Clinical trial NCT04402047: Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis
Official title: Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Osteoarthritis
Keywords: Hand osteoarthritis; Electroacupuncture; Diclofenac sodium gel
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. History of hand OA for at least 3 months before enrolment and use of a NASID for ≥ 1 episode of pain;
2. 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);
3. Posterior-anterior radiographs had to show Kellgren-Lawrence grade 1, 2, or 3 changes in symptomatic joints;
4. Rheumatoid factor and anticyclonic citrullinated peptide were negative in all eligible participants to exclude inflammatory arthritis;
5. Ability to comply with the study protocol, understand the medical information forms as well as having signed informed consent.

Exclusion Criteria:

1. 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;
2. History of inflammatory arthritis(e.g., rheumatoid arthritis (RA), psoriatic arthritis), hemochromatosis, metabolic, or neuropathic arthropathies;
3. History of trauma, dislocation or operation to the hand or arm in the previous 3 months;
4. Hand pain and stiffness due to tissue scarring or tendinitis;
5. Skin damage or serious skin disorders in the hands;
6. Intake of antidepressants, anticonvulsants, vascular or narcotics during the 10 days prior to beginning the study;
7. Oral, intramuscular, intra-articular or intravenous corticosteroids, or hyaluronic acid injection within 3 months preceding enrollment;
8. Serious uncontrolled medical conditions such as cancer, uncontrolled cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder;
9. Known allergy, contraindication or intolerance to diclofenac, acetaminophen, or gel components;
10. Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.

Primary outcomes:
measure: Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to week 4
timeFrame: at baseline and week 4
Secondary outcomes:
measure: Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to weeks 8, 16
timeFrame: at baseline，week 8 and week 16
measure: 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
timeFrame: at week 4, week 8 and week 16
measure: 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
timeFrame: at baseline，week 4, week 8 and week 16
measure: Change in Functional Index for HOA (FIHOA) from baseline to weeks 4, 8 and 16
timeFrame: at baseline，week 4, week 8 and week 16
measure: Change in the number of self-reported painful joints and painful joints at digital pressure from baseline to weeks 4, 8 and 16
timeFrame: at baseline，week 4, week 8 and week 16
measure: Change in the number of swollen joints from baseline to weeks 4, 8 and 16:
timeFrame: at baseline，week 4, week 8 and week 16
measure: Change in hand grip strength and pinch strength of the fingers from baseline to weeks 4, 8 and 16:
timeFrame: at baseline，week 4, week 8 and week 16
measure: Change in patient global assessment of improvement from baseline to weeks 4, 8 and 16
timeFrame: at baseline，week 4, week 8 and week 16
measure: 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
timeFrame: at week 4, week 8 and week 16
measure: 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
timeFrame: at baseline，week 4, week 8 and week 16
measure: Self-reported consumption of acetaminophen for hand OA during weeks 1-4 and weeks 5-12
timeFrame: at weeks 1-4 and weeks 5-12
Other outcomes:
measure: Participants' expectations for acupuncture at baseline
timeFrame: at baseline
measure: Incidence of adverse events
timeFrame: weeks 1-16
Locations:
city: Beijing
country: China
facility: Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Study officials:
affiliation: Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences
name: Zhishun Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.