NCT06578663

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

May 16, 2024

Last Update Submit

July 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

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)

Other: conventional physical therapy

dry needling and conventional program

EXPERIMENTAL

will receive conventional physical therapy, plus electrical dry needling.

Other: conventional physical therapyOther: Electrical Dry Needling

Glucosamine sulfate iontophoresis and conventional program

EXPERIMENTAL

will receive conventional physical therapy, plus Glucosamine sulfate iontophoresis.

Other: conventional physical therapyOther: Glucosamine sulfate iontophoresis

Interventions

including transcutaneous electrical nerve stimulation (TENS) and an exercise therapy program (stretching exercises, both hip and knee strengthening, balance, and stability exercise)

Glucosamine sulfate iontophoresis and conventional programconventional programdry needling and conventional program

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.

dry needling and conventional program

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 \[40mA-min (2mA x 20minutes)\].

Glucosamine sulfate iontophoresis and conventional program

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

out-patient clinic, faculty of physical therapy, Horus university

Damietta, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The sample will be randomly divided into three groups: A, B, and C. Group A: The control group (n=20) Group B: The study group (n=20) will receive conventional physical therapy plus electrical dry needling. Group C: The study group (n=20) will receive conventional physical therapy plus glucosamine sulfate iontophoresis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trail, repeated measured; pre and post-test experimental design will be conducted
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistant

Study Record Dates

First Submitted

May 16, 2024

First Posted

August 29, 2024

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations