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Periosteal Electrical Dry Needling in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
MOBILIZATION with MOVEMENT
Periosteal electrical dry needling
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Dry needling, Acupuncture, Mobilization with movement

Eligibility Criteria

41 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age group >40,
  2. Patient who met American college of Rheumatology criteria of Osteoarthritis,
  3. Chronic knee pain > 3 months,
  4. Morning stiffness <30 mins,
  5. Crepitation
  6. Bony tenderness

Exclusion Criteria:

  1. Diagnosed Meniscal injury or Ligamentous injury,
  2. History of Intraarticular injection in last 3 months,
  3. generalized low back related leg pain,
  4. Patients with fear of needles,
  5. Patients administered with corticosteroids or receiving any other invasive treatment such as PRP, Stem cell therapy, Ozone therapy
  6. History of any surgery of lower extremity in last 6 months
  7. Malignancy

Sites / Locations

  • Athlean Physical Therapy Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MOBILIZATION WITH MOVEMENT

periosteal electrical dry needling

Arm Description

MOBILIZATION with MOVEMENT TENS, MWM techniques for Knee

TENS, periosteal electrical dry needling 4 point technique for Knee

Outcomes

Primary Outcome Measures

WOMAC scale for osteoarthritis
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: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties 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.

Secondary Outcome Measures

NPRS
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")
6 min walk test
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.
Stair climb test
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,
Range of Motion
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.

Full Information

First Posted
April 21, 2022
Last Updated
July 12, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05398601
Brief Title
Periosteal Electrical Dry Needling in Knee Osteoarthritis
Official Title
Effects Of Periosteal Electrical Dry Needling In Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
July 8, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effect of periosteal electrical dry needling as an adjuvant to MWM in knee osteoarthritis for pain management, for improvement in functional activities and for ROM (Range Of Motion)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Dry needling, Acupuncture, Mobilization with movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOBILIZATION WITH MOVEMENT
Arm Type
Active Comparator
Arm Description
MOBILIZATION with MOVEMENT TENS, MWM techniques for Knee
Arm Title
periosteal electrical dry needling
Arm Type
Experimental
Arm Description
TENS, periosteal electrical dry needling 4 point technique for Knee
Intervention Type
Other
Intervention Name(s)
MOBILIZATION with MOVEMENT
Intervention Description
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 Medial glide Medial+ Internal rotation glide Lateral Glide+ Internal Rotation glide Anterior glide Posterior glide
Intervention Type
Other
Intervention Name(s)
Periosteal electrical dry needling
Intervention Description
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: Medial femoral condyle Lateral femoral condyle Flare of the tibia Head of the fibula Needles would be stimulated with 100 Hz for 30 minutes. The intensity of the stimulus would be adjusted so that it would be clearly felt but would not cause discomfort. The stimulus intensity would be adjusted periodically so that it is perceptible for the entire 30 minutes of PST.
Primary Outcome Measure Information:
Title
WOMAC scale for osteoarthritis
Description
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: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties 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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
NPRS
Description
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")
Time Frame
4 weeks
Title
6 min walk test
Description
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.
Time Frame
4 weeks
Title
Stair climb test
Description
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,
Time Frame
4 week
Title
Range of Motion
Description
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.
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KINZA ANWAR, MS-OMPT
Organizational Affiliation
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Athlean Physical Therapy Clinic
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Periosteal Electrical Dry Needling in Knee Osteoarthritis

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