Trial Outcomes & Findings for Effectiveness of a Modern Educational Intervention in Breast Cancer Patients (NCT NCT03351075)
NCT ID: NCT03351075
Last Updated: 2024-11-21
Results Overview
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
Change between baseline and one year follow-up assessment
Results posted on
2024-11-21
Participant Flow
Recruitment took place at the Multidisciplinary Breast Center of the University Hospitals Leuven campus Gasthuisberg (Belgium) between November 2017 and March 2020.
In total, 493 women were eligible, of which 184 were included in the study.
Participant milestones
| Measure |
Intervention Group
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Intensive Treatment Phase (4 mo FU)
STARTED
|
92
|
92
|
|
Intensive Treatment Phase (4 mo FU)
COMPLETED
|
86
|
87
|
|
Intensive Treatment Phase (4 mo FU)
NOT COMPLETED
|
6
|
5
|
|
Maintenance Treatment Phase (12 mo FU)
STARTED
|
86
|
87
|
|
Maintenance Treatment Phase (12 mo FU)
COMPLETED
|
85
|
87
|
|
Maintenance Treatment Phase (12 mo FU)
NOT COMPLETED
|
1
|
0
|
|
End of Trial (18 mo FU)
STARTED
|
85
|
87
|
|
End of Trial (18 mo FU)
COMPLETED
|
84
|
86
|
|
End of Trial (18 mo FU)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Intervention Group
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Intensive Treatment Phase (4 mo FU)
Withdrawal by Subject
|
6
|
4
|
|
Intensive Treatment Phase (4 mo FU)
Death
|
0
|
1
|
|
Maintenance Treatment Phase (12 mo FU)
Withdrawal by Subject
|
1
|
0
|
|
End of Trial (18 mo FU)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=92 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=184 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=92 Participants
|
76 Participants
n=92 Participants
|
150 Participants
n=184 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=92 Participants
|
16 Participants
n=92 Participants
|
34 Participants
n=184 Participants
|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 11.5 • n=92 Participants
|
55.2 years
STANDARD_DEVIATION 11.4 • n=92 Participants
|
55.3 years
STANDARD_DEVIATION 11.4 • n=184 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=92 Participants
|
92 Participants
n=92 Participants
|
184 Participants
n=184 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=92 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=184 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
92 participants
n=92 Participants
|
92 participants
n=92 Participants
|
184 participants
n=184 Participants
|
|
BMI
|
25.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=92 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 5.9 • n=92 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 5.2 • n=184 Participants
|
|
Educational Level
Primary education or no diploma
|
3 participants
n=86 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
3 participants
n=87 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
6 participants
n=173 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
|
Educational Level
Lower secondary education
|
5 participants
n=86 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
5 participants
n=87 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
10 participants
n=173 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
|
Educational Level
Upper secondary education
|
23 participants
n=86 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
28 participants
n=87 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
51 participants
n=173 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
|
Educational Level
Higher education: professional bachelor
|
30 participants
n=86 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
32 participants
n=87 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
62 participants
n=173 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
|
Educational Level
Higher education: academic bachelor or master
|
25 participants
n=86 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
19 participants
n=87 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
44 participants
n=173 Participants • Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present.
|
|
Surgery at dominant side
Surgery at dominant side (yes)
|
44 participants
n=92 Participants
|
41 participants
n=92 Participants
|
85 participants
n=184 Participants
|
|
Surgery at dominant side
Surgery at dominant side (no)
|
48 participants
n=92 Participants
|
51 participants
n=92 Participants
|
99 participants
n=184 Participants
|
|
Type of surgery
BCS+ALND
|
4 participants
n=92 Participants
|
9 participants
n=92 Participants
|
13 participants
n=184 Participants
|
|
Type of surgery
1ME+SLNB
|
41 participants
n=92 Participants
|
43 participants
n=92 Participants
|
84 participants
n=184 Participants
|
|
Type of surgery
ME+ALND
|
47 participants
n=92 Participants
|
40 participants
n=92 Participants
|
87 participants
n=184 Participants
|
|
Radiotherapy
|
74 participants
n=92 Participants
|
66 participants
n=92 Participants
|
140 participants
n=184 Participants
|
|
Hormone therapy
|
69 participants
n=92 Participants
|
68 participants
n=92 Participants
|
137 participants
n=184 Participants
|
|
Chemotherapy
|
63 participants
n=92 Participants
|
55 participants
n=92 Participants
|
118 participants
n=184 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and one year follow-up assessmentPopulation: Using likelihood-based estimation, subjects with a missing at one or more timepoints were still included in the analysis.
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain.
Outcome measures
| Measure |
Intervention Group
n=82 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=84 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Change in Pain-related Disability
|
4.22 score on a scale
Interval 1.4 to 7.03
|
5.53 score on a scale
Interval 2.74 to 8.32
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment and at 1,5 years (after follow-up)Population: Available data differed between timepoints
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Pain-related Disability
Change from baseline to 4 months
|
3.70 score on a scale
Interval 1.37 to 6.04
|
4.67 score on a scale
Interval 2.35 to 6.99
|
|
Self-reported Pain-related Disability
Change from baseline to 1.5 years
|
3.13 score on a scale
Interval 0.59 to 5.67
|
4.19 score on a scale
Interval 1.68 to 6.7
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed between timepoints.
Measured with Visual Analogue Scale (0-100), lower scores indicate a better outcome.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Pain-intensity
Mean change from baseline to 4 months
|
7.26 score on a scale
Interval 1.87 to 12.65
|
9.49 score on a scale
Interval 4.14 to 14.85
|
|
Self-reported Pain-intensity
Mean change from baseline to 12 months
|
6.31 score on a scale
Interval 1.06 to 11.57
|
10.61 score on a scale
Interval 5.43 to 15.79
|
|
Self-reported Pain-intensity
Mean change from baseline to 1.5 years
|
3.91 score on a scale
Interval -1.7 to 9.52
|
8.71 score on a scale
Interval 3.17 to 14.24
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed on timepoints
Measured with the Central Sensitization Inventory (0-100). The Central Sensitization Inventory (CSI) includes 25 items about symptoms related to altered central somatosensory functioning, scored on a five-point Likert scale from 0 (never) to 4 (always). Scores range from 0-100 and a higher score represents greater symptomatology associated with altered central somatosensory processing.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Central Sensitization Symptoms
Mean change from baseline to 4 months
|
3.61 score on a scale
Interval 1.56 to 5.66
|
3.43 score on a scale
Interval 1.15 to 5.14
|
|
Self-reported Central Sensitization Symptoms
Mean change from baseline to 1 year
|
2.14 score on a scale
Interval 0.13 to 4.16
|
2.39 score on a scale
Interval 0.4 to 4.38
|
|
Self-reported Central Sensitization Symptoms
Mean change from baseline to 1.5 years
|
3.15 score on a scale
Interval 1.09 to 5.2
|
3.43 score on a scale
Interval 1.15 to 5.14
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Mechanical detection sensitivity (mN) measured with Von Frey monofilaments at the arm at the affected side. A series of stimulus intensities are given and the stimulus intensity (mN) that is first identified is recorded (min-max 8 mN-512 mN). A lower value indicates a higher sensitivity to mechanical sensitivity.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Altered Somatosensory Functions (Touch)
Mean change from baseline to 4 months
|
2.37 mN
Interval 1.53 to 3.67
|
1.76 mN
Interval 1.13 to 2.72
|
|
Altered Somatosensory Functions (Touch)
Mean change from baseline to 1 year
|
1.68 mN
Interval 1.06 to 2.67
|
1.95 mN
Interval 1.22 to 3.09
|
|
Altered Somatosensory Functions (Touch)
Mean change from baseline to 1.5 years
|
2.35 mN
Interval 1.48 to 3.74
|
1.87 mN
Interval 1.18 to 2.95
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Thermal detection sensitivity (degrees Celsius) for warmth at the arm at the affected side measured with computerized thermotests. Temperature when a change from a thermoneutral state to a distinct warm is recorded. A lower value indicates a higher sentivity to temperature.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Altered Somatosensory Functions (Temperature-warmth)
Mean change from baseline to 1.5 years
|
2.74 degrees celcius
Interval 1.74 to 3.74
|
2.72 degrees celcius
Interval 1.74 to 3.7
|
|
Altered Somatosensory Functions (Temperature-warmth)
Mean change from baseline to 4 months
|
3.54 degrees celcius
Interval 2.51 to 4.57
|
3.32 degrees celcius
Interval 2.28 to 4.36
|
|
Altered Somatosensory Functions (Temperature-warmth)
Mean change from baseline to 1 year
|
2.67 degrees celcius
Interval 1.6 to 3.74
|
2.38 degrees celcius
Interval 1.3 to 3.45
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differs per timepoints
Measured with repetitive pinprick stimuli (using Von Frey Monofilament of 256 mN) at the pectoral region of the affected side. Pain rating after a single stimulation and after 30s of stimulation is recorded. The outcome of interest is the pain rating after 30s stimulation - pain rating single stimulation on a Numeric Rating Scale (0-10) with lower scores meaning less endogenous pain facilitation.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Endogenous Pain Facilitation Assessed by a Temporal Summation Paradigm (0-10)
Mean change from baseline to 1.5 years
|
0.48 score on a scale
Interval -0.02 to 0.97
|
0.17 score on a scale
Interval -0.32 to 0.65
|
|
Endogenous Pain Facilitation Assessed by a Temporal Summation Paradigm (0-10)
Mean change from baseline to 4 months
|
0.95 score on a scale
Interval 0.48 to 1.41
|
0.21 score on a scale
Interval -0.26 to 0.68
|
|
Endogenous Pain Facilitation Assessed by a Temporal Summation Paradigm (0-10)
Mean change from baseline to 1 year
|
0.24 score on a scale
Interval -21.0 to 0.69
|
0.15 score on a scale
Interval -0.3 to 0.6
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Conditioned Pain Modulation Measured with TSA-II NeuroSensory Analyzer from Medoc. Parallel heat design is used with 1. Test stimulus (45s): Individually determined test stimulus (temperature with a Numeric Rating Scale score of at least 4 out of 10) applied alone. Pain rating (Numeric Rating Scale 0-10) at 10s, 20s, 30s and 40s of stimulation. 2. Break (120s) 3. Conditioning stimulus (temperature of test stimulus + 0.5°C) (65s) + test stimulus in parallel (45s). Pain rating (Numeric Rating Scale 0-10) at 10s, 20s, 30s and 40s of stimulation. The outcome of interest is the a rithmetic mean differences between the Numeric Rating Scale score of the conditioning + test stimulus and test stimulus alone for 4 10s-long epochs (Numeric Rating Scale 0-10) Lower scores indicate better endogenous pain inhibition.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Endogenous Pain Inhibition Assessed by a Conditioned Pain Modulation Paradigm (0-10)
Mean change from baseline to 4 months
|
0.30 score on a scale
Interval -0.03 to 0.63
|
-0.01 score on a scale
Interval -0.34 to 0.32
|
|
Endogenous Pain Inhibition Assessed by a Conditioned Pain Modulation Paradigm (0-10)
Mean change from baseline to 1 year
|
0.13 score on a scale
Interval -0.22 to 0.47
|
-0.04 score on a scale
Interval -0.38 to 0.3
|
|
Endogenous Pain Inhibition Assessed by a Conditioned Pain Modulation Paradigm (0-10)
Mean change from baseline to 1.5 years
|
-0.13 score on a scale
Interval -0.49 to 0.22
|
-0.36 score on a scale
Interval -0.71 to -0.01
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per timepoints
Measured with Disability of Arm, Shoulder and Hand Questionnaire (0-100) with lower scores indicating less disability.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Upper Limb Function
Mean change from baseline to 4 months
|
10.05 score on a scale
Interval 7.05 to 13.05
|
7.81 score on a scale
Interval 4.89 to 10.72
|
|
Self-reported Upper Limb Function
Mean change from baseline to 1 year
|
8.51 score on a scale
Interval 5.39 to 11.64
|
10.15 score on a scale
Interval 7.07 to 13.22
|
|
Self-reported Upper Limb Function
Mean change from baseline to 1.5 years
|
6.56 score on a scale
Interval 3.15 to 9.97
|
9.72 score on a scale
Interval 6.37 to 13.07
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment)Population: Available data differed per time point
Step count average (steps/day) measured with an accelerometer
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
General Physical Activity Level
Mean change from baseline to 4 months
|
50 steps/day
Interval -600.0 to 700.0
|
342 steps/day
Interval -316.0 to 1000.0
|
|
General Physical Activity Level
Mean change from baseline to 1 year
|
1100 steps/day
Interval 349.0 to 1850.0
|
261 steps/day
Interval -489.0 to 1010.0
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Measured with the Pain Catastrophizing scale (0-52), with higher scores corresponding to more pain-related catastrophizing.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Emotional Functioning: Pain Catastrophizing
Mean change from baseline to 4 months
|
0.896 score on a scale
Interval 0.676 to 1.188
|
1.077 score on a scale
Interval 0.818 to 1.419
|
|
Self-reported Emotional Functioning: Pain Catastrophizing
Mean change from baseline to 1 year
|
0.894 score on a scale
Interval 0.679 to 1.176
|
1.065 score on a scale
Interval 0.811 to 1.399
|
|
Self-reported Emotional Functioning: Pain Catastrophizing
Mean change from baseline to 1.5 years
|
0.762 score on a scale
Interval 0.562 to 1.033
|
0.898 score on a scale
Interval 0.663 to 1.216
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Measured with Depression Anxiety Stress scales 21(0-42) with lower scores indicating less depression.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Emotional Functioning: Depression
Mean change from baseline to 4 months
|
0.802 score on a scale
Interval 0.588 to 1.092
|
0.930 score on a scale
Interval 0.558 to 1.33
|
|
Self-reported Emotional Functioning: Depression
Mean change from baseline to 1 year
|
0.625 score on a scale
Interval 0.459 to 0.851
|
0.774 score on a scale
Interval 0.57 to 1.052
|
|
Self-reported Emotional Functioning: Depression
Mean change from baseline to 1.5 years
|
0.718 score on a scale
Interval 0.535 to 0.963
|
0.749 score on a scale
Interval 0.56 to 1.003
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Measured with the existential well-being sub scale of the McGill Quality of Life questionnaire (0-10) with higher scores reflecting a better health-related quality of life.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Health-related Quality of Life
Mean change from baseline to 4 months
|
0.19 score on a scale
Interval -0.14 to 0.52
|
0.51 score on a scale
Interval 0.19 to 0.84
|
|
Self-reported Health-related Quality of Life
Mean change from baseline to 1 year
|
0.90 score on a scale
Interval 0.52 to 1.27
|
0.71 score on a scale
Interval 0.34 to 1.09
|
|
Self-reported Health-related Quality of Life
Mean change from baseline to 1.5 years
|
1.07 score on a scale
Interval 0.64 to 1.49
|
0.61 score on a scale
Interval 0.2 to 1.03
|
SECONDARY outcome
Timeframe: Postoperatively after 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: One hundred fifteen participants (62.5%) were working at time of diagnosis (IG=58; CG=57); available data differed per time point
Work status at 12 and 18 months postoperatively, i.e. the proportion of women working at 12 and 18 months after surgery, respectively
Outcome measures
| Measure |
Intervention Group
n=58 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=57 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Socio-economic Outcomes: Return to Work Rate
At 1 year
|
41 Participants
Interval 33.0 to 48.0
|
30 Participants
Interval 22.0 to 38.0
|
|
Socio-economic Outcomes: Return to Work Rate
At 1.5 years
|
47 Participants
Interval 39.0 to 53.0
|
41 Participants
Interval 32.0 to 48.0
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Thermal detection sensitivity (degrees Celsius) for cold at the arm at the affected side measured with computerized thermotests. Temperature when a change from a thermoneutral state to a distinct cold is recorded.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Altered Somatosensory Functions (Temperature-cold)
Mean change from baseline to 4 months
|
-4.77 degrees Celsius
Interval -6.47 to -3.08
|
-5.00 degrees Celsius
Interval -6.7 to -3.31
|
|
Altered Somatosensory Functions (Temperature-cold)
Mean change from baseline to 1 year
|
-3.36 degrees Celsius
Interval -5.0 to -1.71
|
-4.16 degrees Celsius
Interval -5.81 to -2.52
|
|
Altered Somatosensory Functions (Temperature-cold)
Mean change from baseline to 1.5 years
|
-3.90 degrees Celsius
Interval -5.45 to -2.36
|
-4.35 degrees Celsius
Interval -5.87 to -2.84
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Mechanical pain sensitivity (mN) measured at the arm at the affected side with Von Frey Monofilaments. A series of stimulus intensities are given and the stimulus intensity that is first identified as painful (not unbearable) is recorded (mN). Min-max 8mN-512mN.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Altered Somatosensory Functions (Nociception: Pinprick Sensation)
Mean change from baseline to 4 months
|
19.77 mN
Interval -17.31 to 56.85
|
14.99 mN
Interval -22.08 to 52.05
|
|
Altered Somatosensory Functions (Nociception: Pinprick Sensation)
Mean change from baseline to 1 year
|
-22.24 mN
Interval -59.94 to 15.45
|
35.02 mN
Interval -2.66 to 72.69
|
|
Altered Somatosensory Functions (Nociception: Pinprick Sensation)
Mean change from baseline to 1.5 years
|
-17.91 mN
Interval -58.13 to 22.48
|
2.19 mN
Interval -37.45 to 41.83
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Pressure pain sensitivity (kgf) at the pectoralis region at the affected side measured with an algometer. The amount of pressure (kgs) by which the perception of pressure turns for the first time into a painful (not unbearable) sensation. Lower values indicate higher pain sensitivity.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Altered Somatosensory Functions (Nociception: Deep Pain Sensitivity)
Mean change from baseline to 4 months
|
1.05 kgf
Interval 0.95 to 1.15
|
0.94 kgf
Interval 0.86 to 1.03
|
|
Altered Somatosensory Functions (Nociception: Deep Pain Sensitivity)
Mean change from baseline to 1 year
|
0.84 kgf
Interval 0.75 to 0.94
|
0.75 kgf
Interval 0.67 to 0.84
|
|
Altered Somatosensory Functions (Nociception: Deep Pain Sensitivity)
Mean change from baseline to 1.5 years
|
0.81 kgf
Interval 0.73 to 0.91
|
0.78 kgf
Interval 0.69 to 0.87
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Measured with Depression Anxiety Stress scales 21 (0-42). Lower scores indicate less anxiety.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Emotional Functioning: Anxiety
Mean change from baseline to 4 months
|
1.045 score on a scale
Interval 0.772 to 1.415
|
0.987 score on a scale
Interval 0.733 to 1.328
|
|
Self-reported Emotional Functioning: Anxiety
Mean change from baseline to 1 year
|
0.783 score on a scale
Interval 0.575 to 1.067
|
0.839 score on a scale
Interval 0.617 to 1.138
|
|
Self-reported Emotional Functioning: Anxiety
Mean change from baseline to 1.5 years
|
0.829 score on a scale
Interval 0.325 to 1.1
|
0.821 score on a scale
Interval 0.621 to 1.085
|
SECONDARY outcome
Timeframe: Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up)Population: Available data differed per time point
Measured with Depression Anxiety Stress scales 21 (0-42). Lower scores indicate less stress.
Outcome measures
| Measure |
Intervention Group
n=92 Participants
Standard physical therapy program + Modern educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Modern educational program: This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
Control Group
n=92 Participants
Standard physical therapy program + Traditional biomedical educational program
Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
* Start immediately after surgery, sessions are individual and take 30 minutes
* Intensive phase (4 months): 1-2x/week
* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery
Traditional biomedical educational program: Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery
|
|---|---|---|
|
Self-reported Emotional Functioning: Stress
Mean change from baseline to 4 months
|
0.812 score on a scale
Interval 0.598 to 1.101
|
0.760 score on a scale
Interval 0.563 to 1.026
|
|
Self-reported Emotional Functioning: Stress
Mean change from baseline to 1 year
|
0.782 score on a scale
Interval 0.574 to 1.064
|
0.721 score on a scale
Interval 0.532 to 0.979
|
|
Self-reported Emotional Functioning: Stress
Mean change from baseline to 1.5 years
|
0.857 score on a scale
Interval 0.629 to 1.167
|
0.868 score on a scale
Interval 0.639 to 1.178
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place