N/A
N=779
Acupuncture Approaches for Chronic Pain
Chronic Pain · Osteoarthritis · Neck Pain · Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02456727 ↗Enrolled (actual)
779
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) — 6.0; 6.1; 5.1; 4.8 Units on a Scale — p=0.0691
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group/Community Acupuncture (Procedure); Individual Acupuncture (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) |
6.0; 6.1; 5.1; 4.8; 5.3; 5.1 | 0.0691 |
| PRIMARY Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) |
5.8; 5.8; 4.6; 4.5; 5.1; 4.7 | 0.5077 |
| PRIMARY Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) |
82; 108; 189; 180 | 0.24 |
| PRIMARY Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) |
65; 81; 124; 123 | 0.17 |
| PRIMARY Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) |
77; 99; 191; 184 | 0.17 |
| PRIMARY Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) |
56; 78; 126; 119 | 0.40 |
| SECONDARY Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model) |
6.8; 6.8; 5.7; 5.4; 5.9; 5.8 | 0.1387 |
| SECONDARY Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model) |
6.7; 6.8; 5.3; 5.1; 5.7; 5.6 | 0.2725 |
| SECONDARY Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model) |
87; 104; 198; 195 | 0.07 |
| SECONDARY Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model) |
73; 83; 128; 129 | 0.07 |
| SECONDARY Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model) |
65; 74; 220; 217 | 0.02 sig |
| SECONDARY Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model) |
48; 56; 148; 146 | 0.06 |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model) |
3.0; 2.8; 3.6; 3.3 | 0.1475 |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model) |
2.6; 2.5; 3.3; 3.0 | 0.3038 |
| SECONDARY Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model) |
103; 116; 191; 193 | 0.03 sig |
| SECONDARY Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model) |
89; 95; 117; 124 | 0.02 sig |
| SECONDARY Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model) |
76; 75; 214; 223 | 0.00 sig |
| SECONDARY Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model) |
62; 68; 136; 139 | 0.03 sig |
| SECONDARY Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) |
34.8; 34.8; 38.5; 38.7; 37.2; 37.8 | 0.8778 |
| SECONDARY Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) |
35.3; 35.2; 39.4; 39.6; 38.2; 38.7 | 0.5626 |
| SECONDARY Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) |
173; 193; 118; 113 | 0.05 |
| SECONDARY Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) |
125; 147; 79; 70 | 0.22 |
| SECONDARY Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) |
142; 164; 141; 132 | 0.12 |
| SECONDARY Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) |
96; 121; 97; 84 | 0.44 |
| SECONDARY Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model) |
42.8; 42.4; 43.8; 44.5; 43.3; 44.1 | 0.4014 |
| SECONDARY Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model) |
43.6; 43.5; 44.4; 45.2; 44.1; 45.0 | 0.307 |
| SECONDARY Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model) |
75; 84; 213; 220 | 0.01 sig |
| SECONDARY Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model) |
48; 57; 155; 158 | 0.05 |
| SECONDARY Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model) |
72; 86; 213; 209 | 0.05 |
| SECONDARY Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model) |
45; 59; 152; 145 | 0.18 |
| SECONDARY Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model) |
85; 78; 53; 55; 58; 56 | 0.1658 |
| SECONDARY Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model) |
42; 39; 33; 32; 34; 35 | 0.1172 |
| SECONDARY Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model) |
4.3; 5.1; 4.2; 4.9; 4.5; 5.1 | 0.0326 sig |
| SECONDARY Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model) |
4.0; 4.7; 3.6; 4.2; 4.1; 5.0 | 0.0026 sig |
| SECONDARY Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model) |
0; 0 | 0.129 |
| SECONDARY Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model) |
0; -0.5 | 0.031 sig |
| SECONDARY Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model) |
51; 64; 57; 43 | 0.0059 sig |
| SECONDARY Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model) |
26; 35; 28; 22 | 0.0385 sig |
Summary
Chronic pain is a major public health problem that places many burdens on individuals, including impairment of physical and psychological functioning, lost productivity, and side effects of medications used to treat pain. There is also substantial evidence that minority populations differ both in prevalence and outcomes of chronic pain; access to care is a key component in these differences. Strong evidence now supports the use of acupuncture in the treatment of chronic pain conditions, including when provided in the primary care setting to participants from ethnically diverse, medically underserved populations. Acupuncture is slowly being integrated into pain management in many conventional health care settings, but cost and reimbursement for this service remain obstacles to offering acupuncture, especially in primary care and safety net settings. Because group acupuncture can be offered at much lower cost, demonstrating that individual and group delivery are equally effective could reduce barriers to use of this effective pain management approach.
The primary aim of this study will be to evaluate whether acupuncture delivered in the group setting for participants with chronic pain is equal to acupuncture delivered in the individual setting. A secondary objective will be to use qualitative analysis to understand and describe the participants' experience of both acupuncture approaches, and to utilize this data to inform intervention delivery and dissemination, to better incorporate the participants' perspective.
Eligibility Criteria
Inclusion Criteria
- Referred by a primary care provider from one of our participating primary care health centers
- Provider-documented diagnosis of osteoarthritis (any joint), neck pain, OR back pain
- Self-reported pain score of ≥4 for at least 3 months prior to program entry
- Able to provide consent for treatment and data collection in either English or Spanish
Exclusion Criteria
- < 21 years of age
- Chronic pain not documented OR self reported pain of ≥4 for less than 3 months.
- Currently taking oral or injectable anticoagulants.
- Lack of contact information OR unavailable for duration of entire treatment period (24 weeks)
- Inability to consent to treatment and data collection.
- Active psychosis
- Active substance abuse
Data sourced from ClinicalTrials.gov (NCT02456727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.