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Table 1 Details of treatment parameters summarized per STRICTA (version 2010) [61]

From: Central mechanisms of real and sham electroacupuncture in the treatment of chronic low back pain: study protocol for a randomized, placebo-controlled clinical trial

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