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.: PACTR201911521746016 Date of Approval: 06/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effectiveness of knee and hip mobilisation versus proprioceptive neuromuscular facilitation in treating patellofemoral pain syndrome in runners
Official scientific title The effectiveness of knee and hip mobilisation versus proprioceptive neuromuscular facilitation in treating patellofemoral pain syndrome in runners
Brief summary describing the background and objectives of the trial Research has shown that Patellofemoral Pain Syndrome (PFPS) is the most common diagnosis in runners presenting with knee pain. It is also evident that between 16 and 25 percent of all running injuries is PFPS. There has been previous research showing that knee manipulation and mobilisation improve symptoms in patients with PFPS, however, there is no research that includes mobilisation of the hip joint in these patients. There is also limited research that suggests Proprioceptive Neuromuscular Facilitation (PNF) can help improve the pain in patients with PFPS. The aim of this research study is to explore the comparative effect between mobilisation of the knee and hip and PNF stretching of muscles associated with the knee and hip, i.e. the quadriceps muscle group, in the treatment of patellofemoral pain syndrome in runners.
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 13/01/2020
Actual trial start date
Anticipated date of last follow up 21/02/2020
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 Knee and hip mobilisation Twice a week 3 weeks The participants in this group will all receive the same method of knee and hip mobilisation provided by the researcher. In order to keep everything constant, a specific number of movements during the mobilisations will be done to each and every member of this group. Even though most of the participants will only have unilateral knee pain, both the left and right knee and hip joints will be treated as it ensures consistency and it is part of the normal chiropractic treatment protocol to treat bilaterally 10
Experimental Group Proprioceptive Neuromuscular Facilitation Twice a week 3 weeks The researcher will apply a technique of PNF called “contract relax” to the participant’s quadriceps muscles. This will be done with the participant on their stomach and will be done one leg at a time. The researcher will bend the leg as far into knee flexion as possible and the participant will then be required to resist against the researcher. Sharman et al. (2006) concluded that anything between 3 to 15 seconds was an appropriate amount of time to hold the PNF stretch, therefore in this research study, the stretch will be held for 10 seconds as this lies in the range of effectiveness of the stretch. This will be repeated three times, each time pushing the leg more into knee flexion than previously. This will target the quadriceps muscle group and will be done of both legs to keep the treatment consistent. 10
Experimental Group Knee and hip mobilisation and proprioceptive neuromuscular facilitation Twice a week 3 weeks The participants in this group will all receive the same method of knee and hip mobilisation provided by the researcher. In order to keep everything constant, a specific number of movements during the mobilisations will be done to each and every member of this group. Even though most of the participants will only have unilateral knee pain, both the left and right knee and hip joints will be treated as it ensures consistency and it is part of the normal chiropractic treatment protocol to treat bilaterally. The researcher will apply a technique of PNF called “contract relax” to the participant’s quadriceps muscles. This will be done with the participant on their stomach and will be done one leg at a time. The researcher will bend the leg as far into knee flexion as possible and the participant will then be required to resist against the researcher. Sharman et al. (2006) concluded that anything between 3 to 15 seconds was an appropriate amount of time to hold the PNF stretch, therefore in this research study, the stretch will be held for 10 seconds as this lies in the range of effectiveness of the stretch. This will be repeated three times, each time pushing the leg more into knee flexion than previously. This will target the quadriceps muscle group and will be done of both legs to keep the treatment consistent. 10
Control Group Not applicable Not applicable Not applicable 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Males and females 18-50 years old. The reason for the minimum age of 18 is so that parental consent is avoided, meaning all participants will be able to sign their own consent form. The reason for the maximum age of 50 is to avoid any degenerative changes that may be present in the knee joint which is a normal part of aging Runners who run a minimum of 10km a week Runners who are symptomatic with Patellofemoral Pain Syndrome for longer than six weeks Be able to be treated six times in a three-week period with an additional 7th time to do the last recording of pain and muscle strength Contra-indications to Chiropractic mobilisation therapy Acute knee pain of less than six weeks Trauma to the knee in last six months (e.g. Falling directly onto knee, motor vehicle accident) Unable to make prescribed schedule of treatments Knee surgery Participants who are currently taking analgesics or anti-inflammatories as this may interfere with the results of the study Participants who are receiving other forms of treatment that may interfere with the results of the study, including manual therapy such as massage and physiotherapy 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 08/11/2019 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 The possible outcomes of this research study could indicate which of the three groups of runners has the most improvement of pain and symptoms and which treatment protocol may be the most successful in treating PFPS. First, fourth and seventh consultations
Secondary Outcome The results of this research study may help guide Chiropractors and other physical therapists as to which protocol may be the most effective. First, fourth and seventh consultations
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The University of Johannesburg 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 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
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
Role Name Email Phone Street address
Principal Investigator Brittany Madden brittanymadden28@gmail.com +27784560262 7 Pygmy Place, Boksburg
City Postal code Country Position/Affiliation
Johannesburg 1459 South Africa Researcher
Role Name Email Phone Street address
Scientific Enquiries Malany Moodley mmoodley@uj.ac.za +27115596266 55 Beit Street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Supervisor
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 it must be requested from the head of department.
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