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.: PACTR202209825345097 Date of Approval: 02/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of self management protocol in the management of Lumbar radiculopathy
Official scientific title Comparative effectiveness of self management over clinician guided management techniques in the management of lumbar radiculopathy.
Brief summary describing the background and objectives of the trial Lumbar radiculopathy (LR) is a sub type of low back pain with symptoms extending to one or both lower limbs and consequent more pains and complications that may lead to back surgery. The prevalence of lumbar radiculopathy is seen to be increasing more in the developing countries including Nigeria (Park et al., 2016). Due to the persistent pain and disability of the condition, patients with LR are exposed to recurrent increased cost of management of their symptoms. This place more burden on patients and healthcare resources with consequent economic and social impacts. Although, to reduce the cost of managing LR, patients are taught and encourage to take control of their treatment by themselves. This is done through self management technique. Self management Technique(SMT) is a support given to the patients by the therapist in order to reduce burden on patients and therapist involved. The effect of SMT will help reduce number of hospital visits, work absenteeism and risk of disease progression , leading to reduce cost and increased coping strategy to the patient. Therefore the objective of this study is to design a standardised SMT protocol and compare its effectiveness over clinician guided management technique(CMG) in the management of lumbar radiculopathy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SMAT Protocol
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/07/2022
Actual trial start date 15/07/2022
Anticipated date of last follow up 20/12/2022
Actual Last follow-up date 26/10/2022
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 90
Recruitment status Active, not 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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Clinician guided management twice a week 8 weeks Core stabilization will be performed with patient in crook lying position using manual palpatory technique. Set of 10 repetitions will be performed. Isometric back exercises will also be performed in a set of 10 repetitions each. Nerve Flossing Technique (NFT) is a form of neurodynamic mobilization and will be performed actively by the subjects sitting on the chair or plinth. Subjects will be instructed to bend knee backwards under the plinth and simultaneously move the head downwards. Then the subjects will be instructed to straighten out the leg on the affected side and simultaneously move the head backward as if looking at ceiling. The subjects will be instructed to lift the leg out and up in front until she/he experiences pain and should not push beyond that point .As the nerve became less sensitive; the stretching effect will be increased by instructing the subjects to bring foot and toes in upward direction. NFT exercise will be done in 5 sets of 15 repetitions with 1 minute rest in between sets (Hingarajia et al, 2019) 45 Active-Treatment of Control Group
Experimental Group Self Management Technique Twice a week 8 weeks Core stabilization will be performed with patient in crook lying position using manual palpatory technique. Set of 10 repetitions will be performed. Isometric back exercises will also be performed in a set of 10 repetitions each. Nerve Flossing Technique (NFT) is a form of neurodynamic mobilization and will be performed actively by the subjects sitting on the chair or plinth. Subjects will be instructed to bend knee backwards under the plinth and simultaneously move the head downwards. Then the subjects will be instructed to straighten out the leg on the affected side and simultaneously move the head backward as if looking at ceiling. The subjects will be instructed to lift the leg out and up in front until she/he experiences pain and should not push beyond that point .As the nerve became less sensitive; the stretching effect will be increased by instructing the subjects to bring foot and toes in upward direction. NFT exercise will be done in 5 sets of 15 repetitions with 1 minute rest in between sets (Hingarajia et al, 2019) 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants are those with complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report. Age at least 18 to 65 years. At least one of the following signs of nerve root compression: Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees) Sensory impairment to pinprick on the ipsilateral lower extremity Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity. Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.) Evidence of central nervous system involvement, including symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski) Patient reports of complete absence of low back and leg symptoms when seated Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain Current pregnancy Inability to comply with the treatment schedule Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 10/06/2022 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2nd and 3rd floor, Post office Road, Kano Kano 3066 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, Disability, Quality of life At the beginning of the trial and at the end of the trial
Secondary Outcome Pain and fear avoidance belief At the beginning and at the end of data collection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital No 2 Zaria Road, Kano Kano PMB 3452 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Maryam Abdulhadi Department of Physiotherapy, Aminu Kano Teaching Hospital, Kano Kano PMB 3452 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maryam Abdulhadi Department of Physiotherapy, Aminu Kano Teaching Hospital, Kano Kano PMB 3452 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Bashir Bello Department of Physiotherapy, Faculty of Allied health Sciences, College of health Sciences, Bayero University Kano Kano PMB 3011 Nigeria
Kano State Hospital Management Board Post office Road, Kano Kano PMB 12345 Nigeria
Aminu Kano Teaching Hospital Kano No 2 Zaria Road, Kano Kano PMB 3452 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maryam Abdulhadi mamameenah2011@yahoo.com 2348037399903 Plot 2 Zoo Road Opposite Total Filling Station, Kano
City Postal code Country Position/Affiliation
Kano 3452 Nigeria Post graduate Student
Role Name Email Phone Street address
Public Enquiries Maryam Abdulhadi mamameenah2011@yahoo.com 2348037399903 Plot 2 Zoo Road Opposite Total filling station, Kano
City Postal code Country Position/Affiliation
Kano 3452 Nigeria Post graduate student
Role Name Email Phone Street address
Scientific Enquiries Bashir Bello nurubash@yahoo.com 2348037019137 Darmanawa
City Postal code Country Position/Affiliation
Kano 3452 Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the result of this study will be made available to the public via BUK repository Clinical Study Report,Informed Consent Form,Study Protocol immediately after the data analysis Not for profit making
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