NCT04646863

Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: October 6 University · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

the current study was to investigate the effect of class IV laser therapy and Pilates exercises on bone density in Osteoporosis.Sixty patients with osteoporosis (T-score values below -2.5) in lumbar spine with no evidence of vertebral compression fractures were recruited from October 6 University Hospital and Kaser El-aini Hospital, Cairo - Egypt from February 2019 to November 2019. Their age ranged from 40 to 60 years old. Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area were excluded from the study

Detailed description

They were allocated randomly into three groups: Group A consists of 20 patients received a multiwave locked system laser, group B consists of 20 patients received Pilates exercises and group C consists of 20 patients received a multiwave locked system laser and Pilates exercises. Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area were excluded from the study. All patients who participated in the current study did not intake any medications to accelerate bone density like vitamin D or calcium. The randomization method was applied by asking each patient to choose a piece of paper that the (A), (B), or (C) letter was written. (A) considered the LLLT group, (B) considered the Pilates exercise group, while (C) considered the LLLT and Pilates exercises group. Both patients, the examiner, and therapist were blinded from the selection process.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
RADIATION	laser therapy	performed by MLS® Laser Therapy (ASA Srl, Vicenza, Italy). It is designed to synchronize between two modules. One is emitting at 905 nm, with peak optical power = 25 W; each pulse is composed of a pulse train (single pulse width = 100 ns, maximum frequency 90 kHz). The frequency of the pulse trains varied between 1 and 2000 Hz. The other one is emitting at 808 nm in a continuous mode (power 1.1 W) or pulsed mode (pulses repetition rate 1-2000 Hz).
OTHER	exercise	The exercises were applied on a floor mat to achieve a full body workout with 10 repetitions for each exercise and rest for one minute before beginning the next exercise to avoid muscle fatigue as the following. 1. Modified Hundred 2. Modified Single Leg Stretch 3. One Leg Circle 4. Modified Scissors
OTHER	combination	laser therapy + Pilates exercises

Timeline

• Start date: 2019-02-12
• Primary completion: 2019-09-22
• Completion: 2019-11-18
• First posted: 2020-11-30
• Last updated: 2020-12-01

Locations

1 site across 1 country: Egypt