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

NCT07734922 | Not Yet Recruiting

• 1 other identifier: NR. AVZ 4/13 IAN 2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis, Postmenopausal; Osteopenia

Keywords

High-Intensity Laser Therapy; Laser Therapy; Exercise Therapy; Physical Therapy Modalities; Bone Remodeling; Bone Density; Procollagen Type I N-Terminal Propeptide; Menopause; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and end of the 4-week intervention

• 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.

  Baseline and end of the 4-week intervention

• 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.

  Baseline and end of the 4-week intervention

Secondary Outcomes (1)

• Number of participants with adverse events

  Throughout the 4-week treatment period

Study Arms (2)

High-Intensity Laser Therapy + Physiotherapy

EXPERIMENTAL

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 + Physiotherapy

SHAM 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; Behavioral: Standardised Physiotherapy Programme

Interventions

High-Intensity Laser Therapy DEVICE

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.

Also known as: HILT

High-Intensity Laser Therapy + Physiotherapy

Sham Laser DEVICE

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

Also known as: Placebo laser

Sham Laser + Physiotherapy

Standardised Physiotherapy Programme BEHAVIORAL

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.

Also known as: Kinesiotherapy

High-Intensity Laser Therapy + Physiotherapy; Sham Laser + Physiotherapy

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Clinical Rehabilitation Hospital

Cluj-Napoca, Cluj, 400347, Romania

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Titus Vari, MD

CONTACT

+40 743 081 588; titus.vari@elearn.umfcluj.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Conf. Dr. Viorela Mihaela Ciortea

Model Details: Two parallel arms with 1:1 allocation. A standardised physiotherapy programme is delivered identically in both arms as a background co-intervention; the experimental arm additionally receives active high-intensity laser therapy and the control arm a sham laser.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)