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

• ClinicalTrials.gov Identifier: NCT04646863
• Recruitment Status: Completed
• First Posted: November 30, 2020
• Last Update Posted: December 1, 2020
• Sponsor: October 6 University
• Information provided by (Responsible Party): Emad Eldin Mohamed, October 6 University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Osteoporosis	Radiation: laser therapy; Other: exercise; Other: combination	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial
• Actual Study Start Date: February 12, 2019
• Actual Primary Completion Date: September 22, 2019
• Actual Study Completion Date: November 18, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: group A; consists of 20 patients received a multiwave locked system laser	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).
Experimental: group B; consists of 20 patients received Pilates exercises	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.; Modified Hundred; Modified Single Leg Stretch; One Leg Circle; Modified Scissors
Experimental: group C; consists of 20 patients received a multiwave locked system laser and Pilates exercises	Other: combination; laser therapy + Pilates exercises

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Egypt

Bassam

Cairo, Egypt

Sponsors and Collaborators

October 6 University

More Information

• Responsible Party: Emad Eldin Mohamed, Clinical Professor, October 6 University
• ClinicalTrials.gov Identifier: NCT04646863
• Other Study ID Numbers: 00400
• First Posted: November 30, 2020
• Last Update Posted: December 1, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emad Eldin Mohamed, October 6 University:

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

Additional relevant MeSH terms:

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases