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Neck and Shoulder Pain Research Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02940119
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ernesto Cesar Pinto Leal Junior, University of Nove de Julho

Brief Summary:
Pain in the neck and shoulders is a musculoskeletal disorder that affects a significant number of individuals.The aim of this study is to evaluate the effects of PBMT (with a device that combines low level laser therapy and light emitting diode therapy) in chronic pain relief of musculoskeletal origin in the neck and shoulders area.

Condition or disease Intervention/treatment Phase
Neck Pain Shoulder Pain Chronic Pain Musculoskeletal Pain Device: Multi Radiance Medical® Not Applicable

Detailed Description:
Randomized, placebo-controlled, double-blind clinical trial was carried out. Seventy-two patients with chronic pain in neck and shoulder were recruited and randomized into two groups (n = 36 each group), one group received active PBMT and another group received placebo PBMT (with a device with same appearance of the actual laser, including any visible light). Patients were treated at 9 different sites of 3 zones in the neck and shoulders area, twice a week during 3 consecutive weeks with a PBMT device manufactured by Multi Radiance Medical™ (Solon - OH, USA). Primary outcome was intensity of pain using the Visual Analog Pain Scale (VAS), secondary outcomes were range of motion (ROM) of the neck and shoulders and patient satisfaction with therapy employed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Phototherapy With Different Sources of Light in Muscle Skeletal Chronic Pain Relief From Neck and Shoulders
Actual Study Start Date : November 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Active PBMT
The volunteers received active phototherapy in each session.
Device: Multi Radiance Medical®
Volunteers received all procedures of the study with active or placebo phototherapy (PBMT) in 9 sites of the neck and shoulders, twice a week. The PBMT was applied in all sessions.
Other Name: Photobiomodulation therapy

Placebo Comparator: Placebo PBMT
The volunteers received placebo phototherapy in each session.
Device: Multi Radiance Medical®
Volunteers received all procedures of the study with active or placebo phototherapy (PBMT) in 9 sites of the neck and shoulders, twice a week. The PBMT was applied in all sessions.
Other Name: Photobiomodulation therapy




Primary Outcome Measures :
  1. Pain assessment [ Time Frame: one month ]
    Visual anagogic scale (VAS)


Secondary Outcome Measures :
  1. Rage of Motion (ROM) [ Time Frame: one month ]
    pre-defined assessment with a goniometer

  2. Individualized pain management regimen [ Time Frame: one month ]
    questionnaire about perception and what kind of phototherapy was performed (active or placebo). This assessment was answered by subjects, investigator that performed the assessments and investigator that performed phototherapy application.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presenting primary pain is located in the region of the neck (right side and/or left side and/or the back of the neck) and/or the shoulder (right side and/or left side);
  • neck and/or shoulder pain is of benign musculoskeletal origin wherein the etiology is sprain strain and/or muscle spasms;
  • neck/shoulder pain is episodic chronic, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months;
  • self-reported Degree of Pain rating on the 0-100 VAS pain scale for the neck-shoulder region is 50 or greater;
  • subject is willing and able to maintain his or her current pre-study neck/shoulder pain management regimen of pain relief medication and/or treatment/therapy use throughout the course of study duration, whilst refraining from consuming other types of medication and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants, and/or partaking in other treatments/therapies including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.

Exclusion Criteria:

  • subject's presenting primary pain is located outside or in addition to the region of the neck (right side and/or left side and/or the back of the neck) and/or the shoulder (right side and/or left side);
  • subject's neck and/or shoulder pain is of other than, or in addition to, benign musculoskeletal origin wherein the etiology is sprain strain and/or muscle spasms, and/or the etiology of the subject's neck/shoulder pain cannot be satisfactorily ruled out as one or more;
  • neck/shoulder pain is acute, defined as having persisted over less than the last 3 months;
  • neck/shoulder pain is not episodic, such that it has either been continually present without respite over the past 3 months and/or there has not been recurrent episodes within the past 3 months;
  • self-reported Degree of Pain rating on the 0-100 VAS pain scale for the neck-shoulder region is less than 50;
  • local corticosteroids and/or botulinum toxin (Botox®) injection for neck/shoulder pain relief within the prior 30 days;
  • such as chiropractic care and acupuncture;
  • current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain;
  • cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord, diabetes Type 1, significant heart conditions including coronary heart failure and implantable heart devices such as a pacemaker, active infection, wound or other external trauma to the areas to be treated with the laser, surgery to the neck and/or shoulder region in the past 12 months;
  • medical, physical, or other contraindications for, or sensitivity to, light therapy;
  • pregnant, breast feeding, or planning pregnancy prior to the end of study participation, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years;
  • developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements;
  • involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study;
  • subject is less than 18 years of age;
  • participation in a clinical study or other type of research in the past 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940119


Locations
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Brazil
Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)
São Paulo, SP, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Principal Investigator: Ernesto Leal-Junior, PhD University of Nove de Julho
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Responsible Party: Ernesto Cesar Pinto Leal Junior, Full professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02940119    
Other Study ID Numbers: 041016
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Shoulder Pain
Musculoskeletal Pain
Chronic Pain
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases