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.: PACTR201910655740780 Date of Approval: 31/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Chiropractic manipulation versus active release technique of gluteus medius muscle and the combination thereof in the treatment of chronic mechanical low back pain
Official scientific title Chiropractic manipulation versus active release technique of gluteus medius muscle and the combination thereof in the treatment of chronic mechanical low back pain
Brief summary describing the background and objectives of the trial Chronic mechanical low back pain can be defined as pain perceived anywhere from the lower margin of the rib cage to the lower gluteal fold with or without referral pain into the lower extremity, which is present for at least three months or more, arising from structures within the lower back such as the joints of the lumbar spine and pelvis, ligaments and the surrounding musculature. Chronic mechanical low back pain is a primary source of dysfunction which may result from co-activation and activity change within the gluteus medius muscle, as well as a dysfunction of the sacroiliac joint , both resulting in the formation of active gluteus medius trigger points and thus low back pain. Chronic mechanical low back pain is a common complaint with an incidence of between 4%-56% of the general population per year and an estimation of 84% of the general population experiencing low back pain at some point in their lives. The objective of this study is to explore the additive effect of active release of the gluteus medius muscle combined with chiropractic manipulation of the sacroiliac joint and if they are as effective as each other in the treatment for the relief of symptoms caused by chronic mechanical low back pain. Chiropractic manipulation and active release have been shown to be effective in the treatment of chronic mechanical low back pain but no research has been done comparing the two.
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 Treatment: Other
Anticipated trial start date 04/02/2020
Actual trial start date
Anticipated date of last follow up 04/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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 Chiropractic manipulation 6 treatments 3 week period A chiropractic manipulation can be defined as a manual procedure that involves a directed thrust to move a joint past the physiological range of motion, without exceeding the anatomical limit. Chiropractic manipulations utilizes a high velocity, low amplitude thrust on a specific joint or body tissue. This procedure increases the range of motion of a joint, breaks down joint adhesions and reduces pain. 10
Experimental Group Active release technique 6 treatments 3 week period Active release technique is a form of manual therapy which is an effective, non-invasive, soft tissue treatment procedure which breaks down scar tissue and adhesions. Active release technique is performed with the application of deep digital pressure , superiorly to inferiorly using thumbs, fingers or the elbow to the identified trigger point site, coupled with active movement of the tissue from a shortened position to a lengthened position or from a lengthened position to a shortened position. 10
Experimental Group Chiropractic manipulation and Active release technique 6 treatments 3 week period A chiropractic manipulation can be defined as a manual procedure that involves a directed thrust to move a joint past the physiological range of motion, without exceeding the anatomical limit. Chiropractic manipulations utilizes a high velocity, low amplitude thrust on a specific joint or body tissue. This procedure increases the range of motion of a joint, breaks down joint adhesions and reduces pain. Active release technique is a form of manual therapy which is an effective, non-invasive, soft tissue treatment procedure which breaks down scar tissue and adhesions. Active release technique is performed with the application of deep digital pressure , superiorly to inferiorly using thumbs, fingers or the elbow to the identified trigger point site, coupled with active movement of the tissue from a shortened position to a lengthened position or from a lengthened position to a shortened position. 10
Control Group not applicable not applicable not applicable not applicable 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included in the study, potential participants must meet the following criteria: Present with chronic mechanical low back pain for more than 3 months with pain reported anywhere from the lower margin of the rib cage to the lower gluteal fold which may occur with or without referral into the lower extremity. Active trigger points identified in the gluteus medius muscle upon flat palpation with the following diagnostic criteria: The presence of a hyper-irritable taut band within the gluteus medius muscle, palpation tenderness or an involuntary contraction of the muscle in response to flat palpation, a characteristic referral pain presenting medial towards the sacrum, superiorly along the iliac crest and throughout the buttock with pressure application to the gluteus medius muscle. Did not participate in activities or have an occupation that included vigorous activity that may perpetuate or aggravate the existing problem. Male or female participants between ages of 18-40 years old to exclude any degenerative diseases that may alter the study results. Have an initial pain score of at least 3/10 on the Visual Analogue Scale (VAS). On examination, it must be confirmed, using Gillet’s motion palpation technique that the participants have a restricted sacroiliac joint . Potential participants are excluded if : Participants present with a possibility of a serious spinal or pathologic disorder that may alter the study results. Participants have a history of spinal surgery. Participants who present with contra-indications to chiropractic manipulative therapy of the sacroiliac joint as determined by history taking, physical examination and lumbar spine regional examination. Participants who have received any form of treatment to the lumbar spine, including the sacroiliac joint or active gluteus medius trigger points in the last three months, prior to the study, including manual therapy such as massage, physiotherapy and medications such as analgesics, muscle relaxants or non-steroidal anti-inflammatory drugs. Participants who present with contra-indications to soft tissue therapies such as active release technique. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 08/11/2019 University of Johannesburg Health Science Ethics Comittee
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 Possible outcomes of this study could show an additive effect of active release technique of the gluteus medius muscle with chiropractic manipulation of the sacroiliac joint and if they are as effective as each other in the treatment for the relief of symptoms caused by chronic mechanical low back pain. first, fourth and seventh consultations
Secondary Outcome If both treatments are as effective as each other in the treatment for the relief of symptoms caused by chronic mechanical low back pain. first, fourth and seventh consultations.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Doornfontein campus 55 Beit street Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg Health Science Ethics Committee 55 Beit street Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Health Science Ethics Committee 55 Beit street Johannesburg 2018 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr D.M Landman 55 Beit street Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Irmarie Landman dirkiel@uj.ac.za +27844550303 55 Beit street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa supervisor
Role Name Email Phone Street address
Principal Investigator Keagan Schut keagan.chay@gmail.com 0799389363 55 beit street
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Researcher
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 can request it but must be requested from the head of department(HOD)
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