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

Primary Purpose

Osteoporosis Secondary

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High-Intensity laser
Traditional physiotherapy exercises
Shock Wave therapy
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoporosis Secondary focused on measuring Shock Wave, High intensity laser, Osteoporosis, Hemiplegia

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beni-Suef University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group

high-intensity laser group

shock wave group

Arm Description

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.

shock wave (SW) group received the same intervention as the control group in addition to shock wave therapy.

Outcomes

Primary Outcome Measures

Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)
Quality of Life Questionnaire of the European Foundation for Osteoporosis
Pain intensity
Visual analogue scale, a scale of 10 poi to 0 represent no pain at all and 10 represent the worst pain
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

Secondary Outcome Measures

Full Information

First Posted
November 1, 2022
Last Updated
November 7, 2022
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05616611
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Secondary
Keywords
Shock Wave, High intensity laser, Osteoporosis, Hemiplegia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
control group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise)
Arm Title
high-intensity laser group
Arm Type
Experimental
Arm Description
The high-intensity laser (HIL) group received the same intervention as the control group in addition to high-intensity laser therapy.
Arm Title
shock wave group
Arm Type
Experimental
Arm Description
shock wave (SW) group received the same intervention as the control group in addition to shock wave therapy.
Intervention Type
Radiation
Intervention Name(s)
High-Intensity laser
Intervention Description
intervention that lasted 3 sessions/week for 12 weeks).
Intervention Type
Other
Intervention Name(s)
Traditional physiotherapy exercises
Intervention Description
intervention that lasted 3 sessions/week for 12 weeks).
Intervention Type
Radiation
Intervention Name(s)
Shock Wave therapy
Intervention Description
intervention that lasted 3 sessions/week for 12 weeks).
Primary Outcome Measure Information:
Title
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)
Description
Quality of Life Questionnaire of the European Foundation for Osteoporosis
Time Frame
12 weeks
Title
Pain intensity
Description
Visual analogue scale, a scale of 10 poi to 0 represent no pain at all and 10 represent the worst pain
Time Frame
12 weeks
Title
fall risk assessment
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Adel, Mr
Organizational Affiliation
Beni-Suef University
Official's Role
Study Director
Facility Information:
Facility Name
Beni-Suef University
City
Banī Suwayf
State/Province
Sharq
ZIP/Postal Code
11222
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available on personal request

Learn more about this trial

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

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