Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201902788269426 Date of Approval: 19/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effects of culturally sensitive Pain Neuroscience Education program on Hausa patients with Chronic Spinal Pain: A pilot randomized controlled trial
Official scientific title The effects of culturally sensitive Pain Neuroscience Education program on Hausa patients with Chronic Spinal Pain: A pilot randomized control study
Brief summary describing the background and objectives of the trial Pain is a global problem and very costly to manage (1-4) and in fact one of the leading complaints received by health care practitioners (4-6). Up to 80% of physician visits have to do with pain complaints (7). Pain may be acute when it lasts for a shorter period of time and usually has a known cause which makes its management less complicated (8) when compared to chronic pain. Chronic pain mostly have an unknown cause and persists for more than three months and it accounts for more than 38% of patients’ complaints at primary health care centers (7). Chronic pain is probably one of the diseases with the greatest negative impact on quality of life (1, 2). Research emphasis has been on the most effective ways of managing patients with chronic pain taking into account resources and time (9). Pain neuroscience education (PNE) as a program of teaching patients about pain neurophysiology has gained considerable attention in the last decade (10). There is growing evidence for the efficacy of PNE in decreasing pain, disability, fear-avoidance, pain catastrophization, impaired movement, and health care utilization in people struggling with pain (11, 12). The standard PNE materials (teaching and home education leaflets) used may not be appropriate in the Hausa population as they contain examples, characters, drawings and metaphors that are not recognizable or available in Hausa culture. Additionally, the home education leaflets that are meant for patients to read at home may not be helpful to many Hausa patients due to low literacy levels in the region. The primary aims of the study are to evaluate the effects of both standard translated and culturally sensitive pain neuroscience education materials (developed through a previous Delphi study) on pain intensity and disability in Hausa patients with chronic spinal pain using a randomized controlled trial. The outcome measures are pain conceptualization, fear avoidance beliefs, pain catastrophizing and quality of life.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 26/02/2019
Actual trial start date
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional therapy 30 minutes The Conventional therapy (Exercise therapy) group will have exercises for about 20-minutes circuit and will be preceded by 5 minutes of warm and at the end another 5 minutes cool down. Warming up exercises are; i. walking on toes or walking on heels (to be alternated from one session to another) for 1min ii. taking up knees to waist height or taking heels back to touch bottom (to be alternated from one session to another) for 1min iii. walking backwards or walking sideways (to be alternated from one session to another) for 1min iv. calf muscle stretch for left and right limbs each for 10 seconds (20 seconds in total) v. shoulder girdle stretch one each for left and right upper limbs for 10 seconds each (20 seconds in total) vi. spinal and hip extensors stretch for 20 seconds vii. anterior trunk and hip flexors stretch for 20 seconds viii. rectus femoris stretch for left and right limbs, each for 10 seconds (20 seconds in total) Bouncing will not be allowed for the stretches. Guidance will be given to encourage correct positions. Individual exercises will then be followed and will last for about 20mins and will also be guided by the therapist and will include; i. walking on the spot to be progressed to running on the spot and finally to running on the spot with knees high, progression will be done at two weeks interval ii. diagonal trunk curl to the left and right sides iii. sideway steps (to the left and right) then progressing to sideways steps plus swinging arms and finally to star jumps, progression will be done at two weeks intervals iv. iv. press ups; against the wall then progressing to modified press ups from knees and finally to full press ups, progression will be done at two weeks intervals v. leg raise sideways for the left and right vi. leg raise backwards for the left and the right vii. vii. trunk curls viii. stands up from fundamental sitting positions with arms across the chest ix. Arm circling for the left and right x. Bridging 15 Active-Treatment of Control Group
Experimental Group The translated standard PNE group 30 minutes during the first 3 treatment sessions they will receive three sessions of pain education programs (two clinic teaching sessions and one home education leaflet which they will read at home). The documents were translated forward and backward into Hausa language based on the standard translation procedure. Each of the pain education teaching session will last for 30minutes and reading the home education leaflet will also take an average of 30minutes. After the 3rd session, they will receive exercises as in the conventional therapy group from the 4th to the 12th sessions. A total of 12 treatment session (twice weekly and not on the consecutive days) will be given to patients of all the groups. 15
Experimental Group The culturally sensitive PNE group 30 minutes during the first 3 treatment sessions they will receive three sessions of pain education programs (two clinic teaching sessions and one listening of home education audio material). Each of the pain education teaching session will last for 30minutes and listening of the home education audio interview will also take approximately 30minutes. After the 3rd session, they will receive exercises as in the conventional therapy group from the 4th to the 12th sessions. A total of 12 treatment session (twice weekly and not on the consecutive days) will be given to patients of all the groups. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) patients between the age of 18-65years 2) have a chronic nonspecific spinal pain (CNSP) 3) have a pain frequency of at least three days per week hearing or visual impairment, previous spinal surgery, chronic joint disorders, neurological deficit, inflammatory or infectious diseases of the spine or other severe disabling health conditions, pregnant women Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/02/2019 Research Ethical Committee Aminu Kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Zaria Road Kano 700233 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/01/2019 Research Ethics Committee Kano State Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Post Office Road Kano 700000 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain and Disability Before the intervention, after the 12th session of the intervention and at 3 months after the last intervention
Secondary Outcome Pain Catastrophizing and Quality of life Before the intervention, after the 12th session of the intervention and at 3 months after the last intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital Zaria Road Kano Nigeria
National Orthopaedic Hospital Dala Kano Kofar Ruwa Road Kano Nigeria
Murtala Muhammad Specialist Hospital Kofar Mata Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bayero University Kano Gwarzo Road Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero University Kano Gwarzo Road Kano Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Prof Barbara Cagnie Corneel Heymanslaan 10 Ghent 9000 Belgium
Prof Mira Meeus Corneel Heymanslaan Ghent 9000 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naziru Bashir Mukhtar NaziruBashir.Mukhtar@UGent.be +2348069442044 Zaria Road
City Postal code Country Position/Affiliation
Kano Nigeria PhD student
Role Name Email Phone Street address
Public Enquiries Barbara Cagnie Barbara.Cagnie@UGent.be +3293325265 C. Heymanslaan 10
City Postal code Country Position/Affiliation
Ghent Belgium PhD Supervisor
Role Name Email Phone Street address
Scientific Enquiries Mira Meeus mira.meeus@ugent.be 3293326919 C. Heymanslaan 10
City Postal code Country Position/Affiliation
Ghent Belgium PhD Cosupervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information