Patellar TendonitisNCT01612663
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
A study testing Pain relief by Acupuncture needle at non-specific site and Acupuncture needle in people with Patellar Tendonitis and Complete Tear, Knee, Anterior Cruciate Ligament, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to test if specific therapeutic benefits of acupuncture are mostly attributable to contextual and psychosocial factors, such as patients' beliefs and expectations.The investigators propose using the 2 acupuncture methods, which refrains from inserting needles in the affected area, in order… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patellar Tendonitis, Complete Tear, Knee, Anterior Cruciate Ligament
- What is being tested?
- Pain relief by Acupuncture needle at non-specific site and Acupuncture needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to 1 Jun 2015
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (> 18 years old), suffering chronic stable pain score >40 mm on 100 mm VAS of the knee due to patellar tendonitis.
- Patients have had X-rays or other tests confirming they are not candidates for surgery nor are scheduled for steroid injections or hyaluronic acid injections within 8 weeks from the beginning of the study.
- Adult patients (> 18 years old), two weeks after ACL reconstruction surgery (with or without meniscal involvement), with pain score >40 mm on 100 mm VAS of the knee (all patients at this stage have significant ROM limitation).
Who cannot join
- Patient refusal
- Soldiers
- Pregnancy
- Morbid obesity
- Diabetes
- Peripheral vascular disease
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- Lower limb neurological deficit (such as multiple sclerosis, nerve palsy), other serious co-morbidity (including severe back pain or hip pain)
- A history of prolonged or current steroid use
- Received hyaluronic acid injections within the previous 3 months
- Have needle phobia or allergy to sticking plaster.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Acupuncture Methods on Knee Pain
The purpose of this study is to test if specific therapeutic benefits of acupuncture are mostly attributable to contextual and psychosocial factors, such as patients' beliefs and expectations.The investigators propose using the 2 acupuncture methods, which refrains from inserting needles in the affected area, in order to evaluate the short-term and long-term efficacy of acupuncture in a clinical setting compared with placebo and compared with invasive needling that does not adhere to "correct" acupuncture rules.
Read the detailed description
The main novel features of this study:
- First aim to assess the effect of distal needling on knee pain
- Second aim to directly compare two acupuncture techniques, placebo, needling at "wrong" places and "correct" needling for knee pain
Advantages of the study compared to published data:
- Distal needling - enables assessment of range of motion (ROM) and pain level during needling.
- Both acupuncture systems rely on minimal questioning, which simplifies the patient-practitioner interactions.
- Exploratory studies in the clinic of DP show that it is possible to distinguish between "correct" and "incorrect" needling, at least in the short term. Long term effects have not been assessed yet.
- Being tested
- Pain relief by Acupuncture needle at non-specific site, Acupuncture needle
- Keywords
- Knee pain, Acupuncture, Sham acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain relief by Acupuncture needle at non-specific siteDevice
Acupuncture needleDevice
Acupuncture needleDevice
Acupuncture needleDevice
| Study group | Role | What they receive |
|---|---|---|
| deep needle non-site specific | Active comparator | Not described Receives: Device: Pain relief by Acupuncture needle at non-specific site |
| contralateral elbow to the knee pain | Active comparator | Not described Receives: Device: Acupuncture needle |
| Energy of Living Systems Needling | Active comparator | Not described Receives: Device: Acupuncture needle |
| Sham acupuncture | Placebo comparator | Not described Receives: Device: Acupuncture needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
Effect of Distal Needling on Knee Pain Using 4 different Acupuncture Techniques by:
- Pain measurement by Visual Analogue Scale (VAS)
- Range of motion (ROM)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startJun 2012
- Primary completion1 Jun 2014
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendonitisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elyad Davidson, Hadassah Medical Organization
- Investigators
- Elyad Davidson, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612663
- Sponsor's protocol ID
- 007212-HNO-CTIL
- Status last verified
- Mar 2022
- First submitted
- 3 Jun 2012
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Acupuncture Methods on Knee Pain
- ClinicalTrials.gov ID
- NCT01612663
- Acronym / sponsor ID
- 007212-HNO-CTIL
- Keywords
- Knee pain, Acupuncture, Sham acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 6 Jun 2012 (estimated)
- 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.
The purpose of this study is to test if specific therapeutic benefits of acupuncture are mostly attributable to contextual and psychosocial factors, such as patients' beliefs and expectations.The investigators propose using the 2 acupuncture methods, which refrains from inserting needles in the affected area, in order to evaluate the short-term and long-term efficacy of acupuncture in a clinical setting compared with placebo and compared with invasive needling that does not adhere to "correct" acupuncture rules.
Detailed description
The main novel features of this study:
- First aim to assess the effect of distal needling on knee pain
- Second aim to directly compare two acupuncture techniques, placebo, needling at "wrong" places and "correct" needling for knee pain
Advantages of the study compared to published data:
- Distal needling - enables assessment of range of motion (ROM) and pain level during needling.
- Both acupuncture systems rely on minimal questioning, which simplifies the patient-practitioner interactions.
- Exploratory studies in the clinic of DP show that it is possible to distinguish between "correct" and "incorrect" needling, at least in the short term. Long term effects have not been assessed yet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| deep needle non-site specific | Active comparator | Device: Pain relief by Acupuncture needle at non-specific site |
| contralateral elbow to the knee pain | Active comparator | Device: Acupuncture needle |
| Energy of Living Systems Needling | Active comparator | Device: Acupuncture needle |
| Sham acupuncture | Placebo comparator | Device: Acupuncture needle |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (> 18 years old), suffering chronic stable pain score >40 mm on 100 mm VAS of the knee due to patellar tendonitis.
- Patients have had X-rays or other tests confirming they are not candidates for surgery nor are scheduled for steroid injections or hyaluronic acid injections within 8 weeks from the beginning of the study.
- Adult patients (> 18 years old), two weeks after ACL reconstruction surgery (with or without meniscal involvement), with pain score >40 mm on 100 mm VAS of the knee (all patients at this stage have significant ROM limitation).
Key exclusion criteria (10 listed)
- Patient refusal
- Soldiers
- Pregnancy
- Morbid obesity
- Diabetes
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 |
|---|---|---|
| Pain relief by Acupuncture needle at non-specific site | Device | deep needle non-site specific |
| Acupuncture needle | Device | contralateral elbow to the knee pain |
| Acupuncture needle | Device | Energy of Living Systems Needling |
| Acupuncture needle | Device | Sham acupuncture |
Primary outcome
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
Time frame: 2 years
Effect of Distal Needling on Knee Pain Using 4 different Acupuncture Techniques by: 1. Pain measurement by Visual Analogue Scale (VAS) 2. Range of motion (ROM)
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 22 Mar 2022.
Related trials for Patellar Tendonitis
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Patellar Tendinitis, Jumper's Knee
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Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendinitis
Shock Wave Threapy for Patellar Tendinitis
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.
Elyad Davidson, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain relief by Acupuncture needle at non-specific site and Acupuncture needle in people with Patellar Tendonitis and Complete Tear, Knee, Anterior Cruciate Ligament, run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 10 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 22 Mar 2022. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques (time frame: 2 years). 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 22 Mar 2022.