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.: PACTR202209718136908 Date of Approval: 05/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effectiveness of pain neuroscience education in the treatment of recreational marathon runners with chronic running related knee injuries
Official scientific title The effectiveness of pain neuroscience education in the treatment of recreational marathon runners with chronic running related knee injuries
Brief summary describing the background and objectives of the trial Objective one: To determine the effectiveness of pain neuroscience education (Schröder et al.) for the treatment of recreational marathon runners with chronic running related knee injuries using the pain catastrophizing scale (PCS). Objective two: To estimate the effectiveness of PNE, in the reduction of pain for the treatment of recreational marathon runners with chronic running related knee complex and joint injuries, using the pain catastrophizing, numerical pain rating and lower extremity functionality scales respectively (PCS, NPR, LEFS). Objective three: To determine self-reported changes in functionality of the knee joint of the treatment of recreational marathon runners with chronic running related knee injuries using the lower extremity functional scale (LEFS).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PNE
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 23/07/2021
Actual trial start date 23/07/2021
Anticipated date of last follow up 31/08/2022
Actual Last follow-up date 31/08/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 40
Recruitment status 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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pain Neuroscience Education 1 session per week, for 3 consecutive weeks 3 weeks Pain neurosciences education is a rehabilitation and treatment tool. It teaches or uses education through metaphors in order to educate the patient about pain. To teach patients how to interpret pain and how the painful experienced is processed. 20
Control Group Control 1 session per week, for 3 weeks consecutively 3 weeks Manipulation or adjusting the knee joint complex only 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria • Signed informed consent. • Participants aged 18 to 65 years (Knechtle and Nikolaidis 2018; Larsen et al. 2020). • Participants who are male or female with symptomatic chronic knee pain (greater than 3 months duration). • Participants with a weekly training volume between 30 and 80km/week (Rasmussen et al. 2013). • Participants who had completed 2 or more marathon events within the past 2 years (virtual and non-virtual). • Participants with a score greater than 40 on the central sensitization inventory scale (CSI) (Mayer et al. 2012). Exclusion Criteria • Professional and elite marathon runners (Rüst et al. 2011). • Participants who have had previous total knee replacement or any other lower limb surgery within the past six months of the affected knee, co-existing inflammatory, metabolic or neurologic disease (Messier et al. 2008; Lluch et al. 2018). • Participants who have contraindications to chiropractic care and PNE. • Participants who have previously received chiropractic care and/or PNE can require a 3 month wash out period before they can be eligible to enter the study. • Participation in other pain trials prior (3 months) to recruitment. • Lack of the ability to adhere to the protocol, cognitive impairment, illiteracy or unable to speak English (Lluch et al. 2018). 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 23/07/2021 IREC
Ethics Committee Address
Street address City Postal code Country
Gate 1 Steve Biko Campus Durban University of Technology Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measure the difference between manipulation and Pain neuroscience education combined Initial consult and final consult
Secondary Outcome Measure the difference with manipulation alone. initial consult and final consult
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Durban University of Technology Chiropractic day Clinc. Dr K. Padayachy Chiropractic Practise 8 Ritson Road Musgrave, Berea. 233 Main Road Malvern Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Tyren Naidoo 18 Umdoni Place Blackridge Pietermaritzburg 3201 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tyren Naidoo 18 Umdoni Place Blackridge Pietermaritzburg 3201 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tyren Naidoo tynaidoo91@gmail.com 0724910192 18 Umdoni Place Blackridge
City Postal code Country Position/Affiliation
Pietermaritzburg 3201 South Africa Student
Role Name Email Phone Street address
Scientific Enquiries Keseri Padayachy keserip@dut.ac.za 0843716438 233 Main Road Malvern
City Postal code Country Position/Affiliation
Durban 4001 South Africa Supervisor
Role Name Email Phone Street address
Public Enquiries Linda Twiggs lindat@dut.ac.za 27722034169 8 Ritson Road Musgrave
City Postal code Country Position/Affiliation
Durban 4001 South Africa Clinic Administrator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the data collected in this study at any level, either from participants' demographic characteristics or from the results of the interventions, will not be shared with any other researchers or other similar studies. The data collected during the study will not be freely shared without permission to the public or other researchers involved in similar studies without permission. Study Protocol None None
URL Results Available Results Summary Result Posting Date First Journal Publication Date
None 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