Osteoporosis SecondaryNCT05616611
High-Intensity Laser Therapy Versus Shockwave Therapy in Osteoporotic Long Term Hemiparetic Patients
A study testing High-Intensity laser, Traditional physiotherapy exercises and Shock Wave therapy in people with Osteoporosis Secondary, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Background: The relationship between immobilization and localized osteoporosis is well documented in chronic stroke patients. Hemiparetic patients are predisposed to fractures and usual activity impairment due to a considerable loss of bone density. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Osteoporosis Secondary
- What is being tested?
- High-Intensity laser, Traditional physiotherapy exercises and Shock Wave therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Mar 2022
- 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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants were diagnosed by Dual-energy X-ray absorptiometry (DEXA) as osteoporosis or osteopenia, where T-score was -1.5 or less.
- All patients were recruited from Kasr Al-Ainy Hospital, Cairo University.
Who cannot join
- BMI of more than 30 or less than 18
- Advanced musculoskeletal disorders.
- Rheumatoid arthritis.
- Skin diseases.
- Long-term steroids therapy, or any drug affecting bones.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Intensity Laser Therapy Versus Shockwave Therapy on Selected Outcome Measures in Osteoporotic Long Term Hemiparetic Patients: A Randomized Control Trial
Background: The relationship between immobilization and localized osteoporosis is well documented in chronic stroke patients. Hemiparetic patients are predisposed to fractures and usual activity impairment due to a considerable loss of bone density. A serious health care challenge is finding ways to reduce osteoporosis and associated fractures among stroke survivors. This study aimed to compare the effects of HILT and ESWT in treating osteoporosis and its consequences in hemiparetic patients.
Patients and Methods: A randomized controlled trial was performed at the Faculty of Physical Therapy Outpatient Clinic, Cairo University. One hundred and twenty hemiplegic patients with osteoporosis of both sexes were chosen randomly. They were randomly classified into three equal groups (n=40 in each group). The control group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise). The high-intensity laser (HIL) group received the same intervention as the control group in addition to high-intensity laser therapy. The shock wave (SW) group received the same intervention as the control group in addition to shock wave therapy. The three groups received an intervention that lasted 3 sessions/week for 12 weeks). All groups were assessed before and after therapy (3 months) for the degree of pain, which was evaluated by visual analog scale (VAS), fall risk assessment (overall stability index and Short Form of Berg Balance Scale (SFBBS)), and Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41).
Read the detailed description
randomized controlled trial was performed at the Faculty of Physical Therapy Outpatient Clinic, Cairo University. One hundred and twenty hemiplegic patients with osteoporosis of both sexes were chosen randomly. They were randomly classified into three equal groups (n=40 in each group). The control group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise). The high-intensity laser (HIL) group received the same intervention as the control group in addition to high-intensity laser therapy. The shock wave (SW) group received the same intervention as the control group in addition to shock wave therapy. The three groups received an intervention that lasted 3 sessions/week for 12 weeks). All groups were assessed before and after therapy (3 months) for the degree of pain, which was evaluated by visual analog scale (VAS), fall risk assessment (overall stability index and Short Form of Berg Balance Scale (SFBBS)), and Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41).
- Conditions
- Osteoporosis Secondary
- Being tested
- High-Intensity laser, Traditional physiotherapy exercises, Shock Wave therapy
- Keywords
- Shock Wave, High intensity laser, Osteoporosis, Hemiplegia
- Medical subject headings
- Osteoporosis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity laserRadiation
intervention that lasted 3 sessions/week for 12 weeks).
Traditional physiotherapy exercisesOther
intervention that lasted 3 sessions/week for 12 weeks).
Shock Wave therapyRadiation
intervention that lasted 3 sessions/week for 12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | control group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise) Receives: Other: Traditional physiotherapy exercises |
| high-intensity laser group | Experimental | The high-intensity laser (HIL) group received the same intervention as the control group in addition to high-intensity laser therapy. Receives: Radiation: High-Intensity laser |
| shock wave group | Experimental | shock wave (SW) group received the same intervention as the control group in addition to shock wave therapy. Receives: Radiation: Shock Wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)
Quality of Life Questionnaire of the European Foundation for Osteoporosis
Measured: 12 weeks
Pain intensity
Visual analogue scale, a scale of 10 poi to 0 represent no pain at all and 10 represent the worst pain
Measured: 12 weeks
fall risk assessment
Short Form of Berg Balance Scale ,(SFBBS) ranged from 0 poor balance to 28 good balance.consisted of 7 items each item has grades from 1 poor balance to 4 good balance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Oct 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis SecondaryStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Ibrahim Abo Elyazed, Beni-Suef University
- Investigators
- Mohamed A Adel, Mr, Study director, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616611
- Sponsor's protocol ID
- BeniSuefU1
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available on personal request
Publications
Abo Elyazed TI, Al-Azab IM, Abd El-Hakim AAE, Elkady SM, Afifi RMM, Obaya HE. Effect of high-intensity laser therapy versus shockwave therapy on selected outcome measures in osteoporotic long-term hemiparetic patients: a randomized control trial. J Orthop Surg Res. 2023 Sep 2;18(1):653. doi: 10.1186/s13018-023-04141-5.
PubMed 37660042
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Laser Therapy Versus Shockwave Therapy on Selected Outcome Measures in Osteoporotic Long Term Hemiparetic Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05616611
- Acronym / sponsor ID
- BeniSuefU1
- Conditions
- Osteoporosis Secondary
- Keywords
- Shock Wave, High intensity laser, Osteoporosis, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 15 Nov 2022 (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.
Background: The relationship between immobilization and localized osteoporosis is well documented in chronic stroke patients. Hemiparetic patients are predisposed to fractures and usual activity impairment due to a considerable loss of bone density. A serious health care challenge is finding ways to reduce osteoporosis and associated fractures among stroke survivors. This study aimed to compare the effects of HILT and ESWT in treating osteoporosis and its consequences in hemiparetic patients.
Patients and Methods: A randomized controlled trial was performed at the Faculty of Physical Therapy Outpatient Clinic, Cairo University. One hundred and twenty hemiplegic patients with osteoporosis of both sexes were chosen randomly. They were randomly classified into three equal groups (n=40 in each group). The control group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise). The high-intensity laser (HIL) group received the same intervention as the control group in addition to high-intensity laser therapy. The shock wave (SW) group received the same intervention as the control group in addition to shock wave therapy. The three groups received an intervention that lasted 3 sessions/week for 12 weeks). All groups were assessed before and after therapy (3 months) for the degree of pain, which was evaluated by visual analog scale (VAS), fall risk assessment (overall stability index and Short Form of Berg Balance Scale (SFBBS)), and Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41).
Detailed description
randomized controlled trial was performed at the Faculty of Physical Therapy Outpatient Clinic, Cairo University. One hundred and twenty hemiplegic patients with osteoporosis of both sexes were chosen randomly. They were randomly classified into three equal groups (n=40 in each group). The control group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise). The high-intensity laser (HIL) group received the same intervention as the control group in addition to high-intensity laser therapy. The shock wave (SW) group received the same intervention as the control group in addition to shock wave therapy. The three groups received an intervention that lasted 3 sessions/week for 12 weeks). All groups were assessed before and after therapy (3 months) for the degree of pain, which was evaluated by visual analog scale (VAS), fall risk assessment (overall stability index and Short Form of Berg Balance Scale (SFBBS)), and Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Traditional physiotherapy exercisescontrol group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise) |
| high-intensity laser group | Experimental | Radiation: High-Intensity laserThe high-intensity laser (HIL) group received the same intervention as the control group in addition to high-intensity laser therapy. |
| shock wave group | Experimental | Radiation: Shock Wave therapyshock wave (SW) group received the same intervention as the control group in addition to shock wave therapy. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All participants were diagnosed by Dual-energy X-ray absorptiometry (DEXA) as osteoporosis or osteopenia, where T-score was -1.5 or less.
- All patients were recruited from Kasr Al-Ainy Hospital, Cairo University.
Key exclusion criteria (5 listed)
- BMI of more than 30 or less than 18
- Advanced musculoskeletal disorders.
- Rheumatoid arthritis.
- Skin diseases.
- Long-term steroids therapy, or any drug affecting bones.
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 |
|---|---|---|
| High-Intensity laserintervention that lasted 3 sessions/week for 12 weeks). | Radiation | high-intensity laser group |
| Traditional physiotherapy exercisesintervention that lasted 3 sessions/week for 12 weeks). | Other | Control group |
| Shock Wave therapyintervention that lasted 3 sessions/week for 12 weeks). | Radiation | shock wave group |
Primary outcome
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)
Time frame: 12 weeks
Quality of Life Questionnaire of the European Foundation for Osteoporosis
Pain intensity
Time frame: 12 weeks
Visual analogue scale, a scale of 10 poi to 0 represent no pain at all and 10 represent the worst pain
fall risk assessment
Time frame: 12 weeks
Short Form of Berg Balance Scale ,(SFBBS) ranged from 0 poor balance to 28 good balance.consisted of 7 items each item has grades from 1 poor balance to 4 good balance
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 15 Nov 2022.
- Derived from this study: PubMed 37660042Abo Elyazed TI, Al-Azab IM, Abd El-Hakim AAE, Elkady SM, Afifi RMM, Obaya HE. Effect of high-intensity laser therapy versus shockwave therapy on selected outcome measures in osteoporotic long-term hemiparetic patients: a randomized control trial. J Orthop Surg Res. 2023 Sep 2;18(1):653. doi: 10.1186/s13018-023-04141-5.
- Individual participant dataSharing planned: No. IPD will be available on personal request
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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.
Mohamed A Adel, Mr study director
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity laser, Traditional physiotherapy exercises and Shock Wave therapy in people with Osteoporosis Secondary, run by Beni-Suef 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 2 inclusion and 5 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 15 Nov 2022. 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?
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05616611, which also lists 1 linked publication.
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 15 Nov 2022.