Photobiomodulation Therapy for Plantar Fasciitis: A Single-Blind Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Foot and Ankle Ability Measure (FAAM)
研究概览
简要总结
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.
详细描述
Recruitment, Pre-Screening (before consent), Study Introduction & Informed Consent:
Potential participants will be identified via four methods:
- Under the provisions of the Partial HIPAA Waiver, local study providers will review medical records of patients coming into the Orthopedic and Podiatry Clinics for suspected plantar fasciitis to identify prospective research participants for the purposes of seeking their authorization to participate/use their protected health information for this research study. In these cases, the study team will receive approval from the potential participant's provider prior to approaching for possible study participation.
- Direct referral from local healthcare providers in the local Family Medicine, Podiatry, Physical Therapy, and Physical Medicine & Rehabilitation (PM&R) clinics.
- Patients may self-refer to participate in the study. Interested potential participants will be able to contact a member of the study team via phone or email. Potential participants who contact the study team directly will be instructed to access the Physical Therapy clinic or their primary care manager for a physical exam and diagnosis of Plantar Fasciitis (PF) or confirmation of a previous PF diagnosis.
- Study advertisements will be posted, and copies will be provided to clinic staff.
Eligibility will be determined in person. If the potential participant meets eligibility criteria as determined by the Inclusion/Exclusion CRF and expresses interest in participating, an authorized study team member will initiate the formal consent discussion and, if applicable, obtain informed consent.
Baseline Data Collection (post-consent): Prior to receiving the assigned study treatment, participants will provide their contact information and complete a series of baseline outcome measures (Demographics CRF and Baseline Data Collection CRF) and have their plantar fascia thickness measured within the Podiatry clinic. A study team member will also acquire measurements of the participant's calf, ankle, and foot to calculate the appropriate PBMT dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Foot and Ankle Ability Measure (FAAM)
时间窗: 3-month
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.
Pain Diary Defense and Veterans Pain Rating Scale (DVPRS)
时间窗: 3-Month
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.
Ultrasound Measurement (Plantar Fascial Thickness)
时间窗: 6-Week
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.
次要结局
未报告次要终点