Effect of Low-Level Laser Photobiomodulation on Pain, Function, and Ultrasound Findings in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Randomized, Double-Blind, Sham-Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Data completeness feasibility: proportion of complete datasets for key clinical outcomes
研究概览
简要总结
The goal of this clinical trial is to learn if low-level laser therapy (also called photobiomodulation) works to treat knee or heel pain in physically active children and adolescents with Osgood-Schlatter disease or Sever disease. It will also learn about the safety of this treatment. The main questions it aims to answer are:
- Does low-level laser therapy lower pain more than a sham (placebo) laser treatment?
- Does low-level laser therapy improve daily and sport-related function more than a sham laser treatment?
- What medical problems, if any, do participants have during the study?
Researchers will compare active low-level laser therapy to a sham (placebo) laser treatment. The sham treatment looks and feels the same but does not deliver therapeutic light. This comparison will show whether the laser therapy works better than placebo.
Participants will:
- Complete screening and a baseline visit
- Be randomly assigned to active laser therapy or sham laser therapy
- Receive a series of treatment sessions over [2 weeks]
- Answer short questionnaires about pain and function at baseline and follow-up visits
- Have ultrasound imaging and/or provide blood or urine samples for research measurements
Both participants and the study team who assess outcomes will not know which treatment group each participant is in until the study ends.
详细描述
This pilot randomized, placebo-controlled, double-masked clinical trial evaluates the feasibility and preliminary clinical signal of laser photobiomodulation (low-level laser therapy; LLLT) in youth athletes (10-17 years) with symptomatic lower-extremity apophyseal pathology, primarily consistent with Osgood-Schlatter disease and/or calcaneal apophysitis (Sever disease) confirmed clinically and by ultrasound.
Participants will be randomized 1:1 to active LLLT or sham LLLT. The intervention consists of 10 sessions over 2 weeks (5 sessions/week) delivered with a class 3B GaAlAs (Gallium-Aluminum-Arsenide) laser device using standardized parameters (near-infrared wavelength range; continuous mode; preset energy density; contact application over the symptomatic apophyseal region). Sham procedures are identical in appearance, session duration, and device operation but deliver 0 mW output.
The primary objective is feasibility (recruitment, retention, adherence, data completeness, safety). Secondary objectives are estimate-only between-group differences in pain and function at post-intervention and follow-up. Ultrasound is repeated after the intervention as an exploratory mechanistic assessment. Blood and urine biomarkers are collected at baseline only and are not analyzed as post-intervention randomized outcomes.
After completion of the blinded 2-week intervention and immediate post-intervention assessment, participants may enter the separately registered rehabilitation pathway (NCT07521280). Subsequent rehabilitation and other treatment exposure will be documented when interpreting the 3-month follow-up outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized to active photobiomodulation (low-level laser therapy) or sham treatment. The sham procedure uses an identical device and treatment routine but does not deliver therapeutic light. Participants and outcome assessors will be blinded to group assignment. Investigators responsible for study oversight and data analysis will remain blinded until the database is locked.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10 to 17 years
- •Participates in organized sport with at least 12 months of training history
- •Has knee pain at the tibial tubercle (Osgood-Schlatter-type pain) and/or heel pain at the back of the heel (Sever-type pain)
- •Pain is worse with activity and reproduced by pressing on the painful area
- •Pain intensity is 3 out of 10 or higher on the Numeric Pain Rating Scale (NPRS) during the clinical visit and in the last week (0 = no pain, 10 = worst pain imaginable)
- •Symptoms have been present for at least 2 weeks
- •For heel pain consistent with Sever disease, the heel squeeze test is positive
- •Ultrasound shows findings consistent with an apophyseal injury at the painful site
- •Has no signs of acute illness or infection on the assessment day and during the previous 14 days (for example, fever or "flu-like" symptoms)
- •A parent/guardian provides written informed consent
- •The participant provides assent (agreement) to take part
排除标准
- •Current pain episode started after an acute injury (for example, fall, collision, ankle sprain, or similar trauma)
- •Prior surgery on the lower limb
- •Known diagnosis of patellofemoral pain syndrome (pain around/behind the kneecap)
- •Known patellar instability (recurrent kneecap dislocations or giving way)
- •Known complex regional pain syndrome
- •History of lower-limb fracture
- •Ultrasound shows clinically important abnormalities in the assessed area that are not consistent with the target condition (for example, calcifications or other significant findings)
- •Known chronic or systemic disease that may affect the musculoskeletal system (for example, inflammatory joint disease or other clinically significant chronic conditions)
- •Received any of the following in the last 3 months: steroid injection, hydrodilatation, or laser therapy
- •Used non-steroidal anti-inflammatory drugs (NSAIDs) (for example, ibuprofen, naproxen) within the last 14 days, or currently uses them
- •Clinically important abnormal blood test results (complete blood count) that may affect safety or data validity
- •Parent/guardian or participant does not agree to participate, or withdraws consent/assent
研究组 & 干预措施
Active Photobiomodulation (Low-Level Laser Therapy)
Participants will receive active photobiomodulation (low-level laser therapy) applied to the symptomatic apophyseal region (tibial tubercle for Osgood-Schlatter-type pain and/or calcaneal region for Sever-type pain) using standardized device settings and application procedures. Treatment will be delivered in a series of sessions over the intervention period. All participants will also receive the same standardized conservative-care guidance (e.g., education and exercise/activity advice) provided to both study arms.
干预措施: Photobiomodulation (Low-Level Laser Therapy) (Device)
Sham Comparator
Participants will receive sham (placebo) laser treatment using the same device appearance, positioning, contact, and session schedule as the active intervention, but without delivery of therapeutic light. The sham procedure is designed to maintain blinding. All participants will also receive the same standardized conservative-care guidance (e.g., education and exercise/activity advice) provided to both study arms.
干预措施: Sham Photobiomodulation (Sham Laser Treatment) (Device)
结局指标
主要结局
Data completeness feasibility: proportion of complete datasets for key clinical outcomes
时间窗: Baseline to follow-up (≈3 months).
Proportion of participants with complete NPRS/PGIC; threshold ≥90% complete.
Recruitment feasibility: proportion of eligible participants enrolled
时间窗: From first screening contact through completion of enrollment.
Proportion enrolled among eligible candidates; threshold ≥80% within the recruitment window.
Retention feasibility: proportion completing post-intervention and follow-up assessments
时间窗: Baseline to post-intervention (≈2 weeks) and baseline to follow-up (≈3 months).
Proportion with complete assessments at baseline and post-intervention; threshold ≤20% attrition.
Adherence feasibility: proportion of intervention sessions completed
时间窗: During the 2-week intervention period.
Percentage of planned sessions completed (10 total); threshold ≥8/10 sessions and ≥80% adherence.
Safety and tolerability: number and type of adverse events related to the intervention
时间窗: During the 2-week intervention period.
Count and classification of adverse events temporally associated with treatment sessions.
次要结局
- Proportion of Participants Rated as Responders on the Patient Global Impression of Change (PGIC) at 2 Weeks(2 weeks)
- Proportion of Participants Rated as Responders on the Patient Global Impression of Change (PGIC) at 3 Months(3 months)
- Change From Baseline in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) at 2 Weeks(Baseline and 2 weeks)
- Change From Baseline in Pain Intensity as Measured by the Numeric Pain Rating Scale (NPRS) at 3 Months(Baseline and 3 months)
- Change From Baseline in Pediatric Function as Measured by the Pediatric Outcomes Data Collection Instrument (PODCI) at 2 Weeks(Baseline and 2 weeks)
- Change From Baseline in Pediatric Function as Measured by the Pediatric Outcomes Data Collection Instrument (PODCI) at 3 Months(Baseline and 3 months)
- Change From Baseline in Knee Function as Measured by the KOOS-Child at 2 Weeks (Osgood-Schlatter Subgroup)(Baseline and 2 weeks)
- Change From Baseline in Knee Function as Measured by the KOOS-Child at 3 Months (Osgood-Schlatter Subgroup)(Baseline and 3 months)
- Change From Baseline in Foot/Ankle Function (OxAFQ-C) at Post-intervention (2 weeks), Sever Subgroup Only(Baseline and 2 weeks)
- Change From Baseline in Foot/Ankle Function (OxAFQ-C) at Follow-up (3 months), Sever Subgroup Only(Baseline and 3 months)
研究者
Bartosz Wilczyński
Principal Investigator
Medical University of Gdansk