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.: PACTR201906717506525 Date of Approval: 19/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The relative effect of upper cervical spine manipulation, placebo and a control, on neck muscle activity, pain and disability in participants with cervicogenic headache.
Official scientific title The relative effect of upper cervical spine manipulation, placebo and a control, on neck muscle activity, pain and disability in participants with cervicogenic headache.
Brief summary describing the background and objectives of the trial Cervicogenic headache (CGH) arises from dysfunction of the cervical spine and (any structure innervated by the first three cervical nerves such as the cervical facet joints and muscles of the cervical spine) has the potential to produce a CGH (Alix and Bates 1999). Several studies have found that cervical spine manipulation (CSM) is a valid treatment method for CGH (Haldeman and Dagenais 2001; Biondi 2005; Becker 2010; Chaibi and Russell 2012). It is postulated that manipulation results in inhibition of descending pain pathways to bring about its changes in pain and disability (Chaibi et al. 2015). This mechanism is only theoretical at present as the neurophysiological effect of spinal manipulation and aetiology of CGH is not fully understood and requires further investigation (Alix and Bates 1999; Haldeman and Dagenais 2001; Pickar 2002). The aim of this study is to determine the effect of upper cervical spine manipulation compared to a placebo and a control intervention on neck muscle activity, pain and disability in participants with CGH in order to further understand how manipulation brings about its therapeutic effect in this condition. This study uses a quantitative approach and a randomized, controlled, repeated, pre-test, post-test, experimental design. Participants with CGH will be recruited (N=45) and will be randomly allocated to one of three groups, each group will receive either upper CSM, placebo or a control. Muscle activity and maximum voluntary contraction (MVC) of selected cervical spinal muscles will be taken before an intervention is applied and after an intervention is applied. Pain and disability will be measured during the initial consultation and telephonically 48 hours later. In addition a headache diary will be used by the participants to record the frequency, intensity and duration of their CGH prior to initial consultation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Data Collection
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 24/06/2019
Actual trial start date
Anticipated date of last follow up 24/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
IREC 03219 Durban University of Technology-Institutional Research and Ethics Committee
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Upper cervical spine manipulation single dose Intervention duration is five minutes Participants will receive a CSM applied to the identified facet joint in the upper cervical spine which will be identified by the researcher as having hypomobility (i.e. joint fixation) using motion palpation as explained by (Bergmann and Peterson 2010) . The participants will be in the supine position and receive a low amplitude, high-velocity (HVLA) postero-anterior (PA) directed thrust, at the restricted upper cervical spine segment. The student’s indifferent hand will support the head while the student’s thumb contacts the fixated facet segment and delivers a PA rotational thrust (Bergmann and Peterson 2010). 15
Control Group Placebo single dose Five seconds The participants in the placebo group will be lying supine. Their upper cervical spine will be taken to end range of PA rotation of a fixated cervical facet joint. No HVLA thrust will be applied. The student’s indifferent hand will support the head while the student’s thumb contacts the upper cervical spine segment and takes the joint to end range of PA rotation, this position will be held for 5 seconds, similar to the time taken to deliver a HVLA thrust (Bergmann and Peterson 2010). This will allow the participant to perceive that they are experiencing a treatment 15 Placebo
Control Group Control No dose Five minutes Participants in this group will lie supine for 5 minutes, and will not receive any form of intervention but will be subject to all the measurements as per group A and B. 15 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All participants must be between 18 and 50 years of age. A study by Nilsson (1995) used participants between the ages of 20-60 years. The age criterion concerning this study has been lowered to account for people over the age of 50 being more reliant on pain medication. According to Biondi (2005), the mean age for individuals’ presenting with CGH is 42,9 years of age. • Diagnostic criteria for CGH has been established, with authors’ such as Biondi (2005); Becker (2010); Page (2011); Chaibi et al. (2015), agreeing that CGH arise from dysfunction of the upper cervical spine and neck musculature. • Participants must have a minimum of three diagnostic criteria (listed below) in order to qualify for the study (Sjaastad and Fredriksen 2000). Participant diagnostic criteria will be evaluated by the researcher and clinician on duty.  Unilateral headache without side shift.  Precipitation of headache by neck movement, sustained awkward head positioning or by external pressure on the upper cervical or occipital area on the symptomatic side  Restricted range of motion in the upper cervical spine.  Ipsilateral non-radicular neck, shoulder and arm pain.  Upper cervical spine facet fixation. • Contraindications to CSM determined during the case history, physical examination and cervical regional examination. Examples include: • Vertebral-basilar artery insuffiency. • Atherosclerosis of major vessels. • Metabolic disorders such as osteoporosis, osteomalacia and clotting disorders. • Tumours(lung, thyroid, breast and bone). • Bone infections( Osteomyelitis, tuberculosis) • Trauma(Instability, fractures, severe sprains and strains). • Arthritis( Any arthrtide ). • Neurological complications. • Allergic to the adhesive surface of the EMG electrodes. • Those with primary headaches e.g migraines • Participants who are not willing to have the back of their neck shaved. • Participants currently receiving any physical manipulative treatment for their headache. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 24/05/2019 Durban University of Technology IREC
Ethics Committee Address
Street address City Postal code Country
Ritson Road Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The aim of this study is to determine the effect of upper CSM (the independent variable), compared to a placebo and a control, on the following dependant variables: • Subjective measures: - pain - disability - headache intensity, duration and frequency During the first consultation
Secondary Outcome The aim of this study is to determine the effect of upper CSM (the independent variable), compared to a placebo and a control, on the following dependant variables: • Objective measures: - Muscle activity and maximum voluntary contraction of selected muscles of the cervical spine (the trapezius, sternocleidomastoid (SCM) and posterior cervical muscles) in participants with CGH. During the first consultation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Durban University of Technology Ritson Road Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Durban University of Technology National Research Foundation Ritson Road Durban 4001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Durban University of Technology National Research Foundation Ritson Road Durban 4001 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Laura OConnor Ritson Road Durban 4001 South Africa
Dr Yomika Venketsamy Ritson Road Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator William Brann willbrann7@gmail.com 0786639934 8 Madura Grove
City Postal code Country Position/Affiliation
Durban 4001 South Africa Student Researcher
Role Name Email Phone Street address
Public Enquiries Lavisha Deonarian lavishad@dut.ac.za 0313732375 Ritson Road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Dr Laura OConnor lauraw@dut.ac.za 0848480620 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 online at the Durban University of Technology depository. Raw data will be stored for five years at the DUT Chiropractic Day Clinic. Hard copy will be available at the DUT library. Publication in a peer reviewed DHET journal. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Dissertation will always be available as it will be stored on the DUT online depository. Open Access
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