The Effects of High-Intensity Laser Therapy Combined With Physiotherapy on Bone Turnover and Bone Mineral Density in Postmenopausal Women With Osteopenia or Osteoporosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in serum procollagen type I N-terminal propeptide (P1NP)
研究概览
简要总结
The goal of this clinical trial is to learn if adding high-intensity laser therapy (HILT) to a physiotherapy programme helps bone health in women after menopause who have low bone density (osteopenia or osteoporosis). It also looks at safety and quality of life.
The main questions it aims to answer are:
Does adding high-intensity laser therapy change a blood marker of bone formation called P1NP? Does adding high-intensity laser therapy improve participants' quality of life? Researchers will compare a group that gets physiotherapy plus real laser therapy with a group that gets physiotherapy plus a sham laser (a look-alike treatment that gives no real laser energy). This shows if the laser itself makes a difference.
Participants will:
Do the same physiotherapy programme, 3 times a week for 4 weeks Get either real or sham laser therapy at each session Give blood samples before and after treatment to measure the bone marker Fill in two quality-of-life questionnaires before and after treatment Have one bone density scan (DXA) at the start to check they can take part
详细描述
Bone loss accelerates after menopause because of the decline in oestrogen, raising the risk of progression from osteopenia to osteoporosis and of fractures. Current medication options are largely preventive and have limitations. High-intensity laser therapy (HILT) combined with physiotherapy is a non-invasive physical treatment that may stimulate bone formation with a favourable safety profile, but robust evidence in postmenopausal bone health is limited.
This is a randomised, double-blind, placebo (sham)-controlled, parallel-group interventional trial with two equal arms. A standardised physiotherapy programme is delivered identically in both arms as a background co-intervention, so the comparison isolates the added effect of active HILT versus sham.
Randomisation uses permuted blocks of four with 1:1 allocation, concealed with sealed opaque envelopes. Participants, the physiotherapist, the outcome assessor and the statistician are all blinded to allocation.
Intervention parameters: pulsed HILT in the near-infrared spectrum, 7 W, 5 J/cm², applied over the lumbar region (L1-L5) with a scanning handpiece for approximately 150 seconds per session, three sessions per week for four weeks. The sham arm follows an identical procedure with a device that delivers no therapeutic laser energy.
The bone-formation marker P1NP is measured in peripheral blood by ELISA (ng/mL). To avoid the confounding effect of acute exercise on bone turnover markers, the post-treatment sample is collected 72 hours (minimum 48 hours) after the last physiotherapy session, before any further physical activity, and all samples are analysed in a single batch.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The statistician is also blinded to allocation until the analysis is complete. The sham device is identical in appearance and operation to the active laser.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women Osteopenia or osteoporosis diagnosed by DXA (T-score below -1.0) Age 50 to 70 years Body mass index (BMI) between 18.5 and 30 Provides written informed consent
排除标准
- •History of fractures Use of agents that may interfere with bone metabolism (e.g., bisphosphonates, glucocorticoids, hormone therapy) Severe comorbidities or decompensation of pre-existing conditions Recent physiotherapy (within the past 3 months) Rheumatologic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) High-dose calcium or vitamin D supplementation Contraindications to laser therapy (cancer, active bleeding or bleeding disorders, acute infections, photosensitivity, pregnancy, implanted electronic devices, or other conditions that could interfere with laser treatment)
结局指标
主要结局
Change from baseline in serum procollagen type I N-terminal propeptide (P1NP)
时间窗: Baseline and end of the 4-week intervention
P1NP is a marker of bone formation, measured in peripheral blood by enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. The post-intervention sample is collected 72 hours (minimum 48 hours) after the last physiotherapy session, before any further physical activity, and all samples are analysed in a single batch.
Change from baseline in health-related quality of life (Short Form-36, SF-36)
时间窗: Baseline and end of the 4-week intervention
SF-36 is a general health-related quality-of-life questionnaire. Scores range from 0 to 100, with higher scores indicating better quality of life.
Change from baseline in osteoporosis-specific quality of life (Qualeffo-41)
时间窗: Baseline and end of the 4-week intervention
Qualeffo-41 is a quality-of-life questionnaire specific to osteoporosis. Total scores range from 0 to 100; higher scores indicate poorer quality of life.
次要结局
- Number of participants with adverse events(Throughout the 4-week treatment period)
研究者
Viorela Mihaela Ciortea
Conf. Dr. Viorela Mihaela Ciortea
Iuliu Hatieganu University of Medicine and Pharmacy