Wykonalność międzyprofesjonalnego programu rehabilitacji pacjentów z przewlekłym kręgosłupem w etiopskim środowisku medycznym (IRP)
Pilotażowa randomizowana próba kontrolna mająca na celu zbadanie wykonalności oceny skuteczności międzyzawodowego programu rehabilitacji pacjentów z przewlekłym bólem krzyża w Etiopii: protokół badania
The overall aim of this pilot RCT is to assess the feasibility of conducting a future definitive randomized control trial (RCT) for evaluating the effectiveness of an interprofessional rehabilitation program compared to the usual care in adults with chronic low back pain in Ethiopia.
Specific objectives of this study include:
- To evaluate the feasibility of trial procedures (recruitment rate, retention rate, adherence rate).
- To explore the feasibility and acceptability of the intervention from the patients' and care providers' perspectives.
- To estimate the preliminary treatment effect and standard deviation of the relevant clinical outcome measures (physical functioning, pain intensity, workability, HRQoL, global rating of changes) in people with CLBP to inform sample size calculation for the definitive RCT.
People with chronic low back pain diagnosed through focused history and physical examination are accepted for enrolment. Each eligible patient will have an equal chance to be allocated to the intervention or control group.
Participants of the intervention group will receive interprofessional rehabilitation for four weeks. Participants of the intervention group will receive interprofessional rehabilitation that contain components aimed at enabling optimal physical, psychological, and social functioning, including addressing the work abilities of patients. The components will include a comprehensive assessment, intensified physical activities and exercises, pain education, psychological support, occupational therapy, ergonomic interventions, and vocational counselling.
Participants in the comparison group will receive the usual care according to the current standard care for patients with chronic low back pain at the University of Gondar specialized referral hospital in Ethiopia for over four weeks.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Chronic low back pain (CLBP) is the most common type of musculoskeletal pain, and it has a substantial negative consequence on the ability to engage in meaningful activities, participation in work, health-related quality of life, and social relationships. CLBP-related disability is increasing worldwide, and the majority of this increase is associated with the growing burden in low-and-middle-income countries, including Ethiopia.
A growing body of evidence from high-income countries indicates the effectiveness of interprofessional rehabilitation programs for patients with CLBP. The currently implemented biomedically focused fragmented care in low- and middle-income countries appears to have limited lasting effect, owing to long-term disability. Therefore, this pilot RCT aims to evaluate the feasibility of conducting a definitive RCT to assess the effectiveness of an interprofessional rehabilitation program compared to the usual care for patients with CLBP in Ethiopia. Accordingly, the investigators will evaluate some elements of full RCT, including recruitment and retention rate, adherence, acceptability of the intervention, sample size estimation, and participants' preliminary responses to the interventions. Hence, this study will substantially benefit in informing components of the main trial design, minimizing uncertainties, and increasing the likelihood of successfully conducting the definitive RCT in the future. In addition, this pilot RCT is expected to provide a source of evidence for other initiatives aimed at developing and implementing interprofessional rehabilitation programs in a similar context.
A two-arm parallel single-blinded pilot randomized control trial (RCT), with embedded qualitative interviews, will be employed to assess the feasibility of conducting a full RCT to evaluate the effectiveness of an interprofessional rehabilitation program compared to the usual care in patients with CLBP.
Sample size: The investigators will recruit a total of 40 (i.e., 20 in the intervention group and 20 in the control group) patients with CLBP.
A simple block randomization method with random block sizes of 4 to 8 will be employed to randomize participants into the intervention and control groups.
Data collection procedures: The data will be collected by a trained research assistant who will be blind to the group assignment using interviewer administered approach at three time points: at baseline before the start of the intervention, the 5th week immediately following the final visit for the intervention, and the 17th week (after 12 weeks of intervention completion) to investigate whether the effects are sustained over time after the completion of the intervention.
In addition to the primary and secondary outcome measures, the study participants' socio-demographic and behavioural characteristics, such as age, sex, educational level, marital status, and physical activities, will be collected at the baseline. A two-day training will be given to data collectors about the trial process, outcome measures, and tools used by PI.
For the embedded qualitative interviews, a principal investigator will conduct a face-to-face, in-depth interview with treating health professionals and study participants during the intervention phase. A semi-structured interview guide will be used to conduct an interview. The interview will be conducted to explore the acceptability of the intervention and barriers and facilitators associated with the implementation of the intervention from both treating health professionals' and participants' perspectives. The investigators will also explore the perceptions and experiences of the study participants about the intervention they have received.
Data management and statistical analysis: Descriptive statistics like mean, standard deviation, proportions, and frequency distributions of all variables will be computed. The quantitative data analysis will be performed using SPSS version 27. The main analysis will be performed according to the intention-to-treat (ITT) principle.
Content analysis as described by Elo and Kyngäs will be used to analyze the qualitative data.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Amhara
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Gonder, Amhara, Etiopia
- University of Gondar Comprehensive Specialized Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Adults above the age of 18 years
- Patients with chronic low back pain ('pain and discomfort localized below the costal margin and above the inferior gluteal folds, with or without leg pain') that persists for 3 months or more will be included in this trial
Exclusion Criteria:
- Patients who have serious known spinal pathology (e.g., tumours, vertebral fractures, and inflammatory diseases), and spinal surgery within the last 12 months will be excluded.
- Participants with CLBP due to specific pathologies (e.g., infections, neoplasms, metastases, fractures, osteoporosis, rheumatoid arthritis, radiculopathies) or other inflammatory articular conditions (for example, ankylosing spondylitis), spinal stenosis, or fracture will also be excluded from the study
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Interprofessional rehabilitation program
Participants of the intervention group will receive an interprofessional rehabilitation program, which involve a combination of physical, psychological, behavioral, and/or vocational components, for four weeks. |
The interprofessional rehabilitation program includes a comprehensive assessment, progressive physical activity and exercise, pain education, psychological interventions, and task-oriented and ergonomic interventions components. The interprofessional rehabilitation program will be delivered in a combination of individual (one-to-one) and group sessions (in groups of 6 - 10 patients). Care providers will apply a combination of lectures and discussions, individual exercises, and group-based exercises and education. All sessions will be delivered face-to-face (in person). The intervention will be provided by a team of healthcare providers with different professional backgrounds and training. The interprofessional team may include experienced physicians (GPs), neurosurgeons, physiotherapists, occupational therapists, and clinical psychologists.
Inne nazwy:
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Aktywny komparator: Usual standard care
The control group participants will receive the usual standard care according to the current practices at the University of Gondar specialized hospital over the same four weeks. |
Participants in this group will receive the usual care currently implemented mainly pharmacological treatment (pain medication), and back pain advice. The usual care in rare occasions may also include physical therapy such as exercise and massage.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient recruitment rate
Ramy czasowe: The data will be collected at the baseline before the start of the intervention.
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The recruitment rate is described as the number of eligible patients with CLBP recruited and randomized within two to three months at the University of Gondar specialized hospital. Hence, the recruitment rate will be calculated by dividing the total number of patients with CLBP recruited at the University of Gondar specialized hospital by the total recruitment period (number of months). |
The data will be collected at the baseline before the start of the intervention.
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Patient retention rate
Ramy czasowe: The data will be collected through intervention completion, up to five weeks.
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The number of patients recruited, randomized, and considered for the analysis will be used to calculate the retention rate. The retention rate will be calculated as the percentage of participants that complete all secondary outcome measures. |
The data will be collected through intervention completion, up to five weeks.
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Intervention adherence rate
Ramy czasowe: The data will be collected through intervention completion, up to five weeks.
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The intervention adherence rate will be determined by calculating the proportion of group and individual intervention sessions completed by the study participants as per the stated intervention protocol. |
The data will be collected through intervention completion, up to five weeks.
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Acceptability of intervention and trial procedures
Ramy czasowe: The data will be collected through intervention completion, up to five weeks.
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A qualitative description approach will be employed to explore the acceptability of the intervention and trial procedures from both treating health professionals and study participants' perspectives through an in-depth interview using a semi-structured interview guide. intervention from the patients' and care providers perspectives. |
The data will be collected through intervention completion, up to five weeks.
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Treatment fidelity
Ramy czasowe: The data will be collected through intervention completion, up to five weeks.
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The investigators will evaluate whether the intervention is delivered with fidelity according to the developed protocol. The care providers will assess and rate using a treatment fidelity checklist at each visit to evaluate treatment fidelity. Fidelity will be judged acceptable if the score is > 75% compatible with the intervention protocol. |
The data will be collected through intervention completion, up to five weeks.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Physical functioning
Ramy czasowe: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
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The cross-culturally adapted and validated Roland Morris Disability Questionnaire (RMDQ-24) will be used to measure the physical functioning of patients with CLBP. The RMQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Each item is given a 1 (Yes) or 0 (No) score ranging from 0 to 24; higher scores represent higher levels of pain-related disability. |
At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
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Pain intensity
Ramy czasowe: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
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Pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF), a nine-item self-administered questionnaire that evaluates pain severity and pain-related interference with daily functioning. Participants rate their worst, least, average, and current pain intensity on an 11-point numerical rating scale ranging from 0 ("no pain") to 10 ("pain as bad as you can imagine"). Pain severity may be categorized as mild (1-4), moderate (5-6), or severe (7-10), while a score of 0 indicates no pain. |
At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
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Health-related quality of life
Ramy czasowe: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
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Will be measured using the 36-item short-form health survey (SF-36) questionnaire. Possible scores range from 0 to 100, with higher scores representing better health status. |
At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
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Self-efficacy
Ramy czasowe: At baseline before the start of the intervention, and week 5/post-intervention
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To measure self-efficacy of patients with CLBP, the investigators will utilize the pain self-efficacy questionnaire (PSEQ). The PSEQ is a ten-item questionnaire in which patients assess their level of confidence on a scale of 0 (not at all confident) to 6 (very confident) (completely confident). Total scores are derived by adding the individual items' values, which range from 0 (low self-efficacy) to 60 (high self-efficacy) (more self-efficacy). |
At baseline before the start of the intervention, and week 5/post-intervention
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Global rating of change
Ramy czasowe: week 5/post-intervention
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The Global Rating of Change (GRC) scales are used to assess self-perceived improvement/changes in health. To measure the global rating of change, the investigators will use an 11-point global rating of change scale (GROC) (-5 to +5), ranging from -5 (very much worse), through 0 (unchanged) to +5 (completely recovered). |
week 5/post-intervention
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Sintayehu Da Wami, Queen's University
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ETH-IRP-CLBP-001
- MCF (Inny numer grantu/finansowania: MasterCard Foundation Scholarship program)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Efforts will be made to present the results at scientific conferences and publish them in a peer-reviewed journal.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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