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

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

Overview

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

Detailed description

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.

Analyses follow the intention-to-treat principle on all randomised participants, with a per-protocol analysis as a supportive check. For each measure, the change from baseline is compared between arms using parametric or non-parametric tests as appropriate, with results reported as effect sizes and 95% confidence intervals. Safety is monitored throughout the treatment sessions.

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.

Primary outcome measures

• Change from baseline in serum procollagen type I N-terminal propeptide (P1NP) [Time frame: Baseline and end of the 4-week intervention]
• Change from baseline in health-related quality of life (Short Form-36, SF-36) [Time frame: Baseline and end of the 4-week intervention]
• Change from baseline in osteoporosis-specific quality of life (Qualeffo-41) [Time frame: Baseline and end of the 4-week intervention]

Secondary outcome measures (1)

• Number of participants with adverse events [Time frame: Throughout the 4-week treatment period]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Romania · 1 center

• Clinical Rehabilitation Hospital — Cluj-Napoca

Publications

• Coroleuca R, Filipoiu FM, Cherecheanu AP, Enyedi M, Bucsan R, Bostan M, Coroleuca CA, Ladea L, Vrinceanu D, Moraru OE, Iancu R. Laser Scanning Morphometric Measurements of the Main Orbital Communications in Dry Human Skulls. Diagnostics (Basel). 2024 Sep 29;14(19):2168. doi: 10.3390/diagnostics14192168. PMID 39410572
• Fallahnezhad S, Jajarmi V, Shahnavaz S, Amini A, Ghoreishi SK, Kazemi M, Chien S, Bayat M. Improvement in viability and mineralization of osteoporotic bone marrow mesenchymal stem cell through combined application of photobiomodulation therapy and oxytocin. Lasers Med Sci. 2020 Apr;35(3):557-566. doi: 10.1007/s10103-019-02848-8. Epub 2019 Aug 9. PMID 31399862
• Lee DO, Hong YH, Cho MK, Choi YS, Chun S, Chung YJ, Hong SH, Hwang KR, Kim J, Kim H, Lee DY, Lee SR, Park HT, Seo SK, Shin JH, Song JY, Yi KW, Paik H, Lee JY. The 2024 Guidelines for Osteoporosis - Korean Society of Menopause: Part I. J Menopausal Med. 2024 Apr;30(1):1-23. doi: 10.6118/jmm.24000. No abstract available. PMID 38714490
• Abo Elyazed TI, Al-Azab IM, Abd El-Hakim AAE, Elkady SM, Afifi RMM, Obaya HE. Effect of high-intensity laser therapy versus shockwave therapy on selected outcome measures in osteoporotic long-term hemiparetic patients: a randomized control trial. J Orthop Surg Res. 2023 Sep 2;18(1):653. doi: 10.1186/s13018-023-04141-5. PMID 37660042
• Alayat MSM, Abdel-Kafy EM, Thabet AAM, Abdel-Malek AS, Ali TH, Header EA. Long-Term Effect of Pulsed Nd-YAG Laser Combined with Exercise on Bone Mineral Density in Men with Osteopenia or Osteoporosis: 1 Year of Follow-Up. Photomed Laser Surg. 2018 Feb;36(2):105-111. doi: 10.1089/pho.2017.4328. Epub 2017 Oct 25. PMID 29068756
• Macedo P, Cavalcante A, Fernandes S, Salustiano M, Lima M, Jerez-Roig J, Camara S. Association between menopausal status and physical function: A systematic review protocol. PLoS One. 2023 Jan 24;18(1):e0280786. doi: 10.1371/journal.pone.0280786. eCollection 2023. PMID 36693069

Identifiers

NCT: NCT07734922 · NR. AVZ 4/13 IAN 2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗