Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis

NCT04402047 | Unknown

• 1 other identifier: 2020-015-KY
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Osteoarthritis

Keywords

Hand osteoarthritis; Electroacupuncture; Diclofenac sodium gel

Outcome Measures

Primary Outcomes (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.

  at baseline and week 4

Secondary Outcomes (11)

• Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to weeks 8, 16

  at baseline，week 8 and week 16

• 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

  at week 4, week 8 and week 16

• 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

  at baseline，week 4, week 8 and week 16

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

  at baseline，week 4, week 8 and week 16

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

  at baseline，week 4, week 8 and week 16

Other Outcomes (2)

• Participants' expectations for acupuncture at baseline

  at baseline

• Incidence of adverse events

  weeks 1-16

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

Other: Electroacupuncture

Topical DSG group

ACTIVE COMPARATOR

Drug: Topical diclofenac sodium gel

Interventions

Electroacupuncture OTHER

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.

Electroacupuncture group

Topical diclofenac sodium gel DRUG

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.

Topical DSG group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35413861 DERIVED

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Zhishun Liu, MD, PhD

  Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

weiming wang, MD, PhD

CONTACT

010-88001241; wangweiming1a1@163.com

Zhishun Liu, MD, PhD

CONTACT

010-88002331; zhishunjournal@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Efficacy evaluators and data analysts will be blinded to the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: September 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: February 28, 2023
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It depends
• Access Criteria: It depends

Locations

CN (1)