Osteoarthritis, KneeNCT02680912
Warm Needle Acupuncture vs Needle Acupuncture
A study testing Warm needle acupuncture and Needle acupuncture in people with Osteoarthritis, Knee, run by London South Bank University at 1 site in United Kingdom.
Trial summary
This is a two-armed randomised controlled pilot study that investigates the component efficacy of moxibustion for osteoarthritis of the knee. Participants will be randomised to receive either warm needle acupuncture or needle acupuncture. Participants and acupuncturists will be blinded to group allocation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Warm needle acupuncture and Needle acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Jul 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain in at least one knee joint during the last six months.
- At baseline the WOMAC pain score must be ≥ 3 points (on a scale of 0-10)
- In addition to the knee pain at least 3 of the following 6 must be present:
- Age > 50 years
- Stiffness < 30 minutes
- Crepitus
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- Bony Tenderness
- Bony enlargement
- No palpable warmth
- (ACR 2013)
- Plus
- Ability to speak English
- Signed consent form
Who cannot join
- A systemic disease of the musculoskeletal system.
- Bone tumour, bone tumour like lesions or metastasis.
- Bone fracture in the lower extremities during the last three months.
- Acute infection or osteonecrosis in the knee joint.
- Recent sprain injury to the knee joint.
- Surgery of the afflicted extremity during the last six months or planned surgery.
Show all 17Show fewer
- Ongoing cortico-steroid therapy or cortisone injections in the past six weeks.
- Taking anti-coagulant medication.
- Coagulopathy.
- Other pain condition that compels the patient to take analgesics for more than three days during the last four weeks.
- Addiction to analgesics, opiate or other drugs.
- Acupuncture treatment in the past 3 months.
- Dermatological disease within the acupuncture area impairing acupuncture treatment.
- Pregnant or breast-feeding patients.
- Inability to follow instructions or understand the consent form (insufficient command of language, dementia).
- Participation in another clinical study.
- Ongoing legal proceedings concerning degree of disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Warm Needle Acupuncture vs. Needle Acupuncture for Osteoarthritis of the Knee: A Pilot Study
This is a two-armed randomised controlled pilot study that investigates the component efficacy of moxibustion for osteoarthritis of the knee. Participants will be randomised to receive either warm needle acupuncture or needle acupuncture. Participants and acupuncturists will be blinded to group allocation. The primary and secondary outcome measures are WOMAC and SF36 respectively. Qualitative interviews will be used to gather information on the patients' experiences and perceptions of the trial and the treatment provided.
It is hypothesised that warm needle acupuncture will lead to a greater reduction in clinical signs and symptoms than needle acupuncture.
Read the detailed description
Acupuncture Treatment
All participants will receive acupuncture. Only points local to the knee will be used. There will be 4-6 points used per knee, therefore 8 -12 needles per treatment. A record will be kept of the points used at each treatment. Both knees will be treated even if only one knee is painful. This will ensure that participants receive similar treatments.
Patients will be treated seated, as this allows better access to the relevant acupuncture points. It also helps ensure the moxibustion is carried out safely.
Participants will receive 8 treatments in the first 4 weeks (twice a week), then 4 treatments in 4 weeks (once a week).
Blinding procedures
The only difference in the procedures will be that lit cones are placed on the needles of the treatment group whilst unlit moxa cones will be placed on the needles of the control group. Smokeless moxa will be used. All patients will see the needles being inserted and the moxa cones placed on the needles by the acupuncturist. Skin guards will be placed at the base of the needle to reduce the immediate sense of heat on the surface of the skin. Similar skin guards are routinely used in acupuncture treatment to prevent any discomfort.
The acupuncturist will carry out a consultation at each session as per normal practice. After the needles have been inserted and the moxa cones have been placed on needles the acupuncturist leaves and an assistant acupuncturist enters the room. The assistant acupuncturist will place a screen in front of the patient to prevent them from seeing their knees. The assistant acupuncturist will then remove one cone at a time and light it. In the treatment group the lit cone is placed on the needle. In the control group the lit cone is place in a small dish close to the knee, a replacement unlit cone is placed on the needle. This process is repeated until all the cones are lit. The unlit cone is replaced on the needle of the control group to try and ensure they experience the same sensations as the treatment group. The use of a second acupuncturist to light the moxa ensures that the acupuncturist who carries out the consultation and inserts the needles is blinded to group allocation.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Warm needle acupuncture, Needle acupuncture
- Keywords
- Bi syndrome
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm needle acupunctureDevice
There will be 4-6 points used per knee, therefore 8-12 needles per treatment. Two points will be used as the core treatment ST 35 dubi, Ex-LE 5 xiyan. Four other acu-points can also be used from the following: Ahshi painful points local to the knee (locus dolendi), ST 36 zusanli, GB 34 yanglingquan, Sp 9 yinlingquan, ST34 liangqiu, Sp 10 xuehai, GB 33 yangxiguan, LR 7 xiguan, LR 8 ququan, heding Ex-LE 2 In addition to the acupuncture needles the warm needle acupuncture group will receive moxibustion on up to 4 points. Smokeless moxa will be used.
Needle acupunctureDevice
The point selection protocol will be exactly the same as the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Warm needle acupuncture | Experimental | Warm needle acupuncture (wenzhen; 温针) is where moxa cones are placed on the handle of the needle, after the needle has been inserted. Once lit, heat transmits along the shaft of the needle to the acupuncture point.
Moxa refers to the herb mugwort (Artemisia vulgaris) that is burnt to warm specific parts of the body, including acupuncture points. Receives: Device: Warm needle acupuncture |
| Basic needle acupuncture | Active comparator | Basic needle acupuncture is the use of acupuncture needles alone, without other methods of stimulation. Receives: Device: Needle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Change from Baseline to follow up at 16 weeks
Secondary outcomes (1)
SF36 (Rand)
Health Related Quality of Life (HRQL)
Measured: Change from Baseline to follow up at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion16 May 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- London South Bank University
- Sponsor type
- University, hospital or other
- Collaborators
- British Acupuncture Council, Confucius Institute for Traditional Chinese Medicine, London South Bank University
- Responsible party
- Sponsor
- Investigators
- Ian K Appleyard, Principal investigator, London South Bank University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680912
- Sponsor's protocol ID
- 6505
- Status last verified
- Apr 2017
- First submitted
- 4 Feb 2016
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warm Needle Acupuncture vs. Needle Acupuncture for Osteoarthritis of the Knee: A Pilot Study
- ClinicalTrials.gov ID
- NCT02680912
- Acronym / sponsor ID
- 6505
- Conditions
- Osteoarthritis, Knee
- Keywords
- Bi syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- London South Bank UniversityUniversity, hospital or other
- Collaborators
- British Acupuncture Council, Confucius Institute for Traditional Chinese Medicine, London South Bank University
- Study start
- Feb 2016
- Primary completion
- 16 May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 12 Feb 2016 (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.
This is a two-armed randomised controlled pilot study that investigates the component efficacy of moxibustion for osteoarthritis of the knee. Participants will be randomised to receive either warm needle acupuncture or needle acupuncture. Participants and acupuncturists will be blinded to group allocation. The primary and secondary outcome measures are WOMAC and SF36 respectively. Qualitative interviews will be used to gather information on the patients' experiences and perceptions of the trial and the treatment provided.
It is hypothesised that warm needle acupuncture will lead to a greater reduction in clinical signs and symptoms than needle acupuncture.
Detailed description
Acupuncture Treatment
All participants will receive acupuncture. Only points local to the knee will be used. There will be 4-6 points used per knee, therefore 8 -12 needles per treatment. A record will be kept of the points used at each treatment. Both knees will be treated even if only one knee is painful. This will ensure that participants receive similar treatments.
Patients will be treated seated, as this allows better access to the relevant acupuncture points. It also helps ensure the moxibustion is carried out safely.
Participants will receive 8 treatments in the first 4 weeks (twice a week), then 4 treatments in 4 weeks (once a week).
Blinding procedures
The only difference in the procedures will be that lit cones are placed on the needles of the treatment group whilst unlit moxa cones will be placed on the needles of the control group. Smokeless moxa will be used. All patients will see the needles being inserted and the moxa cones placed on the needles by the acupuncturist. Skin guards will be placed at the base of the needle to reduce the immediate sense of heat on the surface of the skin. Similar skin guards are routinely used in acupuncture treatment to prevent any discomfort.
The acupuncturist will carry out a consultation at each session as per normal practice. After the needles have been inserted and the moxa cones have been placed on needles the acupuncturist leaves and an assistant acupuncturist enters the room. The assistant acupuncturist will place a screen in front of the patient to prevent them from seeing their knees. The assistant acupuncturist will then remove one cone at a time and light it. In the treatment group the lit cone is placed on the needle. In the control group the lit cone is place in a small dish close to the knee, a replacement unlit cone is placed on the needle. This process is repeated until all the cones are lit. The unlit cone is replaced on the needle of the control group to try and ensure they experience the same sensations as the treatment group. The use of a second acupuncturist to light the moxa ensures that the acupuncturist who carries out the consultation and inserts the needles is blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm needle acupuncture | Experimental | Device: Warm needle acupunctureWarm needle acupuncture (wenzhen; 温针) is where moxa cones are placed on the handle of the needle, after the needle has been inserted. Once lit, heat transmits along the shaft of the needle to the acupuncture point. Moxa refers to the herb mugwort (Artemisia vulgaris) that is burnt to warm specific parts of the body, including acupuncture points. |
| Basic needle acupuncture | Active comparator | Device: Needle acupunctureBasic needle acupuncture is the use of acupuncture needles alone, without other methods of stimulation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Chronic pain in at least one knee joint during the last six months.
- At baseline the WOMAC pain score must be ≥ 3 points (on a scale of 0-10)
- Age > 50 years
- Stiffness < 30 minutes
- Crepitus
Key exclusion criteria (17 listed)
- A systemic disease of the musculoskeletal system.
- Bone tumour, bone tumour like lesions or metastasis.
- Bone fracture in the lower extremities during the last three months.
- Acute infection or osteonecrosis in the knee joint.
- Recent sprain injury to the knee joint.
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 |
|---|---|---|
| Warm needle acupunctureThere will be 4-6 points used per knee, therefore 8-12 needles per treatment. Two points will be used as the core treatment ST 35 dubi, Ex-LE 5 xiyan. Four other acu-points can also be used from the following: Ahshi painful points local to the knee (locus dolendi), ST 36 zusanli, GB 34 yanglingquan, Sp 9 yinlingquan, ST34 liangqiu, Sp 10 xuehai, GB 33 yangxiguan, LR 7 xiguan, LR 8 ququan, heding Ex-LE 2 In addition to the acupuncture needles the warm needle acupuncture group will receive moxibustion on up to 4 points. Smokeless moxa will be used. | Device | Warm needle acupuncture |
| Needle acupunctureThe point selection protocol will be exactly the same as the experimental group | Device | Basic needle acupuncture |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Change from Baseline to follow up at 16 weeks
1 secondary outcome
SF36 (Rand)
Time frame: Change from Baseline to follow up at 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- WOMAC Osteoarthritis IndexLink provided by the sponsor.
- ACR 2013, "Classification Criteria for Rheumatic Diseases: Idiopathic OA of the knee", American College of Rheumatology, \[Online\], , pp. 5 January 2014.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ian K Appleyard principal investigator
London South Bank University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm needle acupuncture and Needle acupuncture in people with Osteoarthritis, Knee, run by London South Bank University at 1 site in United Kingdom.
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 13 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 21 Apr 2017. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Change from Baseline to follow up at 16 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 21 Apr 2017.