Periosteal Electrical Dry Needling in Knee Osteoarthritis

July 12, 2023 updated by: Riphah International University

Effects Of Periosteal Electrical Dry Needling In Patients With Knee Osteoarthritis

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)

Study Overview

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

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Islamabad, Pakistan
        • Athlean Physical Therapy Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  1. Medial glide
  2. Medial+ Internal rotation glide
  3. Lateral Glide+ Internal Rotation glide
  4. Anterior glide
  5. Posterior glide
Experimental: periosteal electrical dry needling
TENS, periosteal electrical dry needling 4 point technique for Knee

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:

  1. Medial femoral condyle
  2. Lateral femoral condyle
  3. Flare of the tibia
  4. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC scale for osteoarthritis
Time Frame: 4 weeks

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.

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
6 min walk test
Time Frame: 4 weeks

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
Stair climb test
Time Frame: 4 week
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,
4 week
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: KINZA ANWAR, MS-OMPT, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Actual)

July 8, 2023

Study Completion (Actual)

July 10, 2023

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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