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

November 7, 2022 updated by: Tamer Ibrahim Abo Elyazed, Beni-Suef University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharq
      • Banī Suwayf, Sharq, Egypt, 11222
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Study Director: Mohamed A Adel, Mr, Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeniSuefU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will be available on personal request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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