Feasibility of using Cognitive Behavioural Therapy on patients with chronic low back pain in Blantyre, Malawi
| ISRCTN | ISRCTN13658487 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13658487 |
| Secondary identifying numbers | P.08/23-0176 |
- Submission date
- 23/10/2024
- Registration date
- 24/10/2024
- Last edited
- 24/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Globally, low back pain has remained the top cause of disability since 1990. It restricts individuals from participating in social events or their day-to-day activities. Ninety percent of low back pain has no known specific cause; however, studies report psychosocial factors such as negative attitudes and beliefs, depression, and fear avoidance behaviour play a role in activity and participation restriction. In Malawi, 3.8% of people with disability believe that witchcraft is the cause of their disability, while others do not know the causes or any contributing factors. The lack of knowledge and negative beliefs about their condition might lead to adopting lifestyles that promote and prolong disability.
The purpose of the study is to assess the feasibility of conducting a future randomised trial on cognitive behavioural therapy for patients with chronic low back pain in Malawi.
Who can participate?
Adults of 18 years and above who have low back pain of more than 3 months.
What does the study involve?
Participants will be randomly allocated into one of two groups 1) Usual physiotherapy care (control), which will involve the use of infrared bulb, exercises and soft tissue manipulation or 2) CBT where participants will be involved in identifying unhelpful beliefs about their pain, pain education, cognitive restructuring exercise, general exercise and home exercise program.
Both groups will be asked to attend in-person sessions once every two weeks for three months. This is six sessions in total. Both groups will be asked to complete three questionnaires before and after the three-month period. These questionnaires will look at your attitudes and beliefs of low back pain, disability level and quality of life. These will take approximately 15 minutes to complete. Participants allocated to the CBT intervention will be invited to attend an optional interview (face to face) at the end of the intervention. This interview will explore the feasibility, benefits and challenges of receiving the CBT.
What are the possible benefits and risks of participating
Benefits: The study may help to improve the understanding of pain, reshape patients beliefs about their pain and improve patient quality of life.
Risks: Participants will be required to share their fears and uncomfortable thoughts about their pain. As such, participants might be emotionally upset talking about their pain. Trained professionals are delivering the care within a hospital setting and are used to dealing with complex patients, as such, participants will be well taken care to avoid any emotional trauma.
Where is the study run from?
Queen Elizabeth Central Hospital in Blantyre, Malawi
When is the study starting and how long is it expected to run for?
June 2023 to February 2025
Who is funding the study?
Commonwealth scholarship
Who is the main contact?
Grace Mukoka-Bwezani, grace.mukoka@napier.ac.uk
Contact information
Public, Scientific, Principal Investigator
Kamuzu University of Health Sciences
P.Bag 360
Blantyre
P.Bag 360
Malawi
 ORCID ID |
0000-0003-1893-6790 |
|---|---|
| Phone | +265 1 871 911 |
| grace.mukoka@napier.ac.uk |
Study information
| Study design | Single-center randomized controlled feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 46286 PIS v3.0 10Jun2024.pdf |
| Scientific title | Feasibility of using Cognitive Behavioural Therapy on patients with chronic low back pain in Blantyre, Malawi |
| Study objectives | The main aim of the study is to assess the feasibility of Cognitive Behavioural Therapy (CBT) in managing chronic low back pain in Malawi. Considering that CBT in management of chronic musculoskeletal pain is a concept developed in western countries, and still new in Malawi, it is crucial to explore implementation processes needed for future trial. The following are the research questions: 1. What proportion of eligible patients participate (uptake) and engage (adherence) with the feasibility RCT? 2. What data quality and completion rates can be obtained? 3. What sample size is required in a full study? 4. Are Back-PAQ, ODI and SF-20 questionnaires feasible and acceptable methods of assessing self-reported outcomes. 5. What do participants think about the feasibility and acceptability of study and intervention. |
| Ethics approval(s) |
1. Approved 27/09/2023, College of Medicine Research & Ethics Committee (COMREC) (Kamuzu University of Health Sciences, P.Bag 360, Blantyre, 360, Malawi; +265 996 141 000; comrecassadmin@kuhes.ac.mw), ref: P.08/23-0176 2. Approved 23/07/2024, Edinburgh Napier University - School of Health and Social Care Integrity Committee (EH11 4BN, Edinburgh, EH11 4BN, United Kingdom; +44 (0)333 900 6040; ethics.shsc@napier.ac.uk), ref: SHSC3502561 |
| Health condition(s) or problem(s) studied | Chronic low back pain |
| Intervention | Participants will receive the intervention once every fortnight for a period of three months. CBT will involve Identifying unhelpful and helpful thoughts and beliefs, provide information on the neurophysiology of pain, assist with identifying active coping strategies, teach general body exercises and encourage engagement with a home exercise programme. Usual physiotherapy care (control) will involve the use of Manual therapy, Mackenzie, electrotherapy The randomisation process will be done online using Dotmatics-graphpad application. With this online application, all participants will be automatically assigned to either an intervention group or control group. |
| Intervention type | Behavioural |
| Primary outcome measure | The following measures will be obtained during the recruitment and throughout data collection phase: 1. Recruitment and refusal rates (Frequencies and percentages) 2. Withdrawal rate and reason (Frequencies and percentages) 3. Adherence to the intervention (Frequencies and percentages) 4. Barriers and facilitators to CBT implementation |
| Secondary outcome measures | The following measures will be obtained at baseline and after 3 months (completion of the intervention): 1. Disability level will be measured using Oswestry Disability Index (ODI) 2. Quality of life using 20-item short form questionnaire 3.Attitudes and beliefs using Back Pain Attitudes Questionnaire (Back-PAQ) 4. Pain will be measured using Numerical Rating Scale (NRS) |
| Overall study start date | 01/06/2023 |
| Completion date | 01/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 30 participants (15 participants in each arm) |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Adult patients age ≥18 years suffering from non-specific low back pain for more than 3 months 2. Those who are currently attending physiotherapy treatment at QECH, in Blantyre, Malawi 3. Those who are willing to provide informed consent to participate in the study |
| Key exclusion criteria | Those presenting with chronic low back pain for other reasons such as cancer, tuberculosis, or spinal surgery |
| Date of first enrolment | 28/10/2024 |
| Date of final enrolment | 30/11/2024 |
Locations
Countries of recruitment
- Malawi
Study participating centre
Blantyre
P.O.BOX 95
Malawi
Sponsor information
University/education
Sighthill
EH11 4BN
Edinburgh
EH11 4BN
Scotland
United Kingdom
| Phone | +44(0)333 900 6040 |
|---|---|
| researchadmissions@napier.ac.uk | |
| Website | https://www.napier.ac.uk/research-and-innovation/explore-our-research |
"ROR" |
https://ror.org/03zjvnn91 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Commonwealth Fund, CF
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal Conference oral and poster presentations Internal report |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Grace Mukoka-Bwezani; grace.mukoka@napier.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 10/06/2024 | 24/10/2024 | No | Yes |
Additional files
Editorial Notes
24/10/2024: Trial's existence confirmed by Kamuzu University of Health Sciences.
