Table 1.
Item | Detail |
---|---|
1. Acupuncture rationale (explanations and examples) | 1a) Style of acupuncture: - French energetics, channel theories from Chinese medicine, and neuro-anatomical (percutaneous electrical nerve stimulation (PENS)) [62] |
1b) Reasoning for treatment provided: - Point selections are based on the book by Dr J Helms, publications, and expert consensus | |
1c) Extent to which treatment is varied: - We allow flexibility to include hip points if the participant reports hip/buttock pain; we also allow up to 3 additional points to be added if participants do not report at least 30% pain reduction after 4 sessions. | |
2. Details of needling (explanations and examples) | 2a) Number of needle insertions per subject per session: - 20 (up to 30 if hip pain is present and if there is no response by the fifth session |
2b) Names (or location if no standard name) of points used: - Obligatory: GV-20, 4, BL-23, 25, 26, 28, KI-3, 7, HR-3, SI-3, BL-40 - Optional: GB-30 if there is hip/buttock pain (laterality depends on location of that pain); BL-10, 60, KI-10 if there is no response by the fifth session | |
2c) Depth of insertion: - 0.5 (GV-20) to 6 cm (GB-30), depending on the location and patient size (most fall between 1 and 2 cm) | |
2d) Response sought: - Deqi | |
2e) Needle stimulation: - After Deqi is achieved at each needle, the following needles will also be electrically stimulated for 20–25 min: BL-23, 25, 26, 28, KI-3, 7. Then, if hip/buttock pain is present, posterior superior iliac spine (PSIS) and GB-30 - All e-stims will be bipolar, DC, at 2 Hz, and will be titrated to cause gentle muscle twitch, or to the amount that the patient can comfortably tolerate for 20 min if twitch is not obtainable | |
2f) Needle retention time: 30 min | |
2 g) Needle type (diameter, length, and manufacturer or material): - Auricular: Seirin J15 (0.12 × 15 mm) - Gluteal (GB-30): Huaxia (0.3 × 75 mm) - All other body needles: DBC Spring-10 (0.2 × 40 mm) | |
3. Treatment regimen (explanations and examples) | 3a) Number of treatment sessions: 16 sessions over 8 weeks |
3b) Frequency and duration of treatment sessions: - First session up to 90 min, including the initial assessment - All subsequent sessions will be 45 min long | |
4. Other components of treatment (explanations and examples) | 4a) Details of other interventions administered to the acupuncture - Heat lamp to low back - Auricular acupuncture to Shenmen, point zero, thalamus, and lumbar spine points |
4b) Setting and context of treatment - Participants will be informed that they may receive either real or sham EA and that both have been shown to be helpful in relieving pain | |
5. Practitioner background (explanations and examples) | 5) Description of participating acupuncturists: 1. Licensed and ensured to administer acupuncture in the State of California 2. At least 3 years of acupuncture experience prior to treating study participants 3. Attendance at a full-day training session at the Stanford Center for Back Pain, and half-day on-site training at their own facility by the protocol co-director (JK) 4. Adequate ability to follow both the real and placebo treatment administration protocols, as assessed by the protocol co-director (JK) 5. Adequate facility to provide acupuncture treatment, approved by the protocol co-director (JK) |
6. Control or comparator interventions (explanations and examples) | 6a. Rationale for the control or comparator: - To minimize specific and physiologic effects, non-penetrating, Streitberger needles will be used at non-acupuncture, off-meridian points [46] - Sham electrical stimulation will be delivered via real machines with broken wires, based on a validated protocol from Wayne et al. [48] - Sham auricular points will be treated by placing a small piece of tape at the top and bottom apex of the ear - Heap lamp will be placed over the calf for approximately 20–25 min |
6b. Precise description of the control or comparator: - Point location: S1--in the middle of deltoid, 3 Cun below the lateral edge of acromion; S2--5 Cun lateral to the T-12 spinous process; S3--5 Cun lateral to L-5 spinous process; S4--midpoint on the line connecting BL-57 and GB-34 on the posterior calf - Point stimulation: minimal palpation to locate point, no Deqi. All points (S1-S4) receive sham electrical stimulation, which is performed after the acupuncturist informs the participant that he/she may or may not feel the paresthesia, because sometimes therapeutic electrical treatments are below the sensory detection threshold - The duration of needle retention and sham stimulation will be identical to that of the real treatment - Treatment regimen: same frequency and total number of treatment sessions as the real treatment in item #3, above |