For Grade I and II Knee Meniscal Injuries Patients ,Glucosamine, Chondroitin and Some Herbs Extract Phonophoresis Will Be Used (A) Versus Placebo(B)

NCT06798428 | Completed DMC

• 1 other identifier: HAH00014
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: In grade I and II meniscal injury patients, 1) GL and CH (PH) decrease knee pain severity measured by Numerical Rating Scales (NRS) more than only topical application. 2) GL and CH (PH) improve knee functional abilities measured by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) more than only topical application.

Conditions

Grade I and II Knee Meniscal Injuries

Outcome Measures

Primary Outcomes (1)

• pain severity measured by Numerical Rating Scales (NRS)

  zero , no pain .10 maximum pain

  before intervention and two days after last session

Secondary Outcomes (1)

• knee functional abilities measured by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)

  before intervention and two dayes after last sesssion

Study Arms (3)

expermental ( A)

EXPERIMENTAL

group A, will receive ultrasound phonophoresis (Glucosamine, Chondroitin and Some Herbs Extract ) Ultrasound parameters are 1 W/cm for intensity, 1 MHz for frequency and 5 min continuous mode then 5 min pulsed mode

Device: group A will receive ultrasound phonophoresis (Glucosamine, Chondroitin and Some Herbs Extract )

B

EXPERIMENTAL

group B, will receive ultrasound with topical gel , same parameter as group A

Device: Group B will receive ultrasound with topical gel , same parameter as group A

C

SHAM COMPARATOR

group C, will receive ultrasound( machine is off) massage for 5 minutes

Device: Group C sham ultrasound for massage - 5 minutes

Interventions

group A will receive ultrasound phonophoresis (Glucosamine, Chondroitin and Some Herbs Extract ) DEVICE

Group (A)will have GL, CH and natural herbs phonophoresis .Ultrasound parameters are 1 W/cm for intensity, 1 MHz for frequency and 5 min continuous mode then 5 min pulsed mode. The device that will be used is medserve, England (the head of the device is 5cm).

expermental ( A)

Group B will receive ultrasound with topical gel , same parameter as group A DEVICE

Ultrasound parameters are 1 W/cm for intensity, 1 MHz for frequency and 5 min continuous mode then 5 min pulsed mode. The device that will be used is medserve, England (the head of the device is 5cm). Topical gel with no drugs

B

Group C sham ultrasound for massage - 5 minutes DEVICE

sham ultrasound for massage - 5 minutes

C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• grade I or II knee meniscal tear assessed by MRI according to radiologist report, positive McMurray's test assessed by physical therapist and aged from 18 to 60 years.

You may not qualify if:

• We suggest not to include grade III meniscal injury as it is supposed that they need more physical therapy sessions. Ages above 40 is excluded to exclude arthritic changes. Presence of any other knee injury or systemic diseases affecting joints (e.g. rheumatoid arthritis) will be excluded. Patients with body mass index (BMI) more than 30 will be excluded as their knees may have some arthritic changes and need longer PT sessions.

Sponsors & Collaborators

• Eslam Elsayed Ali Shohda: lead

Study Sites (1)

Al ahrar teaching hospital

Zagazig, Sharqia Province, 44511, Egypt

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Massage

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Eslam Shohda-Principal Investigator

Model Details: randomization

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 29, 2025
• Study Start: October 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)