Treatment Trials

84 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
The Comparison of Semiconductor Embedded Therapeutic Arm Sleeves for the Treatment of ECRB Tendinopathy
Description

This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded fabric combined with PRP+ASC injections in the affected area.

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
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.

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.

RECRUITING
Measuring Pain Experience in Individuals With Lateral Elbow Tendinopathy
Description

The study will address the gaps in the pain experience measurement in those with lateral elbow tendinopathy (LET) by building on the current body of literature, as well as applying modern pain science measures. The comprehensive measurement of various biomedical, psychological, and psychosocial constructs will provide pain profiles that will allow for the subclassification of LET to better inform loading prescriptions based on the systemic effects from LET.

RECRUITING
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Description

Osteoarthritis (OA) and inflammatory conditions of the tendons and joints of the shoulder, elbow, hand, and wrist are common yet disabling diseases. Standard management utilizes conservative measures to minimize pain and improve function. Conservative pharmacological management commonly includes corticosteroid and ketorolac injections which have been well investigated as a modality of pain control and improved function in large joint OA. However, fewer studies yielding mixed results on the duration of symptomatic relief exist for arthropathy and tendinopathy of these joints. The goal of this study is to evaluate the efficacy of ketorolac and triamcinolone injections for common shoulder, elbow, wrist, and hand tendinopathy or arthropathy. Participants will be blinded to the treatment received. The duration of an individual participant's participation in this study is 24 weeks. During this time period, patients will be asked to return to the clinic for an in-person follow-up 6 weeks after the injection with either ketorolac or triamcinolone) in order to assess participants' outcomes. All work related to this project will take place at the Emory Sports Medicine Complex, Emory Executive Park, Emory Musculoskeletal Institute, the Emory University Orthopaedic and Spine Hospital, and the Emory Saint Joseph's Hospital. This study will add to existing knowledge by providing further insight into how wrist arthropathy should be most optimally and conservatively managed.

COMPLETED
Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
Description

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.

COMPLETED
Achilles Tendinopathy, Treatment With eXercise Comparing Men and Women
Description

This study will evaluate if there is a difference in recovery of tendon structure and mechanical properties between males and females with Achilles tendinopathy receiving exercise treatment. It will evaluate recovery of tendinopathy with exercise intervention using outcome measures for tendon structure and mechanical properties along with validated measures of muscle-tendon function and symptoms.

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
The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy
Description

The purpose of this study is to determine differences in lower extremity landing biomechanics and real-world physical activity between individuals with patellar tendinopathy compared to individuals without patellar tendinopathy,and to determine the acute effects of an isometric loading intervention on lower extremity landing biomechanics in individuals with patellar tendinopathy.

Conditions
TERMINATED
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
Description

Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking. Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair. Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes. However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear. In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.

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.

WITHDRAWN
A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
Description

Patellar tendinopathy is one of the most frequent causes of non-traumatic knee pain and reduced function in patients. Standard treatment options for patellar tendinopathies include non-steroidal anti-inflammatory drugs, corticosteroids, cryotherapy, manual therapy, eccentric exercises, and ultrasound. Unfortunately many patients fail to respond to these therapies and return to normal activity levels, and recurrence rates for those who do respond are unacceptably high. Many patients who fail to respond display persistent degenerative changes on imaging studies suggesting a failure to regenerate the pathological tissue. Developing new therapies that can directly promote the synthesis of new, healthy extracellular matrix tissue could therefore address an important therapeutic need and make a substantial improvement in our ability to effectively treat patellar tendinopathy and reduce recurrence rates. Somatropin (human growth hormone of recombinant DNA origin) has been shown to increase protein synthesis and matrix production when delivered directly into the tendon. This study will evaluate the ability of somatropin to improve clinical outcomes and tissue quality in patients with chronic tendinopathy.

Conditions
COMPLETED
A Pilot Study: Treatment of Achilles Tendinopathy With Platelet-Rich Plasma Therapy
Description

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).

COMPLETED
Platelet-Rich Plasma (PRP) Injection for the Treatment of Chronic Patellar Tendinopathy
Description

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.

NOT_YET_RECRUITING
RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
Description

The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit.

COMPLETED
Effects Compressive Tissue Flossing on Lateral Elbow Tendinopathy in US Service Members
Description

The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Dependent variables will be the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements.

RECRUITING
AM for Refractory Achilles Tendinopathy
Description

To evaluate outcomes after use of micronized amniotic membrane to replace or supplement damaged or inadequate integumental tissue in patients with "chronic" insertional or non-insertional Achilles tendinopathy that remains refractory to standard care. Outcomes between a control and treatment group in this pilot study will be used to devise a multi-center study with larger sample size.

SUSPENDED
Embody Insertional Achilles Tendinopathy
Description

The primary objective of this study is to evaluate the long-term effects on ankle/Achilles tendon pain after repair of insertional Achilles tendinopathy (IAT) augmented with TAPESTRY Biointegrative Implant.

RECRUITING
Diagnostic POCUS of Patellar Tendinopathy in Female Athletes
Description

Purpose: The purpose of this study is to determine the clinical effectiveness of point-of-care diagnostic ultrasound in the assessment of patellar tendon pathologies

TERMINATED
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
Description

The purpose of the present study is to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in participants with moderate to severe rotator cuff tendinopathy (RCT), using a randomized, double-blind, placebo controlled, parallel group design to minimize bias.

COMPLETED
Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy
Description

The goal of this clinical trial is to learn more about and compare the effectiveness of standard of care (SOC) physical therapy (PT), PT with photobiomodulation therapy (PBMT; low-level laser therapy), PT with shockwave therapy (SWT; high-energy acoustic wave therapy), and PT with PBMT and SWT, to improve function, decrease pain, and resolve symptoms in individuals with non-insertional Achilles tendinopathy. The main question it aims to answer is: • What is the most effective treatment method for non-insertional Achilles tendinopathy? Participants will Researchers will compare PT, PT + SWT, PT + SWT and PBMT to assess the most effective treatment for Achilles tendinopathy.

TERMINATED
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
Description

The purpose of the present study is to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in participants with moderate to severe rotator cuff tendinopathy (RCT), using a randomized, double-blind, placebo controlled, parallel group design to minimize bias.

RECRUITING
A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy
Description

The purpose of this study is to measure local and systemic safety and tolerability as well as improvement of Achilles tendon mechanical properties after a single peritendon injection of NGI226 MP in comparison to placebo MP in patients with mid-portion Achilles tendinopathy.

RECRUITING
Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms
Description

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.

ACTIVE_NOT_RECRUITING
Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
Description

This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.

ACTIVE_NOT_RECRUITING
Doxycycline for Elbow Tendinopathy
Description

To evaluate the feasibility of subantimicrobial -dose (SD) doxycycline to improve outcomes of nonsurgical management of elbow tendinopathy via matrix metalloproteinase (MMP) inhibition as well as evaluate if participants will be compliant to with prescribed medication and exercise treatment. Our working hypothesis is that patients with elbow tendinopathy will be receptive to treatment with SD-doxycycline and compliant with the prescribed treatment.

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.

WITHDRAWN
Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy
Description

This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy.

COMPLETED
Tendinopathy Education on the Achilles
Description

This is a randomized double-blind, placebo-controlled trial with individuals who have chronic Achilles tendinopathy (AT). This study investigates the effects of education on outcomes (specified in hypotheses below) related to participation in an exercise program. Participants will be randomized to one of two educational programs. All participants will receive the same exercise intervention. This study will consent and randomize 66 participants, who will complete 2 in-person evaluation sessions (baseline, 8-week follow-up), 8 treatment sessions with a physical therapist (between baseline and 8-week follow-up), and 1 online evaluation sessions (12-week follow-up). We hypothesize that 1) a biopsychosocial approach to education will decrease pain (NPRS) and disability (PROMIS physical function) more than the standard of care for patients with AT, 2) exercise will improve all three pain mechanisms examined in this RCT (increased PPT, decreased kinesiophobia, increased number of heel raises).