Table 4A. Biofield Studies Conducted with Pain Patients, in Order of Total Quality Ratings

Table 4a

Table 4a. Biofield studies conducted with pain patients, in order of total quality ratings (highest to lowest). Problematic studies marked with (*). (HT = Healing Touch, TT = Therapeutic Touch, TAU= Treatment as Usual, STAI = State-Trait Anxiety Inventory, POMS = Profile of Mood States, VAS = Visual Analog Scale)

Study Reference / Patient Population (N, gender, ethnicity) / Intervention(s)
(duration, design) / Biomarkers/ functional measures
examined / Psych and other outcome variables / Results / Study +/- / Comments
(Lin & Taylor, 1999) / 90 Elderly chronic pain patients (76 female, 14 male; mean age 78; 76% Caucasian, 11% African American, 3% other) / B/wn Ss design
TT (n = 31)
mimic TT (n = 29)
standard care (n = 30)
3 20-min TT or mock TT sessions on 3 consecutive days
One TT practitioner, one mimic TT practitioner / salivary cortisol / NRS scale for pain intensity, measured pre-post intervention
STAI / Significant group differences on NRS pain and STAI state anxiety change scores; TT group showed decreases in both measures compared to mimic TT and control groups (effect sizes were .92 for pain, .35 for anxiety)
No group differences on cortisol / + standard care control
+ placebo control
+ reliable/valid measures
+ examination of confidence intervals when testing group effects
+ reported effect sizes / Not clear if time of day was controlled for for cortisol samples
Only one TT practitioner used
(Gerard et al., 2003) / 68 patients with restricted neck movement (male = 24, female = 44; mean age 53; ethnicity not reported) / B/wn Ss design
Spiritual healing (n = 34)
No-tx control (n = 34)
3 weekly 30-min sessions of healing
1 healer used, with 14 yrs experience / Range of neck movement:
Rotation
Flexion-extension
Lateral flexion / VAS of pain severity
VAS of overall well-being
SF-36 Quality of Life Scale
Hospital Anxiety and Depression Scale (HAD)
Chronic Pain Grade questionnaire / Treatment group showed significantly greater increases in rotation and flexion-extension compared to controls; these changes began to decline at 4-week follow up
Significant decrease in pain severity VAS scores for treatment vs. control group, but no significant differences on Chronic Pain Grade questionnaire
Significant increase in SF-36 physical function and energy/vitality for treatment vs. control group
No between-group differences on overall VAS well-being or HAD scores / + control group
- no alpha control
- no control for covariates / Only 1 healer used
Study Reference / Patient Population (N, gender, ethnicity) / Intervention(s)
(duration, design) / Biomarkers/ functional measures
examined / Psych and other outcome variables / Results / Study +/- / Comments
Gillespie, Gillespie, & Stevens (2007) / 207 patients with Type II diabetes and painful diabetic neuropathy (mean age =65; males =126; females = 81; ethnicity not reported) / B/wn Ss design
Reiki (n = 93)
Mimic Reiki (n = 88)
Standard care control (n = 26)
25-min sessions for 12 weeks – twice the first week, and once/week for the remaining 11
Number of Reiki practitioners and experience not reported; mimic Reiki administered by trained actors / 6 min walk-test
(secondary outcome) / Primary:
McGill Pain Questionnaire
Secondary:
Epidemiology of Diabetes Intervention and Complications quality of life questionnaire (EDIC)
Well-being questionnaire
Diabetes Treatment Satisfaction Questionnaire / Significant within-group reductions for pain ratings and walking distance for Reiki and mimic Reiki, but no between-group differences for Reiki vs. mimic Reiki
No significant pre-post changes for Diabetes Treatment Satisfaction or well-being for any group
Reiki group showed borderline (p = .05) increase in EDIC / + placebo control
+ stratification for covariates
+ alpha control
+ good sample size
-no statistical control for covariates / Attrition for usual care group was so high that investigators chose to stop allocating patients to that group
(Abbot et al., 2001) / 120 Chronic pain patients (of completed, male = 46, female = 59; mean age = 51, ethnicity not reported) / B/wn Ss design
Proximal spiritual healing (n = 25)
Mock spiritual healing (n = 25)
Distance spiritual healing (n = 28)
No healing control (n = 27)
8 weekly 30-min sessions of proximal/mock spiritual healing / None / Primary: Total Pain Rating Index (PRIT) of McGill Pain Questionnaire
Secondary: VAS for pain intensity
SF36 Quality of Life Scale
Hospital Anxiety and Depression Scale (HAD)
Measure Yourself Medical Outcomes Scale (MYMOP)
Qualitative questionnaire of experience after healing / All 4 arms showed decrease in PRIT over 8 weeks
No significant difference in HAD, VAS, or MYMOP between groups over time
Significant difference in physical function subscale of SF36; proximal healing showed improvement compared to mock healing
Proximal and distance healing groups both reported significantly more unusual experiences than mock healing or control groups / + control group
+ placebo control group
+ multiple measures with specified primary/secondary outcomes
- no alpha control
- no assessment/use of covariates / Authors tested for blinding of participants and found no difference between healing vs. control groups on guesses of group status at end of intervention
Study Reference / Patient Population (N, gender, ethnicity) / Intervention(s)
(duration, design) / Biomarkers/ functional measures
examined / Psych and other outcome variables / Results / Study +/- / Comments
(Redner et al., 1991) / 47 Chronic Pain patients (male = 12, female = 35; mean age = 49; 96% Caucasian, 2% African-American, 2% Malaysian) / B/wn Ss design
Johnson bioenergy technique
Placebo bioenergy technique
Sessions were 35 min duration, 1 session/week for 4 weeks; pt treated by 2 healers simultaneously
11 healers participated who had completed at least 2 out of 3 training courses & 2 or more years of practice / None / McGill-Melzack Pain Questionnaire (MPQ) – 4 subscales
McGill-Melzack Home Recording Form
POMS / Significant group x time interaction for MPQ sensory and affective subscales; bioenergy group showed significant improvements over treatment compared to placebo
Significant group x time interaction for POMS subscale anxiety; biofield healing group showed increased anxiety pre-post treatment compared to placebo
No significant changes in Home Recording form / + placebo control
+ clear and appropriate statistical procedure / Placebo condition consisted of actual healers using hand placements and not intending to heal, using attentional distraction
(Gordon et al., 1998) / 25 patients with osteoarthritis of the knee ( 18 females and 7 males; mean age = 65; ethnicity not reported) / B/wn Ss design
TT (n = 8), Mock TT (n = 11), control (TAU) (n = 8)
TT and mock TT received tx 1x/wk for 6 wks / None / Pre-post intervention:
Stanford Health Assessment Questionnaire (HAQ)
West Haven-Yale Multidimensional Pain Inventory (MPI)
pre-post each Tx:
VAS for pain
VAS for well-being / TT group showed significant improvement in MPI function and decreased pain compared to mock TT and control group
No differences in HAQ Disability Index
No change in VAS pre-post tx for TT or mock TT
Qualitative data depicted decreased pain and arthritis symptoms for all but 1 patient in TT group; for mock TT group, 5/11 reported decreased pain / +control group
+ placebo control group
+ follow-up assessment
- underpowered
- no alpha control for multiple statistical tests for subscales / No info on practitioner experience
Study Reference / Patient Population (N, gender, ethnicity) / Intervention(s)
(duration, design) / Biomarkers/ functional measures
examined / Psych and other outcome variables / Results / Study +/- / Comments
(Peck, 1998) / 108 Elderly patients with degenerative arthritis ( mean age = 72; 15 male, 66 female; no ethnicity reported / B/wn-Ss design
4 week baseline period
Then Ss randomized to either TT, or progressive muscle relaxation (PMR)
TT practitioners had >2yrs experience; PMR administered by nurses trained in PMR for study
TT and PMR treatments were 15-20 min in length; 1x/week for 6 weeks / None / Arthirtis Impact Measurement Scale (AIMS-2); 11 subscales / Within-Ss analysis revealed significant pre-post improvements in 5 of 11 subscales for TT, and 8 of the 11 for PMR.
Between-group repeated measures analysis revealed that PMR and TT significantly differed on hand and mobility function, with trend for difference in arm function.
However, post-hoc analysis is not clear (only provided by graphs, unclear whether differences between groups at baseline for mobility scores) / + comparison group
+ assessment of potential covariates b/wn groups
- no alpha control for multitude of statistical tests; unclear whether authors accounted for baseline differences in repeated measures analysis / 24% Attrition reported
Treatments given either in practitioner’s office or patient’s home
Notable difference in practitioner experience for TT vs PMR
(Yang, Kim, & Lee., 2005) / 40 Elderly persons with chronic pain (mean age 72; 8 male, 32 female; ethnicity not reported) / B/wn Ss
Qi-therapy
Standard Care control
One Qi-master with 10 years experience
20-min sessions twice/week for 4 weeks / None / Korean POMS
VAS for pain / Qi-therapy group showed significant improvement on all POMS subscales except for anger/hostility compared to control group
Qi-therapy group showed significant decreases in VAS pain ratings compared to control group
Participants in Qi-therapy group showed maintainance of improvement (at 2 week follow-up) on same scales except vigor and positive mood / + control group
+ follow-up
- no assessment/control for covariates / use of culturally-validated measure for population studied
apppears to replicate prior study (Lee et al. 2001)
although did not formally employ alpha control, p-values reported would have remained significant after Bonferroni correction
Study Reference / Patient Population (N, gender, ethnicity) / Intervention(s)
(duration, design) / Biomarkers/ functional measures
examined / Psych and other outcome variables / Results / Study +/- / Comments
(Keller & Bzdek, 1986) / 60 patients with tension headache pain; 45 female, 15 male; mean age = 30; 92% Caucasian / B/wn Ss design
TT
mock TT
One 5-min session; TT conducted by “the researcher” (experience unknown)
Unclear who performed mock TT interventions / None / 3 subscales of McGill-Melzack Pain Questionnaire:
Pain Rating Index (PRI)
Number of Words Chosen (NWC)
Present Pain Intensity (PPI) / Authors found significant differences in reduction of pain for TT vs. mock TT group for all 3 subscales immediately after TT session
Reductions in pain for TT maintained 4 hours post treatment; however, not significantly different from mock TT at 4 hrs post-tx – investigators discovered that 50% of mock TT participants used headache medicine during these 4 hours post-tx, compared to 16% of those in TT group / + placebo control
+ tested for internal consistency of subscales (scale itself is reliable/valid)
+ assessment for covariates / “Researcher” conducted TT and made calls to pts
to assess changes in pain at 4-hr post TT; thus possible subject role/expectancy bias in follow-up measure
(Sundblom et al., 1994) / 24 patients with idiopathic chronic pain / B/wn Ss design
Spiritual healing (n = 12)
No-treatment control
(n = 12)
Healing group received 3-8 sessions within 2 weeks of 40min duration each; one female healer used / None / Hopkins Symptom Checklist (SCL-90)
Middlesex Hospital Questionnaire (MHQ)
Beck Depression Inventory (BDI)
Coping Strategy Questionnaire (CHQ)
Finnish Health Locus of Control (HLC) / No changes in any measure noted for just after treatment; 6 of 12 people in healing group reported subjective benefit but this was not reflected in significant improvements in measures
Spiritual healing group showed sig decrease in hopelessness subscale of CHQ and acceptance as coping strategy for pain subscale in HLC at 1-yr followup / + follow-up data
- no alpha control for multitude of tests
- underpowered
- no assessement/control for covariates / Authors note that healer in study is “considered one of the best spiritual healers in the entire country”; healer’s reports of perceived patient benefit were similar to patient reports of therapy benefit
(M. S. Lee et al., 2003b) / 94 Elderly persons with reported chronic pain; mean age 64; 66 male and 28 female; no info on ethnicity (study in Korea) / B/wn Ss design
Qi-therapy (n = 47)
Placebo Qi-therapy (n = 47)
8 Qi-therapy Masters used (5 male, 3 female); all trained at least 1 year - administered both Qi and placebo Qi therapy
One Qi-therapy session for 10 minutes / BP / VAS for anxiety
VAS for pain
VAS for depression
VAS for fatigue
# pain points / Significant group x time interactions for VAS scores of anxiety, depression, fatigue, and pain, as well as significant interaction for pain points, SBP and DBP; Qi-therapy showed larger pre-post decreases in all these measures compared to placebo Qi-therapy group / + placebo control group
- no reliability/validity info for psych outcome measures / Authors report on findings for pain points, but do not describe how this was assessed
Unclear interpretation of statistical results by authors
Study Reference / Patient Population (N, gender, ethnicity) / Intervention(s)
(duration, design) / Biomarkers/ functional measures
examined / Psych and other outcome variables / Results / Study +/- / Comments
(M. S. Lee et al., 2001b) / 40 elderly persons with chronic pain; mean age = 73, 8 male, 32 female (study in Korea, but no info reported on ethnicity) / B/wn Ss design
External Qi therapy (n = 20)
Standard Care control (n = 20)
Used one Qi practitioner had 6 years of training; Qi therapy session was 10 min; 2x/week for 2 weeks (4 sessions) / Korean POMS
VAS for pain / Significant group x time interaction on POMS vigor/activity, friendliness, and tension/anxiety subscales of POMS; Qi-therapy group showed increases in vigor and friendliness over time, and decreases in tension/anxiety over time compared to controls
Significant group x time interaction for VAS pain scores; Qi-therapy group showed significant decreases in rated pain levels over time compared to controls / + control group / use of culturally-validated measure for population studied
(Olson & Hanson, 1997) / 20 participants with reported pain (male = 2, female = 18; mean age 44 years; ethnicity not reported) / W/in Ss design
Reiki
One 1.25 hr treatment by Reiki practitioner (experience/level unknown) / None / VAS for pain
Likert scale for pain / Significant reduction in VAS and Likert scales pre-post Reiki; 85% of patients showed the reduction / - no control or placebo condition / pilot study
Study Reference / Patient Population (N, gender, ethnicity) / Intervention(s)
(duration, design) / Biomarkers/ functional measures
examined / Psych and other outcome variables / Results / Study +/- / Comments
(Blankfield et al., 2001)* / 21 carpal tunnel patients; mean age = 56; 10 female, 11 male; 20 Caucasian / W/in Ss design
Each patient received TT 1x/wk for 6 wks, and mock TT 1x/wk for 6 wks; txs were 30 min duration
TT and mock TT conducted by nurses, TT had 3 practitioners with 1, 5, and 6 ye, beginning to advanced / distal latencies of median motor nerve pre-post each tx / VAS for pain/discomfort pre-post each tx / Both TT and sham TT showed changes from baseline on median motor nerve distal latency, pain and relaxation; no dif between groups / + placebo control
- no control for covariates
- underpowered (small N)
- no info on attrition
- rudimentary use of statistics (no repeated measures analysis reported, combined data from crossover with between-ss data)
-no testing for carryover effects / Ranked problematic due to poor statistical procedure due to design issues: Started as b/wn group design, but because not enough enrollment, switched to crossover design
only 25 % of TT persons correctly guessed tx, remaining 75% were unsure
50% of sham TT thought they were assigned to “real” TT, other 50% were unsure
practitioner who administered the tx also conducted the electroneurometer readings
(Denison, 2004)* / 15 Fibromyalgia patients (mean age = 51, no info on gender or ethnicity) / B/wn Ss design
TT (n = 10)
CG (n = 5) (sitting and listening to tapes on complementary therapies)
10-15 minute session each week for 6 weeks
2 TT practitioners used, with >10 years experience / Cutaneous skin temperature / McGill Pain Questionnaire short form
Fibromyalgia Health Assessment Questionnaire (FHAQ) / Significant pre-post within-group difference for TT recipients on FHAQ
Significant within-group increases in cutaneous skin temperature for mean front body hotspot for pretest vs. weeks 1-4, but not for pretest vs. week 5 or 6; also, a trend for CG to show higher skin temperature than TT group
No significant effects for pain scores / + control group
- no alpha control for a multitude of statistical tests
- questionable statistical procedure
- underpowered
- no control for covariates / Rated as problematic due to unclear statistical procedure: unclear why authors chose to perform series of paired t-tests over multiple timepoints for questionnaires, rather than repeated measures ANOVA