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.: PACTR201812840142310 Date of Approval: 21/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Spinal Manipulation Compared with Spinal Mobilization for Lumbar Disc Herniation with Radiculopathy: A Randomized Clinical Trial with 1 Year Follow-up
Official scientific title Effects of Spinal Manipulation Compared with Spinal Mobilization for Lumbar Disc Herniation with Radiculopathy: A Randomized Clinical Trial with 1 Year Follow-up
Brief summary describing the background and objectives of the trial Studies [26, 47] demonstrate that most patients with LDHR have signs of joint dysfunction at the level and on the sides of the dysfunction and thus, they have indications for manipulation at the involved level and there are overwhelming evidence [48-60] that patients with lumbar radiculopathy can be treated with manipulation without adverse reaction beyond the occasional short-term increase in pain. In spite of this, LDHR particularly in the acute stage can be very volatile with the pain easily provoked in response to spinal manipulation and some authors [61-69] have even gone as far as to dissuade the use of spinal manipulation in the presence of neurological symptoms due to the possible risk of increased herniation or a threat to causing cauda equine syndrome (CES) [70-73] and disc herniation is the leading cause of claims against chiropractors [74]. Thankfully, a systematic review and risk assessment of the literature [75] revealed the risk of spinal manipulation causing a clinically worsened disk herniation or CES in a patient presenting with LDH from published data to be less than 1 in 3.7 million which advocated the apparent safety of spinal manipulation. On the other hand, spinal mobilization may be useful in the management of LDHR as it is less likely to cause flare-up of pain in many cases compared to spinal manipulation and many studies [76-83 63, 64] have reported its therapeutic efficacy. However, despite the conflicting literatures reporting the therapeutic efficacy of spinal manipulation and mobilization individually, extensive literature search revealed limited evidence that compared the efficacy of both techniques in individuals with LDHR. In addition, patients’ safety should always be prioritized in an attempt to administer any therapeutic intervention. Therefore the identification of groups of patients with LDHR who respond favorably to either manipulation or mobilization has been deemed a research priority.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SMT Vs MOB for DHR
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 04/09/2019
Actual trial start date 04/09/2019
Anticipated date of last follow up 15/09/2021
Actual Last follow-up date 15/09/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Spinal manipulation 2 times in a week For 3 months High Velocity Low Amplitude spinal manipulation will be given. In addition, each participant will receive progressive inhibition of neuromuscular structures and therapeutic exercises in form of neuromobilization, lumbar stabilization and stretching exercises as adjunct therapies. 20
Control Group spinal mobilisation 2 times in week for 3 months spinal mobilization with leg movement will be give. In addition, each participant will receive progressive inhibition of neuromuscular structures and therapeutic exercises in form of neuromobilization, lumbar stabilization and stretching exercises as adjunct therapies. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Criteria for inclusion will be; patients with age of 18-65 years having unilateral radiculopathy and pain in distribution of sciatic nerve. Pain will be accepted as evidence of L5 root compression when distributed to anterolateral aspect of calf and to dorsum of foot and as evidence to S1 root compression when distributed to posterior aspect of calf extending to the heel and lateral aspect of the foot. If pain did not extend below the ankle, at least one additional neurological sign will be demanded for the patient to be included. These signs are; painful passive knee flexion, weakness of resisted hip flexion and resisted knee extension and absence or sluggishness of knee jerk reflex for L2/L3 nerve roots, hypoesthesia in the dorsum of the foot, weakness of dorsiflexion of foot or first toe and impaired medial hamstring reflex for the L4/L5 nerve roots, hypoesthesia at the lateral aspect of the foot, weakness of the plantar flexion of the foot or first toe, impaired Achilles tendon reflex and painless weakness on resisted eversion for the L5/S1 verve roots, gluteal mass wasting and weakness on tip toeing on the affected leg for the S1/S2 verve roots. The exclusion criteria will be; subjects diagnosed with dementia or other cognitive impairment, subjects diagnosed with claudication, inflammatory or other specific disorders of spine such as ankylosing spondylitis, vertebral collapse, rheumatoid arthritis, stenosis, spondylolisthesis, osteoporosis, previous spinal surgery, a known pregnancy, bilateral radiculopathy, and presence of red flags (History of significant trauma, cancer, constitutional symptoms; fever, malaise, weight loss, recent infection, bladder and/or bowel dysfunction). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),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
No 02/01/2019 FEDERAL MEDICAL CENTER NGURU
Ethics Committee Address
Street address City Postal code Country
MACHINA ROAD Yobe 630101 Nigeria
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 10/01/2019 FEDERAL MEDICAL CENTER NGURU YOBE STATE NIGERIA
Ethics Committee Address
Street address City Postal code Country
MACHINA ROAD Nguru 630101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Back pain, Leg pain, Disability, sciatica bothersomeness, sciatica frequency AT BASELINE, AT 12 WEEKS, AT 3-MONTH FOLLOW-UP, AT 9-MONTH FOLLOW-UP
Secondary Outcome Functional mobility, Quality of life, Global effect AT BASELINE, AT 12 WEEKS, AT 3-MONTH FOLLOW-UP, AT 9-MONTH FOLLOW-UP
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTER NGURU YOBE STATE MACHINA ROAD YOBE STATE 630101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Musa Sani Danazumi Machina Road Yobe 630101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor FEDERAL MEDICAL CENTER NGURU MACHINA ROAD YOBE 630101 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Mubarak Abubakar Falke Machina road, Nguru town Yobe 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MUSA SANI DANAZUMI musadanazumisani@mail.com +2348145123496 Machina road, Nguru town
City Postal code Country Position/Affiliation
Yobe 630101 Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries MUBARAK FALKE ABUBAKAR abumuhibbat17@gmail.com +2347030433882 Machina road, Nguru town
City Postal code Country Position/Affiliation
Yobe 630101 Nigeria principal therapist
Role Name Email Phone Street address
Scientific Enquiries SHEHU USMAN IBRAHIM usmanik28@gmail.com +2348037019137 Machina road, Nguru town
City Postal code Country Position/Affiliation
Yobe 630101 Nigeria principal therapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will include each participant's outcome scores (both primary and secondary. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after completion of the study Through publication
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