Clinical trial NCT05616611: High-Intensity Laser Therapy Versus Shockwave Therapy in Osteoporotic Long Term Hemiparetic Patients
Official title: High-Intensity Laser Therapy Versus Shockwave Therapy on Selected Outcome Measures in Osteoporotic Long Term Hemiparetic Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis Secondary
Keywords: Shock Wave
High intensity laser
Osteoporosis
Hemiplegia
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)
timeFrame: 12 weeks
measure: Pain intensity
timeFrame: 12 weeks
measure: fall risk assessment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University
state: Sharq
Study officials:
affiliation: Beni-Suef University
name: Mohamed A Adel, Mr
role: STUDY_DIRECTOR
References: