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High-Intensity Laser Therapy and Physiotherapy for Bone Health in Postmenopausal Women: A Randomized Trial

NCT07734922 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-29

No results posted yet for this study

Summary

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

Conditions

  • Osteoporosis, Postmenopausal
  • Osteopenia

Interventions

DEVICE

High-Intensity Laser Therapy

Pulsed 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.

DEVICE

Sham Laser

A 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

BEHAVIORAL

Standardised Physiotherapy Programme

A 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.

Sponsors & Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-27
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734922 on ClinicalTrials.gov