Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01835756
Eligibility Criteria:
Inclusion Criteria:
* Primary pain is in the lower back
* Low back pain is of musculoskeletal origin stemming from benign musculoskeletal problems wherein the etiology is lumbar sprain or strain
* Diagnosis based on review of patient history, physical examination, medication use history and review of prior medical records
* Low back pain is episodic chronic, having occurred and recurred over regular or irregular intervals of time over at least the last 3 months
* Degree of Pain rating on the visual analog scale (VAS) is 40 or greater
* Subject is willing and able to refrain from taking non study medications and herbal supplements for the relief of pain or inflammation including muscle relaxants throughout study participation
* Subject is willing and able to refrain from non study procedure therapies for the management of low back pain throughout study participation
* Primary language is English
Exclusion Criteria:
* Low back pain is undiagnosed or has been diagnosed as being other than of benign musculoskeletal origin wherein the etiology is lumbar sprain or strain
* Low back pain has been diagnosed or cannot be satisfactorily ruled out as being in whole or in part due to one or more of the following origins - mechanical, inflammatory, neoplastic, metabolic origin, psychosomatic
* Tension myositis syndrome
* Known herniated disc injury
* Osteoporosis with compression fractures
* Congenital deformity of spine
* Current active chronic pain disease
* Cancer or cancer treatment in the past 6 months
* Use of the following analgesics within 7 days of study onset - paracetamol, acetominophen, non-steroidal anti-inflammatory drugs (NSAIDs), compound analgesics, topical analgesics
* Use of the following muscle relaxants within the prior 30 days of study onset - cyclobenzaprine, diazepam, meprobamate
* Use of the following muscle relaxants within 7 days of study onset - carisoprodol, Metaxalone
* Use of the following antidepressants within 30 days of study onset if consumption has commenced within that 30 day period - duloxetine, amitriptyline, imipramine, clomipramine, nortriptyline, desipramine, selective serotonin reuptake inhibitors (SSRIs)
* Systemic corticosteroid therapy or narcotics taken within 30 days (inhaled and topical corticosteroids okay) of study onset
* Local or epidural injection of corticosteroids within 3 months of study onset
* Botulinum toxin injection for chronic low back pain within 4 months of study onset
* Active infection, wound, other external trauma to the treatment area
* Surgery to the lower back or spine in the past 12 months
* Medical, physical or other contraindications for, or sensitivity to, light therapy
* Pregnant, breast feeding or planning pregnancy prior to study end
* Serious mental health illness such as dementia or schizophrenia or psychiatric hospitalization in past 2 years
* Developmental disability or cognitive impairment that precludes adequate comprehension of consent form or the ability to record study measurements
* Participation in other research in the past 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01835756
Study Brief:
Protocol Section:
NCT01835756