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NCT Number: NCT05616611

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

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).

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Key information

Conditions

Osteoporosis Secondary Bone Diseases Bone Diseases, Metabolic Hemiplegia Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Osteoporosis Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University

Banī Suwayf, Sharq, 11222, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-Intensity laser

Radiation

intervention that lasted 3 sessions/week for 12 weeks).

Traditional physiotherapy exercises

Other

intervention that lasted 3 sessions/week for 12 weeks).

Shock Wave therapy

Radiation

intervention that lasted 3 sessions/week for 12 weeks).

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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