- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398601
Periosteal Electrical Dry Needling in Knee Osteoarthritis
Effects Of Periosteal Electrical Dry Needling In Patients With Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Periosteal stimulation therapy (PST) or periosteal electroacupuncture applies direct electrical stimulation of the periosteum and its associated nerves using parsimoniously applied acupuncture needles over bony prominences. It is an aggressive local treatment for deep pain problems such as OA (osteoarthritis ) .
Mobilization with movement (MWM) is a manual therapy technique that is used most frequently for the management of musculoskeletal conditions. In this technique, the physiological movement is performed in a pain-free manner with accessory glides being applied in the direction towards the opposite of the previously painful movement to have the greatest improvement MWMs has shown promising various therapeutic benefits such as reduction of pain and improved range of motion. Previous evidence has shown the effectiveness of MWM on pain reduction and functional improvement in patients with knee OA.
The rationale for the use of PST in comparison with MWM techniques is to determine the effectiveness of periosteal electrical dry needling for the common use intervention for knee osteoarthritis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Islamabad, Pakistan
- Athlean Physical Therapy Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group >40,
- Patient who met American college of Rheumatology criteria of Osteoarthritis,
- Chronic knee pain > 3 months,
- Morning stiffness <30 mins,
- Crepitation
- Bony tenderness
Exclusion Criteria:
- Diagnosed Meniscal injury or Ligamentous injury,
- History of Intraarticular injection in last 3 months,
- generalized low back related leg pain,
- Patients with fear of needles,
- Patients administered with corticosteroids or receiving any other invasive treatment such as PRP, Stem cell therapy, Ozone therapy
- History of any surgery of lower extremity in last 6 months
- Malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: MOBILIZATION WITH MOVEMENT
MOBILIZATION with MOVEMENT TENS, MWM techniques for Knee |
They would be receiving conventional treatment as follow: TENS (Transcutaneous electrical nerve stimulation) applied asymmetrical, biphasic waveform, pulse duration at 100 ms, intensity 10 percent below the motor threshold - 10 mins Hot Pack - 10 mins ULTRASOUND - 10 mins Additionally, the would receive MWM techniques for Knee
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Experimental: periosteal electrical dry needling
TENS, periosteal electrical dry needling 4 point technique for Knee
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They would be receiving conventional treatment as follow: TENS (asymmetrical, biphasic waveform, pulse duration at 100 ms, intensity 10 percent below the motor threshold) - 10 mins HOT PACK - 10 mins ULTRASOUND - 10 mins Additionally, the would receive periosteal electrical dry needling 4 point technique for Knee Four sterile, single-use 30-gauge dry needles would be inserted into the following locations of the symptomatic knee(s) until they touch bone:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WOMAC scale for osteoarthritis
Time Frame: 4 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function. |
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS
Time Frame: 4 weeks
|
The NPRS is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") |
4 weeks
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6 min walk test
Time Frame: 4 weeks
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The Six-minute walk (6MW) is short walk tests commonly used to evaluate functional recovery after total knee arthroplasty (TKA). The object of the test is to walk as far as possible for six minutes. You will walk at your normal pace to a chair or cone, and turn around. And you continue to walk back and forth for six minutes. Time measurement will determine the functional recovery. |
4 weeks
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Stair climb test
Time Frame: 4 week
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The stair climb test (also known as stair climb power test) is a clinically relevant, safe, and inexpensive field-based assessment of lower body strength, power, and physical function for older adults Stairs (8 - 14 steps) with handrails, stopwatch.
Where possible, the 9-step stair test with 20cm (8 inch) step height (range 16-20 cm) and handrail is recommended.
2 mins are required to complete and score,
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4 week
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Range of Motion
Time Frame: 4 week
|
A goniometer is an instrument that measures the available range of motion at a joint. Normal range of motion, using the anatomical position as zero degrees. Flexion = 0 to 140 degrees. Extension - zero degrees = full extension. |
4 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: KINZA ANWAR, MS-OMPT, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01209 Mudassar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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