Blue Light Device for Pain Therapy

NCT01528332 | Completed Phase 3 Results

• 1 other identifier: PAINCT02
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine if the Pain Relief Patch, which shines light of a limited wavelength on the painful area of the back, relieves chronic musculoskeletal back pain. At the same time, this study will gather information on side effects associated with use of the Pain Relief Patch. The study will compare the Pain Relief Patch to a patch that is similar in appearance, but which shines a different, presumed nontherapeutic, wavelength of light.

Conditions

Low Back Pain; Low Back Pain, Recurrent; Musculoskeletal Pain; Chronic Pain

Keywords

Musculoskeletal pain; Back pain; Chronic pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Mean of Three Measurements at Screening, Prior to Treatment Visit 1 and Treatment Visit 1 Pretreatment) in the Average Visual Analog Scale (VAS) Pain Intensity Over the 5 Treatment Days

  Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable

  Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)

Secondary Outcomes (9)

• Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5

  Baseline (days -7 to +1) to Treatment 5 (day +14)

• Change From Baseline in VAS Pain Intensity at Follow up

  Baseline (day -7 to 1) to Follow-up (up to day +42)

• Change From Treatment in VAS Pain Intensity at Follow up

  Treatment (day +1 to +14) to Follow-up (up to day +42)

• Change From Baseline in RMDQ at Follow up

  Baseline (days -7 to +1) to Follow-up (up to day +42)

• Change From Treatment in RMDQ at Follow up

  Treatment (days +1 to +14) to Follow up (up to day +42)

Study Arms (2)

Pain Relief Patch

EXPERIMENTAL

Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes

Device: Pain Relief Patch

Control PRP device

ACTIVE COMPARATOR

Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes

Device: Control PRP device

Interventions

Pain Relief Patch DEVICE

The Pain Relief Patch is a non CE-marked device that is worn on the painful area of the back, where it shines light (453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm²). It will be used 5 times over 14 days for 30 minutes each time.

Also known as: Blue light device, PRP patch, LED patch

Pain Relief Patch

Control PRP device DEVICE

The Control PRP device is also a non CE-marked device. It is similar in appearance to the active Pain Relief Patch, except that it shines light of a different wavelength(531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm²) for just 5 seconds before it turns off. Participants in the control arm will be treated with the control PRP device 5 times over 14 days for 30 minutes each time.

Control PRP device

Eligibility Criteria

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

You may qualify if:

• Is between 18 and 65 years of age, inclusive
• Is able to consent to participation by signing the informed consent form
• Has had localized mild to moderate (a score ≥ 2 and ≤ 6 on a 0 - 10 point pain intensity VAS) back pain for the 3 months prior to enrollment in study or longer
• Has a mean pain intensity VAS value (calculated from pain intensity VAS at Screening Visit, home assessment and pretreatment at Visit 1) between ≥ 2 and ≤6 at baseline prior to randomization
• Has skin type II, III or IV on the Fitzpatrick skin type scale (Types I - VI)
• Is willing and able to adhere to all study requirements, including accurate completion of VAS and questionnaires at the required time points, and is willing and able to travel to investigator's site to attend all required visits
• Is able to understand the study plan, its conditions, the therapy goals and expected outcomes

You may not qualify if:

• General:
• Is participating in another clinical study at time of this study, or has participated in another study within the 30 days prior to signing the informed consent form
• Is pregnant or breast-feeding
• Is a sexually active female of childbearing potential and is not using a medically approved form of contraception
• Has moderate or severe arterial hypertension (WHO/ISH grade 2 or higher; systolic BP ≥ 160 and/or a diastolic BP ≥ 100), a history of stroke, myocardial infarction, angina pectoris, arteriosclerotic vascular disease (ASVD), or peripheral vascular disease, or (severe) congestive heart failure
• Is in poor general health
• Is an employee of the investigational site directly affiliated with this study and/or their immediate family members; an employee of the sponsor or the CRO
• Back Pain Related:
• Has had any failed back surgery, or has had any surgery to torso, head or back within the previous 8 weeks
• Had an acute dislocation or fracture within the previous 8 weeks
• Has a degenerative central nervous system disease such as Multiple Sclerosis or Parkinson's disease; or a spinal stenosis that contributes to or is the cause of back pain; or Cauda equina syndrome, or other neurological symptoms indicating neuropathy
• Has any sensory deprivation or diagnosis of shingles or postherpetic neuralgia (specifically in mid-trunk region)
• Has wide spread pain
• Has any inflammatory disease that causes pain or any other chronic disease or infection known to cause pain (e.g. spondyloarthropathy, rheumatoid arthritis, Lupus erythematodes, Lyme borreliosis, etc.)
• Has schizophrenia, borderline syndrome or severe depression

Sponsors & Collaborators

• Philips Electronics Nederland BV: lead

Study Sites (3)

Clinic for Anaesthesiology and Supra-regional Center of Pain Therapy and Palliative Care, University Hosp Heidelberg

Heidelberg, Germany

Location

Pain Therapy Section, Dept of Orthopedic Surgery and Traumatology, University Hosp Heidelberg

Heidelberg, Germany

Location

University Medical Care Center Mannheim, Dept of Anaesthesiology and Surgical Care Medicine

Mannheim, Germany

Location

Related Publications (1)

• Baron R, Morlion B, Dahan A, Uberall M, von Basum G, Wild I. A prospective, randomized, controlled, double-blind, multi-center study to evaluate the efficacy and safety of a blue light device for the treatment of chronic back pain. Front Pain Res (Lausanne). 2024 Jul 23;5:1444401. doi: 10.3389/fpain.2024.1444401. eCollection 2024.

  PMID: 39109241 DERIVED

MeSH Terms

Conditions

Low Back Pain; Musculoskeletal Pain; Chronic Pain; Back Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Elke Naujokat
• Organization: Philips Consumer Lifestyle

elke.naujokat@philips.com

+31 (0) 631974213

Study Officials

• Hubert Bardenheuer, Prof. Dr.

  Clinic for Anaesthesiology and Supra-regional Centre of Pain Therapy and Palliative Care, University Hosp Heidelberg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 12, 2014
• Results First Posted: January 8, 2014

Record last verified: 2014-02

Locations

DE (3)