Table 2.
Key Features of Acupuncture Treatments (Standard and Maintenance Phases)
| STRICTA* Domain | BIA Treatment Parameters |
|---|---|
| Treatment Rationale | |
| Treatment Rationale: Style of Acupuncture | Traditional East Asian Medicine, typically including an interview and palpation before providing acupuncture treatment. Exclusively microsystem focused treatments NOT permitted. |
| Treatment Rationale: Basis for Treatment | Modified Delphi Process made recommendations based on treatment information from large clinical trials of chronic low back pain and other published literature on treatments provided in advance to panel members [REFs] |
| Treatment Rationale: Variability of Treatment | Variability in treatment to respond to patient’s presentation is expected |
| Needling Details: Needles/Study Participant | Recommend 6 – 20 needles |
| Needling Details | |
| Needling Details: Names of Points | Recommend both local and distal points, selecting from a series of 113 named acupoints (214 acupoints total if counting bilaterally): low back acupoints (29; 58 if bilateral; 4 central for total of 62), acupoints on the mid and upper back (33; 66 if bilateral; 2 central for total of 68), front of the body including distal leg acupoints (33; 66 if bilateral; 6 central points for total of 72) and ear acupoints (6; 12 if bilateral). In addition, ashi points – selected by tenderness to palpation - are permitted. Other acupoints should include the rationale. |
| Needling Details: Depths of Insertion | Recommend needling to 75% of safe needling depth for a particular point; shallow needling prohibited |
| Needling Details: De qi sought? | Recommend obtaining de qi |
| Needling Details: Type of Needle Stimulation | Require manual stimulation only |
| Needling Details: Needle Retention Time | Recommend 20-30 minutes for needling only one side of the body (though needles could be in place for up to 40 minutes) and 10-25 minutes/side for both sides |
| Needling Details: Needle Type | Uncoated needles are recommended. Other needle details such as gauge and length are entirely up to the discretion of the acupuncturist. |
| Treatment Regimen and Components | |
| Treatment Regimen: Number of Treatment Sessions | Standard period: allow no more than 15 treatment sessions, and recommend at least 8. Maintenance period: allow no more than 6 treatment sessions, and recommend at least 4 treatment sessions. |
| Treatment Regimen: Frequency and Duration of Sessions | Standard period: recommend at least 6-8 treatments in the first 60 days and at least 1-2 treatments in the last 30 days. Maintenance period: a minimum of 4 treatments is recommended, no further guidance on temporality. |
| Other Key Descriptors of Treatment | |
| Other Components of Treatment: Adjunctive treatments | No adjunctive treatments are permitted. Life style recommendations are permitted. |
| Other Components of Treatment: Setting and Context of Treatment | In the offices of community acupuncturists (3-sites) or in the primary care clinic (1-site). Acupuncturists required to complete training on the protection of human subjects in the context of research, an orientation to the trial and intervention protocol, a review of best practices for safe administration of acupuncture, and study logistics including getting patients from the study team and recording the treatment. |
| Qualifying Acupuncturist Experience | At least 3 years of experience (5 yrs preferred); experience treating older adults; experience treating chronic low back pain and multimorbidities; willingness to adhere to the study constraints |
*
STRICTA=Standards of Reporting for Clinical Trials of Acupuncture; STRICTA is an extension of the CONSORT statement for reporting acupuncture interventions in clinical trials.