OsteoporosisNCT04646863
Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial
A study testing laser therapy, exercise and combination in people with Osteoporosis, run by October 6 University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- laser therapy, exercise and combination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2019to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with osteoporosis (T-score values below -2.5)
Who cannot join
- Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- laser therapy, exercise, combination
- Keywords
- Osteoporosis, LLLT, multiwave locked system laser, Physical therapy modalities, DEXA, Pilates exercises
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapyRadiation
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).
exerciseOther
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
combinationOther
laser therapy + Pilates exercises
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | consists of 20 patients received a multiwave locked system laser Receives: Radiation: laser therapy |
| group B | Experimental | consists of 20 patients received Pilates exercises Receives: Other: exercise |
| group C | Experimental | consists of 20 patients received a multiwave locked system laser and Pilates exercises Receives: Other: combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start12 Feb 2019
- Primary completion22 Sep 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Eldin Mohamed, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646863
- Sponsor's protocol ID
- 00400
- Status last verified
- Nov 2020
- First submitted
- 21 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04646863
- Acronym / sponsor ID
- 00400
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, LLLT, multiwave locked system laser, Physical therapy modalities, DEXA, Pilates exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 22 Sep 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Radiation: laser therapyconsists of 20 patients received a multiwave locked system laser |
| group B | Experimental | Other: exerciseconsists of 20 patients received Pilates exercises |
| group C | Experimental | Other: combinationconsists of 20 patients received a multiwave locked system laser and Pilates exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with osteoporosis (T-score values below -2.5)
Key exclusion criteria (1 listed)
- Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to the back area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser therapyperformed 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). | Radiation | group A |
| exerciseThe 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 | Other | group B |
| combinationlaser therapy + Pilates exercises | Other | group C |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy, exercise and combination in people with Osteoporosis, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEXA (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.