Osteoarthritis of KneeNCT06578663
Electrical Dry Needling Versus Iontophoresis in Treating Chronic Unilateral Knee Osteoarthritis
A study testing conventional physical therapy, Electrical Dry Needling and Glucosamine sulfate iontophoresis in people with Osteoarthritis of Knee, run by Horus University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- conventional physical therapy, Electrical Dry Needling and Glucosamine sulfate iontophoresis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Age will range from 40 to 60 years.
- Body mass index will range from 25 to 29.9 kg/m2.
- Duration of knee pain not less than 3 months prior to study .
Who cannot join
- Patients with history of cardiac disorder with pacemaker.
- Knee surgery.
- Diabetes and nutritional disorder.
- Neuromuscular and other musculoskeletal diseases.
- Any red flags to dry needling, or conventional therapy.
- Had received physical therapy, acupuncture, massage therapy, chiropractic, or intra-articular injections for the painful knee in the last 3 months.
- Presented with positive neurological signs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Horus university
Damietta
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis of Knee
- Being tested
- conventional physical therapy, Electrical Dry Needling, Glucosamine sulfate iontophoresis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
including transcutaneous electrical nerve stimulation (TENS) and an exercise therapy program (stretching exercises, both hip and knee strengthening, balance, and stability exercise)
Electrical Dry NeedlingOther
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.
Glucosamine sulfate iontophoresisOther
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)].
| Study group | Role | What they receive |
|---|---|---|
| conventional program | Sham comparator | 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) Receives: Other: conventional physical therapy |
| dry needling and conventional program | Experimental | will receive conventional physical therapy, plus electrical dry needling. Receives: Other: conventional physical therapy; Other: Electrical Dry Needling |
| Glucosamine sulfate iontophoresis and conventional program | Experimental | will receive conventional physical therapy, plus Glucosamine sulfate iontophoresis. Receives: Other: conventional physical therapy; Other: Glucosamine sulfate iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: at baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trail, repeated measured; pre and post-test experimental design will be conducted
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fayez Zehiry, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578663
- Sponsor's protocol ID
- Horus_Phd_2024
- Status last verified
- Jul 2025
- First submitted
- 16 May 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Dry Needling Versus Iontophoresis in Treating Chronic Unilateral Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06578663
- Acronym / sponsor ID
- Horus_Phd_2024
- Conditions
- Osteoarthritis of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trail, repeated measured; pre and post-test experimental design will be conducted
| Arm | Type | Receives |
|---|---|---|
| conventional program | Sham comparator | Other: conventional physical therapywill 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) |
| dry needling and conventional program | Experimental | Other: conventional physical therapy, Other: Electrical Dry Needlingwill receive conventional physical therapy, plus electrical dry needling. |
| Glucosamine sulfate iontophoresis and conventional program | Experimental | Other: conventional physical therapy, Other: Glucosamine sulfate iontophoresiswill receive conventional physical therapy, plus Glucosamine sulfate iontophoresis. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- Age will range from 40 to 60 years.
- Body mass index will range from 25 to 29.9 kg/m2.
- Duration of knee pain not less than 3 months prior to study .
Key exclusion criteria (7 listed)
- Patients with history of cardiac disorder with pacemaker.
- Knee surgery.
- Diabetes and nutritional disorder.
- Neuromuscular and other musculoskeletal diseases.
- Any red flags to dry needling, or conventional therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional physical therapyincluding 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 and conventional program, conventional program, dry needling and conventional program |
| Electrical Dry NeedlingIn 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. | Other | dry needling and conventional program |
| Glucosamine sulfate iontophoresisGalvanic 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)]. | Other | Glucosamine sulfate iontophoresis and conventional program |
Primary outcome
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)
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy, Electrical Dry Needling and Glucosamine sulfate iontophoresis in people with Osteoarthritis of Knee, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity level measurement (time frame: at baseline and after 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.