Electrical Dry Needling Versus Iontophoresis in Treating Chronic Unilateral Knee Osteoarthritis

The goal of this clinical trial is to compare the effects of electrical dry needling versus glucosamine sulfate iontophoresis on pain intensity level, functional ability, and knee range of motion in chronic unilateral knee osteoarthritis patients.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of Knee
• Intervention / Treatment: Other: conventional physical therapy; Other: Electrical Dry Needling; Other: Glucosamine sulfate iontophoresis

Detailed Description

Knee Osteoarthritis (OA) is a chronic disease affecting 240 million people worldwide, with a higher prevalence in older adults. The disease leads to knee deformity, laxity, and ligament instability. Dry needling, a new treatment modality, uses needle electrodes to deliver an electric current to the pain-generating trigger point, improving the physiological effects and analgesic and anesthetic effects. Iontophoresis, a safer method of drug therapy, has shown to be more effective in pain reduction in knee osteoarthritic patients. The study aims to investigate the effect of electrical dry needling versus glucosamine sulfate iontophoresis on pain intensity level, knee function, and range of motion (ROM) in chronic knee OA patients. This approach aims to maximize drug bioavailability, optimize therapeutic efficacy, and minimize side effects.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Damieta, Egypt
    • out-patient clinic, faculty of physical therapy, Horus university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient will be selected from the outpatient clinic of physical therapy at Horus University, New Damietta, Egypt, diagnosed with a Kellgren/Lawrence grade 2,3 radiological severity of knee osteoarthritis (OA). and referred by an orthopedist.
2. Age will range from 40 to 60 years.
3. Body mass index will range from 25 to 29.9 kg/m2.
4. Duration of knee pain not less than 3 months prior to study .

Exclusion Criteria:

1. Patients with history of cardiac disorder with pacemaker.
2. Knee surgery.
3. Diabetes and nutritional disorder.
4. Neuromuscular and other musculoskeletal diseases.
5. Any red flags to dry needling, or conventional therapy.
6. Had received physical therapy, acupuncture, massage therapy, chiropractic, or intra-articular injections for the painful knee in the last 3 months.
7. Presented with positive neurological signs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: conventional program; will receive conventional physical therapy, including transcutaneous electrical nerve stimulation (TENS) and an exercise therapy program (stretching exercises, both hip and knee strengthening, balance, and stability exercise)	Other: conventional physical therapy; including transcutaneous electrical nerve stimulation (TENS) and an exercise therapy program (stretching exercises, both hip and knee strengthening, balance, and stability exercise)
Experimental: dry needling and conventional program; will receive conventional physical therapy, plus electrical dry needling.	Other: conventional physical therapy; including transcutaneous electrical nerve stimulation (TENS) and an exercise therapy program (stretching exercises, both hip and knee strengthening, balance, and stability exercise); Other: Electrical Dry Needling; In electrical dry needling, needle electrodes are used to deliver an electric current to the taut muscle band or the pain-generating trigger point. Low-frequency currents are thought to improve the physiological effects of the therapy by using electrical stimulation to enhance certain physiological reactions and achieve a speedier analgesic and anesthetic effect than that obtained with standard dry needling.
Experimental: Glucosamine sulfate iontophoresis and conventional program; will receive conventional physical therapy, plus Glucosamine sulfate iontophoresis.	Other: conventional physical therapy; including transcutaneous electrical nerve stimulation (TENS) and an exercise therapy program (stretching exercises, both hip and knee strengthening, balance, and stability exercise); Other: Glucosamine sulfate iontophoresis; Galvanic current mode will be used to deliver the cream through the skin. One gram of GS will be placed on positive electrode (being positively charged using Trans-arthral electrode placement technique) for administration of Iontophoresis [40mA-min (2mA x 20minutes)].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity level measurement	The visual analog scale (VAS) is a pain rating scale .A 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)	at baseline and after 6 weeks
Functional ability measurement	Knee Injury and Osteoarthritis Outcome (KOOS) Score.A 0-100 scale, with zero express extreme knee problems and 100 for no knee problems, as common in orthopedic scales.	at baseline and after 6 weeks
Knee ROM measurement	A digital goniometer will be used to measure active knee ROM. The subject will be supine, flexing and extending their knee to the maximum. Bony landmarks will be identified for standardization and repeatability. The goniometer will be positioned over the lateral epicondyle of the femur, with the greater trochanter for reference. Measurements will be made three times, and the average value will be analyzed. Knee ROM measurements in patients with knee OA show high reliability.	at baseline and after 6 weeks

Collaborators and Investigators

• Sponsor: Horus University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 12, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Horus_Phd_2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No