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.: PACTR201701001979279 Date of Approval: 17/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effectiveness of Graded Motor Imagery on phantom limb pain and function in upper and lower limb amputees: A randomised controlled trial
Official scientific title The effectiveness of Graded Motor Imagery on phantom limb pain and function in upper and lower limb amputees: A randomised controlled trial
Brief summary describing the background and objectives of the trial Background: Diabetic peripheral neuropathy, cardiovascular diseases, infection and trauma are among the leading causes of amputations in patients. Subsequent to amputation, up to 80% of individuals report pain in the missing portion of the amputated limb impeding the patient¿s progress to full recovery and function. Routine physiotherapy has previously been used to manage phantom limb pain (PLP). However, several studies have found that routine physiotherapy might not be targeting the pathology of Phantom limb pain. Neuroimaging studies investigating the pathology of phantom limb pain revealed neuroplastic alterations in various areas of the brain. These neuroplastic alterations are positively correlated to the severity of phantom limb pain in amputees. Graded motor imagery (GMI) is a treatment program which addresses these neuroplastic changes using a sequence of three strategies including laterality recognition, explicit motor imagery and mirror visual feedback. Aim: To investigate the effectiveness of GMI in upper and lower limb amputees with phantom limb pain compared to routine physiotherapy alone. Objectives: -To determine whether GMI decreases PLP on the brief pain inventory (BPI) in upper and lower limb amputees with PLP -To determine whether GMI improves function on the EuroQol (EQ-5D-5L) in upper and lower limb amputees. - To determine whether GMI is more effective than routine physiotherapy in treating upper and lower limb amputees with PLP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Phantom limb pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 24/01/2017
Actual trial start date 24/01/2017
Anticipated date of last follow up 17/10/2017
Actual Last follow-up date 17/10/2017
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
Recruitment status 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 randomized computer-generated list Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Graded motor imagery 2 times fortnightly 6 weeks graded motor imagery is a sequence of treatment strategies including laterality recognition, explicit motor imagery and mirror visual feedback 23 Active-Treatment of Control Group
Control Group Routine Physiotherapy uncontrolled 6 weeks Routine physiotherapy includes any treatment modality used routinely to treat patients with pain. TENS, Ultrasound, exercise and massage are among some of these treatment modalities. 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Amputees with self-reported PLP as assessed on the BPI. Amputations due to Diabetic peripheral neuropathy, cardiovascular diseases, infection and trauma. Trans-humeral and Trans-radial amputations; Elbow and wrist disarticulations, Trans-femoral and Trans-tibial amputations; Knee and Ankle disarticulations. 3 or more months since amputation. Medically stable for a period of 3 months post amputation. Should be 18 years and older. Should be able to understand, write or read either English, isiXhosa or Afrikaans. Double amputees Psychopathological disorders as recorded in their medical folder. Motor Problems screened through cerebellar dysfunction tests (Walker, Hall & Hurst, 1990). Visual impairment such that they are unable to read the information sheet and informed consent forms unaided or with their normal reading glasses. Patients with Nil to mild pain (scored as <3 on the pain severity scale) (Zelman et al., 2005). Associated severe medical problems preventing participation. Previous GMI treatment. 18 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
Yes 16/05/2016 Faculty of Health Sciences Human research Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Phantom limb pain pre-intervention, 6 weeks post intervention, 3 and 6 months at follow-up
Secondary Outcome Quality of Life pre-intervention, 6 weeks post intervention, 3 and 6 months at follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Somerset Hospital portswood road cape town 8001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
PainSA Postnet Suite Houghton 2041 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PainSA postnet suite Houghton 2041 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
n/a n/a n/a n/a
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Katleho Limakatso lmkmax001@myuct.ac.za 0788418510 groote schuur hospital
City Postal code Country Position/Affiliation
Cape Town 7800 South Africa researcher
Role Name Email Phone Street address
Principal Investigator Romy Parker romy.parker@uct.ac.za 021-4066431 Groote Schuur
City Postal code Country Position/Affiliation
Cape Town 7800 South Africa Director of Pain unit: Groote Schuur Hospital
Role Name Email Phone Street address
Public Enquiries Romy Parker romy.parker@uct.ac.za 021-4066431 Main Rd
City Postal code Country Position/Affiliation
Observatory 7935 South Africa Director of Pain unit: Groote Schuur Hospital
Role Name Email Phone Street address
Scientific Enquiries Katleho Limakatso lmkmax001@uct.ac.za 0788418510 Main Rd,
City Postal code Country Position/Affiliation
Observatory 7935 South Africa University of Cape Town
REPORTING
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Result URL Hyperlinks
Changes to trial information