Neck and Shoulder Pain Research Study

NCT02940119 | Completed

• 1 other identifier: 041016
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Shoulder Pain; Chronic Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Pain assessment

  Visual anagogic scale (VAS)

  one month

Secondary Outcomes (2)

• Rage of Motion (ROM)

  one month

• Individualized pain management regimen

  one month

Study Arms (2)

Active PBMT

ACTIVE COMPARATOR

The volunteers received active phototherapy in each session.

Device: Multi Radiance Medical®

Placebo PBMT

PLACEBO COMPARATOR

The volunteers received placebo phototherapy in each session.

Device: Multi Radiance Medical®

Interventions

Multi Radiance Medical® DEVICE

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.

Also known as: Photobiomodulation therapy

Active PBMT; Placebo PBMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)

São Paulo, São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Neck Pain; Shoulder Pain; Chronic Pain; Musculoskeletal Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Ernesto Leal-Junior, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 20, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

BR (1)