- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403448
Effects of 9 Points Electrical Dry Needling in Knee Osteoarthritis
Effects of 9 Points Electrical Dry Needling on Pain, Range of Motion, Function and Quality of Life in Patients With Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Ph.D
- Phone Number: +923324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Balochistan
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Quetta, Balochistan, Pakistan, 87900
- Sheikh Khalifa Bin Zayed Hospital, Quetta
-
Contact:
- Umair Baloch, MS-SPT
- Phone Number: +923313768279
- Email: drumairsiddqui77@gmail.com
-
Principal Investigator:
- Malaika Imran, MS-OMPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- participants age group from 40-60 years
- Both male and female genders
- Knee osteoarthritis (OA) confirmed by radiographic evidence (Kellgren- Lawrence grade 3).
- Numerical Pain Rating Scale (NPRS) ≥ 4/10.
- Able to stand and bear weight on affected knee.
- WOMAC score > 25 moderate level of difficulty performing ADL
- Participant with restricted range of motion
- Pain while walking and ascending stairs
- Patients volunteered to participate in the study and signed informed consent
Exclusion Criteria:
- Mild to severe knee osteoarthritis (Kellgren-Lawrence grade 2 or 4).
- Recent knee surgery or injection (<6 months).
- Knee instability and ligamentous injury.
- Pregnancy and breastfeeding.
- Patient with needle phobia and with history of abnormal reaction to needles.
- Diagnosed psychological disorders
- Anticoagulant patient, tumors and hematomas.
- All acute emergencies and acute systematic fevers.
- Pacemakers and implantable cardioverter defibrillators
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental : 9 points electrical dry needling along with standard physical therapy
3 times per week for 6 weeks
|
9 points electrical dry needling, stainless steel dry needles of size 0.25 into 30mm will be used, inserted perpendicularly into popliteus, adductor magnus, tibialis anterior, quad tendon, vastus lateralis, medialis, medial & lateral infrapatellar sulcus, extensor digitorum longus.
Standarized physical therapy: HOT pack for 5 min, hams & quads stretching for 30 sec & 6 reps, quads strengthening straight leg raise & leg press will be performed 15 reps & 3 sets, for hams seated leg curls & gluteal bridges will be performed 15 reps & 3 sets. MWM in weight bearing position: The glide will be applied in weight bearing, effected knee on stepper, the therapist will be exactly sitting in front of the patient & patient will be asked to place the limb up on the stepper one hand of the therapist has to be on the lateral side of the tibia and other hand on the medial side of the femur & now the patient will be asked to climb, therapist will apply medial & lateral pressure 10 reps & 3 sets. |
|
Active Comparator: active comparator: standard physical therapy
3 times per week for6 weeks
|
Standarized physical therapy: HOT pack for 5 min, hams & quads stretching for 30 sec & 6 reps, quads strengthening straight leg raise & leg press will be performed 15 reps & 3 sets, for hams seated leg curls & gluteal bridges will be performed 15 reps & 3 sets. MWM in weight bearing position: The glide will be applied in weight bearing, effected knee on stepper, the therapist will be exactly sitting in front of the patient & patient will be asked to place the limb up on the stepper one hand of the therapist has to be on the lateral side of the tibia and other hand on the medial side of the femur & now the patient will be asked to climb, therapist will apply medial & lateral pressure 10 reps & 3 sets. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: from enrollment to the end of 6 week
|
Numeric Pain Rating Scale (NPRS) measures subjective pain intensity using an 11-point numeric scale (0-10) where 0 = "no pain" and 10 = "worst pain imaginable". Patients verbally or mark on a horizontal line the whole number best reflecting current pain severity, typically assessing "current pain," "worst pain," "least pain," or "average pain" over the prior 24 hours. Mild pain = 1-3, moderate pain = 4-6, severe pain = 7-10 guides clinical decision-making. changes in NPRS scale will be measured baseline and at the end of 6 week. |
from enrollment to the end of 6 week
|
|
Goniometer measures joint range of motion (ROM)
Time Frame: from enrollment to the end of 6 week
|
Goniometer: Precision instrument measuring joint range of motion (ROM) in degrees using protractor body with two arms (stationary and movable) aligned to anatomical bony landmarks spanning the joint axis. Primary Use: Quantifies active (AROM) and passive (PROM) joint excursion for objective baseline, progress tracking, and impairment rating. Universal goniometer most common; digital/smartphone apps offer improved reliability (ICC >0.9 vs 0.74-0.91 traditional). Reliability: Long-arm > short-arm (MSD 6° vs 10°); inter/intra-rater ICC 0.84-0.99 with standardized technique. changes in knee flexion and extension ROM will be measured baseline and at the end of 6 week. |
from enrollment to the end of 6 week
|
|
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time Frame: from enrollment to the end of 6 week
|
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a validated, disease-specific patient-reported outcome measure for hip/knee osteoarthritis assessing pain (5 items, 0-20), stiffness (2 items, 0-8), and physical function (17 items, 0-68) over past 48 hours. Scoring: Likert 0-4 scale per item (0=None, 4=Extreme); higher total scores (0-96) indicate worse symptoms. MCID: 12% improvement (~9-12 points) represents clinically meaningful change. changes in WOMAC score will be measured baseline and at the end of 6 week. |
from enrollment to the end of 6 week
|
|
EQ-5D 3L (QUALITY OF LIFE)
Time Frame: From enrollment to the end of 6 week
|
EQ-5D-3L is developed by EuroQol groups is standardized instrument for measurement of health-related quality of life. it administers strong test-retest reliability for knee OA which of 0.73 to 0.91. Changes in EQ-5D 3L will be measured at baseline and at 6 weeks. |
From enrollment to the end of 6 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shakil ur Rehman, Ph.D, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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/RCR & AHS/24/0197
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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