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| Name | Class |
|---|---|
| Fund for Scientific Research, Flanders, Belgium | OTHER |
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In addition to fatigue, pain is the most frequent and persistent symptom following breast cancer and breast cancer treatment. Despite the effectiveness of different physical therapy modalities, such as manual techniques, passive mobilizations and exercises, many patients still experience pain and subsequent difficulties in daily functioning at short and long term. Past decades, the awareness on the important role of educational interventions in the management of pain in general has increased. Educational interventions aim at explaining and improving the knowledge, control and attitude of the patient regarding his/her pain complaint. However, these educational interventions are often restricted to more biomedical pain management instructions and general advice on physical activity and analgesics (= traditional biomedical education). Only recently, increased knowledge on pain mechanisms led to a more modern educational approach. This modern approach is suited to explain more complex issues associated with pain and takes into account many more factors related to pain. To our knowledge, only one controlled trial investigated the effectiveness of a modern educational intervention in the early stage of breast cancer treatment. The results were very promising for shoulder function. However, only short-term effects were examined, no randomization was performed and no pain-related and socio-economic outcomes were evaluated. Therefore, the aim of the proposed project is to investigate the effectiveness of a similar modern educational program, in addition to standard physical therapy care, in the early treatment phase of breast cancer in comparison with traditional biomedical education. A randomized controlled trial will be performed with a long-term follow up period. The primary outcome parameter is pain-related disability. Secondary outcomes are different dimensions of pain, physical and mental functioning, return to work and health-care related costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Standard physical therapy program + Modern educational program |
|
| Control group | Active Comparator | Standard physical therapy program + Traditional biomedical educational program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard physical therapy program | Other | Mobilisations, stretching, scar tissue treatment and exercises
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Change in Pain-related Disability | 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. | Change between baseline and one year follow-up assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Pain-related Disability | 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. | Postoperatively after 4 months of intensive treatment and at 1,5 years (after follow-up) |
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Inclusion Criteria:
Axillary lymph node dissection and mastectomy/breast -conserving/reconstructive surgery OR Sentinel Node Biopsy and mastectomy/reconstructive surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lore Dams, Dra | University of Leuven | Principal Investigator |
| Elien Van der Gucht, Dra | University of Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30612114 | Background | De Groef A, Devoogdt N, Van der Gucht E, Dams L, Bernar K, Godderis L, Morlion B, Moloney N, Smeets A, Van Wilgen P, Meeus M. EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning. BMJ Open. 2019 Jan 4;9(1):e025742. doi: 10.1136/bmjopen-2018-025742. | |
| 36637138 |
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In total, 493 women were eligible, of which 184 were included in the study.
Recruitment took place at the Multidisciplinary Breast Center of the University Hospitals Leuven campus Gasthuisberg (Belgium) between November 2017 and March 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Standard physical therapy program + Modern educational program Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
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.
|
| FG001 | Control Group | Standard physical therapy program + Traditional biomedical educational program Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
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
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intensive Treatment Phase (4 mo FU) |
|
| |||||||||||||||||||||
| Maintenance Treatment Phase (12 mo FU) |
| ||||||||||||||||||||||
| End of Trial (18 mo FU) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Standard physical therapy program + Modern educational program Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
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.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-reported Change in Pain-related Disability | 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. | Using likelihood-based estimation, subjects with a missing at one or more timepoints were still included in the analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Change between baseline and one year follow-up assessment |
|
Total study duration, i.e. 1.5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Standard physical therapy program + Modern educational program Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
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.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. An De Groef | KU Leuven | +32 16 342 171 | an.degroef@kuleuven.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2024 | Aug 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Modern educational program | Other | 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.
|
|
| Traditional biomedical educational program | Other | 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
|
|
| Self-reported Pain-intensity | Measured with Visual Analogue Scale (0-100), lower scores indicate a better outcome. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Self-reported Central Sensitization Symptoms | 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. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Altered Somatosensory Functions (Touch) | 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. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Altered Somatosensory Functions (Temperature-warmth) | 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. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Endogenous Pain Facilitation Assessed by a Temporal Summation Paradigm (0-10) | 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. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Endogenous Pain Inhibition Assessed by a Conditioned Pain Modulation Paradigm (0-10) | Conditioned Pain Modulation Measured with TSA-II NeuroSensory Analyzer from Medoc. Parallel heat design is used with
| Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Self-reported Upper Limb Function | Measured with Disability of Arm, Shoulder and Hand Questionnaire (0-100) with lower scores indicating less disability. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| General Physical Activity Level | Step count average (steps/day) measured with an accelerometer | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) |
| Self-reported Emotional Functioning: Pain Catastrophizing | Measured with the Pain Catastrophizing scale (0-52), with higher scores corresponding to more pain-related catastrophizing. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Self-reported Emotional Functioning: Depression | Measured with Depression Anxiety Stress scales 21(0-42) with lower scores indicating less depression. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Self-reported Health-related Quality of Life | 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. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Socio-economic Outcomes: Return to Work Rate | Work status at 12 and 18 months postoperatively, i.e. the proportion of women working at 12 and 18 months after surgery, respectively | Postoperatively after 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Altered Somatosensory Functions (Temperature-cold) | 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. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Altered Somatosensory Functions (Nociception: Pinprick Sensation) | 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. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Altered Somatosensory Functions (Nociception: Deep Pain Sensitivity) | 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. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Self-reported Emotional Functioning: Anxiety | Measured with Depression Anxiety Stress scales 21 (0-42). Lower scores indicate less anxiety. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Self-reported Emotional Functioning: Stress | Measured with Depression Anxiety Stress scales 21 (0-42). Lower scores indicate less stress. | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
| Result |
| Dams L, Van der Gucht E, Devoogdt N, Smeets A, Bernar K, Morlion B, Godderis L, Haenen V, De Vrieze T, Fieuws S, Moloney N, Van Wilgen P, Meeus M, De Groef A. Effect of pain neuroscience education after breast cancer surgery on pain, physical, and emotional functioning: a double-blinded randomized controlled trial (EduCan trial). Pain. 2023 Jul 1;164(7):1489-1501. doi: 10.1097/j.pain.0000000000002838. Epub 2022 Dec 8. |
| 36594663 | Result | Dams L, Van der Gucht E, Haenen V, Devoogdt N, Smeets A, Bernar K, Morlion B, Moloney N, Fieuws S, De Groef A, Meeus M. Effectiveness of pain neuroscience education on somatosensory functioning after surgery for breast cancer: A double-blinded randomized controlled trial. Anat Rec (Hoboken). 2024 Feb;307(2):248-272. doi: 10.1002/ar.25127. Epub 2023 Jan 3. |
| 37171771 | Result | De Groef A, Van der Gucht E, Devoogdt N, Smeets A, Bernar K, Morlion B, Godderis L, De Vrieze T, Fieuws S, Meeus M, Dams L. Returning to Work After Breast Cancer Surgery: A Randomised Controlled Trial on the Effect of Pain Neuroscience Education. J Occup Rehabil. 2023 Dec;33(4):757-765. doi: 10.1007/s10926-023-10103-9. Epub 2023 May 12. |
| 39419367 | Derived | Amber G, Lore D, Elien VG, Jan S, Michel M, An G, Mira M. From breast cancer diagnosis to survivorship: Analyzing perioperative biopsychosocial phenotypes and their relationship to pain on long term. J Pain. 2025 Jan;26:104709. doi: 10.1016/j.jpain.2024.104709. Epub 2024 Oct 16. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Control Group | Standard physical therapy program + Traditional biomedical educational program Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
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
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Educational Level | Assessed retrospectively at 4 months after surgery, so only calculated from data available at 4 months postoperatively. Missing data is present. | Number | participants |
|
| Surgery at dominant side | Number | participants |
|
| Type of surgery | ALND: axillary lymph node dissection, BCS: breast conserving surgery, ME=mastectomy, SLNB=Sentinel Lymph Node Biopsy | Number | participants |
|
| Radiotherapy | Number | participants |
|
| Hormone therapy | Number | participants |
|
| Chemotherapy | Number | participants |
|
| OG001 | Control Group | Standard physical therapy program + Traditional biomedical educational program Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
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
|
|
|
|
| Secondary | Self-reported Pain-related Disability | 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. | Available data differed between timepoints | Posted | Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Self-reported Pain-intensity | Measured with Visual Analogue Scale (0-100), lower scores indicate a better outcome. | Available data differed between timepoints. | Posted | Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Self-reported Central Sensitization Symptoms | 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. | Available data differed on timepoints | Posted | Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Altered Somatosensory Functions (Touch) | 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. | Available data differed per time point | Posted | Mean | 95% Confidence Interval | mN | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Altered Somatosensory Functions (Temperature-warmth) | 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. | Available data differed per time point | Posted | Mean | 95% Confidence Interval | degrees celcius | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Endogenous Pain Facilitation Assessed by a Temporal Summation Paradigm (0-10) | 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. | Available data differs per timepoints | Posted | Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Endogenous Pain Inhibition Assessed by a Conditioned Pain Modulation Paradigm (0-10) | Conditioned Pain Modulation Measured with TSA-II NeuroSensory Analyzer from Medoc. Parallel heat design is used with
| Available data differed per time point | Posted | Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Self-reported Upper Limb Function | Measured with Disability of Arm, Shoulder and Hand Questionnaire (0-100) with lower scores indicating less disability. | Available data differed per timepoints | Posted | Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | General Physical Activity Level | Step count average (steps/day) measured with an accelerometer | Available data differed per time point | Posted | Mean | 95% Confidence Interval | steps/day | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) |
|
|
|
|
| Secondary | Self-reported Emotional Functioning: Pain Catastrophizing | Measured with the Pain Catastrophizing scale (0-52), with higher scores corresponding to more pain-related catastrophizing. | Available data differed per time point | Posted | Geometric Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Self-reported Emotional Functioning: Depression | Measured with Depression Anxiety Stress scales 21(0-42) with lower scores indicating less depression. | Available data differed per time point | Posted | Geometric Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Self-reported Health-related Quality of Life | 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. | Available data differed per time point | Posted | Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Socio-economic Outcomes: Return to Work Rate | Work status at 12 and 18 months postoperatively, i.e. the proportion of women working at 12 and 18 months after surgery, respectively | One hundred fifteen participants (62.5%) were working at time of diagnosis (IG=58; CG=57); available data differed per time point | Posted | Number | 95% Confidence Interval | Participants | Postoperatively after 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Altered Somatosensory Functions (Temperature-cold) | 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. | Available data differed per time point | Posted | Mean | 95% Confidence Interval | degrees Celsius | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Altered Somatosensory Functions (Nociception: Pinprick Sensation) | 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. | Available data differed per time point | Posted | Mean | 95% Confidence Interval | mN | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Altered Somatosensory Functions (Nociception: Deep Pain Sensitivity) | 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. | Available data differed per time point | Posted | Mean | 95% Confidence Interval | kgf | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Self-reported Emotional Functioning: Anxiety | Measured with Depression Anxiety Stress scales 21 (0-42). Lower scores indicate less anxiety. | Available data differed per time point | Posted | Geometric Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| Secondary | Self-reported Emotional Functioning: Stress | Measured with Depression Anxiety Stress scales 21 (0-42). Lower scores indicate less stress. | Available data differed per time point | Posted | Geometric Mean | 95% Confidence Interval | score on a scale | Postoperatively after 4 months of intensive treatment, at 1 year (after maintenance treatment) and at 1,5 years (after follow-up) |
|
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Control Group | Standard physical therapy program + Traditional biomedical educational program Standard physical therapy program: Mobilisations, stretching, scar tissue treatment and exercises
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
| 1 | 92 | 0 | 92 | 0 | 92 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Change from baseline to 1.5 years |
|
|
| Difference in change in self-reported pain-related disability from baseline to 1.5 years | multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.5592 | P<.05 was considered significant. No corrections for multiple testing were performed. | Mean Difference (Net) | -1.07 | 2-Sided | 95 | -4.64 | 2.51 | Superiority |
| Mean change from baseline to 12 months |
|
|
| Mean change from baseline to 1.5 years |
|
|
| Difference in change in self-reported pain intensity from baseline to 12 months | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.2524 | No corrections for multiple testing were performed. | Mean Difference (Net) | -4.30 | 2-Sided | 95 | -11.68 | 3.09 | Superiority |
| Difference in change in self-reported pain intensity from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.2315 | Mean Difference (Net) | -4.80 | 2-Sided | 95 | -12.69 | 3.09 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
| The difference in change in self-reported central sensitisation symptoms from baseline to 12 months. | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.8617 | Mean Difference (Net) | -0.25 | 2-Sided | 95 | -3.09 | 2.58 | Superiority |
| Difference in change in self-reported central sensitisation symptoms from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.8454 | Mean Difference (Net) | -0.29 | 2-Sided | 95 | -3.16 | 2.59 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in mechanical detection sensitivity at the arm from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.6613 |
| Mean Difference (Net) |
| 0.86 |
| 2-Sided |
| 95 |
| 0.451 |
| 1.66 |
| Superiority |
| Difference in change in mechanical detection sensitivity at the arm from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.4908 | Mean Difference (Net) | 1.26 | 2-Sided | 95 | 0.65 | 2.42 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in warmth detection sensitivity from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.7060 |
| Mean Difference (Net) |
| 0.29 |
| 2-Sided |
| 95 |
| -1.23 |
| 1.81 |
| Superiority |
| Difference in change in warmth detection sensitivity from baseline to 1.5 years | Multivariate linear model | 0.9806 | Mean Difference (Net) | 0.02 | 2-Sided | 95 | -1.38 | 1.42 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in wind-up from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome |
| 0.7776 |
| Mean Difference (Net) |
| 0.09 |
| 2-Sided |
| 95 |
| -0.55 |
| 0.73 |
| Superiority |
| Difference in change in wind-up from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome | 0.3829 | Mean Difference (Net) | 0.31 | 2-Sided | 95 | -0.39 | 1.01 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in conditioned pain modulation from baseline to 1 year |
| Multivariate linear model |
| 0.4937 |
| Mean Difference (Net) |
| 0.17 |
| 2-Sided |
| 95 |
| -0.31 |
| 0.65 |
| Superiority |
| Difference in change in conditioned pain modulation from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.3690 | Mean Difference (Net) | 0.23 | 2-Sided | 95 | -0.27 | 0.73 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in self-reported upper limb function from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.4632 |
| Mean Difference (Net) |
| -1.63 |
| 2-Sided |
| 95 |
| -6.02 |
| 2.75 |
| Superiority |
| Difference in change in self-reported upper limb function from baseline to 1,5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.1944 | Mean Difference (Net) | -3.16 | 2-Sided | 95 | -7.94 | 1.63 | Superiority |
| Mean change from baseline to 1 year |
|
|
Difference in change in step count from baseline to 1 year |
| Multivariate linear model |
| 0.1201 |
| Mean Difference (Net) |
| 839 |
| 2-Sided |
| 95 |
| -221 |
| 1900 |
| Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in self-reported pain catastrophizing from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.3744 |
| Mean Difference (Net) |
| 0.839 |
| 2-Sided |
| 95 |
| 0.570 |
| 1.236 |
| Superiority |
| Difference in change in self-reported pain catastrophizing from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.4533 | Median Difference (Net) | 0.848 | 2-Sided | 95 | 0.522 | 1.304 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in self-reported depression from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.3362 |
| Mean Difference (Net) |
| 0.808 |
| 2-Sided |
| 95 |
| 0.522 |
| 1.248 |
| Superiority |
| Difference in change in self-reported depression from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.8375 | Mean Difference (Net) | 0.958 | 2-Sided | 95 | 0.633 | 1.449 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in self-reported health-related quality of life from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.5025 |
| Mean Difference (Net) |
| 0.18 |
| 2-Sided |
| 95 |
| -0.35 |
| 0.71 |
| Superiority |
| Difference in change in self-reported health-related quality of life from baseline to 1,5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.1363 | Mean Difference (Net) | 0.45 | 2-Sided | 95 | -0.14 | 1.05 | Superiority |
| Fisher Exact |
| 0.352 |
| Percentage |
| -0.09 |
| 2-Sided |
| 95 |
| -0.26 |
| 0.078 |
| Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in cold detection sensitivity from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.4971 |
| Mean Difference (Net) |
| 0.81 |
| 2-Sided |
| 95 |
| -1.52 |
| 3.14 |
| Superiority |
| Difference in change in cold detection sensitivity from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.6831 | Mean Difference (Net) | 0.45 | 2-Sided | 95 | -1.72 | 2.62 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in mechanical pain sensitivity at the arm from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.0353 |
| Mean Difference (Net) |
| -57.25 |
| 2-Sided |
| 95 |
| -110.57 |
| -3.93 |
| Superiority |
| Difference in change in mechanical pain sensitivity at the arm from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.4865 | Mean Difference (Net) | -20.10 | 2-Sided | 95 | -76.72 | 36.52 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.1875 |
| Mean Difference (Net) |
| 1.11 |
| 2-Sided |
| 95 |
| 0.95 |
| 1.30 |
| Superiority |
| Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.5612 | Mean Difference (Net) | 1.05 | 2-Sided | 95 | 0.89 | 1.23 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in self-reported anxiety from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.7578 |
| Mean Difference (Net) |
| 0.934 |
| 2-Sided |
| 95 |
| 0.604 |
| 1.443 |
| Superiority |
| Difference in change in self-reported anxiety from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.9600 | Mean Difference (Net) | 1.010 | 2-Sided | 95 | 0.679 | 1.504 | Superiority |
| Mean change from baseline to 1 year |
|
|
| Mean change from baseline to 1.5 years |
|
|
Difference in change in self-reported stress from baseline to 1 year |
| Multivariate linear model |
A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. |
| 0.7169 |
| Mean Difference (Net) |
| 1.087 |
| 2-Sided |
| 95 |
| 0.702 |
| 1.673 |
| Superiority |
| Difference in change in self-reported stress from baseline to 1.5 years | Multivariate linear model | A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome. | 0.9535 | Mean Difference (Net) | 0.987 | 2-Sided | 95 | 0.639 | 1.525 | Superiority |