- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646863
Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial
November 28, 2020 updated by: Emad Eldin Mohamed, October 6 University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- Bassam
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group A
consists of 20 patients received a multiwave locked system laser
|
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
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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.
|
Experimental: group C
consists of 20 patients received a multiwave locked system laser and Pilates exercises
|
laser therapy + Pilates exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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8 weeks
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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
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2019
Primary Completion (Actual)
September 22, 2019
Study Completion (Actual)
November 18, 2019
Study Registration Dates
First Submitted
November 21, 2020
First Submitted That Met QC Criteria
November 26, 2020
First Posted (Actual)
November 30, 2020
Study Record Updates
Last Update Posted (Actual)
December 1, 2020
Last Update Submitted That Met QC Criteria
November 28, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00400
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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