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
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Parallel
High-Intensity Laser Therapy
DevicePulsed near-infrared laser, 7 W, 5 J/cm², applied over the lumbar spine (L1-L5) with a scanning handpiece for about 150 seconds per session, three sessions per week for four weeks (12 sessions total). Delivered in the experimental arm only.
Sham Laser
DeviceA sham device identical in appearance and operation to the active laser but delivering no therapeutic energy. Applied on the same schedule: about 150 seconds per session over the lumbar spine (L1-L5), three sessions per week for four weeks. Delivered in the control arm only, to preserve blinding
Standardised Physiotherapy Programme
BehavioralA standardised physiotherapy (exercise) programme delivered identically in both arms as a background co-intervention. The programme is the same in content, frequency and duration for all participants, so the comparison isolates the added effect of the active laser versus sham.
Change from baseline in serum procollagen type I N-terminal propeptide (P1NP)
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)
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)
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.
Number of participants with adverse events
Adverse events are monitored throughout the treatment sessions and recorded by type, severity and relationship to the intervention.
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This trial is not recruiting at the moment. You can still explore other options:
