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

NCT ID: NCT05616611

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-03-01

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).

Conditions

Osteoporosis Secondary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control group

control group received medication and traditional physiotherapy programs for stroke patients (strengthening, stretching, and balance exercise)

Group Type: ACTIVE_COMPARATOR

Traditional physiotherapy exercises

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

High-Intensity laser

Intervention Type: RADIATION

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

shock wave group

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

Group Type: EXPERIMENTAL

Shock Wave therapy

Intervention Type: RADIATION

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

Interventions

High-Intensity laser

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

Intervention Type: RADIATION

Traditional physiotherapy exercises

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

Intervention Type: OTHER

Shock Wave therapy

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Tamer Ibrahim Abo Elyazed

Ass.prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A Adel, Mr

Role: STUDY_DIRECTOR

Beni-Suef University

Locations

Beni-Suef University

Banī Suwayf, Sharq, Egypt

Countries

Egypt

References

Abo Elyazed TI, Al-Azab IM, Abd El-Hakim AAE, Elkady SM, Afifi RMM, Obaya HE. Effect of high-intensity laser therapy versus shockwave therapy on selected outcome measures in osteoporotic long-term hemiparetic patients: a randomized control trial. J Orthop Surg Res. 2023 Sep 2;18(1):653. doi: 10.1186/s13018-023-04141-5.

Reference Type: DERIVED

PMID: 37660042 (View on PubMed)

Other Identifiers

BeniSuefU1

Identifier Type: -

Identifier Source: org_study_id