High-Intensity Laser Therapy and Physiotherapy for Bone Health in Postmenopausal Women: A Randomized Trial | NCT07734922

NCT07734922

Overview

NCT ID: NCT07734922
Lead Sponsor: Iuliu Hatieganu University of Medicine and PharmacyOTHER
Official Title: 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
Brief 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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jul 27, 2026Estimated
Primary Completion Date: Jan 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 40Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Titus Vari, MDContact
titus.vari@elearn.umfcluj.ro+40 743 081 588

Similar Studies

Participant Group/Arms

High-Intensity Laser Therapy + PhysiotherapyExperimental

Participants receive a standardised physiotherapy programme plus active high-intensity laser therapy (HILT). HILT is 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).

Device: High-Intensity Laser Therapy

Behavioral: Standardised Physiotherapy Programme

Sham Laser + PhysiotherapySham Comparator

Participants receive the same standardised physiotherapy programme plus a sham laser. The sham device looks and operates identically to the active laser but delivers no therapeutic energy. It follows the same schedule: about 150 seconds per session over the lumbar spine (L1-L5), three sessions per week for four weeks (12 sessions total).

Device: Sham Laser