NCT05866146

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

April 18, 2023

Last Update Submit

May 18, 2023

Conditions

Chronic Low-back Pain

Keywords

Low back painMultidisciplinary rehabilitationInterprofessional rehabilitationBiopsychosocialLow back pain management

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (6)

  • Physical functioning

    At baseline before the start of the intervention, the 5th week , and the 16th week (after 12 weeks of intervention completion).

  • Pain intensity

    At baseline before the start of the intervention, the 5th week , and the 16th week (after 12 weeks of intervention completion).

  • Health-related quality of life

    At baseline before the start of the intervention, the 5th week , and the 16th week (after 12 weeks of intervention completion).

  • Self-efficacy

    At baseline before the start of the intervention, the 5th week , and the 16th week (after 12 weeks of intervention completion).

  • Global rating of change

    At baseline before the start of the intervention, the 5th week , and the 16th week (after 12 weeks of intervention completion).

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Usual standard care

Interventions

Interprofessional rehabilitation programOTHER

The interprofessional rehabilitation program includes a comprehensive assessment, intensified physical activities and exercises, pain education, psychotherapy, occupational therapy, ergonomic interventions, and psychosocial counselling in addition to the current treatment standards. 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, nurses, occupational therapists, and clinical psychologists.

Also known as: Multidisciplinary rehabilitation program
Interprofessional rehabilitation program
Usual standard careOTHER

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.

Also known as: Routine care
Usual standard care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sintayehu Da Wami

    Queen's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sintayehu Da Wami, PhD cand

CONTACT

613483466019sdw6@queensu.ca

Jordan Miller, PhD

CONTACT

+1 6135336710jordan.miller@queensu.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In this study, research staff collecting outcome data from patients will be blinded to the group allocation. However, the treating health professionals and patients will not be blinded to group allocation due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A two-arm parallel single-blinded pilot randomized control trial (RCT) will be employed to evaluate the feasibility and preliminary effectiveness of an interprofessional rehabilitation program compared to the usual care in patients with CLBP. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 19, 2023

Study Start

May 20, 2023

Primary Completion

July 15, 2023

Study Completion

October 31, 2023

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Efforts will be made to present the results at scientific conferences and publish them in a peer-reviewed journal.