conservative treatments such non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen, naproxen, etc.) and physical therapy. However, when these treatments fail, shoulder surgery may be the only option. Platelet Rich Plasma therapy, or PRP, is a treatment option for non-healing muscle and tendon injuries such as those that cause shoulder pain in persons with SCI. Using one's own blood, cells within the blood called "platelets" are concentrated and then re-injected into the muscle and tendon of the shoulder. These platelets release substances known as "growth factors" that lead to tissue healing. By concentrating the platelets we increase the growth factors up to eight times which will promote the healing of tendons. PRP therapy has shown promise in treating tendon and muscle injuries in able-bodied persons; however, its effectiveness in persons with SCI is unknown. The purpose of this study is to explore the feasibility, safety, and efficacy of PRP therapy for chronic shoulder pain in persons with SCI. The human body has a remarkable ability to heal itself and we hypothesize that re-injecting concentrated platelets will facilitate the natural healing process and will reduce shoulder pain in persons with SCI.
The purpose of this pilot study is to conduct research to determine the most effective physical therapy treatment for a condition called shoulder impingement. This condition occurs when tissue in the shoulder is caught between the humerus (arm bone) and the scapula (shoulder blade). This causes pain when one tries to reach overhead or behind the back. Two treatment methods will be used in the study. The first method uses the traditional treatments of hands-on shoulder stretching, shoulder exercise, posture, and education. The second method will use the traditional methods of shoulder treatment in addition to treatment of the cervical spine. It is hypothesized that a group of patients between 40 and 70 years of age with signs and symptoms of shoulder impingement who receive physical therapy to the cervical spine and shoulder will report a higher level of functioning, will report less pain, and will gain more range of motion than a group of patients receiving physical therapy solely to the shoulder.
The proposed project will be the first to assess pain- and function-dependent, elbow-specific quality of life and in-vivo mechanical properties of common extensor tendons post-treatment with PRP in a Level 1, RCT with subject and assessor blinding. The valuable data gained will significantly add to the knowledge base of treatment effects of PRP for a chronic tendinopathy. Positive findings of PRP compared to control (corticosteroid injection) would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of CLE. Correlating US and shear wave acoustoelastography imaging assessments with validated clinical outcomes will provide a powerful tool for future outcomes analyses using a non-invasive imaging modality to monitor tissue healing both morphologically as well as biomechanically, and may even be used to evaluate injury risk.
The goal of this study is to find an effective treatment for chronic patellar tendinopathy (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes with correlation to a new method of ultrasound (US) imaging assessment called Acoustoelastography (AE). Positive findings of PRP compared to control would suggest future larger scale studies to help establish an optimal protocol for the nonsurgical management of PT.
Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function. We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.
This is a research study to evaluate the outcomes after the study procedure for pain and discomfort in the heel caused from an injury in the Achilles tendon which is located on the back of the foot (commonly called "Achilles tendinitis"-Achilles tendinosis) that has not gotten better with medicine and/or other therapy. Researchers want to see if using the study device changes outcomes for 1 year after the study procedure.