NCT05398601

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

April 21, 2022

Last Update Submit

July 12, 2023

Conditions

Keywords

Dry needlingAcupunctureMobilization with movement

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (4)

  • NPRS

    4 weeks

  • 6 min walk test

    4 weeks

  • Stair climb test

    4 week

  • Range of Motion

    4 week

Study Arms (2)

MOBILIZATION WITH MOVEMENT

ACTIVE COMPARATOR

MOBILIZATION with MOVEMENT TENS, MWM techniques for Knee

Other: MOBILIZATION with MOVEMENT

periosteal electrical dry needling

EXPERIMENTAL

TENS, periosteal electrical dry needling 4 point technique for Knee

Other: Periosteal electrical dry needling

Interventions

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

MOBILIZATION WITH MOVEMENT

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.

periosteal electrical dry needling

Eligibility Criteria

Age41 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athlean Physical Therapy Clinic

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Movement

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • KINZA ANWAR, MS-OMPT

    RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

June 1, 2022

Study Start

September 14, 2022

Primary Completion

July 8, 2023

Study Completion

July 10, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations