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The Godelieve Denys-Struyf method GDS is a motor learning intervention that may be applied in group or individualized sessions. Clusters were randomized into 3 groups. All participants received medical treatment and a minute group education session on active management. Additional interventions were mudculares follows: Primary outcomes at baseline and 2, 6, and 12 months later were LBP and pain referred down the leg separate pain intensity numeric rating scales and disability Roland-Morris Questionnaire [RMQ].
Secondary outcomes were use of medication and self-reported health mental and physical component summaries of the Item Short-Form Health Survey [SF]. Separate linear mixed models for LBP, pain referred down the leg, and disability were developed to adjust for potential confounders. Randomization, outcome assessment, and data analyses were masked. At 12 months, disability improved 0.
There were no differences in pain. The amount of exercise was smaller in the muscularee group, and GDS-I sessions were provided by junior physical therapists. The improvement in disability was slightly higher with group GDS sessions than with the program routinely used in clusters within the SNHS. Adding individualized GDS sessions eliminated this advantage. Further studies should compare the GDS ccadenas other types of exercise. Nonspecific or common low back pain LBP is defined as pain that is located between the costal margins and the inferior gluteal folds and that is not related to fracture, direct trauma, systemic diseases, or conditions for which decompressive surgery is appropriate, such as certain cases of symptomatic spinal stenosis or disk herniation.
Many attempts have been made to classify patients with LBP into subgroups to determine the most appropriate mussculares. It builds on the assumption that balance across these muscle chains contributes to adequate neuromuscular, biomechanical, muschlares psychomotor control, whereas unbalanced tension across them accounts for muscupares or chronic LBP. To balance gfs tensions, 11 group and 4 one-on-one, individualized sessions of manual therapy, stretching, and exercises are applied to those muscles eg, transversospinalis, multifidus, transversus abdominis, diaphragm, and pelvic floor muscles cacenas, and patients are taught movements intended to improve central nervous system automatic control over body positions and movements.
The GDS was shown to be more effective at improving pain and disability than the physical therapy program routinely used within the SNHS, 13 which comprises transcutaneous electrical nerve stimulation, microwave treatment, and standardized exercises. High-quality systematic reviews have shown that exercise is effective for treating LBP.
The learning curve for therapists also is not known. Therefore, the objective of this study was to test the following 3 hypotheses: The Institutional Review Boards in charge of primary care within the SNHS in Madrid selected 5 of 11 primary care areas that—for operational reasons—were more suitable for participation in this trial.
They covered a population of 3,, approximately The 43 physical therapy units belonging to the SNHS in Madrid in those areas were invited to join the study. The first 21 units that accepted carenas included.
Participant musculages criteria were an age of 18 to 65 years, having requested care for LBP from a primary care physician, having been referred for physical therapy by the primary care physician, and signing the informed consent form to participate in the study. Participants were told that the objective of the study was to assess the effects of physical therapy treatments.
In this study, because we assessed interventions that were provided to groups of participants as opposed to participants individuallywe anticipated a high risk of contamination between participants within the same physical therapy unit.
Randomization was performed in a masked fashion on the basis of the chronological sequence with which each physical therapy unit joined the umsculares. A coordination office prepared consecutively numbered, opaque, sealed envelopes, each musxulares a number extracted from a random numbers table.
Only the study coordinator M. At the end of the study, the study coordinator verified that the sequence of randomization matched that determined by the random numbers table and the dates on which each physical therapy gdz was included and compared the list of participants who were recruited in each cluster with the list of participants who received each kind of treatment.
Primary care physicians managed LBP in their patients in accordance with routine practice within the SNHS, which includes advice, drug treatment, potential request for diagnostic procedures, or potential referral to physical therapy, rehabilitation, orthopedic surgery, neurosurgery, rheumatology, or pain units.
This trial was conducted only with people referred to physical umsculares. They had received 2 hours of training for this purpose from a senior medical lecturer in this field M. Other studies have shown that this short education program is effective under these application conditions.
The additional treatments provided in the physical therapy units depended on the group to which each one caddenas been assigned. In the control group, the physical therapy regimen implemented was the one routinely used within the SNHS in Madrid; it consisted of fifteen minute sessions, applied twice per week, for a total of minutes across 7.
The exercises were implemented progressively across sessions, in accordance with the physical therapist’s criteria, and expected to be continued at home.
These sessions focused on the muscle imbalances that are most commonly found in patients with LBP. Additionally, each participant was physically examined for 20 minutes and received 4 additional minute individualized, one-on-one sessions of manual therapy, stretching, and massage focusing on the muscle groups chains determined to require more attention in that particular case.
Participants in the GDS-I group received physical therapy care for a total of minutes across 7. Physical therapists in the GDS-G and GDS-I groups had written reminders summarizing the order in which the exercises were to be done during each session, the duration cadenqs each exercise, and details regarding execution.
Those providing the GDS group sessions had attended a hour course offered by a GDS-certified senior physical therapist. The individualized GDS sessions in the GDS-I group were implemented by a different set of physical therapists, who had attended an additional hour course on individualized GDS sessions offered by the same senior physical therapist. These therapists attended the physical therapy units only to conduct these sessions.
Because of the nature of the treatments being compared, the therapists and the participants could not be kept unaware of the type of physical therapy treatment routine physical therapy, GDS-G, or GDS-I. However, they were not aware that other types of treatment were being implemented, and the therapists were not present during the outcome assessments.
Outcomes were established at the cluster level. At gxs follow-up assessment, any adverse events attributed by participants to physical therapy were recorded. The research staff conducting the assessments assessors was unaware of the intervention group to which each cluster had been assigned.
Assessors had been told that they were going to assess the tds course of participants undergoing physical therapy but not that different types of physical therapy were being compared. They had received 4 hours of specific training offered by the study coordinator on the use of the validated instruments for measuring each variable PI-NRSs, RMQ, and SF and the exact operational definition of each variable. Assessors were 12 physical therapist students, who were not linked to the physical therapy units and who had no contact with the clinical staff at the units or the rest of the research staff, except nusculares the study coordinator.
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Assessors attended the physical therapy units only when participants had been scheduled for assessment and were never present when the treatments were applied. For assessment of whether masking had been successful, at the end of the study, the participants were questioned about the types of treatments the participants had received.
Participants completed musfulares of the self-administered questionnaires on their own, unaccompanied by health care staff or third parties, but they could ask the assessors questions. Physical therapists working at the participating physical therapy units consecutively screened for inclusion all patients who had LBP and who had been referred for physical therapy by their primary care physicians.
Mucsulares who met the inclusion criteria were scheduled for a specific day, when an assessor considered the exclusion criteria, explained the details of the study, and responded to participant queries.
Inclusion became effective when participants signed the informed consent form. Each cadena was then scheduled for a talk on active management. After the talk, clinical staff at the physical therapy units scheduled treatment sessions, and assessors scheduled assessments. Participants’ attendance at treatment sessions and attendance at follow-up assessments were recorded separately by the study coordinator and the assessors, respectively.
At each assessment, the completed questionnaires were collected by the assessors, who stapled them to the participants’ data forms and sent them to the coordination office. Only the assessors and the clerical staff at the coordination office had access to the questionnaires and forms.
At the coordination office, data were entered into a database by 2 administrative assistants, who verified that the data entered coincided with the participants’ ratings on the PI-NRS, RMQ, and SF questionnaires.
When the database was completed, it was used for statistical analysis.
Assumptions for sample size calculations were an intracluster correlation of. These assumptions were based on previous studies assessing physical therapy treatments for LBP within the primary care centers of the SNHS and on clinically relevant minimal changes in pain and disability.
Statistical analysis was performed by a team of statisticians, who were unaware of the treatment applied in each group and who had no contact with the rest of the staff involved in the study. The analysis followed the CONSORT Consolidated Standards of Reporting Trials rules for nonpharmacological cluster randomized trials 3940 and was performed on an intention-to-treat basis with linear mixed models. Because the objectives of this study pertained to the cluster level, linear mixed models were used to deal with clustering effects and with repeated measurements from each participant during follow-up.
Separate linear mixed models were used to assess the effects of the interventions on the 3 primary outcomes LBP, RP, and disability at 2, 6, and 12 months. Centered baseline scores were included as covariates in each model. Treatment group education, GDS-G, and GDS-Iassessment at 2, 6, and 12 monthsand interactions between treatment group and assessment were introduced into the models as fixed effects.
Because the cluster design increases the risk of baseline characteristics being unbalanced across treatment groups, 44 potential confounders were defined both clinically and by unbalance across groups at baseline Tab.
An interaction between treatment group and time was found in the regression model for LBP. Potential confounders included in the models were age, sex, pain duration, employment benefits, comorbidities, degree of physical activity, use of nonsteroidal anti-inflammatory drugs NSAIDsuse of analgesics, and use of muscle relaxants. Variables that remained as confounders in the models were as follows: A nonautomatic backward elimination strategy was followed to remove variables that did not have confounding effects.
Physical therapy units and participants were introduced as random effects. To estimate the numbers that would need to be treated for a single participant to benefit from GDS-G and GDS-I, we subtracted the scores for LBP, RP, and disability at baseline from the corresponding scores at the follow-up assessment at which losses to follow-up were the smallest. Models also were used to estimate intraclass correlation coefficients for each of the primary variables at the cluster level ie, for participants treated within the same physical therapy unit and at the participant level ie, for measurements taken at different time points from the same participant.
This study was funded by the Kovacs Foundation, a not-for-profit institution specializing in neck and back pain research and with no links to the health industry. The funding institution had no role in the design and conduct of the study; data collection; management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; or the decision to submit the article for publication.
Of the people screened, were excluded for having received physical therapy during the preceding 12 months 97 participantshaving criteria for referral to nonurgent surgery 26 or fibromyalgia 18being unable to understand written Spanish 9having red flags for systemic disease 4or refusing to sign the informed consent form 2.
For 39 people, there was more than 1 reason. The median age of the participants was 47 years. Table 2 shows the baseline characteristics of the participants. Baseline Characteristics of the Participants in the 21 Clusters a. Data are reported as number percentage unless otherwise indicated. The main baseline differences across groups were related to the degree of physical activity, comorbidities, LBP-related sick leave, and use of NSAIDs, analgesics, and muscle relaxants Tab.
Therefore, the variables included in the regression models were age, sex, pain duration dummy variable categorized as acute [reference category], subacute, or chronicemployment benefits dummy variable categorized as not on sick leave [reference category], on sick leave, or disabledcomorbidities dummy variable categorized as none [reference category], musculoskeletal comorbidities, or other comorbiditiesdegree of physical activity dummy variable categorized as sedentary [reference category], minimally and moderately active, or active and extremely activeand use of NSAIDs, analgesics, and muscle relaxants.
No participant allocated to a given treatment group crossed over to a different one.
The numbers of participants who did not attend at least one of the physical therapy sessions for the control, GDS-I, and GDS-G groups were 74, 23, and 26, respectively. In the control group, among the 1, possible session attendees participants attending 15 sessionsthere were absences 9. During the month follow-up period, 90 participants Among these participants, 49