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.: PACTR202002763876912 Date of Approval: 17/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effects of Chiropractic Manipulation, Mobilisation and Exercise Therapy on Knee Joint Position Sense in the Treatment of Osteoarthritis of the Knee.
Official scientific title The Effects of Chiropractic Manipulation, Mobilisation and Exercise Therapy on Knee Joint Position Sense in the Treatment of Osteoarthritis of the Knee.
Brief summary describing the background and objectives of the trial Osteoarthritis (OA) is a degenerative joint disease primarily affecting the weightbearing joints of the body. It is one of the most common chronic diseases, and the most prevalent type of arthritis; responsible for the leading cause of functional impairment, pain and disability in the elderly.The primary aim of the research is to explore what effects the interventions: manipulation, mobilisation and exercise therapy have on the JPS in osteoarthritic knees. The secondary aim of the research will be to evaluate pain, stiffness and physical functioning of the knee joint, using the Western Ontario questionnaire.
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 30/03/2020
Actual trial start date
Anticipated date of last follow up 25/05/2020
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chiropractic manipulation 7 treatments 4 week period Chiropractic manipulation is a manual technique used by chiropractors whereby a high velocity, low amplitude thrust is applied at the end of range of motion to a joint. The aim of the technique is to decrease joint stiffness, free articular adhesions, improve muscle spasm and reposition subluxated joints. Chiropractic manipulation is used to decrease mechanical stress casing pain and modulate pain via ascending and descending neural pathways. 10
Experimental Group Mobilisation 7 treatments 4 week period Mobilisation is the use of repetitive and rhythmic passive movement directed to a joint, without a high velocity thrust, whilst remaining in the physiological range of motion of the joint. The movement can either be a sustained stretch or a low or high amplitude oscillatory movement. There are various mobilisation techniques, which include distraction and non-thrust, which are graded I, II, III, IV, and V: Grade I = Small amplitude movements performed at the beginning of the range of articulation motion. Grade II = large amplitude movements performed within a resistance free part of the articular range of motion. Grade III = large amplitude movements performed at the limit of the articular range of motion. Grade IV = small amplitude movements performed at the end range of articulation motion. Grade V = movements performed into the paraphysiological range of articular motion. 10
Experimental Group Exercise therapy 7 treatments 4 week period • Active range of motion (AROM): knee in mid-flexion to full-extension, and knee in mid-flexion to full-flexion. • Resisted isometric exercises targeting the knee extensors, utilising concentric 90 degree full knee flexion, to full knee extension. Or eccentric contraction from full knee extension, to 90 degree knee flexion. • Stretches: prone quadriceps femoris muscle stretch and supine hamstring muscle stretch. 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
The participants who are to be included in the study must meet the following criteria: 45-80 years old, as this age group represents OA. Male or female. Clinical diagnosis of knee osteoarthritis based on the EULAR guideline Participants are to be excluded from the study if they meet any of the following exclusion criteria: Participant has a history of knee surgery. Participant in which chiropractic manipulation is contraindicated. Participant in which mobilisation techniques are contraindicated. Participant in which exercise therapy is contraindicated. Participant who has consumed or received analgesics, corticosteroid medication, non-steroidal anti-inflammatory drugs or muscle relaxants within a week of starting the trial. Participant who have received physical therapy treatment (physiotherapist, biokineticist and /or chiropractor) within the last week of starting the trial. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 80 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 Possible outcomes of the study could show that the joint position sense in osteoarthritic knees improve, with each of the interventions: manipulation, mobilisation and exercise therapy. 1st, 4th and 7th consultations
Secondary Outcome Possible outcomes of the study could show that the pain, stiffness and physical functioning in osteoarthritic knees improve, with each of the interventions: manipulation, mobilisation and exercise therapy. 1st, 4th and 7th 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 Department 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 Department 55 Beit Street Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Malany Moodley 55 Beit Street Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Malany Moodley mmoodley@uj.ac.za +275596266 55 Beit Street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Supervisor
Role Name Email Phone Street address
Principal Investigator Damian Deacon Havemann damiandhavemann@gmail.com +27843674215 82 Aberdeen Street
City Postal code Country Position/Affiliation
Johannesburg 2092 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 Any person may request the data, but it 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