High-Intensity Laser Therapy Versus Shockwave Therapy in Osteoporotic Long Term Hemiparetic Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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High-Intensity Laser Therapy Versus Shockwave Therapy on Selected Outcome Measures in Osteoporotic Long Term Hemiparetic Patients: A Randomized Control Trial

Conditions
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Osteoporosis Secondary

Intervention / Treatment
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* Radiation: High-Intensity laser
* Other: Traditional physiotherapy exercises
* Radiation: Shock Wave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>control group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise) | Other: Traditional physiotherapy exercises<br>* intervention that lasted 3 sessions/week for 12 weeks).<br>|
| Experimental: high-intensity laser group<br>The high-intensity laser (HIL) group received the same intervention as the control group in addition to high-intensity laser therapy. | Radiation: High-Intensity laser<br>* intervention that lasted 3 sessions/week for 12 weeks).<br>|
| Experimental: shock wave group<br>shock wave (SW) group received the same intervention as the control group in addition to shock wave therapy. | Radiation: Shock Wave therapy<br>* intervention that lasted 3 sessions/week for 12 weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) | Quality of Life Questionnaire of the European Foundation for Osteoporosis | 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 | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock Wave, High intensity laser, Osteoporosis, Hemiplegia