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.: PACTR202001586284982 Date of Approval: 27/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of lumbar spine manipulation on the muscle activity of the quadriceps femoris and hamstring muscle groups
Official scientific title The effect of lumbar spine manipulation on the muscle activity of the quadriceps femoris and hamstring muscle groups
Brief summary describing the background and objectives of the trial This study was a quantitative, randomised controlled trial using a pre-and-post experimental design. The sample size consisted of 48 participants that were later placed into four subgroups. The groups were symptomatic intervention, symptomatic control, asymptomatic intervention, and asymptomatic control. Aim: To determine and compare the effects of a lumbar spine manipulation on the muscle activity in the quadriceps femoris and hamstring muscle groups in asymptomatic and symptomatic participants (low back pain) Objectives: 1. To determine the immediate and short-term effect of lumbar spinal manipulative therapy on the muscle activity on the quadriceps femoris and hamstring muscle groups in asymptomatic participants. 2. To determine the immediate and short-term effect of lumbar spinal manipulative therapy on the muscle activity on the quadriceps femoris and hamstring muscle groups in symptomatic participants. 3. To compare and correlate the data between the asymptomatic and symptomatic groups.
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 Early detection /Screening
Anticipated trial start date 01/10/2019
Actual trial start date 11/10/2019
Anticipated date of last follow up 11/12/2019
Actual Last follow-up date 11/12/2019
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Spinal manipulative therapy Symptomatic Intervention Spinal manipulative therapy was used once during one appointment. Approximately 3 minutes. The amount of spinal manipulative therapy used was dependent on the number of restrictions that the participant presented with. The diversified spinal manipulative therapy technique was used. 12
Control Group Control Group Symptomatic Control Not applicable. 3 minutes. Patient was required to lie on the bed for the same amount of time that it would take for a participant in the intervention group to receive spinal manipulation. 12 Placebo
Experimental Group Spinal Manipulation Asymptomatic Intervention Spinal manipulative therapy was used once during the appointment. 3 minutes The amount of spinal manipulative therapy used was dependent on the number of restrictions that the participant presented with. The diversified spinal manipulative therapy technique was used. 12
Control Group Control Group Asymptomatic Control Not applicable 3 Minutes Patient was required to lie on the bed for the same amount of time that it would take for a participant in the intervention group to receive spinal manipulation. 12 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Individuals will be required to have completed the letter of informed consent (Appendix E) and sign the letter of information (Appendix E) in order to participate in this study. o Participants between the ages of 18-45 years will be required for this study. Subjects older than 45 years will not be able to participate in the study as Ding (2005) found evidence that knee cartilage defects were far more common in subjects over 45 years of age than those that are younger. o Participants must be older than 18 years old to avoid having to obtain parental permission. o Each participant must present with at least one fixation in the relevant levels (L2-L5) of the lumbar spine as the purpose of the study is to investigate the effects of a lumbar spine manipulation on the muscle activity and joint position sense of the lower limb. Motion palpation of the lumbar spine will be used to determine if there is a fixation in these areas (Bergmann and Peterson 2010). Symptomatic Participants o Low back pain for a duration of three or more months. o Diagnosis of low back pain must be of a mechanical origin. Asymptomatic Participants No history of low back pain or no lower back pain three weeks prior to the study o The eligible participant must not have been adjusted 4 weeks prior to their visit to participate in the study as this may allow for possible effects of previous treatment to alter the outcome of the readings and results o Participants that do not present with fixations in the relevant spinal levels (L2-L5). o Individuals who present with hip, knee, or ankle pain as a result of trauma or surgery (Hurley, Jones and Newham 1994; Hurley 2003). o Participants that have primary or secondary disorders that may compromise normal neurological function (Diabetes Mellitus) (Eliassen 1964) as this may alter results in the study. o Participants who are taking medication that may affect muscle activity (i.e. sedatives and stimulants) (Kruk 2014). o Participants that have a Body Mass Index (BMI) of 30 or greater as this may affect surface EMG readings (Nordander et al. 2003). o Participants will not be a part of the study if they have any contraindications to spinal manipulative therapy (SMT) based on a case history and physical exam (Bergmann and Peterson 2010). This may include, but are not limited to the following: Neurological conditions (cauda equine syndrome, neuropathies) Malignancy (tumour) Vascular (aortic aneurysm, atherosclerosis) Infections (osteomyelitis) Skeletal conditions (osteoporosis, osteoarthritis, fractures) Symptomatic Participants o Participants who present with low back pain due to trauma or structural anomalies. o Low back pain with neurological deficits (muscle weakness, reflex changes) and radiation into the legs. o Previous back surgery o Spinal tumours or infections. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 06/09/2019 Durban University of Technology Institutional Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
41 ML Sultan Road Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Muscle activity in the asymptomatic participants Pre-intervention/control, post-intervention/control and 10 minute post-intervention/control
Secondary Outcome Muscle activity in the symptomatic participants pre-intervention/control, post-intervention/control and 10 minute post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chiropractic Day Clinic at the Durban University of Technology 11 Ritson Road Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation Meiring Naude Road Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alan Parkes 32 Pumula Terrace Port Shepstone 4320 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Ashura Abdul Rasheed 11 Ritson Road Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jenna Leigh Parkes justjen02@gmail.com +27732971602 87 Peter Mokaba Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Primary Researcher
Role Name Email Phone Street address
Public Enquiries Linda Twiggs lindat@dut.ac.za 0313732205 11 Ritson Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Administrative
Role Name Email Phone Street address
Scientific Enquiries Ashura Abdul Rasheed ashuraa@dut.ac.za 0313732102 11 Ritson Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Dissertation will be available at the institutional library repository. Once published at a peer reviewed journal the article will be available. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Dissertation will be handed in for examination in Feb 2020, results will be available by June 2020. DUT repository - Open Access (www.dut.ac.za)
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