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

NCT05616611 | Completed

• 1 other identifier: BeniSuefU1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoporosis Secondary

Keywords

Shock Wave; High intensity laser; Osteoporosis; Hemiplegia

Outcome Measures

Primary Outcomes (3)

• Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41)

  Quality of Life Questionnaire of the European Foundation for Osteoporosis

  12 weeks

• Pain intensity

  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

  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

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Other: Traditional physiotherapy exercises

high-intensity laser group

EXPERIMENTAL

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

shock wave group

EXPERIMENTAL

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

Radiation: Shock Wave therapy

Interventions

High-Intensity laser RADIATION

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

high-intensity laser group

Traditional physiotherapy exercises OTHER

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

Control group

Shock Wave therapy RADIATION

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

shock wave group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University

Banī Suwayf, Sharq, 11222, Egypt

Location

Related Publications (1)

• 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.

  PMID: 37660042 DERIVED

MeSH Terms

Conditions

Osteoporosis; Hemiplegia

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mohamed A Adel, Mr

  Beni-Suef University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.prof

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 15, 2022
• Study Start: October 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)