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Completed

NCT Number: NCT05398601

Periosteal Electrical Dry Needling in 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)

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

41 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athlean Physical Therapy Clinic

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mobilization with movement

Other

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

Periosteal electrical dry needling

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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")

  2. 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.

  3. 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. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects Of Periosteal Electrical Dry Needling In Patients With Knee Osteoarthritis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2022
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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