Low-Level Laser Therapy for Plantar Fasciitis

NCT05763381 | Completed Results FDA Device

• 1 other identifier: 222072
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plantar Fascitis

Keywords

Plantar Fasciitis; Photobiomodulation Therapy; Tendinopathy; Low Level Laser Therapy

Outcome Measures

Primary Outcomes (11)

• Foot and Ankle Ability Measure (FAAM)

  The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.

  Baseline

• Foot and Ankle Ability Measure (FAAM)

  The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.

  3-Week

• Foot and Ankle Ability Measure (FAAM)

  The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.

  6-week

• Foot and Ankle Ability Measure (FAAM)

  The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included PF cases in development. There are two subscales, Activities of Daily Living(ADL) (21- item) and Sports (7-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). The minimum clinically important difference 8 \& 9 points for ADL \& Sports subscale, respectively. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction and 0% being dysfunction.

  3-month

• Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)

  Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.

  Baseline

• Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)

  Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.

  3-Week

• Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)

  Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.

  6-Week

• Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)

  Defense and Veterans Pain Rating Scale (DVPRS) 72. The 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Rating scale from 0-10 (0=No pain, 10=As bad as it could be nothing else matters); higher score equal worse outcomes.

  3-Month

• Ultrasound Measurement (Plantar Fascial Thickness)

  Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.

  Baseline

• Ultrasound Measurement (Plantar Fascial Thickness)

  Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.

  3-Week

• Ultrasound Measurement (Plantar Fascial Thickness)

  Plantar fascia thickness was measured by an MSK US trained provider utilizing an ultrasound system. The patient was positioned prone on an examination table with the leg extending off the end so the foot projects downward in a relaxed state. Using a linear transducer for best resolution, the plantar fascia was evaluated in the long axis to determine the site to be measured as identified by the bony contour. The vertical thickness of the plantar fascia will be documented in both long and short axis at this point. The points measured were from the edge of the bone to the outer layer of the plantar fascia. The average of both long and short-axis measurements was analyzed for the PF thinness results.

  6-Week

Other Outcomes (6)

• Foot and Ankle Ability Measure (FAAM)

  3-Week Cross-over

• Foot and Ankle Ability Measure (FAAM)

  6-Week Cross-over

• Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)

  3-Week Cross-over

Study Arms (2)

The Usual Care + PBM Group

ACTIVE COMPARATOR

Participants that are assigned to this group will receive active treatment with PBM 3 times a week for 3 weeks for a total of 9 treatments.

Device: Photobiomodulation Therapy (PBMT)

The Usual Care + Sham (Placebo) PBM Group

PLACEBO COMPARATOR

Participants that are assigned to this group will receive Sham PBM therapy 3 times a week for 3 weeks for a total of 9 treatments. Sham PBM therapy is an inactive harmless treatment that is intended to mimic the active PBM treatment. At the completion of the initial 6 weeks, the Usual Care + Sham (Placebo) PBM Group will be unblinded, and may choose to cross-over and complete another 6 weeks in the active treatment group. If participants choose to cross-over and receive active PBMT, they will re-complete all of the original study procedures (with the exception of screening, as participants have qualified for the study, and baseline data collection, as the study team will use the 6-week follow-up data as the new baseline prior to active PBMT treatment.

Device: Sham-Photobiomodualtion Therapy (Sham-PBMT)

Interventions

Photobiomodulation Therapy (PBMT) DEVICE

Participants will receive PBMT with the PBM device over the course of three consecutive weeks (three treatments per week). PBM treatments will take approximately 5-10 minutes to administer at each session. Specific treatment parameters will be based on measurements of calf, ankle, and foot using pre-calculated treatment tables; participants will receive 10 J/cm2, 25W output power, and the length of the treatment will be dependent on treatment area (size). PBMT will be administered by a trained member of the study team using the LightForce® XPi therapy laser, provided by LiteCure, LLC/DJO Global (New Castle, DE). The LightForce® XPi therapy laser is an FDA cleared device for the treatment of pain. The trained team members will use the Smart Hand Piece technology, which achieves effective treatments and improves dosing accuracy by assessing the operator's speed and providing real-time visual (red - amber - green light) and sensory feedback.

The Usual Care + PBM Group

Sham-Photobiomodualtion Therapy (Sham-PBMT) DEVICE

Sham-PBM treatment time will be calculated in the same way as the PBM treatment group, with the time of treatment dependent on the size of the treatment area. The sham-PBMT will be administered by rolling the massage ball over the plantar surface of the foot and dorsal aspect of the calf in contact with the participants' skin. Because emission of photons at the selected treatment parameters may cause participants in the treatment group to feel warmth, the massage ball will be warmed in the sham-PBMT. The device will be turned on, so the red aiming beam will be visible, but the operator will not activate the switch to emit photons.

The Usual Care + Sham (Placebo) PBM Group

Eligibility Criteria

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

You may qualify if:

• DEERS eligible
• Able to read and understand English language for consent purposes
• Experience pain in the bottom of foot and/or heel at any time during the day
• Diagnosis of Plantar Fasciitis (PF) by a healthcare provider based on accepted diagnostic criteria
• Abel to commit to study procedures, including a 6-week intervention and 3 month follow-up
• Have experienced symptoms of PF for at least 3 months

You may not qualify if:

• Diagnosed with a calcaneal (heel) fracture by a healthcare provider
• Currently pregnant or plan to become pregnant during intervention period (safety of PBM not established in pregnancy)
• History of traumatic injury to symptomatic foot/feet
• Previous surgery, or other invasive treatment for same condition
• Significant portion of calf area covered in tattoos/ink/scarring (pigment in ink can absorb light, causing overheating of skin)
• History of neuropathy or inability to detect changes in skin temperature (increased risk of skin warming due to inability to detect change)
• Current use of medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
• Concurrent participation in another research study addressing pain issue
• Current use of pacemaker
• Current or chronic sciatica resulting in chronic or intermittent lower extremity pain, numbness, or tingling
• Previous enrollment in this study for contralateral foot

Sponsors & Collaborators

• The Geneva Foundation: lead
• Uniformed Services University of the Health Sciences: collaborator
• Musculoskeletal Injury Rehabilitation Research for Operational Readiness: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (36)

• Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257.

  PMID: 19952249 BACKGROUND

• Dyck DD Jr, Boyajian-O'Neill LA. Plantar fasciitis. Clin J Sport Med. 2004 Sep;14(5):305-9. doi: 10.1097/00042752-200409000-00010. No abstract available.

  PMID: 15377971 BACKGROUND

• Rosenbaum AJ, DiPreta JA, Misener D. Plantar heel pain. Med Clin North Am. 2014 Mar;98(2):339-52. doi: 10.1016/j.mcna.2013.10.009. Epub 2013 Dec 10.

  PMID: 24559879 BACKGROUND

• DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.

  PMID: 12851352 BACKGROUND

• Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.

  PMID: 24626080 BACKGROUND

• Franceschi F, Papalia R, Paciotti M, Franceschetti E, Di Martino A, Maffulli N, Denaro V. Obesity as a risk factor for tendinopathy: a systematic review. Int J Endocrinol. 2014;2014:670262. doi: 10.1155/2014/670262. Epub 2014 Aug 19.

  PMID: 25214839 BACKGROUND

• Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.

  PMID: 21882780 BACKGROUND

• Roy TC, Knapik JJ, Ritland BM, Murphy N, Sharp MA. Risk factors for musculoskeletal injuries for soldiers deployed to Afghanistan. Aviat Space Environ Med. 2012 Nov;83(11):1060-6. doi: 10.3357/asem.3341.2012.

  PMID: 23156094 BACKGROUND

• Cameron KL, Owens BD. The burden and management of sports-related musculoskeletal injuries and conditions within the US military. Clin Sports Med. 2014 Oct;33(4):573-89. doi: 10.1016/j.csm.2014.06.004.

  PMID: 25280610 BACKGROUND

• Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. doi: 10.7547/87507315-93-3-234.

  PMID: 12756315 BACKGROUND

• Orchard J. Plantar fasciitis. BMJ. 2012 Oct 10;345:e6603. doi: 10.1136/bmj.e6603. No abstract available.

  PMID: 23054045 BACKGROUND

• Franceschi F, Papalia R, Franceschetti E, Paciotti M, Maffulli N, Denaro V. Platelet-rich plasma injections for chronic plantar fasciopathy: a systematic review. Br Med Bull. 2014 Dec;112(1):83-95. doi: 10.1093/bmb/ldu025. Epub 2014 Sep 19.

  PMID: 25239050 BACKGROUND

• Hammer WI. The effect of mechanical load on degenerated soft tissue. J Bodyw Mov Ther. 2008 Jul;12(3):246-56. doi: 10.1016/j.jbmt.2008.03.007. Epub 2008 Jun 3.

  PMID: 19083680 BACKGROUND

• Tountas AA, Fornasier VL. Operative treatment of subcalcaneal pain. Clin Orthop Relat Res. 1996 Nov;(332):170-8. doi: 10.1097/00003086-199611000-00023.

  PMID: 8913160 BACKGROUND

• Miller LE, Latt DL. Chronic Plantar Fasciitis is Mediated by Local Hemodynamics: Implications for Emerging Therapies. N Am J Med Sci. 2015 Jan;7(1):1-5. doi: 10.4103/1947-2714.150080.

  PMID: 25709971 BACKGROUND

• Jones BH, Canham-Chervak M, Canada S, Mitchener TA, Moore S. Medical surveillance of injuries in the u.s. Military descriptive epidemiology and recommendations for improvement. Am J Prev Med. 2010 Jan;38(1 Suppl):S42-60. doi: 10.1016/j.amepre.2009.10.014.

  PMID: 20117600 BACKGROUND

• Canyilmaz E, Canyilmaz F, Aynaci O, Colak F, Serdar L, Uslu GH, Aynaci O, Yoney A. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis. Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):659-66. doi: 10.1016/j.ijrobp.2015.02.009. Epub 2015 Apr 28.

  PMID: 25936814 BACKGROUND

• Rompe JD. Plantar fasciopathy. Sports Med Arthrosc Rev. 2009 Jun;17(2):100-4. doi: 10.1097/JSA.0b013e3181a3d60e.

  PMID: 19440137 BACKGROUND

• Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.

  PMID: 25844681 BACKGROUND

• Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.

  PMID: 22045511 BACKGROUND

• Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3.

  PMID: 23912778 BACKGROUND

• Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.

  PMID: 19913903 BACKGROUND

• Tumilty S, McDonough S, Hurley DA, Baxter GD. Clinical effectiveness of low-level laser therapy as an adjunct to eccentric exercise for the treatment of Achilles' tendinopathy: a randomized controlled trial. Arch Phys Med Rehabil. 2012 May;93(5):733-9. doi: 10.1016/j.apmr.2011.08.049.

  PMID: 22541305 BACKGROUND

• Tumilty S, Munn J, Abbott JH, McDonough S, Hurley DA, Baxter GD. Laser therapy in the treatment of achilles tendinopathy: a pilot study. Photomed Laser Surg. 2008 Feb;26(1):25-30. doi: 10.1089/pho.2007.2126.

  PMID: 18248158 BACKGROUND

• Tumilty S, Munn J, McDonough S, Hurley DA, Basford JR, Baxter GD. Low level laser treatment of tendinopathy: a systematic review with meta-analysis. Photomed Laser Surg. 2010 Feb;28(1):3-16. doi: 10.1089/pho.2008.2470.

  PMID: 19708800 BACKGROUND

• Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2.

  PMID: 25450903 BACKGROUND

• Oliveira FS, Pinfildi CE, Parizoto NA, Liebano RE, Bossini PS, Garcia EB, Ferreira LM. Effect of low level laser therapy (830 nm) with different therapy regimes on the process of tissue repair in partial lesion calcaneous tendon. Lasers Surg Med. 2009 Apr;41(4):271-6. doi: 10.1002/lsm.20760.

  PMID: 19347936 BACKGROUND

• Ng GY, Fung DT. The combined treatment effects of therapeutic laser and exercise on tendon repair. Photomed Laser Surg. 2008 Apr;26(2):137-41. doi: 10.1089/pho.2007.2145.

  PMID: 18341419 BACKGROUND

• Basford JR, Malanga GA, Krause DA, Harmsen WS. A randomized controlled evaluation of low-intensity laser therapy: plantar fasciitis. Arch Phys Med Rehabil. 1998 Mar;79(3):249-54. doi: 10.1016/s0003-9993(98)90002-8.

  PMID: 9523774 BACKGROUND

• Jastifer JR, Catena F, Doty JF, Stevens F, Coughlin MJ. Low-Level Laser Therapy for the Treatment of Chronic Plantar Fasciitis: A Prospective Study. Foot Ankle Int. 2014 Jun;35(6):566-571. doi: 10.1177/1071100714523275.

  PMID: 24510123 BACKGROUND

• Macias DM, Coughlin MJ, Zang K, Stevens FR, Jastifer JR, Doty JF. Low-Level Laser Therapy at 635 nm for Treatment of Chronic Plantar Fasciitis: A Placebo-Controlled, Randomized Study. J Foot Ankle Surg. 2015 Sep-Oct;54(5):768-72. doi: 10.1053/j.jfas.2014.12.014. Epub 2015 Mar 10.

  PMID: 25769363 BACKGROUND

• Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.

  PMID: 16309613 BACKGROUND

• Buckenmaier CC 3rd, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population. Pain Med. 2013 Jan;14(1):110-23. doi: 10.1111/j.1526-4637.2012.01516.x. Epub 2012 Nov 8.

  PMID: 23137169 BACKGROUND

• Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent Validity of the Defense and Veterans Pain Rating Scale in VA Outpatients. Pain Med. 2015 Nov;16(11):2152-61. doi: 10.1111/pme.12866. Epub 2015 Aug 8.

  PMID: 26257151 BACKGROUND

• Tumilty S, Mani R, Baxter GD. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial. Lasers Med Sci. 2016 Jan;31(1):127-35. doi: 10.1007/s10103-015-1840-4. Epub 2015 Nov 26.

  PMID: 26610637 BACKGROUND

• Redberg RF. Sham controls in medical device trials. N Engl J Med. 2014 Sep 4;371(10):892-3. doi: 10.1056/NEJMp1406388. No abstract available.

  PMID: 25184861 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar; Tendinopathy

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Muscular Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Elizabeth Metzger, Scientific Program Manager
• Organization: The Geneva Foundation

emetzger@genevausa.org

253-383-1398

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind masking. The study team knew which group participants were randomized to. Participants did not know which group they were in until after 6 week follow up visit.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two treatment groups: usual care with PBM therapy, or usual care with sham PBM therapy.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 10, 2023
• Study Start: August 11, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: De-identified research data will be shared with Military Injury Rehabilitation Research for Operational Readiness (MIRROR) and maintained indefinitely for possible use in future research.
• Access Criteria: De-identified data will only be accessible by authorized study team members and oversight officials, the local Madigan Human Research Protections Office, the IRB, authorized staff from USU, and authorized staff from Musculoskeletal Injury Rehabilitation Research for Operational Readiness, which is based out of the department of Physical Medicine \& Rehabilitation at USU, and is serving as the data coordinator.

Locations

US (1)