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.: PACTR201906639063537 Date of Approval: 19/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of spinal manipulative therapy and ischaemic compression versus muscle energy technique in chronic nonspecific neck pain.
Official scientific title The effect of spinal manipulative therapy and ischaemic compression versus muscle energy technique in chronic nonspecific neck pain.
Brief summary describing the background and objectives of the trial Chronic nonspecific neck pain is described as chronic neck pain with no specific disease rooted to be the underlying cause of the complaint (Bertozzi et al. 2013). The pain experienced has been found to be caused by myofascial trigger points (MFTPs) (Simons, Travell and Simons 1999). Various conservative treatment options are available for chronic nonspecific neck pain and can be categorised into manual and physical therapy (Haldeman, Carroll and Cassidy 2010). Ischaemic compression is used to remove tension and tenderness associated with MFTPs (Simons, Travell and Simons 1999). Spinal manipulation has been shown to relieve pain, reduce disability and increase active range of motion (Hoving et al. 2002; Haldeman, Carroll and Cassidy 2010). Another form of physical therapy which is commonly used is muscle energy technique (MET) (Greenman 1996). Although MET has shown to be an effective manual therapy, it is currently understudied and not frequently compared to other manual therapies (de las Penas, Cleland and Huijbregts 2011). This study will be quantitative in nature using a single blinded compcomparative clinical trial. A sample of 40 participants will be used for this study. They are randomly allocated into two groups of 20 each. Each participant will undergo four consultations over a period of two and a half weeks, with the fourth consultation for measurements only. The subjective and objective measurements will be taken before the three treatments at the first three visits. The fourth visit will be purely for subjective and objective measurements. Subjective measurements include numerical pain rating scale and a neck disability index questionnaire; objective measurements will be done using an algometer and a CROM-II goniometer to measure cervical spine range of motion (ROM).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IREC
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 01/08/2019
Actual trial start date
Anticipated date of last follow up 30/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
IREC 07919 Durban University of Technology IREC
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 a randomization table created by a computer software program 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 manipulation and Ischaemic compression Single dose of each per consultation. 30 minutes Spinal manipulation involves a high velocity low amplitude thrust to a joint restriction. Ischaemic compression can be described as the use of slowly increasing, non-painful pressure over a MFTP until a resistance is felt at the tissue barrier, contact will remain constant until the tissue barrier releases, and pressure is increased to reach a new barrier to remove tension and tenderness associated with MFTPs. 20
Control Group Muscle energy technique Single dosage. 20 minutes Muscle energy technique is performed with the patient’s muscle voluntarily contracting in a precise direction, at varying degrees of intensity and against a counter-force that is distinctly implemented by the manual therapist. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Participants must be between the ages of 20 and 50 years. With respect to age, individuals in their mature years (31-50) are more likely to suffer from MPS (Simons, Travell and Simons 1999). However, the condition does occur in younger individuals. These statistics would support the current age group limits set for this study. This will be applied during the telephonic screening. • Signed consent (available in English and isiZulu) for involvement in the study will be required for inclusion. • Non-specific neck pain (≥12 weeks duration) of at least 4 and a maximum of 6 on an 11-point Numerical Pain Rating Scale 101 (NRS 101) (to maintain sample homogeneity) (Gemmell, Miller and Nordstrom 2008) with associated myofascial pain syndrome of the upper trapezius. • Participants diagnosed with active trigger points one and/or two in the trapezius muscle that shows the characteristics as outlined by Travell, Simons and Simons, (1999), including:  Taut band of muscle fibers palpated by snapping or rolling the muscle under the finger.  Tender nodule palpated within this taut band of muscle fibers.  Local twitch response of the taut band fibers to snapping palpation.  Pain reference to the reference zone specific to the muscle involved. This will be applied during the initial consultation. Any participant for whom spinal manipulation is contraindicated as described by (Gatterman 1990) will be excluded from the study. These include: Vertebral artery insufficiency syndrome, History of positional vertigo, transient ischaemic attack, or severe arteriosclerosis, Uncontrolled hyper or hypotension , Severe cardiovascular disease and diabetes, Patients on medications such as anticoagulants that could predispose to vascular insult, Rheumatoid Arthritis or other arthritides, Vertebral malignancy, spondylolisthesis or recent traumatic injuries (whiplash), Presence of neurological symptoms such as chronic headaches, visual disturbances, drop attacks, transient weakness in the legs and family history of stroke, Participants can be excluded from the study even after case history, physical and regional examinations should contra-indications only then be found or noted. Participants who displayed any of the following contra-indications to myofascial manipulation therapy as recommended by Nook (1998): Vascular compromise; Use of anticoagulants and haemophiliacs; Severe diabetes with associated peripheral neuropathy; Sensory deficit; and Infection which can either be local or systemic. Participants who display any contra-indications of MET (including but not limited to): tissue fragility, hypermobility, myositis, tumours (Chaitow and Crenshaw 2006; Fernández-de-las-Peñas, Cleland and Huijbregts 2011). Participants who are any oral non-steroidal anti-inflammatory drug would be required to participate in a three day wash out period prior to entering the study (Poul et al. 1993). Participants who exhibit signs of fibromyalgia syndrome (Schneider 1996). Participants refusing to sign the informed consent form (Appendix F). This will be applied prior to the initial consultation. Participants suffering from neck or shoulder pain caused by trigger points other those included in the study. This will be applied during the initial consultation. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 03/06/2019 Durban University of Technology IREC
Ethics Committee Address
Street address City Postal code Country
Berwyn court Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain rating according to the Numerical pain rating scale. At each consultation, all four.
Secondary Outcome Neck disability via the CMCC Neck disability index At each consultation, all four.
Primary Outcome Pressure pain threshold via the Algometer measurements. At each consultation, all four.
Primary Outcome Cervical range of motion via the Goniometer instrument. At each consultation, all four.
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 Ritson road Durban 4001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Research Fund Ritson road Durban 4001 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr. Desiree Varatharajullu Ritson road Durban 4001 South Africa
Dr Ashura Abdul Rasheed Ritson Road Durban 4001 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tyron Dicks dickstyron@gmail.com 0766368684 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 Lecturer
Role Name Email Phone Street address
Scientific Enquiries Desiree Varatharajullu desireev@dut.ac.za 0782220942 Ritson road
City Postal code Country Position/Affiliation
Durban 4001 South Africa Research 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 repository. Hard copy of dissertation at the Durban University of Technology Library. Raw data stored at Durban University of Technology Chiropractic Clinic reception for five years. Publication of article from dissertation in accredited DHET journal. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Access to dissertation will be constant through online availability in accredited journals. 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