Electrical Dry Needling Versus Iontophoresis in Treating Chronic Unilateral Knee Osteoarthritis

July 12, 2025 updated by: Ahmed Fayez Zehiry, Horus University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity level measurement
Time Frame: at baseline and after 6 weeks
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
Time Frame: at baseline and after 6 weeks
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
Time Frame: at baseline and after 6 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Horus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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