Treatment Trials

52 Clinical Trials for Various Conditions

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COMPLETED
Low-Level Laser Therapy for Plantar Fasciitis
Description

Plantar fasciitis (PF), a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and contributes to decreased physical activity and excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy to return individuals to pain-free activity. Photobiomodulation therapy (PBMT) uses non-ionizing light to elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence supports use of PBM for other degenerative connective tissue conditions, such as achilles tendinopathy and epicondylitis. A previous pilot study was completed in an active-duty military and civilian population, which demonstrated a positive effect of two PBM dose parameters on function and pain levels in participants with chronic PF when combined with stretching and ice. These positive findings from the aforementioned study are promising in the treatment of this common and debilitating issue, but require the addition of a sham comparison to rigorously eliminate any potential placebo effect of the treatment protocol, and further refine the treatment protocol in order to make evidence-based clinical recommendations. As such, proposing a follow-up study and the addition of an objective outcome measure will strengthen the impact of the study. SPECIFIC AIM 1: To assess the clinical effectiveness of photobiomodulation compared to sham photobiomodulation to improve function and decrease pain. SPECIFIC AIM 2: To evaluate the effectiveness of photobiomodulation compared to sham photobiomodulation to resolve plantar fascial thickening. DESIGN: A prospective randomized sham-controlled trial to meet the aims of the study. METHOD: A sample of up to 100 active-duty military members will be randomly assigned to the Sham-PBMT or PBMT group. At baseline, during the treatment protocol, and at long-term (3 and 6 months) follow-up, measures of foot function, pain, and plantar fascial thickness will be collected for analysis. The proposed methods will allow the study team to establish if PBMT is clinically effective to accelerate recovery compared to Sham-PBMT and result in resolution of fascial thickening, decrease in pain, and improved function. LONG-TERM GOAL: The long-term goals of the research include developing PBMT protocols for broad application to other painful and duty-limiting conditions.

TERMINATED
Transvaginal Low-level Laser Therapy to Improve Pelvic Pain and Sexual Function in Patients with Endometriosis.
Description

Dyspareunia is defined as pain with penetrative sexual intercourse. Women with endometriosis have a nine-fold increased risk of dyspareunia, when compared to the general female population. A prospective single-blinded randomized controlled trial will be performed evaluating the change in pelvic pain and sexual satisfaction scores from baseline to 6 weeks after treatment with transvaginal photobiomodulation therapy or sham therapy. Treatment will involve 9 planned treatment sessions over 3-4 weeks. 40 women will be included in the study.

TERMINATED
Low-Level Laser Therapy Treatment of Lung Inflammation in Post-COVID-19 Recovery
Description

An informational evaluation of COVID-19 patients who receive low-level laser therapy in addition to a normal regimen of treatment for symptoms associate with COVID-19. Results are compared to statistical observations published in literature from patients receiving standard care for COVID-19 symptoms without low-level laser therapy.

COMPLETED
The Effect of the Erchonia GVL Low Level Laser Therapy on Neck and Shoulder Pain
Description

This study is to see if applying green and violet low level laser light to the neck and shoulders can help to reduce pain in the neck and shoulders.

UNKNOWN
Pilot Study on the Effects of Low-Level Laser Therapy Treatment for Acute and Persistent Discomfort
Description

This study will examine the effectiveness of Low-Level Laser Therapy (LLLT) for the management of pain in various locations of the body. All subjects selected for participation in the study will be assigned to a LLLT treatment group for a duration of 12 sessions.

RECRUITING
Low Level Laser Therapy (LLLT) for the Treatment of Hand Osteoarthritis.
Description

This study is a randomized, control trial of Active Duty and DoD Beneficiaries, age 18 years or older, with complaints of hand osteoarthritis. Subjects will be randomized into one of two groups receiving either LLLT or sham LLLT. Subjects will receive LLLT or sham LLLT weekly over a period of six weeks. At each visit, patients will rate their pain using the Defense and Veterans Pain Rating Scale (DVPRS) and assess their functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Subjects will have a follow up visit six weeks after the treatment protocol for a final assessment of pain and function. The Phoenix Thera-Lase laser is a Class II, 510k cleared device (#K151521) and is legally marketed in the US. Investigators are using in accordance with its approved labeling and no changes to the approved labeling are being sought.

TERMINATED
An Evaluation of the Effect of Low Level Laser Therapy on Diabetic Peripheral Neuropathy Pain
Description

The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy.

RECRUITING
Evaluating Different Low-level Laser Therapies to Treat Neck Pain in Air Force Pilots and Flight Crew
Description

Determine the most effective and efficient treatment protocols for treating neck pain with LLLT.

Conditions
COMPLETED
The Effect of Low Level Laser Therapy on Neck and Shoulder Pain
Description

This study is to see if applying red and violet low level laser light to the neck and shoulders can help to reduce pain in the neck and shoulders.

UNKNOWN
Study of Low-level Laser Therapy in the Acute Treatment of Migraine
Description

This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).

TERMINATED
Low-level Laser Therapy in Patients With Chronic Fibromyalgia
Description

The purpose of this study is to examine the use of low level therapeutic laser (LLLT) for its effects on pain, fatigue, and physical function in individuals with fibromyalgia.

Conditions
TERMINATED
Low Level Laser Therapy With Physical Therapy for Chronic Musculoskeletal Pain
Description

1. Examine the use of low level therapeutic laser (LLLT) combined with physical therapy for improvements in pain, range of motion, and function in individuals with chronic pain from musculoskeletal conditions. 2. Compare changes in pain, mobility, and ability to return to home/work/recreational activities between treatments with standard physical therapy plus LLLT or the standard physical therapy program alone.

Conditions
COMPLETED
Low-Level Laser Therapy for Prevention of Oral Mucositis
Description

The overall purpose of this study is to examine the efficacy of prophylactic low-level laser therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients receiving combined modality therapy consisting of chemotherapy and radiation therapy for head and neck cancer.

Conditions
COMPLETED
Low-Level Laser Therapy for Prevention of Oral Mucositis
Description

The overall purpose of this study is to examine the efficacy of prophylactic low-level laser therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients receiving combined modality therapy consisting of chemotherapy and radiation therapy for head and neck cancer.

Conditions
TERMINATED
Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference
Description

The purpose of this study is to determine whether low level laser light therapy applied using the Erchonia Verju Laser combined with manual lymph drainage applied using the Iskra Medical Green PRESS 8 Lymph Drainage System is effective in reducing the circumference of the waist, hips and upper abdomen.

COMPLETED
Study of Low Level Laser Therapy to Treat Diabetic Peripheral Neuropathy Foot Pain
Description

The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy.

COMPLETED
Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma
Description

This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.

WITHDRAWN
Effect of Low Level Laser Therapy on Pain Induced by Placement of Orthodontic Separators in Pediatric Patients
Description

The primary goal of the study is to determine if there is a difference in pain levels following the use of low level laser therapy versus placebo and control after placement of elastomeric orthodontic separators in pediatric patients. To test this, the investigators will assess the patient's pain levels immediately following separator placement and 24 hours post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS). Patients will be randomly assigned to one of three groups: treatment, placebo, and control. The aim of this study is to establish whether or not low level laser therapy can be used to reduce pain in pediatric patients following separator placement.

Conditions
COMPLETED
Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management
Description

Currently in the United States about 97 million adults are considered obese, accounting for about 33% of the American adult population (compared to 22.9% in 1988). Obesity, defined as a body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the ischemic heart disease and between 7% and 41% of certain cancers. The Erchonia® Zerona™ 2.0 Laser (which will be used in this study) has been approved by the FDA (K123237) as a non-invasive dermatological aesthetic treatment which can be used by individuals intending to reduce circumference of hips, waist, and thighs. Lorcaserin is a selective serotonin 2C (5-HT(2C)) receptor agonist. The exact mechanism of action is not known, but lorcaserin is believed to promote satiety and decrease food intake by activating 5-HT(2C) receptors on anorexigenic pro-opiomelanocortin neurons in the hypothalamus. Lorcaserin was approved by the FDA on June 2012 for weight management in people with a BMI of \> 27 kg/m2 (overweight) when accompanied by a weigh-related condition such as type 2 diabetes or high blood pressure or in people with a BMI \> 30 kg/m2 (obese). The purpose of this pilot study is to obtain preliminary data on: 1) effectiveness of the combination of LLLT and lorcaserin for reducing abdominal subcutaneous fat in overweight/obese individuals; 2) impact of LLLT on inflammatory biomarkers, blood sugar, and cholesterol.

Conditions
COMPLETED
A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
Description

This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks.

COMPLETED
Study of Low Level Laser Therapy to Treat Low Back Pain
Description

The purpose of this study is to determine whether the Erchonia® ML Scanner (MLS) is effective in the treatment of acute minor episodic chronic low back pain of musculoskeletal origin.

Conditions
COMPLETED
Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis
Description

The purpose of this study is to determine whether the Erchonia HPS Laser is effective in the treatment of chronic heel pain arising from plantar fasciitis.

COMPLETED
Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals
Description

The purpose of this study is to determine whether low level laser light therapy is effective in reducing circumference of the waist, hips and upper abdomen in obese individuals.

Conditions
COMPLETED
Study of the Use of Low Level Laser Therapy to Reduce Acne
Description

The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of acne blemishes.

Conditions
COMPLETED
Treatment Trial Using Low Level Laser Therapy (LLLT) for Treatment of Chemotherapy Induced Peripheral Neuropathy
Description

The purpose of this research study is to determine if treatment with Low Level Laser Therapy (LLLT) is effective in treating the pain, numbness or tingling patients are experiencing following their chemotherapy. The investigators would also like to know the number of treatments that were needed in order to reduce their symptoms.

COMPLETED
Low Level Laser Treatment and Breast Cancer Related Lymphedema
Description

Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the arm) is the current standard of treatment for breast cancer related lymphedema (arm swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT has possible value in the treatment of lymphedema and warrants subsequent evaluation in a larger study.

Conditions
TERMINATED
Study of Low Level Laser Therapy and Tinnitus Relief
Description

The purpose of this study is to determine if low level laser light therapy might help to relieve tinnitus in adults.

Conditions
COMPLETED
Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
Description

The purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.

COMPLETED
Study of Low Level Laser Therapy for Body Contouring
Description

The purpose of this study is to determine whether green diode low level laser therapy is effective for body contouring of the waist, hips and thighs.

Conditions
WITHDRAWN
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery
Description

The primary objective of this study is to assess whether or not low level laser therapy (LLLT) decreases pain in post-operative orthopedic patients following lumbar fusion surgery.

Conditions