Knee OsteoarthritisNCT05398601
Periosteal Electrical Dry Needling in Knee Osteoarthritis
A study testing MOBILIZATION with MOVEMENT and Periosteal electrical dry needling in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial 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) Read more about this study
- Who is it for?
- Ages 41 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- MOBILIZATION with MOVEMENT and Periosteal electrical dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Sep 2022to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- MOBILIZATION with MOVEMENT, Periosteal electrical dry needling
- Keywords
- Dry needling, Acupuncture, Mobilization with movement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBILIZATION with MOVEMENTOther
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 needlingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MOBILIZATION WITH MOVEMENT | Active comparator | MOBILIZATION with MOVEMENT
TENS, MWM techniques for Knee Receives: Other: MOBILIZATION with MOVEMENT |
| periosteal electrical dry needling | Experimental | TENS, periosteal electrical dry needling 4 point technique for Knee Receives: Other: Periosteal electrical dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (4)
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")
Measured: 4 weeks
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.
Measured: 4 weeks
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,
Measured: 4 week
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.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start14 Sep 2022
- Primary completion8 Jul 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KINZA ANWAR, MS-OMPT, Principal investigator, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398601
- Sponsor's protocol ID
- REC/01209 Mudassar
- Status last verified
- Jul 2023
- First submitted
- 21 Apr 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Periosteal Electrical Dry Needling In Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05398601
- Acronym / sponsor ID
- REC/01209 Mudassar
- Conditions
- Knee Osteoarthritis
- Keywords
- Dry needling, Acupuncture, Mobilization with movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 8 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOBILIZATION WITH MOVEMENT | Active comparator | Other: MOBILIZATION with MOVEMENTMOBILIZATION with MOVEMENT TENS, MWM techniques for Knee |
| periosteal electrical dry needling | Experimental | Other: Periosteal electrical dry needlingTENS, periosteal electrical dry needling 4 point technique for Knee |
Who may qualify
- Ages
- 41 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age group >40,
- Patient who met American college of Rheumatology criteria of Osteoarthritis,
- Chronic knee pain > 3 months,
- Morning stiffness <30 mins,
- Crepitation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOBILIZATION with MOVEMENTThey 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 | Other | MOBILIZATION WITH MOVEMENT |
| Periosteal electrical dry needlingThey 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. | Other | periosteal electrical dry needling |
Primary outcome
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 secondary outcomes
NPRS
Time frame: 4 weeks
6 min walk test
Time frame: 4 weeks
Stair climb test
Time frame: 4 week
Range of Motion
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KINZA ANWAR, MS-OMPT principal investigator
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOBILIZATION with MOVEMENT and Periosteal electrical dry needling in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC scale for osteoarthritis (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.