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

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Other: combination; Other: exercise; Radiation: laser therapy

• Registration Number: NCT04646863
• Lead Sponsor: October 6 University

Brief 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.

Study Timeline

• Study Start: 2019-02-12
• Primary Completion: 2019-09-22
• Study Completion: 2019-11-18
• Status Verified: 2020-11
• Study First Submitted: 2020-11-21
• Study First Submitted QC: 2020-11-26
• Last Update Submitted: 2020-11-28
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with osteoporosis (T-score values below -2.5)

Exclusion Criteria

• Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	combination	consists of 20 patients received a multiwave locked system laser and Pilates exercises
group B	exercise	consists of 20 patients received Pilates exercises
group A	laser therapy	consists of 20 patients received a multiwave locked system laser

Primary Outcome Measures

Name	Time	Method
DEXA	8 weeks	Model QDR-1000W, NORLAND; Hologic Inc., Waltham, Massachusetts, USA was used to measure bone mineral density (BMD) of the lumbar spine in mg/cm2.
Numeric pain rating scale (NPRS)	8 weeks	Pain intensity was measured by using NPRS which consists of an11-points numeric scale range from '0' representing 'no pain' to '10' representing 'the worst pain'. All patients were instructed to choose a number from 0 to 10 that describe their pain. The classification of pain intensity on the scale was: 0 indicate no pain, points from 1-3 indicate mild pain, points from 4-6 indicate moderate pain, and points from 7-10 indicate severe pain

Trial Locations

Locations (1)

Bassam; 🇪🇬 Cairo, Egypt