Treatment Trials

30 Clinical Trials for Various Conditions

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COMPLETED
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
Description

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist. The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.

TERMINATED
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
Description

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee

COMPLETED
Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
Description

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee.

WITHDRAWN
TrueRelief Efficacy for Supraspinatus Tendonitis
Description

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.

COMPLETED
A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis
Description

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.

TERMINATED
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection
Description

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.

COMPLETED
Micronized dHACM Injectable for the Treatment of Achille Tendonitis
Description

Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis

COMPLETED
MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder
Description

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder.

COMPLETED
Chronic Insertional Achilles Tendonitis Treated With or Without Flexor Hallucis Longus Tendon Transfer
Description

The purpose of this study is to determine whether Achilles tendon debridement and decompression augmented with flexor hallucis longus (FHL) tendon transfer results in improved clinical and functional outcome as measured by ankle plantar flexion strength and American Orthopedic Foot and Ankle Society (AOFAS) score compared to debridement and decompression alone in patients over 50 years of age with chronic insertional Achilles tendinosis. H0: There will be no difference in ankle plantar flexion strength measured using a handheld dynamometer between patients randomized to achilles tendon decompression and debridement alone (Group 1) and patients randomized to achilles tendon decompression and debridement augmented with FHL transfer (Group 2). HA: Patients randomized to achilles tendon decompression and debridement alone (Group 1) will have less ankle plantar flexion strength compared to patients randomized to achilles tendon decompression and debridement augmented with FHL transfer (Group 2).

COMPLETED
A Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee
Description

Open-label study to be conducted at 2 US investigational sites in subjects who have acute tendonitis or bursitis of the shoulder, elbow, or knee. Eligible subjects receive treatment with the KTP, applied once daily at the same application site for 3 consecutive days.

COMPLETED
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Description

A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.

Conditions
COMPLETED
Accuracy of Needle Placement Into The Subacromial Space of The Shoulder
Description

This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. It has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.

COMPLETED
Work and Health Disparities Among Rural Women
Description

This is a study of the effects of fast paced assembly line work on women. We are studying problems women in poultry processing have with their muscles, tendons, and nerves as well as acute injuries they have in the workplace. We are also studying how their work affects the quality of their lives.

COMPLETED
Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery
Description

The standard practice for arthroscopic shoulder surgery at our institution is a general anesthetic with a long-acting interscalene block for post-operative pain control, which can reduce the amount of opiates needed after surgery. The interscalene block is effective in providing analgesia to the majority of the shoulder joint and has been shown to reduce post-operative pain scores after arthroscopic shoulder surgeries. However, there is a subset of arthroscopic shoulder surgery patients who have pain in the axilla even in the setting of a functioning interscalene brachial plexus nerve block. One of our surgeons has reported a high incidence of axillary pain in patients who undergo a sub-pectoral biceps tenodesis as part of their arthroscopic procedure. A newly described nerve block approach to the nerves that supply sensation to the axillary region called the PECS "Pectoralis" 1 \& 2 block may provide additional analgesia to these patients. The purpose of this prospective, randomized, observer and patient blinded, single-center, sham block trial is to determine if the addition of PECS blocks to an interscalene block will reduce the severity of axillary pain following arthroscopic shoulder surgery that involves a sub-pectoral biceps tenodesis. Secondarily, the study will assess the duration of PECS 1 \& 2 and whether the block reduces post-operative opioid usage. We hypothesize that the addition of the PECS 1 \& 2 block will reduce the severity of axillary pain at 6hrs and reduce postoperative narcotic usage for the first 24 hours.

TERMINATED
Prospective Clinical Analysis of Ultrasound-guided Biceps Corticosteroid Injections
Description

Using randomization, prospectively determine superiority of either ultrasound-guided or landmark-guided biceps corticosteroid injections with regard to various clinical variables.

WITHDRAWN
Analysis of Suprapectoral and Subpectoral Biceps Tenodesis
Description

Biceps pathology typically includes pain in the anterior shoulder that is reproduced with provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in the shoulder). Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open subpectoral biceps tenodesis results in better function.

RECRUITING
Embo Registry; National Registry for Artery Embolization
Description

Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

COMPLETED
A Study Examining Changes in Pain After Manual Therapy in People With Achilles Tendon Pain
Description

The purpose of this research is to find out how pain sensation may change in the Achilles tendon after the use of manual physical therapy. The testing itself will use a device that gradually produces a sensation of heat or cold on your skin, which we will place directly over your Achilles Tendon. You will let the researcher know when the heat or cold becomes what you would describe as "slight discomfort," at which point the pressure will be stopped. Testing will be completed three (3) times in a row. The device has built-in programming which ensures that the heat or cold applied will be safe, even though it may be briefly uncomfortable. After this first testing the researchers will perform 1-3 repetitions of the ankle joint mobilization/manipulation. This technique involves the researcher providing a small quick stretching movement downwards at the ankle. This is a common therapeutic technique utilized by Physical Therapists, chiropractors, and physicians and is considered very safe. After this treatment we will perform the same measurements of hot and cold discomfort on your Achilles tendon

COMPLETED
Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder
Description

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder.

NOT_YET_RECRUITING
Waterproof Casting Versus Standard Casting for Short Leg Walking Casts
Description

The purpose of the study is to determine whether the use of waterproof padding in short leg walking casts will lead to an increase in cast-related complications, as compared to the standard non-waterproof casting in children.

WITHDRAWN
Isometric Intervention for Lateral Elbow Tendinopathy
Description

This study will be looking at people with lateral elbow tendinopathy (elbow pain). The goal is to determine if a one-time isometric intervention will positively change the level of pain and strength as compared to baseline measurements. After determining baseline strength and pain level, an intervention consisting of several trials of isometric hand/wrist contractions will be performed by the participant. Pain and strength will again be assessed immediately after the intervention.

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.

UNKNOWN
PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)
Description

Chronic tendinopathy is often very difficult to treat and causes many patients who suffer from it to have significant pain and loss of function leading to disability. Ultrasound has been shown to be very effective in aiding in the diagnosis of soft tissue disorders including tendinopathy and can help to rule in or out other potential causes that may be confounders. Numerous methods have been tried to treat tendinopathy including rest, NSAIDs, bracing, physical therapy, extracorporal shock wave therapy, anesthetic injections, steroid injections, prolotherapy, nitro patches, surgery and more recently platelet rich plasma, all of which have had conflicting results in the literature. Platelet rich plasma (PRP) is an autologous blood product that contains a high concentration of platelet-derived growth factors that have the potential to enhance healing. In a study by Mishra et al, common extensor tenindosis showed improved pain symptoms (71% vs 55% at 24 weeks) with tenontomy combined with PRP compared to percutaneous needle tenontomy alone. Current studies show conflicting results as to whether PRP improves chronic tendinopathy when compared to steroid injections, and many do not have any control group or comparison group. Percutaneous needle tenotomy is the use of a large gauge needle (18 gauge), which may be performed under ultrasound guidance, to fenestrate repeatedly the area of tendinopathy within a tendon in order to disrupt tendinopathic tissue and to induce bleeding and clot formation with release of growth factors. To date there are no published studies comparing percutaneous needle tenotomy (PNT) alone vs. PRP without concomitant tenotomy. Current literature suggests that needle tenotomy may be superior but no head to head studies are currently found in the literature. Most of the published literature of non-operative treatment of tendinosis does not yield clearly designed trials with clear selection criteria. Current literature also lacks studies with significant number of patients that meet both clinical and ultrasound criteria thus previous studies lack sufficient power. The PRINT TRIAL: may enhance the understanding of a superior treatment if it exists. Hypothesis: In active adults with chronic tendinopathy who have failed to respond to standard of care treatment, the use of ultrasound guided percutaneous needle tenotomy (PNT) alone is superior to PRP without concomitant tenotomy.

TERMINATED
Ultrasound-guided Injection for DeQuervain's
Description

The investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.

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.

COMPLETED
Treatment of Acute and Chronic Ligament and Tendon Injuries With Platelet Rich Plasma
Description

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.

Conditions
COMPLETED
Performance-Enhancing Effects of Platelet-Rich Plasma (PRP) Injections
Description

Platelet-Rich Plasma (PRP) has been banned in competitive athletes because some people think it may enhance athletic performance. However, there is very little published research to support or undermine this point of view. The purposes of this study are: (1) To assess the effects of local platelet-rich plasma (PRP) therapy on systemic levels of growth factors with suspected or known performance-enhancing effects; and (2) To understand whether the effect of PRP therapy on these growth factors differs between intramuscular and intratendinous PRP injections. This research study is looking for 40 people who are receiving platelet-rich plasma therapy for a tendon or muscle injury. The study involves collecting seven blood samples (2 teaspoons each) from each patient, before and after the PRP treatment. Blood samples may be donated at any location of the patient's choosing, and participants will be paid for their time.

COMPLETED
Comparison of Outcomes Between Biceps Tenotomy and Tenodesis in the Treatment of the Long Head of the Biceps Pathology
Description

The purpose of the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology.

COMPLETED
Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome
Description

The purpose of this study is to evaluate and compare the short and long-term effectiveness of two common interventions, manual physical therapy versus corticosteroid injection, for the treatment of shoulder impingement syndrome.

COMPLETED
Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy
Description

The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy.