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Completed

NCT Number: NCT04646863

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

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bassam

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laser therapy

Radiation

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).

Exercise

Other

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.

  • Modified Hundred
  • Modified Single Leg Stretch
  • One Leg Circle
  • Modified Scissors

combination

Other

laser therapy + Pilates exercises

Primary outcomes

  1. DEXA

    Time frame: 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.

  2. Numeric pain rating scale (NPRS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2020
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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