Chronic Low-back Pain Clinical Trial
— IRPOfficial title:
A Pilot Randomized Control Trial to Test the Feasibility of Evaluating the Effectiveness of an Interprofessional Rehabilitation Program for Patients With Chronic Low Back Pain in Ethiopia: A Study Protocol
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, psychological functioning) in patients with CLBP to inform sample size calculation for the definitive RCT. Patients 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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | October 31, 2023 |
Est. primary completion date | July 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Queen's University | MasterCard Foundation Scholarship Program |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient recruitment rate | 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. | |
Primary | Patient retention rate | 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. | |
Primary | Intervention adherence rate | 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. | |
Primary | Acceptability of intervention and trial procedures | 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. | |
Primary | Treatment fidelity | 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 > 80% compatible with the intervention protocol. | The data will be collected through intervention completion, up to five weeks. | |
Secondary | Physical functioning | 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 16th week (after 12 weeks of intervention completion). | |
Secondary | Pain intensity | Pain intensity will be measured using a brief pain inventory - short form (BPI-sf) standard questionnaire. The Brief Pain Inventory - Short Form (BPI-sf) is a nine-item self-administered questionnaire that is used to assess the degree of a patient's pain and its influence on daily functioning. On a 10-point scale, the patient is asked to rate their worst, least, average, and current pain intensity. A score of 1 - 4 = Mild Pain, 5 - 6 = Moderate Pain and a score of 7 - 10 = Severe Pain. | At baseline before the start of the intervention, the 5th week , and the 16th week (after 12 weeks of intervention completion). | |
Secondary | Health-related quality of life | 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 16th week (after 12 weeks of intervention completion). | |
Secondary | Self-efficacy | 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, the 5th week , and the 16th week (after 12 weeks of intervention completion). | |
Secondary | Global rating of change | 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). | At baseline before the start of the intervention, the 5th week , and the 16th week (after 12 weeks of intervention completion). | |
Secondary | Psychological functioning | The investigators will use the Hospital Anxiety and Depression Scale (HADS) to measure psychological functioning. Scoring for each item ranges from zero to three, with three denoting the highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. | At baseline before the start of the intervention, the 5th week , and the 16th week (after 12 weeks of intervention completion). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05963451 -
Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
|
||
Completed |
NCT04283370 -
A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain
|
N/A | |
Completed |
NCT04824547 -
Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals
|
N/A | |
Completed |
NCT04046419 -
In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
|
||
Completed |
NCT04399772 -
COgNitive FuncTional Therapy+ for Chronic Low Back paIn
|
N/A | |
Recruiting |
NCT05780021 -
Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation
|
N/A | |
Completed |
NCT04555278 -
Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
|
N/A | |
Completed |
NCT04530071 -
Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06080464 -
Clinician Satisfaction With the VERABANDâ„¢
|
N/A | |
Not yet recruiting |
NCT06347328 -
The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain
|
N/A | |
Not yet recruiting |
NCT04940715 -
Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT04683718 -
A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management
|
N/A | |
Recruiting |
NCT05724160 -
Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT06030128 -
Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults
|
N/A | |
Recruiting |
NCT05846087 -
Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
|
N/A | |
Active, not recruiting |
NCT05396014 -
The BEST Trial: Biomarkers for Evaluating Spine Treatments
|
Phase 4 | |
Active, not recruiting |
NCT06140862 -
Ankle Spine Syndrome "RAFFET Syndrome II
|
N/A | |
Completed |
NCT05512338 -
Motivation and Adherence to Exercise Recommendations
|
N/A | |
Recruiting |
NCT05021146 -
Essential Oil for Chronic Low Back Pain
|
N/A | |
Completed |
NCT05690178 -
Deep Tissue Massage in Office Workers With Chronic Low Back Pain
|
N/A |