Treatment Trials

13 Clinical Trials for Various Conditions

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RECRUITING
Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
Description

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.

COMPLETED
Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy
Description

This is a single-center, prospective, randomised, controlled study, with two parallel groups, designed to assess the clinical impact of a digital exercise program against conventional rehabilitation for shoulder tendonitis. The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain at least the same outcomes than the ones attained by the conventional PT group.

RECRUITING
Connective Tissue Matrix Compared to Steroid Injections for Rotator Cuff Tendinopathy
Description

The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix boost (CTM) or a steroid shot. Patients will be randomized (like flipping a coin) to the treatment. Patients and researchers will be blinded (not know) what group the patients are in. Patients will come back to the study clinic at 6 weeks, 3 months and 6 months after the shot to answer questionnaires, have a physical exam, and complete physical function tests to check their shoulder.

RECRUITING
Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients
Description

Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.

Conditions
RECRUITING
Connective Tissue Matrix for Rotator Cuff Tendinopathy
Description

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.

UNKNOWN
Ultrasound-Guided Treatments for Shoulder Pain in Wheelchair Users With Spinal Cord Injury
Description

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. Corticosteroid injections are another alternative to provide temporary relief, but can over time accelerate degeneration of the tendon and lead to further damage. 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 efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI compared with the standard-of-care, corticosteroid injection.

COMPLETED
Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy
Description

This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without systemic inflammatory disease.

Conditions
COMPLETED
Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
Description

The purpose of this study is to examine deficits in activation and motor patterns, as well as central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients with rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle activation between patients with rotator cuff tendinopathy and healthy controls.

ACTIVE_NOT_RECRUITING
Natural History of Shoulder Pathology in Manual Wheelchair Users
Description

Over 300,000 people in the United States have spinal cord injuries and many use manual wheelchairs for mobility. Most manual wheelchair users will develop shoulder injuries and pain that greatly affect quality of life and level of independence. Understanding when shoulder disease starts in manual wheelchair users and which daily activities contribute to the disease will provide necessary evidence for effective primary prevention methods to inhibit the development of further disability. Our central hypothesis is that the development of shoulder disease in manual wheelchair users will be strongly associated with the cumulative exposure to elevated shoulder postures combined with high upper body loading.

RECRUITING
BFRT for Subacromial Pain
Description

The goal of this pilot clinical trial is to learn if blood flow restriction training is safe and feasible in patients with subacromial pain. The main questions the investigators aim to answer are: * What problems do participants with shoulder pain encounter when training with blood flow restriction? * Is it feasible to apply blood flow restriction training as part of a physical therapy intervention? * What are some preliminary effects of blood flow restriction training on the recovery of shoulder function and strength? The investigators will compare active blood flow restriction training to sham (an inactive procedure designed to mimic the active training as closely as possible). Participants will: * Visit the clinic for physical therapy visits and exercise with blood flow restriction training for up to 8 weeks * Visit the clinic for tests before starting the treatment, during the treatment (4 weeks), and after the end of the treatment (8 and 26 weeks).

Conditions
COMPLETED
Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis
Description

Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a person's ability to perform daily activities and recreation. Traditional conservative treatments include activity modification, exercises, ice/heat, and medications and corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which the affected area is repetitively needled to disrupt pathological tissue and induce bleeding. This turns a nonhealing chronic injury into an acute injury with enhanced healing capability. Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are injected into the affected area, also activating growth factors. There has been promising research in these tendinopathy treatments but more research is needed. The investigators plan to expand on prior studies to identify a reproducible and efficacious treatment for chronic tendinopathy to reduce pain and improve function and quality of life. Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT with peritendinous PRP as a treatment for chronic tendinopathy.

TERMINATED
Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions
Description

This aims of this study are: 1. To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months. 2. To determine if there is a significantly different side effect profile between particulate and non-particulate corticosteroids when used for hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa injections.

COMPLETED
Dry Needling for Sub Acromial Pain Syndrome
Description

This trial will investigate the benefit of trigger point dry needling (DN) for individuals with a common cause of shoulder pain - sub-acromial pain syndrome. Sub-acromial pain syndrome, also knowns as SAPS, is one of the most common causes of shoulder pain. Physical therapy treatments are routinely used for treating SAPS. One treatment approach that has been shown to be beneficial is a combination of exercises and manual or manipulative therapy. This approach has been shown to reduce pain and improve overall shoulder function in individuals with SAPS. Recently, a novel treatment approach for SAPS has emerged that involves trigger point DN to muscles of the shoulder and ribcage. Some studies have shown promising results for this approach while others have not found it to be helpful. Overall there is currently little research available on the benefit of trigger point DN for individuals with SAPS. This study will investigate whether adding trigger point DN to a treatment program of exercise and manual therapy provides any benefit to individuals with SAPS. To answer this question, this study will divide subjects into three groups. One group will receive just exercise and manual therapy; one group will receive manual therapy and exercise plus trigger point DN and one group will receive manual therapy and exercise plus a sham trigger point DN treatment. All patients receiving treatment in the study will attend 10 visits to a physical therapy clinic over a 6-week period. Subjects in the dry needling and sham dry needling groups will receive 6 sessions of this treatment in addition to their 10 sessions of exercise and manual therapy. The investigators will assess the effectiveness of the three treatment protocols by measuring patients pain, shoulder function and disability levels. These outcomes will be assessed at baseline, six weeks, 6 months and one year from enrolling in the study. In addition to assessing clinical outcomes following treatment, the investigators will assess the amount of health care utilized by each participant in the year following enrollment in the study. The 3 groups will be analyzed to determine if there is a difference in the amount or type of additional healthcare utilized in the year following study enrollment. Examples of healthcare utilization include x-rays, medication and/or surgical procedures. The investigators hypothesis is that individuals that receive actual trigger point DN in addition to manual therapy and exercise interventions will demonstrate greater improvements in pain, shoulder function and disability when compared to individuals receiving exercise and manual therapy alone or exercise and manual therapy with sham needling. The investigators think these differences in clinical outcomes will be present at each of the follow-up points. Additionally, the investigators hypothesize that individuals receiving actual DN will use less healthcare than those in the other two groups.