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.: PACTR201904767474260 Date of Approval: 03/04/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rib manipulations versus ultrasound therapy of rhomboid trigger points and a combination of both protocols in the treatment of inter-scapular pain.
Official scientific title Costovertebral Manipulation versus Ultrasound Therapy of Rhomboid Trigger Points and a Combination thereof in Treating Inter-Scapular Pain.
Brief summary describing the background and objectives of the trial Inter-scapular pain is a common cause of upper back pain. Pain felt in between the shoulders may be attributed to restrictions of the costovertebral joints. Costovertebral joint dysfunction produces a functional disruption between the rib and its two vertebral joints; the costovertebral and costotransversal articulations.Excessive strain, effort or false movements are mechanisms which will cause a dysfunction to occur, thus leading to the initiation of abnormal firing of nociceptive impulses from deep musculoskeletal structures and causing long-lasting local and referred pain. Dysfunctions of the costovertebral joint may lead to formation of myofascial trigger points in surrounding musculature. Myofascial trigger points are defined as focal areas of hyperirritability within skeletal muscles that are sensitive to pressure and active trigger points may refer pain to other regions of the body. Thirty volunteers within the ages of 18-49 years old will be recruited to participate in this study, all of which have to present with inter-scapular pain with active myofascial rhomboid trigger points. Participants will then be randomly allocated into 3 groups of 10 participants respectively. Group 1 will receive chiropractic manipulative therapy to their costovertebral joints, Group 2 will receive ultrasound therapy to rhomboid myofascial trigger points and Group 3 will receive chiropractic manipulative therapy to their costovertebral joints and ultrasound therapy to rhomboid myofascial trigger points. Each participant in all three groups, will receive 6 treatments over a three week period with the seventh and final treatment being a data collection consult only. Subjective data will be obtained from a Numerical Pain Rating Scale as well as a McGill Pain Questionnaire. Objective data will be obtained from Pressure Algometer readings. Subjective and objective data will be collected on the 1st, 4th and 7th visits.
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 Education /Training
Anticipated trial start date 15/04/2019
Actual trial start date
Anticipated date of last follow up 06/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Active, not 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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 0 0 0 0. 0 Active-Treatment of Control Group
Experimental Group Group B twice a week for 3 weeks 10 minutes At the first and follow-up consultations, Group 2 will receive ultrasound therapy to active rhomboid myofascial trigger points. Treatment will take 10 minutes to complete and will occur twice a week for 3 weeks for a total of 6 treatments 10
Experimental Group Group C twice a week for 3 weeks 20 minutes At the first and follow-up consultations, Group 3 will receive a combination of chiropractic manipulative therapy, in the form of Diversified Chiropractic technique, to restricted costovertebral segments, as well as ultrasound therapy to the active trigger points of the rhomboid musculature. Treatment will approximately take 20 minutes to complete 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Female or male participants must be between the ages 18 – 49 to exclude any degenerative diseases that may alter the results of the study. • Participants with active rhomboid myofascial trigger points (Appendix I). Myofascial trigger points are hypersensitive nodules found within taut bands of skeletal musle. Active rhomboid trigger points produce referred pain patterns that begin along the vertebral border of the scapula between the scapula and paraspinal muscles. The pain can also extend over the supraspinatus portion of the scapula. • Participants who suffer with inter-scapular pain due to costovertebral restrictions. Pain is sharp and stabbing in nature and is accentuated by deep inspiration, sneezing and coughing. Costovertebral restrictions can be identified by the absence of normal costovertebral motion and local point tenderness which is determined through motion palpation. • Any contraindications found to spinal manipulative therapy of the thoracic spine and costovertebral joint as determined by history taking, physical examination and cervical spine regional examination. • Patients receiving addition therapy for inter-scapular pain at the time of recruitment and for the duration of the study. Additional treatments of chiropractic or medical background may interfere and obscure data which compromises the studies design. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 49 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 15/05/2019 Faculty of Health Sciences Research Ethics Commitee at the Univeristy of Johannesburg
Ethics Committee Address
Street address City Postal code Country
Sherwell Street, Doornfontein Johanneburg 2094 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Costovertebral manipulation would be an effective treatment approach in patients with inter-scapular pain. 4th treatment
Secondary Outcome Ultraound therapy is an effective treatment approach for inter-scapular pain 4th treatment
Secondary Outcome Both chiropractic costovertebral manipulation and ultrasound therapy is an effective treatment approach for inter-scapular pain 4th treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chiropractic Clinic of the University of Johannesburg 55 Beit Street, Doornfontein Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Super visor linked bursary Sherwell Street, Doornfontein Johannesburg 2094 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Sherwell Street, Doornfontein Johannesburg 2094 South Africa University
COLLABORATORS
Name Street address City Postal code Country
D.M. Landman Sherwell Street, Doornfontein Johannesburg 2094 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kirsten Petrie www.petriekirsten3@gmail.com +27823878498 62 Wilge road, Farramere
City Postal code Country Position/Affiliation
Benoni 1501 South Africa Investigator
Role Name Email Phone Street address
Scientific Enquiries Chris Yelverton chrisy@uj.ac.za +27115596646 Sherwell Street,Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2094 South Africa Head of Chiropractic
Role Name Email Phone Street address
Public Enquiries Irmarie landman dirkiel@uj.ac.za +27115596820 Sherwell Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2049 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I do intend to share individual data. If anyone wants information on the data or wants access to the data, they must request access to the data by contacting the HOD of Chiropractic, Dr Chris Yelverton. Individuals will need to state the reason why are the are requesting the data and he will grant access. Contact Dr Chris Yelerton on: Email: chrisy@uj.ac.za Telephone: +27 11 559 6646 Informed Consent Form Dr Chris Yelverton typically replies within a week. Individuals will need to contact the HOD of Chiropractic, Dr Chris Yelverton in order to request the data. Individual will need to state the reason why are the are requesting the data and he will grant access. Contact Dr Chris Yelerton on: email: chrisy@uj.ac.za telephone: +27 11 559 6646
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