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.: PACTR202002862223572 Date of Approval: 20/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Spinal Manipulative Therapy Versus Core Strengthening in Chronic Mechanical Lower Back Pain in Horse Riders
Official scientific title Effect of Spinal Manipulative Therapy Versus Core Strengthening in Chronic Mechanical Lower Back Pain in Horse Riders
Brief summary describing the background and objectives of the trial To explore the comparative effects of spinal manipulation and core strengthening exercises on the lower back pain of horse riders. It will explore the effectiveness of the two different methods of intervention and to establish whether a combination of the two therapies will have an additive effect on the outcome.
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 Spinal Manipulative Therapy and Core strengthening
Anticipated trial start date 18/04/2020
Actual trial start date
Anticipated date of last follow up 23/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet 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 Adjustment Group 1 treatment per week 6 weeks Spinal Manipulative Therapy to a lumbar spine vertebral segment predetermined by myofascial trigger point of quadratus lumborum muscle. Spinal manipulative therapy can be described as a high amplitude low velocity thrust administered to a specific spinal segment by the hands of the manipulator. The procedure is aimed at moving the joint past the physiological range of motion but not exceeding the anatomical range of motion. 10
Control Group Core Strengthening Group 3 times per week 6 weeks Side Plank performed be starting on the side with feet together and one forearm directly below the shoulder. Contract the abdominals and raise hips until the body is in a straight line from head to feet. Hold the position without letting hips drop for 8 seconds for each set, then repeat on the other side, 10 repetitions on each side. Curl up is performed by raising the head and the upper shoulders off of the floor. The motion takes place in the thoracic spine- not the lumbar or cervical spine. The hands may be placed beneath the lumbar spine to main neutral spine position. Hold posture for 8 seconds for 10 repetitions. Bird dog is performed by starting from kneeling position on hands and knees. One arm is lifted to the shoulder level arm horizontal to ground. Contra-lateral leg is raised to horizontal to the ground position, posture is held for 8 seconds for 10 repetitions. 10 Active-Treatment of Control Group
Experimental Group Combination Group 1 treatment per week and 3 exercise regimes per week 6 weeks Side Plank performed be starting on the side with feet together and one forearm directly below the shoulder. Contract the abdominals and raise hips until the body is in a straight line from head to feet. Hold the position without letting hips drop for 8 seconds for each set, then repeat on the other side, 10 repetitions on each side. Curl up is performed by raising the head and the upper shoulders off of the floor. The motion takes place in the thoracic spine- not the lumbar or cervical spine. The hands may be placed beneath the lumbar spine to main neutral spine position. Hold posture for 8 seconds for 10 repetitions. Bird dog is performed by starting from kneeling position on hands and knees. One arm is lifted to the shoulder level arm horizontal to ground. Contra-lateral leg is raised to horizontal to the ground position, posture is held for 8 seconds for 10 repetitions. Each participant will also receive weekly spinal manipulative therapy.Spinal Manipulative Therapy to a lumbar spine vertebral segment predetermined by myofascial trigger point of quadratus lumborum muscle. Spinal manipulative therapy can be described as a high amplitude low velocity thrust administered to a specific spinal segment by the hands of the manipulator. The procedure is aimed at moving the joint past the physiological range of motion but not exceeding the anatomical range of motion. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants aged 18-50. Participants Symptomatic with chronic lower back pain. Participants with low back pain limited to somatic referred pain/ non-radicular pain limited to above the knee only All contra-indications for spinal manipulative therapy to be established by history taking, physical examination and lumbar spine regional examination. Participants on anti-inflammatory medications and analgesics. Participants receiving other intervention therapies. Exclusion criteria listed by the North American Spine Society for the diagnosis and treatment of low back pain. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 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
No 21/02/2020 University of Johannesburg Health Science Ethics Committee
Ethics Committee Address
Street address City Postal code Country
55 Beit Street Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To explore the therapeutic effects of chiropractic treatment in sports specific musculoskeletal conditions and to assert what the possible effect of combination therapy is for the lower back pain in horse riders. 1st, 4th and 7th consultation
Secondary Outcome The research may have value for future studies After dissertation publication
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg 55 Beit street Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University Of Johannesburg 55 Beit Treet Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg 55 Beit Street Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Fatima Ismail 55 Beit Street Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Antalaya Botha layabotha@gmail.com +27732821387 62 Dann Road
City Postal code Country Position/Affiliation
Kempton Park 1630 South Africa Researcher
Role Name Email Phone Street address
Scientific Enquiries Fatima Ismail fismail@uj.ac.za +27711931745 55 Beit Street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Supervisor
Role Name Email Phone Street address
Public Enquiries Chris Yelverton chrisy@uj.ac.za +27115596646 55 Beit Street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Head of Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data capturing sheet Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 Years Anyone may request but must be requested from Head of Department of Chiropractic
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