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Hand OsteoarthritisNCT04402047

Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis

A study testing Electroacupuncture and Topical diclofenac sodium gel in people with Hand Osteoarthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hand osteoarthritis (OA) is a prevalent joint disorder characterized by pain, stiffness, and bony enlargements/swellings of multiple joints, in particular distal interphalangeal (DIP), proximal interphalangeal (PIP) and first carpometacarpal (CMC) joints. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hand Osteoarthritis
What is being tested?
Electroacupuncture and Topical diclofenac sodium gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
1 Sep 2020to 28 Feb 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of hand OA for at least 3 months before enrolment and use of a NASID for ≥ 1 episode of pain;
  • Reported an average possible overall finger joints pain intensity in the dominant hand over the past 48 hours of at least 40mm according to a 100-mm visual analog scale (VAS) after 1-week wash-out period of previous OA medications(Patients applying NSAIDs at the screening had to have an increase in pain in the dominant hand of ≥ 20 mm during washout);
  • Posterior-anterior radiographs had to show Kellgren-Lawrence grade 1, 2, or 3 changes in symptomatic joints;
  • Rheumatoid factor and anticyclonic citrullinated peptide were negative in all eligible participants to exclude inflammatory arthritis;
  • Ability to comply with the study protocol, understand the medical information forms as well as having signed informed consent.

Who cannot join

  • History or current evidence of secondary OA(due to causes other than a solely degenerative joint disease) or symptomatic OA at additional locations besides the hand(s) requiring treatment, or any painful syndrome of the upper limb which may interfere with evaluation of hand pain;
  • History of inflammatory arthritis(e.g., rheumatoid arthritis (RA), psoriatic arthritis), hemochromatosis, metabolic, or neuropathic arthropathies;
  • History of trauma, dislocation or operation to the hand or arm in the previous 3 months;
  • Hand pain and stiffness due to tissue scarring or tendinitis;
  • Skin damage or serious skin disorders in the hands;
  • Intake of antidepressants, anticonvulsants, vascular or narcotics during the 10 days prior to beginning the study;
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  • Oral, intramuscular, intra-articular or intravenous corticosteroids, or hyaluronic acid injection within 3 months preceding enrollment;
  • Serious uncontrolled medical conditions such as cancer, uncontrolled cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder;
  • Known allergy, contraindication or intolerance to diclofenac, acetaminophen, or gel components;
  • Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.

Trial locations and contacts

1 site in 1 country.

weiming wang, MD, PhD contact

010-88001241

wangweiming1a1@163.com

Zhishun Liu, MD, PhD contact

010-88002331

zhishunjournal@163.com

China1 site, 1 recruiting
  • Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital

    Beijing

    Recruiting

Other trials in China

About this study

Official title: Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis: Study Protocol for a Randomized Controlled Trial

Hand osteoarthritis (OA) is a prevalent joint disorder characterized by pain, stiffness, and bony enlargements/swellings of multiple joints, in particular distal interphalangeal (DIP), proximal interphalangeal (PIP) and first carpometacarpal (CMC) joints. Symptomatic hand OA is estimated to affecting 15.9% of women and 8.2% of men in the general population with a variable disease course, occurring more frequently in the elderly. Many factors including age, gender, obesity, genetic predisposition, joint deformity, joint hypermobility, and trauma are implicated in the development of hand OA. In addition to pain and stiffness, patients with hand OA often suffer from the reduced grip and pinch strength, decreased range of motion in involved and noninvolved joints, and difficulty performing dexterous tasks, resulting in disability in activities of daily living and considerable frustration.

At present, no therapies can completely cure hand OA and few therapeutic options with proven effectiveness for hand OA exist. Diclofenac sodium gel (DSG) is one of the commonly used topical NSAIDs, which can provide local pain relief for patients with hand OA with reduced systemic exposure, potentially reducing the risk of adverse events (AE). Acupuncture is effective in a host of pain-related conditions, ranging from low back pain, neck pain, shoulder pain, migraine to pain from knee OA. The research on the effects of acupuncture in people with hand OA is very limited.

The purpose of this study is to investigate the clinical effectiveness of 4-week electroacupuncture(EA) compared to topical DSG in the treatment of hand OA. Our primary hypothesis was that EA would result in a greater pain relief improvement in hand OA compared with topical DSG.

Being tested
Electroacupuncture, Topical diclofenac sodium gel
Keywords
Hand osteoarthritis; Electroacupuncture; Diclofenac sodium gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElectroacupunctureOther

    We will apply Ashi points, Ex-UE9, SI3, and TE5. Sterile needles (0.3mm× 40mm) and SDZ-V EA apparatus will be utilized. Acupuncturists will insert needles perpendicularly into Ashi points for approximately 2-3mm until they pierce into the bone surface; acupuncturists will insert needles horizontally into Baxie points towards the wrist with a depth of 5-10mm; and acupuncturists will insert needles perpendicularly into SI3 and TE5 for approximately 5-10mm. All needles except Ashi points will be manually manipulated to achieve De qi. The needles at Baxie 1 and Baxie 4 will be connected using alligator clips from the EA apparatus. The electrical stimulation will last for 30 minutes with a continuous wave of 10 Hz and a fixed current intensity of 0.5 to 2 mA. All the needles will be retained for 30 minutes. Participants will undergo EA treatment three times per week for a total of 12 sessions in four consecutive weeks. If bilateral hands were affected, both sides will be treated.

  • Topical diclofenac sodium gelDrug

    The gel will be gently rubbed over the affected joints without excessive joint movement four times per day for 4 weeks and will be asked not to wash hands for one hour after application. Each hand treatment will be used in identical dispensing doses of gel (4 cm strip, approximately 2g, which was judged sufficient for approximately half the surface of each hand (200 cm2)). Dosing times should be distributed evenly over waking hours.If bilateral hands were affected, both sides will be treated.

Study groups in NCT04402047
Study groupRoleWhat they receive
Electroacupuncture groupExperimentalNot described
Receives: Other: Electroacupuncture
Topical DSG groupActive comparatorNot described
Receives: Drug: Topical diclofenac sodium gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to week 4

    Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.

    Measured: at baseline and week 4

Secondary outcomes (11)
  1. Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to weeks 8, 16

    Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.

    Measured: at baseline,week 8 and week 16

  2. The proportion of participants achieving at least a 15-point reduction in average overall finger joints pain intensity in the dominant hand from baseline to weeks 4, 8 and 16

    Measured: at week 4, week 8 and week 16

  3. Change in Australian Canadian Osteoarthritis Hand Index (AUSCAN) total score, and pain, stiffness and physical function subscales from baseline to weeks 4, 8 and 16

    The AUSCAN index contains a 15-item scale referring to hand pain (5 items), stiffness (1 item), and function (9 items) during the preceding 48 hours, which is valid, reliable and responsive in patients with hand OA. All items are scaled on a 0-100 VAS (0=none to 100= very severe), with higher scores indicating more severe symptoms/function.

    Measured: at baseline,week 4, week 8 and week 16

  4. Change in Functional Index for HOA (FIHOA) from baseline to weeks 4, 8 and 16

    The FIHOA is a patient-reported hand function questionnaire, comprising 10 items with a four-point Likert scale, in which 0 represents "possible without difficulty", 1 indicates "possible with slight difficulty", 2 represents "possible with important difficulty" and 3 indicates "impossible"

    Measured: at baseline,week 4, week 8 and week 16

  5. Change in the number of self-reported painful joints and painful joints at digital pressure from baseline to weeks 4, 8 and 16

    All finger joints will be reported spontaneously for the presence of pain by the participants, and examined by a trained research nurse for the presence of pain at digital pressure.

    Measured: at baseline,week 4, week 8 and week 16

  6. Change in the number of swollen joints from baseline to weeks 4, 8 and 16:

    All soft swollen finger joints count (0-30) will be assessed by a trained research nurse at each study visit.

    Measured: at baseline,week 4, week 8 and week 16

  7. Change in hand grip strength and pinch strength of the fingers from baseline to weeks 4, 8 and 16:

    Hand grip strength and pinch strength of the fingers of the dominant hand will be tested using a hand dynamometer and a Jamar digital pinch gauge respectively.

    Measured: at baseline,week 4, week 8 and week 16

  8. Change in patient global assessment of improvement from baseline to weeks 4, 8 and 16

    The patients will be asked to respond to the question 'Considering all the ways your hand OA affects you, how have you been during the last 48 h?' on a self-administered 0-100 VAS (0, worst possible, to 100, best possible, in 10-point increments)

    Measured: at baseline,week 4, week 8 and week 16

  9. The proportion of responder according to the Outcome Measures in Rheumatological Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) responder criteria at weeks 4,8 and 16

    The OMERACT-OARSI response is defined as an improvement in either pain (0-100 overall finger joints pain) or function (0-36 AUSCAN physical function) with ≥50% (relative) and ≥20/100 (absolute); or if the improvement is ≥20% (relative) and ≥10/100 (absolute) in ≥2 of the following: pain, functioning and patient global assessment of improvement.

    Measured: at week 4, week 8 and week 16

  10. Change in quality of life assessed by the World Health Organization Quality of Life abbreviated version (WHOQOL-BREF) from baseline to weeks 4, 8 and 16

    The WHOQOL-BREF is a 26-item self-report questionnaire rated on a 5-point Likert-type scale with four domains of QOL: physical (seven items), psychological (six items), social (three items), and environment (eight items), plus 2 items representing the general QOL. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life.

    Measured: at baseline,week 4, week 8 and week 16

  11. Self-reported consumption of acetaminophen for hand OA during weeks 1-4 and weeks 5-12

    The proportion of participants using acetaminophen and the average dosage of acetaminophen used weekly will be calculated and assessed.

    Measured: at weeks 1-4 and weeks 5-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start1 Sep 2020
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion28 Feb 2023 (estimated)

Resources

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
Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04402047
Sponsor's protocol ID
2020-015-KY
Status last verified
Oct 2020
First submitted
20 May 2020
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data are available on reasonable request. You can send e-mail to us if you have any question

Publications

  • Wang W, Kang J, Shi J, Jiao R, Zang Z, Long Z, Wang X, Liu X, Liu Y, Liu Z. Efficacy of Electroacupuncture Compared With Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis: A Randomized Controlled Trial. Mayo Clin Proc. 2026 May 27:S0025-6196(25)34683-5. doi: 10.1016/j.mayocp.2025.12.018. Online ahead of print.

    PubMed 42201269
  • Wang W, Yu S, Long Z, Liu Y, Yan Y, Sun T, Liu Z. Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trial. J Orthop Surg Res. 2022 Apr 12;17(1):233. doi: 10.1186/s13018-022-03125-1.

    PubMed 35413861

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture and Topical diclofenac sodium gel in people with Hand Osteoarthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

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 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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 China. 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?

Contact weiming wang, MD, PhD (010-88001241, wangweiming1a1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to week 4 (time frame: at baseline and week 4). 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 NCT04402047, which also lists 2 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 8 Oct 2020.

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