Author Names
Jesús Baltasar González‑Rubino, Rocío Martín‑Valero, María Jesús Vinolo‑Gil3
Reviewer Name
Rachel Scott
Reviewer Affiliation(s)
Duke University DPT Student
Paper Abstract
Objective To reduce the evolution time of axillary web syndrome in women who have undergone breast cancer surgery. Methods A prospective, randomized, single-blind clinical trial was conducted on 46 post breast cancer surgery patients from October 2021 to September 2024, in a single university hospital with painful Axillary Web Syndrome (AWS) that restricts arm mobility. The treatment for the intervention group consisted of stretching combined with manual therapy and scar massage to release adhesion and lymphatic cord during 15 physiotherapy sessions of 30 min duration each. The main outcome measures were: healing time, pain, evaluated with Visual Analogue Scaler (VAS) and arm Range of Motion (ROM), evaluated with goniometry.
Results Significant differences were detected in pain and in ROM. The effect of the intervention varied over time with 95% confidence interval (risk alpha 0.05) and a statistical power of 90% (risk beta 0.1). Comparisons between Control and Intervention Groups showed significant statistical and clinical differences in favour of Intervention Group after 30, 60 and 90 days of intervention at follow-ups for all measured parameters. The proportion of healed patients was significantly higher in the intervention group from day 30 onwards (two-sample test for equality of proportions: p < 0.001), indicating a faster recovery in the intervention group.
Conclusion The results suggested that stretching combined with scar massage and manipulative tissue release techniques lead to a faster recovery and reduce the evolution time of axillary web syndrome. The physiotherapy technique described in this article could be the technique of choice for this surgical sequela.
Trial Registration: ClinicalTrials.gov Registry (NCT05115799) on June 10th 2021 and the approval of the Andalucía Ethics Committee (PEIBA code 1909-N1-21, reg. number 171.21).
Keywords Axillary Web Syndrome · Breast Cancer · Physiotherapy · Stretching · Lymphatic System · Physical Therapy
NIH Risk of Bias Tool: Answer Only the Questions Specific to Tool Used, Delete All Other Tool Items, THEN DELETE THIS HIGHLIGHTED INSTRUCTIONS.
Quality Assessment of Controlled Intervention Studies
Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
yes
Was the method of randomization adequate (i.e., use of randomly generated assignment)?
yes
Was the treatment allocation concealed (so that assignments could not be predicted)?
yes
Were study participants and providers blinded to treatment group assignment?
no
Were the people assessing the outcomes blinded to the participants’ group assignments?
Unable to determine
Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
yes
Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
yes
Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
yes
Was there high adherence to the intervention protocols for each treatment group?
yes
Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
yes
Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
yes
Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
yes
Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
yes
Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
yes
Key Finding #1
Stretching combined with scar massage and manipulative tissue release led to better recovery of axillary web syndrome.
Key Finding #2
The control group received only pendulum exercises and self-assisted stretching along with group therapy sessions. At the end of 90 days, all patients in the control group still suffered AWS as compared to only 2 out of 24 in the intervention group.
Key Finding #3
Patients who received the intervention treatment demonstrated greatly decreased VAS pain scored at 30 days, 60 days, and 90 days compared to the control group.
Please provide your summary of the paper
This study is a randomized control trial which was done on 46 patients post breast cancer surgery with axillary web syndrome (AWS). The control group received pendulum exercises and self-stretching in a group therapy setting while the intervention group received stretching combined with manual therapy manipulative tissue release and scar massage to release adhesions. The outcome measures used to measure progress were Visual Analog Scale, and arm range of motion. The results of the study showed significant difference between groups in pain and ROM. The intervention group showed greater improvements after 30 days, 60 days, and 90 days follow up, indicating a faster recovery time.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
Patients who are experiencing axillary web syndrome after breast cancer surgery will benefit from scar massage and soft tissue release to improve pain scores and range of motion of the affected shoulder and elbow. This can be implemented in this patient population to make a significant and meaningful difference in function and pain control by performing scar massage and tissue manipulation to reduce adhesions.
Author Names
Fabio Scoppa, Andrea Graffitti, Alessio Pirino , Jacopo Piermaria, Federica Tamburella, and Marco Tramontano
Reviewer Name
John Wellers
Reviewer Affiliation(s)
Duke University Doctorate of Physical Therapy
Paper Abstract
Abstract: Background/Objectives: Manual therapies like Osteopathic Manipulative Treatment (OMT) and Gentle Touch Intervention (GTI) are widely employed for improving posture and spinal alignment, but their effects as measured using advanced technologies remain underexplored. This study aims to evaluate the short-term postural effects of these interventions using a non-invasive three-dimensional rasterstereography-based approach, focusing on the cervical arrow, lumbar arrow, kyphotic angle, and lordotic angle parameters. Methods: A three-armed randomized controlled trial was conducted with 165 healthy participants. The subjects were divided into control (CTRL), OMT, and GTI groups. Their postural parameters were assessed pre- and post-intervention using the Spine3D system by Sensor Medica (Guidonia Montecelio, Italy). The statistical analyses included paired t-tests and an ANOVA, with the significance set at p < 0.05. Results: Significant reductions in the cervical arrow were observed in both the OMT (p < 0.005) and GTI (p < 0.05) groups, while the kyphotic angle significantly improved only in the GTI group (p < 0.05). No significant changes were found in the lumbar arrow or the lordotic angle across the groups. The control group showed no postural variations, reinforcing the specificity of the interventions. Conclusions: Both OMT and GTI influence spinal posture, particularly in the cervical and thoracic regions. GTI, with its gentle approach, demonstrated unique effects on the thoracic curvature, suggesting neurophysiological mechanisms. These findings highlight the potential of manual therapies for posture modulation and suggest future research should explore their long-term benefits and applications in clinical populations.
NIH Risk of Bias Tool: Answer Only the Questions Specific to Tool Used, Delete All Other Tool Items, THEN DELETE THIS HIGHLIGHTED INSTRUCTIONS.
Quality Assessment of Controlled Intervention Studies
Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
yes
Was the method of randomization adequate (i.e., use of randomly generated assignment)?
yes
Was the treatment allocation concealed (so that assignments could not be predicted)?
yes
Were study participants and providers blinded to treatment group assignment?
yes
Were the people assessing the outcomes blinded to the participants’ group assignments?
No
Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
unknown
Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
yes
Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
yes
Was there high adherence to the intervention protocols for each treatment group?
yes
Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
no
Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
yes
Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
yes
Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
no
Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
yes
Key Finding #1
The Osteopathic Manual Therapy group demonstrated significant reductions in the Cervical Arrow index, indicating an improvement in cervical alignment, and although the Lumbar Arrow index showed a trend of reduction, this did not reach statistical significance, however.
Key Finding #2
Gentle touch intervention therapy showed significant reductions in both cervical arrow and kyphotic angle when compared to the control group.
Please provide your summary of the paper
165 participants were divided into a three-arm randomized control trial. One control group was given no interventions, another osteopathic manual therapy was given 45 minutes of supine manual therapy, and a third Gentle Touch intervention group was given 45 minutes of gentle touch therapy. Participants were measured using rasterstereography-based imaging of spinal angles. OMT and GTI were found to significantly decrease cervical arrow when compared to the control group, and GTI was found to significantly reduce kyphotic angle.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
There is no clinical value to this paper because this is a very low quality paper. There are number of aspect of this paper that are very poorly described and the journal company it is published under “MDPI” is notoriously low quality. The sampling process is very poorly described, the control group is not given any placebo treatment. There were 165 original participants without a single one of them dropping out by the end of the trial, which is cause for extreme suspicion. There is also no description for how the participants were found and screened. They are all healthy patients without spinal pathologies, yet there was a significant finding in postural alignment, a relationship that is surprising and not discussed. Additionally, rasterstereography-based imaging techniques are hardly validated. The control arms are too different to be reasonably compared. Both the GTI and OTM therapy techniques are not adequately described.
This is a good example of low-quality research from a predatory journal. There should be no clinical takeaways concerning manual therapy techniques.
Author Name: René Castien, PT, MSPT1, Annette Blankenstein, PhD1, Daniëlle van der Windt, PhD2, Martijn W. Heymans, PT, PhD3, Joost Dekker, PhD4
Reviewer Name: Albert Yang, SPT
Reviewer Affiliation(s): DPT student at Duke University
Paper Abstract: n/a
Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies
Was the research question or objective in this paper clearly stated?
Yes
Was the study population clearly specified and defined?
Yes
Was the participation rate of eligible persons at least 50%?
Not specified
Were all the subjects selected or recruited from the same or similar populations (including the same time period)? Were inclusion and exclusion criteria for being in the study prespecified and applied uniformly to all participants?
Yes
Was a sample size justification, power description, or variance and effect estimates provided?
Not specified
For the analyses in this paper, were the exposure(s) of interest measured prior to the outcome(s) being measured?
Yes
Was the timeframe sufficient so that one could reasonably expect to see an association between exposure and outcome if it existed?
Yes
For exposures that can vary in amount or level, did the study examine different levels of the exposure as related to the outcome (e.g., categories of exposure, or exposure measured as continuous variable)?
Not specified
Were the exposure measures (independent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?
Yes
Was the exposure(s) assessed more than once over time?
Not specified
Were the outcome measures (dependent variables) clearly defined, valid, reliable, and implemented consistently across all study participants?
Yes
Were the outcome assessors blinded to the exposure status of participants?
Not specified
Was loss to follow-up after baseline 20% or less?
Not specified
Were key potential confounding variables measured and adjusted statistically for their impact on the relationship between exposure(s) and outcome(s)?
Yes
Key Finding #1
The study summarized that manual therapy decreased the intensity and frequency of chronic tension type headaches in participants
Key Finding #2
There seemed to be some long term effectiveness in managing chronic tension-type headaches due to the prolonged therapeutic benefits of manual therapy persisting beyond the initial treatment period
Key Finding #3
The participants experienced a reduction in muscle tenderness and an improvement in cervical and pericranial muscle function following manual therapy interventions
Please provide your summary of the paper
This paper was used to study the effects of manual therapy on individuals with chronic tension headaches (CTTH), and it focused on their mechanisms of action(s) and therapeutic outcomes. Patients with CTTH underwent manual therapy interventions which aimed to target musculoskeletal dysfunctions associated with CTTH. Outcome measures such as headache frequency, intensity, muscle tenderness, and pain perception mechanism were measured both before and after the treatment. Overall, it appears that the results demonstrate manual therapy significantly reduced headache frequency and intensity. It also suggests that manual therapy works by influencing both the central and peripheral nervous system, leading to decreased pain perception, and that these effects may be effective in long-term headache management. The paper suggests that integration of manual therapy as a non-pharmacological approach in managing CTTH may be effective.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
This paper suggests that manual therapy can be used as an effective intervention for patients with chronic tension type headaches (CTTH). Since this diagnosis is both a common yet challenging condition to manage, the paper’s findings suggest that non-pharmacological and hands-on interventions like manual therapy may be effective in improving patient outcomes. With regards to implementation in the clinic, the paper suggests that combining manual therapy with therapeutic exercise or cognitive behavior therapy may enhance the effects of these treatment methods, and educating patients on stress management techniques may also be a beneficial way to reduce the prevalence of CTTH.
