Back to resultsElectroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis
Primary Purpose
Hand Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Topical diclofenac sodium gel
Sponsored by
About this trial
This is an interventional treatment trial for Hand Osteoarthritis focused on measuring Hand osteoarthritis; Electroacupuncture; Diclofenac sodium gel
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electroacupuncture group
Topical DSG group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
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"
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.
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.
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.
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)
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.
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.
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.
Full Information
NCT ID
NCT04402047
First Posted
May 20, 2020
Last Updated
October 6, 2020
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04402047
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Osteoarthritis
Keywords
Hand osteoarthritis; Electroacupuncture; Diclofenac sodium gel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Efficacy evaluators and data analysts will be blinded to the group assignments.
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture group
Arm Type
Experimental
Arm Title
Topical DSG group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Topical diclofenac sodium gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to week 4
Description
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
Time Frame
at baseline and week 4
Secondary Outcome Measure Information:
Title
Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to weeks 8, 16
Description
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
Time Frame
at baseline，week 8 and week 16
Title
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
Time Frame
at week 4, week 8 and week 16
Title
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
Description
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.
Time Frame
at baseline，week 4, week 8 and week 16
Title
Change in Functional Index for HOA (FIHOA) from baseline to weeks 4, 8 and 16
Description
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"
Time Frame
at baseline，week 4, week 8 and week 16
Title
Change in the number of self-reported painful joints and painful joints at digital pressure from baseline to weeks 4, 8 and 16
Description
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.
Time Frame
at baseline，week 4, week 8 and week 16
Title
Change in the number of swollen joints from baseline to weeks 4, 8 and 16:
Description
All soft swollen finger joints count (0-30) will be assessed by a trained research nurse at each study visit.
Time Frame
at baseline，week 4, week 8 and week 16
Title
Change in hand grip strength and pinch strength of the fingers from baseline to weeks 4, 8 and 16:
Description
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.
Time Frame
at baseline，week 4, week 8 and week 16
Title
Change in patient global assessment of improvement from baseline to weeks 4, 8 and 16
Description
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)
Time Frame
at baseline，week 4, week 8 and week 16
Title
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
Description
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.
Time Frame
at week 4, week 8 and week 16
Title
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
Description
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.
Time Frame
at baseline，week 4, week 8 and week 16
Title
Self-reported consumption of acetaminophen for hand OA during weeks 1-4 and weeks 5-12
Description
The proportion of participants using acetaminophen and the average dosage of acetaminophen used weekly will be calculated and assessed.
Time Frame
at weeks 1-4 and weeks 5-12
Other Pre-specified Outcome Measures:
Title
Participants' expectations for acupuncture at baseline
Description
At baseline, participants in the EA group will be asked to answer the following question: "What do you expect from EA treatment to improve your hand OA?"
Time Frame
at baseline
Title
Incidence of adverse events
Description
Any adverse events (AEs) during the whole study, whether reported spontaneously by the participants, or observed by the researcher, will be recorded and categorized as acupuncture-related AEs(e.g., fainting, broken needle, localized hematoma, dizziness, or), the side effect of TDG (e.g., skin irritation/itching, reddening, scaly skin), and non-treatment-related AEs. All AEs will be recorded in detail in the case report form.
Time Frame
weeks 1-16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
weiming wang, MD, PhD
Phone
010-88001241
Email
wangweiming1a1@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishun Liu, MD, PhD
Phone
010-88002331
Email
zhishunjournal@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, MD, PhD
Organizational Affiliation
Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data are available on reasonable request. You can send e-mail to us if you have any question
IPD Sharing Time Frame
It depends
IPD Sharing Access Criteria
It depends
Citations:
PubMed Identifier
35413861
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.
Results Reference
derived
Learn more about this trial
Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis
We'll reach out to this number within 24 hrs