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

NCT04646863 | Completed DMC

• 1 other identifier: 00400
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis

Keywords

Osteoporosis, LLLT, multiwave locked system laser, Physical therapy modalities, DEXA, Pilates exercises

Outcome Measures

Primary Outcomes (2)

• DEXA

  Model QDR-1000W, NORLAND; Hologic Inc., Waltham, Massachusetts, USA was used to measure bone mineral density (BMD) of the lumbar spine in mg/cm2.

  8 weeks

• Numeric pain rating scale (NPRS)

  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

  8 weeks

Study Arms (3)

group A

EXPERIMENTAL

consists of 20 patients received a multiwave locked system laser

Radiation: laser therapy

group B

EXPERIMENTAL

consists of 20 patients received Pilates exercises

Other: exercise

group C

EXPERIMENTAL

consists of 20 patients received a multiwave locked system laser and Pilates exercises

Other: combination

Interventions

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).

group A

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. 1. Modified Hundred 2. Modified Single Leg Stretch 3. One Leg Circle 4. Modified Scissors

group B

combination OTHER

laser therapy + Pilates exercises

group C

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Bassam

Cairo, Egypt

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Laser Therapy; Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: November 30, 2020
• Study Start: February 12, 2019
• Primary Completion: September 22, 2019
• Study Completion: November 18, 2019
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

EG (1)