Background
Methods
Trial design
Participants
Criteria | Participants with chronic thoracic pain |
---|---|
Inclusion criteria | ▪ 18 and 60 years old. ▪ Thoracic pain * for at least 3 months (constant or recurrent). ▪ Pain within T6 to T8 region indicated on the pain diagram and/or during physical examination at the start of the first session. ▪ Pain intensity at the start of the first session ≥5/100. |
Exclusion criteria | ▪ Having a history of thoracic surgery or fracture. ▪ Diagnosed with a non-spine-related condition that might refers pain to the chest wall (e.g. heart, lung or oesophagus conditions). ▪ Diagnosed or suspected with one of the following conditions: spine-related inflammatory arthritis, aorta aneurism, advanced osteoporosis, neuromuscular disease, myelopathy, malignant tumors, uncontrolled hypertension, radiculopathy, neurologic deficit, thoracic herniated disc, current infection, thoracic scoliosis (Cobb’s angle > 20°). ▪ Being a pregnant woman. |
Procedures and intervention
Questionnaires at baseline
Spinal manipulative therapy procedure
Spinal stiffness procedure
sEMG procedure
Outcomes
Outcome | Session 1 | Session 2 | Session 3 | Session 4 (follow-up) |
---|---|---|---|---|
Primary outcomes | ||||
Pain intensity (VAS) at the session beginning | X | X | X | X |
Back disability (QBPDQ) at the session beginning | X | X | X | X |
Secondary outcomes | ||||
Spinal stiffness at T6, T7 and T8 (N/mm) | Before SMT/rest | X | ||
Muscle activity during spinal stiffness at T6, T7 and T8 (nRMS) | During spinal stiffness procedure before SMT/rest | X | ||
Tenderness during spinal stiffness at T6, T7 and T8 (VAS) | During spinal stiffness procedure before SMT/rest | X | ||
Outcome for the exploratory analysis | ||||
Subjective improvement | X |
Sample size
Randomization
Blinding
Data analysis
Spinal stiffness calculation
sEMG data processing
Statistical analysis
Baseline descriptive and comparative analysis
Primary outcomes analysis
Secondary outcomes analysis
Exploratory analysis of factors associated with clinical improvement
Results
Recruitment
Participant flow
Baseline data
Characteristic |
Dose1
−peak/−rate |
Dose 2
+peak/+rate |
Dose 3
+peak/−rate | Control | F3,77 or H3 value and p value | |
---|---|---|---|---|---|---|
Males: Females | 6: 14 | 8: 14 | 8: 13 | 6: 12 | – | |
Age (years) | 41.50 (13.79) | 37.45 (13.48) | 37.19 (11.14) | 35.83 (13.68) | F = 0.57; p = 0.64 | |
Weight (kg) | 70.88 (12.66) | 72.21 (18.80) | 74.66 (18.90) | 68.85 (13.15) | F = 2.03; p = 0.12 | |
Height (m) | 1.65 (0.08) | 1.67 (0.07) | 1.68 (0.10) | 1.68 (0.07) | F = 0.69; p = 0.56 | |
Body mass index (kg/m2) | 26.12 (4.62) | 28.91 (7.15) | 26.09 (4.51) | 24.48 (4.27) | F = 2.43; p = 0.07 | |
Average pain intensity in the past three months (0–100, median, IQR) | 30.00 (20.00) | 27.50 (10.00) | 30.00 (26.00) | 50.00 (40.00) | H = 7.51; p = 0.06 | |
Pain intensity at the start of the first session (0–100, median, IQR) | 20.00 (10.00) | 20.00 (15.00) | 30.00 (29.97) | 50.00 (44.00) | H = 12.06, p = 0.01* | |
TSK score (/68) | 30.45 (7.26) | 31.64 (6.89) | 31.71 (8.23) | 33.39 (6.17) | F = 0.53; p = 0.66 | |
QBPDQ score (%, median, IQR) | 9.00 (15.00) | 16.31 (18.09) | 12.92 (11.51) | 12.50 (15.00) | H = 1.47 p = 0.69 | |
SBST score (/9, median, IQR) | 2.00 (3.00) | 2.00 (3.00) | 3.00 (3.00) | 3.50 (2.00) | H = 6.73; p = 0.08 | |
Global spinal stiffness at the first session before SMT/rest (N/mm) | T6 | 8.02 (1.20) | 7.49 (1.62) | 7.70 (1.62) | 8.14 (1.43) | F = 0.81; p = 0.49 |
T7 | 7.96 (1.05) | 7.38 (1.80) | 7.72 (1.83) | 8.03 (1.18) | F = 0.75; p = 0.52 | |
T8 | 7.73 (1.18) | 7.39 (1.87) | 7.62 (1.98) | 7.80 (1.63) | F = 0.23; p = 0.87 | |
Terminal spinal stiffness at the first session before SMT/rest (N/mm) | T6 | 8.06 (1.26) | 7.50 (1.65) | 7.73 (1.64) | 8.20 (1.44) | F = 0.88; p = 0.46 |
T7 | 7.98 (1.07) | 7.41 (1.88) | 7.75 (1.95) | 8.06 (1.21) | F = 0.69; p = 0.56 | |
T8 | 7.77 (1.24) | 7.39 (1.90) | 7.64 (2.07) | 7.86 (1.66) | F = 0.27; p = 0.84 | |
Tenderness during spinal stiffness assessment (%, median, IQR) | T6 | 18.83 (22.50) | 13.33 (23.33) | 16.67 (18.67) | 19.17 (23.33) | H = 2.42; p = 0.49 |
T7 | 13.33 (24.33) | 5.00 (16.33) | 10.00 (20.00) | 15.00 (16.33) | H = 2.84; p = 0.42 | |
T8 | 9.33 (19.33) | 4.17 (21.00) | 8.33 (16.67) | 10.00 (18.33) | H = 1.26; p = 0.74 | |
Muscle response amplitude during spinal stiffness assessment (nRMS, median, IQR) | T6 | 0.10 (0.09) | 0.13 (0.11) | 0.08 (0.15) | 0.11 (0.10) | H = 4.78; p = 0.19 |
T7 | 0.10 (0.06) | 0.14 (0.13) | 0.08 (0.06) | 0.11 (0.11) | H = 5.12; p = 0.16 | |
T8 | 0.09 (0.05) | 0.13 (0.13) | 0.08 (0.04) | 0.11 (0.09) | H = 5.02; p = 0.17 | |
Expectation (+: - or neutral) | 13: 7 | 18: 4 | 18: 3 | 10: 8 | – |
Results for the primary outcomes
Results for the secondary outcomes
Results for the exploratory analysis
Independent variables | b (SE) |
p
| 95% CI for Odds Ratio | ||
---|---|---|---|---|---|
Lower | Odds Ratio | Upper | |||
Intercept | −3.51 (1.25) | 0.01 | |||
STarT Back Screening Tool score | 0.43 (0.23) | 0.07 | 0.97 | 1.53 | 2.41 |
Initial expectation: positive vs negative | −1.53 (0.94) | 0.11 | 0.03 | 0.22 | 1.37 |
Slope of the change in pain intensity across the four sessions | 0.39 (0.14) | 0.01* | 1.13 | 1.48 | 1.94 |
Slope of the change in T6 tenderness across the four sessions | 0.01 (0.01) | 0.50 | 0.98 | 1.01 | 1.04 |
Slope of the change in T6 tenderness between the first two sessions | 0.13 (0.07) | 0.048* | 1.00 | 1.14 | 1.29 |
Slope of the change in T7 tenderness between before-and-after the first SMT/rest | 0.09 (0.15) | 0.57 | 0.81 | 1.09 | 1.48 |
Slope of the change in T8 tenderness between the first two sessions | 0.07 (0.05) | 0.22 | 0.96 | 1.07 | 1.19 |
Slope of the change in T8 terminal spinal stiffness between the first two sessions | −1.00 (0.71) | 0.16 | 0.09 | 0.37 | 1.48 |