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

NCT ID: NCT04646863

Last Updated: 2020-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2019-11-18

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.

Conditions

Osteoporosis

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A

consists of 20 patients received a multiwave locked system laser

Group Type: EXPERIMENTAL

laser therapy

Intervention Type: 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 B

consists of 20 patients received Pilates exercises

Group Type: EXPERIMENTAL

exercise

Intervention Type: 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 C

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

Group Type: EXPERIMENTAL

combination

Intervention Type: OTHER

laser therapy + Pilates exercises

Interventions

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).

Intervention Type: RADIATION

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

Intervention Type: OTHER

combination

laser therapy + Pilates exercises

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Emad Eldin Mohamed

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bassam

Cairo, , Egypt

Countries

Egypt

Other Identifiers

00400

Identifier Type: -

Identifier Source: org_study_id