Chronic Low-back PainIRPNCT05866146
Feasibility of an Interprofessional Rehabilitation Program for Chronic Low Back Patients in the Ethiopian Health Setting
A study testing Interprofessional rehabilitation program in people with Chronic Low-back Pain, run by Sintayehu Wami at 1 site in Ethiopia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Interprofessional rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEthiopia
- Study dates
- 11 Apr 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
University of Gondar Comprehensive Specialized Hospital
Gonder, Amhara
About this study
Official 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Interprofessional rehabilitation program, Usual standard care
- Keywords
- Low back pain, Multidisciplinary rehabilitation, Interprofessional rehabilitation, Biopsychosocial, Low back pain management
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interprofessional rehabilitation programOther
Also called Multidisciplinary rehabilitation program
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.
Usual standard careOther
Also called Routine care
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.
| Study group | Role | What they receive |
|---|---|---|
| Interprofessional rehabilitation program | Experimental | 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. Receives: Other: Interprofessional rehabilitation program |
| Usual standard care | Active comparator | 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. Receives: Other: Usual standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The data will be collected at the baseline before the start of the intervention.
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.
Measured: The data will be collected through intervention completion, up to five weeks.
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.
Measured: The data will be collected through intervention completion, up to five weeks.
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.
Measured: The data will be collected through intervention completion, up to five weeks.
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 > 75% compatible with the intervention protocol.
Measured: The data will be collected through intervention completion, up to five weeks.
Secondary outcomes (5)
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.
Measured: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
Pain intensity
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.
Measured: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
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.
Measured: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
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).
Measured: At baseline before the start of the intervention, and week 5/post-intervention
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).
Measured: week 5/post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start11 Apr 2023
- Primary completion22 Sep 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm parallel open-label pilot randomized control trial (RCT) with a 1:1 allocation to an interprofessional rehabilitation program or usual care will be conducted along with embedded mixed methods process evaluation. Each eligible patient will have an equal chance to be allocated to the intervention or control group. Those who provide informed consent will complete a baseline assessment before being randomly assigned to the intervention or the control group without knowing the allocation of the group. Each group will be allocated/randomized 1:1 to the intervention and control groups. Except for the intervention being evaluated, all groups will be treated identically in every way.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintayehu Wami
- Sponsor type
- University, hospital or other
- Collaborators
- MasterCard Foundation Scholarship Program
- Responsible party
- Sponsor-investigator, Sintayehu Wami, Queen's University
- Investigators
- Sintayehu Da Wami, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866146
- Sponsor's protocol ID
- ETH-IRP-CLBP-001
- Other IDs
- MCF
- Acronym
- IRP
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Efforts will be made to present the results at scientific conferences and publish them in a peer-reviewed journal.
Publications
Wami SD, Donnelly C, Alemu K, Adefris E, Miller J. Feasibility of evaluating the effectiveness of an interprofessional rehabilitation program for people with chronic low back pain in Ethiopia: a pilot randomized control trial protocol. Pilot Feasibility Stud. 2026 Jun 11. doi: 10.1186/s40814-026-01866-y. Online ahead of print.
PubMed 42277897
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05866146
- Acronym / sponsor ID
- IRP / ETH-IRP-CLBP-001
- Conditions
- Chronic Low-back Pain
- Keywords
- Low back pain, Multidisciplinary rehabilitation, Interprofessional rehabilitation, Biopsychosocial, Low back pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sintayehu WamiUniversity, hospital or other
- Collaborators
- MasterCard Foundation Scholarship Program
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm parallel open-label pilot randomized control trial (RCT) with a 1:1 allocation to an interprofessional rehabilitation program or usual care will be conducted along with embedded mixed methods process evaluation. Each eligible patient will have an equal chance to be allocated to the intervention or control group. Those who provide informed consent will complete a baseline assessment before being randomly assigned to the intervention or the control group without knowing the allocation of the group. Each group will be allocated/randomized 1:1 to the intervention and control groups. Except for the intervention being evaluated, all groups will be treated identically in every way.
| Arm | Type | Receives |
|---|---|---|
| Interprofessional rehabilitation program | Experimental | Other: Interprofessional rehabilitation programParticipants 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. |
| Usual standard care | Active comparator | Other: Usual standard careThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interprofessional rehabilitation programAlso: Multidisciplinary rehabilitation programThe 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. | Other | Interprofessional rehabilitation program |
| Usual standard careAlso: Routine careParticipants 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. | Other | Usual standard care |
Primary outcome
Patient recruitment rate
Time frame: The data will be collected at the baseline before the start of the intervention.
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).
Patient retention rate
Time frame: The data will be collected through intervention completion, up to five weeks.
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.
Intervention adherence rate
Time frame: The data will be collected through intervention completion, up to five weeks.
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.
Acceptability of intervention and trial procedures
Time frame: The data will be collected through intervention completion, up to five weeks.
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.
Treatment fidelity
Time frame: The data will be collected through intervention completion, up to five weeks.
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.
5 secondary outcomes
Physical functioning
Time frame: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
Pain intensity
Time frame: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
Health-related quality of life
Time frame: At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).
Self-efficacy
Time frame: At baseline before the start of the intervention, and week 5/post-intervention
Global rating of change
Time frame: week 5/post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Derived from this study: PubMed 42277897Wami SD, Donnelly C, Alemu K, Adefris E, Miller J. Feasibility of evaluating the effectiveness of an interprofessional rehabilitation program for people with chronic low back pain in Ethiopia: a pilot randomized control trial protocol. Pilot Feasibility Stud. 2026 Jun 11. doi: 10.1186/s40814-026-01866-y. Online ahead of print.
- Individual participant dataSharing planned: No. Efforts will be made to present the results at scientific conferences and publish them in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sintayehu Da Wami principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interprofessional rehabilitation program in people with Chronic Low-back Pain, run by Sintayehu Wami at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recruitment rate (time frame: The data will be collected at the baseline before the start of the intervention.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.