Floatation-REST for Chronic Pain

This dataset was acquired at Hannover Medical School, Hannover, Germany. The study complied with the Declaration of Helsinki, and was approved by the local ethics committee. All subjects gave written informed consent, and consent to publish their data anonymously. The study was registered at ClinicalTrials.gov (NCT03584750).

We conducted a single-blind, randomized clinical trial comparing floatation-REST (restricted environmental stimulation therapy) with an indistinguishable placebo, and a wait-list control. A total of 99 patients with a diagnosis of chronic pain disorder with psychological and somatic factors (ICD-10-GM code F45.41) were randomly assigned to one of the three groups. Patients in the intervention and the in the placebo group underwent five sessions lasting 60-90 minutes; each session separated by approximately four days. The placebo treatment was delivered in the same floating tank, but controlled for effortless floating and environmental stimulus restriction. The wait-list control group did not receive any additional treatment. Participants in all three groups where asked not to start any new therapy, and to continue their prescribed treatments at the time of enrollment.

Further details on the inclusion and exclusion criteria, outcomes and measures, as well as study dates can be found on the trial registration page at ClinicalTrials.gov. This dataset contains the raw data as well as necessary scripts for reproducing the results of this study. The scripts for calculating questionnaire scores are not included within this dataset as they include proprietary data. However, we provide the output of the respective "data_extraction.py" scripts with calculated scores.

Data structure

raw

sub_i: Raw data of subject i

patient.txt: contains either 1 (male) or 2 (female)

questionnaires_0.json: Baseline long-term questionnaires. Includes participant's age at recruitment

questionnaires_1.json: long-term questionnaires 1 week after the last session

questionnaires_2.json: long-term questionnaires 12 weeks after the last session

questionnaires_3.json: long-term questionnaires 24 weeks after the last session

visit_1: participants gave written informed consent at this visit

physio.json: physiological measurements

symptoms: electronic drawings

si_v0.png: symptom i front view

si_v1.png: symptom i back view

records.json: includes symptoms description

visit_2-6: five floatation-REST or placebo sessions

float_duration.txt: float duration in minutes

physio_0.json: physiological measurements before the session

physio_1.json: physiological measurements after the session

questionnaires_0.json: short-term questionnaires before the session

questionnaires_1.json: short-term questionnaires after the session

symptoms_0: electronic drawings before the session (files as above)

symptoms_1: electronic drawings after the session (files as above)

sensations: electronic drawings of unusual sensations during the session (files as above)

remarks.txt: contains information about further unusual sensations or whether the lid was opened

visit_7: one week after the last session

physio.json: physiological measurements

symptoms: electronic drawings (files as above)

analyses: scripts for reproducing the results

00_excluded_subjects: participants who dropped out of the study

00_subjects: all other participants

extract_drawings.sh: loop through the participants to convert all drawings from png to nifti, and merge and binarise them (for calculation of pain area and WPI)

Jpng2nii.py: script to convert drawings from png to nii

JWPI.sh: calculates WPI from electronic drawings

JWPI.py: used to calculate WPI by JWPI.sh

WPI_3D_back.nii.gz: 4D image containing masks of the 19 regions defined in the WPI (back view)

WPI_3D_front.nii.gz: 4D image containing masks of the 19 regions defined in the WPI (front view)

baseline

data.csv: output from data_extraction.py

data_complete.csv: output from data_extraction.py

data_extraction.py: creates a csv with all data required for baseline calculations

statistical_tests.py: computes baseline statistical analyses

long-term

data.csv: output from data_extraction.py

data_complete.csv: output from data_extraction.py

data_extraction.py: creates a csv with all data required for long-term calculations

statistical_tests.py: computes long-term statistical analyses and plots

short-term

data.csv: output from data_extraction.py

data_complete.csv: output from data_extraction.py

data_extraction.py: creates a csv with all data required for short-term calculations

statistical_tests.py: computes short-term statistical analyses and plots

Subjects and groups
A: Floatation-REST
B: Placebo floating
C: Wait-list control

    01    A
    02    A
    03    A
    04    A
    05    C
    06    C
    07    B
    08    C
    09    B
    10    C
    11    A
    12    B
    13    A
    14    C
    15    C
    16    B
    17    B
    18    A
    19    C
    20    B
    21    B
    22    A
    23    B
    24    A
    25    B
    26    C
    27    A
    28    B
    29    B
    30    B
    31    A
    32    C
    33    A
    34    C
    35    B
    36    C
    37    B
    38    A
    39    C
    40    B
    41    A
    42    B
    43    B
    44    A
    45    A
    46    B
    47    C
    48    B
    49    C
    50    C
    51    A
    52    B
    53    B
    54    C
    55    A
    56    B
    57    A
    58    C
    59    C
    60    C
    61    A
    62    B
    63    A
    64    B
    65    B
    66    A
    67    C
    68    B
    69    A
    70    B
    71    B
    72    C
    73    A
    74    C
    75    B
    76    C
    77    C
    78    A
    79    C
    80    C
    81    A
    82    C
    83    B
    84    B
    85    C
    86    A
    87    B
    88    C
    89    B
    90    B
    91    A
    92    C
    93    B
    94    A
    95    A
    96    A
    97    A
    98    B
    99    B

Missing data

09: Second follow-up

29: Visit_1 physio

31: Visit_3_post physio

42: Visit_7

47: Visit_1 physio

51: Visit_7

66: Visit_7

67: Incomplete first follow-up. Visit_1 physio

83: Visit_7

86: Visit_7

90: Visit_7

93: Visit_1 physio

96: Visit_7

97: Visit_7

98: Visit_7

Dropouts

01: Operation

06: Loss of interest

07: Illness (GI)

10: Other study

12: Job

13: Loss of interest

17: Loss of interest

21: Loss of interest

27: Contact lost

37: Loss of interest

44: Haemorrhoids

46: Too cold

52: Herpes zoster

58: Loss of interest

63: Otitis media

64: Contact lost

65: Pregnancy

68: Illness of relative

69: Open psoriasis

75: Loss of interest

79: Loss of interest

80: Loss of interest

91: Illness of relative

93: Illness