Laser + Cryo-thermal Therapy Following Total Knee Replacement Surgery

NCT04183673 | Completed

• 1 other identifier: 2200 CE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Objective To investigate the effectiveness of the use of the QMD Helios Laser device in association with standard rehabilitation therapy in reducing inflammatory symptoms in patients following total knee replacement. Design Randomized controlled trial. Setting Rehabilitation structure, inpatient Main outcome measures Pain subscale of the WOMAC and Lequesne's Algo-Functional Index (LIKERT scale), knee circumference (measured at the middle line of the knee joint space) and knee flexion /extension range of motion by goniometer.

Conditions

Knee Arthropathy

Keywords

Laser Therapy; Cryotherapy; Thermotherapy; Rehabilitation; knee replacement

Outcome Measures

Primary Outcomes (3)

• Change in Womac Pain subscale

  Pain subscale of the Western Ontario and McMaster Universities Activity Index (scored on a five point (0-4) LIKERT scale)

  Before treatment (admission) and after treatment (3 weeks after admission)

• Change in knee circumference

  Knee circumference measured at the middle line of the knee joint space

  Before treatment (admission) and after treatment (3 weeks after admission)

• Change in Lequesne's algo Functional Index

  Lequesne's algo Functional Index (scored on a five point (0-4) LIKERT scale)

  Before treatment (admission) and after treatment (3 weeks after admission)

Study Arms (2)

Laser-cryo-usual care

EXPERIMENTAL

Sessions 5 days a week for 3 weeks. Each session includes laser therapy+ cryo-thermal followed by standard rehabilitation program

Procedure: Laser therapy-cryo thermal therapy

usual care

ACTIVE COMPARATOR

Sessions 5 days a week for 3 weeks. Each session includes only standard rehabilitation program

Procedure: Usual care

Interventions

Laser therapy-cryo thermal therapy PROCEDURE

5 days per week, 3 weeks, sessions including laser therapy + cryo therapy followed by usual rehabilitation

Laser-cryo-usual care

Usual care PROCEDURE

5 days per week, 3 weeks, sessions of usual rehabilitation

usual care

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• good general physical conditions
• first total knee replacement

You may not qualify if:

• diabetic neuropathy
• renal or hearth disease
• allergic reactions
• Reynaud's disease
• lupus
• rheumatoids arthritis
• peripheral vascular disease

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

ICS Maugeri, Montescano Rehabilitation Center

Montescano, Pavia, 27040, Italy

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 3, 2019
• Study Start: May 29, 2018
• Primary Completion: January 31, 2019
• Study Completion: February 28, 2019
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)