Carole Paley BSc(Hons); M.Med.Sci; MCSP. Airedale NHS Founda:on Trust/Leeds Metropolitan University

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1 Carole Paley BSc(Hons); M.Med.Sci; MCSP Airedale NHS Founda:on Trust/Leeds Metropolitan University

2 Introduc:on and Background Study was a part of a PhD programme of research: Acupuncture for Cancer-Induced Bone Pain Pilot studies show promising results for acute pain conditions Very little published research on rapid-onset acupuncture analgesia Possibility of using acupuncture for breakthrough cancer pain and acute musculoskeletal injury

3 Aim of the Inves:ga:on To compare the hypoalgesic effects of bidirectional rotation of 4 and 2 needles using contact thermal pain in healthy volunteers using a mock acupuncture group as a comparator.

4 Methods Repeated measures, parallel groups design Participants: 42 healthy volunteers M/F age 18+ No exclusion if familiar with acupuncture Randomised to receive acupuncture with 4 needles, 2 needles or mock acupuncture Pain induction via TSA delivering contact heat pain Baseline: pain threshold + 2⁰C 10 mins needling using bi-directional rotation 5 mins post-needling Pain recorded using VAS

5 Outcome Measures Main outcome measure: time taken to achieve a 33% pain intensity difference (PID) from initial VAS score. Secondary outcome measures included total PID over the 10 minute needling phase and during the post-needling phase. Participants were also asked which group they thought they had been allocated to.

6 Pain Induc:on Screen Thermode

7 Sing le Experimenta l C yc le Needles inserted or sha m inse rtion carriedout First e xp e rime nta l cycle temperature 2nd exp erimenta l cycle TSA TSA Tim e 0 min Rest (4s) Pa rticipa nt records VAS when TSA re a c h e s p re - se t ma ximum te mp within each cycle. This will vary depending on how high the threshold temp era ture w a s for ea c h in d iv id u a l. Needles bi- directionally rotated at 2Hz for 15 sec ond s ea c h in turn or sha m rota tion of guide tube above the skin.

8 Group 4N 2N Acupuncture point and anatomical location of needles LI4 - Dorsum of hand between 1 st and 2 nd metacarpals within adductor policis. LI11 Midway between radial aspect of biceps tendon and the lateral epicondyle of humerus into ext carpi radialis. LI10 Radial aspect of forearm 2cun distal to LI11 on line connecting LI11 with LI5. TE5 2 cun proximal to dorsal wrist crease in the depression between radius and ulna. LI4 LI11 Depth/ direction of Insertion and needle dimensions Perpendicular cm. Seirin J-type needle 25 x 30mm Perpendicular 2cm. Seirin J-type needle 25 x 30mm Perpendicular 1.5-2cm. Seirin J-type needle 25 x 30mm Perpendicular 1cm.Seirin J-type needle 25 x 30mm As above 0N Skin tap over LI4, LI11, LI10 and TE5 As above

9 Results 42 participants: 14 in each arm of the study 27 female, 15 male Age range (mean 36 years ± 14.1) 24 participants were acupuncture naive Differences in experimental temperatures were not significant between or within groups using ANOVA Differences in heat cycle length were not significant using one-way ANOVA Data was normally distributed.

10 Correlation Statistics Pre and Post-Needling Group/Condition Spearman Correlation coefficient (r s ) P Value Significance 4N during acup Significant α = N during acup Significant α = 0N during mock Significant α = acup 0.05 Spearman s Rank Correlation Coefficient: VAS vs Heat Cycle Group/Condition Spearman Correlation coefficient (r s ) P Value Significance 4N post acup Significant α = N post acup Significant α = 0N post mock acup Not significant Spearman s Rank Correlation Coefficient: VAS vs Heat Cycle Post- Needling

11 Source df SS MS F P Between Groups: Within Groups: Total: One Way ANOVA: Comparison of VAS scores during 10 minute needling phase (4N, 2N, 0N) Source df SS MS F P Between Groups: Within Groups: Total: One-way ANOVA: Time to 33% PID vs Group (4N, 2N, 0N)

12 4N group Time (s) 2N group Time (s) 0N Group Time (s) * * * * 22.5 Mean * Values missing (participant did not reach 33% PID) SD Time to 33% PID (s)

13 Boxplot of 4N, 2N, 0N for time to 33% PID Time (s) N 2N 0N

14 Source df SS MS F P Between Groups: Within Groups: Total: One-way ANOVA comparing VAS differences post-needling

15 Adverse Events Some participants recorded painful needling sites Minor bleeding One participant was withdrawn because of fainting One participant complained of burning, although this was not apparent when thermode was removed. Participant Blinding Ten participants were unaware of their group allocation Most were acupuncture naive Of the remaining participants, few were able to identify their correct group allocation

16 Summary of Results One-way ANOVA for needling period showed no difference in VAS scores between groups Strong negative correlation between pain cycle and VAS score during needling in all groups One-way ANOVA for post-needling period showed no difference between groups One-way ANOVA for time to 33% PID showed no significant difference although the P value was out of 14 participants in 4N group achieved 33% PID within 90 seconds, whereas the other groups were both > 160 secs

17 Limita:ons Relatively small sample size Use of participants familiar with acupuncture possibly resulted in unblinding Possible learning effect Thermal contact pain possibility of desensitisation?

18 Conclusions and Recommenda:ons acupuncture with strong bi-directional rotation might reduce contact thermal pain in some individuals the 4N group experienced a 33% reduction in VAS scores within 93.7 seconds rapid enough for cancer BTP there was a marked effect on VAS scores during needling in the control group (? Why?) the use of thermal pain presented problems a different pain induction method is recommended Acupuncture naive participants should be used Mock acupuncture technique was effective in blinding

19 Key References Kong J, Fufa DT, et al(2005) Psychophysical outcomes from a randomized pilot study of manual, electro, and sham acupuncture treatment on experimentally induced thermal pain. The Journal of Pain 6(1): Langevin HM, Bouffard NA, et al(2007) Connective tissue fibroblast response to acupuncture: dose-dependent effect of bidirectional needle rotation. J Altern Complement Med 13(3): Le Bars D, Villanueva L, et al(1991) Diffuse Noxious Inhibitory Controls (DNIC) in Animals and in Man. Acupunct Med 9(2): Sprenger C, Bingel U, et al(2011) Treating pain with pain: Supraspinal mechanisms of endogenous analgesia elicited by heterotopic noxious conditioning stimulation. Pain 152(2): White A, Cummings M, et al(2008) Defining an adequate dose of acupuncture using a neurophysiological approach - a narrative review of the literature. Acupunct Med 26(2): Yarnitsky D, Sprecher E, et al(1995) Heat pain thresholds: normative data and repeatability. Pain 60(3):

20 Any Ques/ons?

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