Osteoarthritis, KneeEATOAKNCT02299713
Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK)
A study testing Electroacupuncture in people with Osteoarthritis, Knee, run by Hospital Son Llatzer at 2 sites in Spain.
Trial summary
The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2015to Nov 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
- Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2 and chronic pain in the knee joint for more than 3 months.
Who cannot join
- The patients with secondary osteoarthritis of knees
- Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
- Patients on steroids
- Disease modifying drugs, e.g. methotrexate and azathioprine
- Patients with recent trauma in the area of acupuncture
- History of intra articular injection of steroid within last two months
- Patients missing two or more sessions of electro-acupuncture consecutively were excluded from the study
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Son Llatzer University Hospital
Palma, Balear Islands, 07198
Son LLàtzer Hospital
Palma, Balearic Islands, 07198
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial, Parallel Design Used To Evaluate Pain, Endocrinologic Variations, Life Quality And Medication Use, After Electro-Acupuncture Treatment In Patients With Osteoarthritis Of The Knee
The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain.
Read the detailed description
Previous randomised trials and meta-analyses have shown certain efficacy of acupuncture in some chronic painful conditions, in spite of methodological weaknesses. The hypothalamic-pituitary-adrenal (HPA) axis and the endogenous opioid (EO) system are the mechanisms appear to explain how acupuncture works in part. These systems have been shown to be important mediators of stress, pain and other stimuli. The Osteoarthritis Research International suggest that osteoarthritis (OA) treatment should be multidisciplinary and recommended acupuncture as one of 12 possible non-pharmacological modalities for treating OA.
This study is a randomized, double-blind, placebo-controlled trial, parallel design. 128 out-patients over 50 years with OA of the knee will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: placebo/sham acupuncture, non insertion technique, and EA. Acupuncture treatments will be used the Traditional Chinese Medicine (TCM) style. The patients will be evaluated after a period of one month (2 sessions weekly), three months (1session monthly), six months (1 session every 45 days) and again one year later (1 session every 2 months), at the end of the study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Electroacupuncture
- Keywords
- acupuncture, knee pain
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
Electro acupuncture is a relatively new method of treatment in Chinese Medicine. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation. The device allows the practitioner to adjust the frequency and intensity of the electric stimulation in a consistent manner which is not operator dependant.
| Study group | Role | What they receive |
|---|---|---|
| placebo/sham acupuncture | Sham comparator | There are different types of controls used in acupuncture trials. We used the control described as sham and by some as minimal acupuncture. This group had the same schedule as the electro-acupuncture group. Sham acupuncture was administered, with the same duration and frequency and by the same specialist who performed the non-sham acupuncture. Retractable needles were placed into small adhesive cylinders, so that the needles were supported but did not perforate the skin. The acupuncturist placed the needles at the same points as the non-sham group and used the same pairs of electrodes to simulate the electrical connection. Receives: Device: Electroacupuncture |
| Electroacupuncture | Active comparator | The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat knee pain. The points selected were local points St 34, St 35, St 36,Liv 8, Sp 10. One distal point St 44.A total of six needles were inserted into each leg by the acupuncturist (the out come measures were not specifically targeted to whether the patient had one or both knees involved). All patients belonging to this group experienced a De Qi sensation, which is a tingling and numbness sensation upon needling of specific points. Receives: Device: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). (VAS pain intensity score)
Measured: baseline and the completion of treatment at 12 weeks.
Secondary outcomes (22)
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
patient-perceived quality of life
Measured: at 1 month
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
patient-perceived quality of life
Measured: at 3 months
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
patient-perceived quality of life
Measured: at 6 months
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
patient-perceived quality of life
Measured: up to 1 year
Change from baseline in plasma cortisol and beta-endorphins levels
analysis of blood samples
Measured: at 1 month
Change from baseline in plasma cortisol and beta-endorphins levels
analysis of blood samples
Measured: at 3 months
Change from baseline in plasma cortisol and beta-endorphins levels
analysis of blood samples
Measured: at 6 months
Change from baseline in plasma cortisol and beta-endorphins levels
analysis of blood samples
Measured: up to 1 year
Change from Baseline in Goldberg Depression and Anxiety scales
measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Measured: at 1 month
Change from Baseline in Goldberg Depression and Anxiety scales
measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Measured: at 3 months
Change from Baseline in Goldberg Depression and Anxiety scales
measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Measured: at 6 months
Change from Baseline in Goldberg Depression and Anxiety scales
measured with the Goldberg Anxiety and Depression Scale. The Spanish version validated by Montón et al. will be used
Measured: up to 1 year
Change from baseline in WOMAC index
WOMAC scale. There are two questions for stiffness (scale of 0-8) and 17 questions for functional limitation (score range of 0-68). Each question will be answered orally with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are unanswered, the scale scores will be declared invalid and not counted.
Measured: at 1 month
Change from baseline in WOMAC index
WOMAC scale. There are two questions for stiffness (scale of 0-8) and 17 questions for functional limitation (score range of 0-68). Each question will be answered orally with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are unanswered, the scale scores will be declared invalid and not counted.
Measured: at 6 months
Change from baseline in WOMAC index
WOMAC scale. There are two questions for stiffness (scale of 0-8) and 17 questions for functional limitation (score range of 0-68). Each question will be answered orally with the following criteria: "none" = 0, "a bit" = 1, "quite a bit" = 2, "a lot" = 3, and "very much" = 4. If two or more questions are unanswered, the scale scores will be declared invalid and not counted.
Measured: up to 1 year
Changes in baseline use of medication
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Measured: at 1 month
Changes in baseline use of medication
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Measured: at 3 months
Changes in baseline use of medication
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Measured: at 6 months
Changes in baseline use of medication
EUROHIS (European Health Survey System) theoretical recommendations and design of a questionnaire
Measured: up to 1 year
Change from baseline in a visual analogue scale (VAS)
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). (VAS pain intensity score)
Measured: at 1 month
Change from baseline in a visual analogue scale (VAS)
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). (VAS pain intensity score)
Measured: at 6 months
Change from baseline in a visual analogue scale (VAS)
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). (VAS pain intensity score)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Mata, Hospital Son Llatzer
- Investigators
- Javier Mata, M.D., Principal investigator, Anaesthesia Department, Son Llàtzer University Hospital. Palma de Mallorca. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299713
- Sponsor's protocol ID
- ACU-001
- Acronym
- EATOAK
- Status last verified
- Nov 2017
- First submitted
- 11 Nov 2014
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahsin S, Saleem S, Bhatti AM, Iles RK, Aslam M. Clinical and endocrinological changes after electro-acupuncture treatment in patients with osteoarthritis of the knee. Pain. 2009 Dec 15;147(1-3):60-6. doi: 10.1016/j.pain.2009.08.004. Epub 2009 Sep 18.
PubMed 19766392Vas J, Mendez C, Perea-Milla E, Vega E, Panadero MD, Leon JM, Borge MA, Gaspar O, Sanchez-Rodriguez F, Aguilar I, Jurado R. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial. BMJ. 2004 Nov 20;329(7476):1216. doi: 10.1136/bmj.38238.601447.3A. Epub 2004 Oct 19.
PubMed 15494348Sangdee C, Teekachunhatean S, Sananpanich K, Sugandhavesa N, Chiewchantanakit S, Pojchamarnwiputh S, Jayasvasti S. Electroacupuncture versus diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. BMC Complement Altern Med. 2002 Mar 21;2:3. doi: 10.1186/1472-6882-2-3.
PubMed 11914160Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005 Jul 9-15;366(9480):136-43. doi: 10.1016/S0140-6736(05)66871-7.
PubMed 16005336Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. doi: 10.7326/0003-4819-141-12-200412210-00006.
PubMed 15611487Selfe TK, Taylor AG. Acupuncture and osteoarthritis of the knee: a review of randomized, controlled trials. Fam Community Health. 2008 Jul-Sep;31(3):247-54. doi: 10.1097/01.FCH.0000324482.78577.0f.
PubMed 18552606Kwon YD, Pittler MH, Ernst E. Acupuncture for peripheral joint osteoarthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2006 Nov;45(11):1331-7. doi: 10.1093/rheumatology/kel207. Epub 2006 Aug 27.
PubMed 16936326White A, Foster NE, Cummings M, Barlas P. Acupuncture treatment for chronic knee pain: a systematic review. Rheumatology (Oxford). 2007 Mar;46(3):384-90. doi: 10.1093/rheumatology/kel413. Epub 2007 Jan 10.
PubMed 17215263Manheimer E, Cheng K, Linde K, Lao L, Yoo J, Wieland S, van der Windt DA, Berman BM, Bouter LM. Acupuncture for peripheral joint osteoarthritis. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD001977. doi: 10.1002/14651858.CD001977.pub2.
PubMed 20091527Mata J, Cabrera S, Sanchis P, Valenti P, Hernandez P, Fortuny R, Lirola S, Aguilar JL. Electro-acupuncture for treatment of knee pain from osteoarthritis and the possible endocrinology changes: a study protocol for a randomized controlled trial. Trials. 2015 Jun 3;16:248. doi: 10.1186/s13063-015-0766-2.
PubMed 26037626
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial, Parallel Design Used To Evaluate Pain, Endocrinologic Variations, Life Quality And Medication Use, After Electro-Acupuncture Treatment In Patients With Osteoarthritis Of The Knee
- ClinicalTrials.gov ID
- NCT02299713
- Acronym / sponsor ID
- EATOAK / ACU-001
- Conditions
- Osteoarthritis, Knee
- Keywords
- acupuncture, knee pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 24 Nov 2014 (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 assess the efficacy of electroacupuncture (EA) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain.
Detailed description
Previous randomised trials and meta-analyses have shown certain efficacy of acupuncture in some chronic painful conditions, in spite of methodological weaknesses. The hypothalamic-pituitary-adrenal (HPA) axis and the endogenous opioid (EO) system are the mechanisms appear to explain how acupuncture works in part. These systems have been shown to be important mediators of stress, pain and other stimuli. The Osteoarthritis Research International suggest that osteoarthritis (OA) treatment should be multidisciplinary and recommended acupuncture as one of 12 possible non-pharmacological modalities for treating OA.
This study is a randomized, double-blind, placebo-controlled trial, parallel design. 128 out-patients over 50 years with OA of the knee will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: placebo/sham acupuncture, non insertion technique, and EA. Acupuncture treatments will be used the Traditional Chinese Medicine (TCM) style. The patients will be evaluated after a period of one month (2 sessions weekly), three months (1session monthly), six months (1 session every 45 days) and again one year later (1 session every 2 months), at the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo/sham acupuncture | Sham comparator | Device: ElectroacupunctureThere are different types of controls used in acupuncture trials. We used the control described as sham and by some as minimal acupuncture. This group had the same schedule as the electro-acupuncture group. Sham acupuncture was administered, with the same duration and frequency and by the same specialist who performed the non-sham acupuncture. Retractable needles were placed into small adhesive cylinders, so that the needles were supported but did not perforate the skin. The acupuncturist placed the needles at the same points as the non-sham group and used the same pairs of electrodes to simulate the electrical connection. |
| Electroacupuncture | Active comparator | Device: ElectroacupunctureThe electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat knee pain. The points selected were local points St 34, St 35, St 36,Liv 8, Sp 10. One distal point St 44.A total of six needles were inserted into each leg by the acupuncturist (the out come measures were not specifically targeted to whether the patient had one or both knees involved). All patients belonging to this group experienced a De Qi sensation, which is a tingling and numbness sensation upon needling of specific points. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
- Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2 and chronic pain in the knee joint for more than 3 months.
Key exclusion criteria (7 listed)
- The patients with secondary osteoarthritis of knees
- Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
- Patients on steroids
- Disease modifying drugs, e.g. methotrexate and azathioprine
- Patients with recent trauma in the area of acupuncture
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 |
|---|---|---|
| ElectroacupunctureElectro acupuncture is a relatively new method of treatment in Chinese Medicine. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation. The device allows the practitioner to adjust the frequency and intensity of the electric stimulation in a consistent manner which is not operator dependant. | Device | Electroacupuncture, placebo/sham acupuncture |
Primary outcome
Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale
Time frame: baseline and the completion of treatment at 12 weeks.
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). (VAS pain intensity score)
22 secondary outcomes
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
Time frame: at 1 month
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
Time frame: at 3 months
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
Time frame: at 6 months
Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey
Time frame: up to 1 year
Change from baseline in plasma cortisol and beta-endorphins levels
Time frame: at 1 month
Change from baseline in plasma cortisol and beta-endorphins levels
Time frame: at 3 months
Change from baseline in plasma cortisol and beta-endorphins levels
Time frame: at 6 months
Change from baseline in plasma cortisol and beta-endorphins levels
Time frame: up to 1 year
Change from Baseline in Goldberg Depression and Anxiety scales
Time frame: at 1 month
Change from Baseline in Goldberg Depression and Anxiety scales
Time frame: at 3 months
Change from Baseline in Goldberg Depression and Anxiety scales
Time frame: at 6 months
Change from Baseline in Goldberg Depression and Anxiety scales
Time frame: up to 1 year
Change from baseline in WOMAC index
Time frame: at 1 month
Change from baseline in WOMAC index
Time frame: at 6 months
Change from baseline in WOMAC index
Time frame: up to 1 year
Changes in baseline use of medication
Time frame: at 1 month
Changes in baseline use of medication
Time frame: at 3 months
Changes in baseline use of medication
Time frame: at 6 months
Changes in baseline use of medication
Time frame: up to 1 year
Change from baseline in a visual analogue scale (VAS)
Time frame: at 1 month
Change from baseline in a visual analogue scale (VAS)
Time frame: at 6 months
Change from baseline in a visual analogue scale (VAS)
Time frame: up to 1 year
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 7 Apr 2020.
- Background: PubMed 19766392Ahsin S, Saleem S, Bhatti AM, Iles RK, Aslam M. Clinical and endocrinological changes after electro-acupuncture treatment in patients with osteoarthritis of the knee. Pain. 2009 Dec 15;147(1-3):60-6. doi: 10.1016/j.pain.2009.08.004. Epub 2009 Sep 18.
- Background: PubMed 15494348Vas J, Mendez C, Perea-Milla E, Vega E, Panadero MD, Leon JM, Borge MA, Gaspar O, Sanchez-Rodriguez F, Aguilar I, Jurado R. Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial. BMJ. 2004 Nov 20;329(7476):1216. doi: 10.1136/bmj.38238.601447.3A. Epub 2004 Oct 19.
- Background: PubMed 11914160Sangdee C, Teekachunhatean S, Sananpanich K, Sugandhavesa N, Chiewchantanakit S, Pojchamarnwiputh S, Jayasvasti S. Electroacupuncture versus diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. BMC Complement Altern Med. 2002 Mar 21;2:3. doi: 10.1186/1472-6882-2-3.
- Background: PubMed 16005336Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005 Jul 9-15;366(9480):136-43. doi: 10.1016/S0140-6736(05)66871-7.
- Background: PubMed 15611487Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. doi: 10.7326/0003-4819-141-12-200412210-00006.
- Background: PubMed 18552606Selfe TK, Taylor AG. Acupuncture and osteoarthritis of the knee: a review of randomized, controlled trials. Fam Community Health. 2008 Jul-Sep;31(3):247-54. doi: 10.1097/01.FCH.0000324482.78577.0f.
- Background: PubMed 16936326Kwon YD, Pittler MH, Ernst E. Acupuncture for peripheral joint osteoarthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2006 Nov;45(11):1331-7. doi: 10.1093/rheumatology/kel207. Epub 2006 Aug 27.
- Background: PubMed 17215263White A, Foster NE, Cummings M, Barlas P. Acupuncture treatment for chronic knee pain: a systematic review. Rheumatology (Oxford). 2007 Mar;46(3):384-90. doi: 10.1093/rheumatology/kel413. Epub 2007 Jan 10.
- Background: PubMed 20091527Manheimer E, Cheng K, Linde K, Lao L, Yoo J, Wieland S, van der Windt DA, Berman BM, Bouter LM. Acupuncture for peripheral joint osteoarthritis. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD001977. doi: 10.1002/14651858.CD001977.pub2.
- Derived from this study: PubMed 26037626Mata J, Cabrera S, Sanchis P, Valenti P, Hernandez P, Fortuny R, Lirola S, Aguilar JL. Electro-acupuncture for treatment of knee pain from osteoarthritis and the possible endocrinology changes: a study protocol for a randomized controlled trial. Trials. 2015 Jun 3;16:248. doi: 10.1186/s13063-015-0766-2.
- 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.
Javier Mata, M.D. principal investigator
Anaesthesia Department, Son Llàtzer University Hospital. Palma de Mallorca. Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Osteoarthritis, Knee, run by Hospital Son Llatzer at 2 sites in Spain.
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 2 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale (time frame: baseline and the completion of treatment at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299713, which also lists 10 linked publications.
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 7 Apr 2020.