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.: PACTR201902696585440 Date of Approval: 20/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of instrument assisted soft tissue mobilization versus kinesiotape on pain intensity, pain pressure threshold, range of motion and functional disability.
Official scientific title EFFECT OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION VERSUS KINESIOTAPE ON CHRONIC MECHANICAL LOW BACK PAIN
Brief summary describing the background and objectives of the trial Chronic Mechanical Low Back Pain (CMLBP) is pain lasting over (3) months. About 80% of the adults are affected by non-specific LBP or Mechanical Low Back Pain (MLBP) at least once in their life time. Instrument Assisted Soft Tissue Mobilization (IASTM) is a process in which the clinician uses a set of hand-held instruments to break down the scar tissue and fascial restrictions in soft tissues (muscles, ligaments, tendons, fascia, and nerves). Kinesiotape (KT) is thin adhesive tape and has elastic mechanical properties, similar to skin to allow normal range of motion. It was designed to mimic the qualities of human skin. Subjects will randomly be divided into three equal groups; Group A will receive conventional treatment, Group B will receive IASTM and conventional treatment and Group C will receive Kinesiotape and conventional treatment. Assessment procedures a. Visual Analogue Scale (VAS) will be used to measure the pain intensity level. b. Pressure Algometer will be used to measure the pain threshold. c. Inclinometer will be used to measure ROM of the lumbar spine. d. Oswestry low back pain disability questionnaire will be used to measure functional disability index. Treatment procedures Group A (Control Group): Conventional treatment a- Strengthening Exercises: High repetition with low load exercise, for 3 sets, each set 10 times. - Pelvic Tilt - Back strength exercises - Abdominal exercises b. Stretching exercises for three times, each stretch time is 30 seconds. - Knee to chest - Ilipsoas Stretch Group B 1- Conventional treatment 2- Instrument assisted soft tissue mobilization will be applied for 2 times per week for 4 weeks. Group C 1- Conventional treatment 2-Kinesiotape will be applied for 2 times per week for 4 weeks. This study will be conducted to compare the effect of instrument assisted soft tissue mobilization and kinesiotape in patients with chronic mechanical low back pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) no
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2019
Actual trial start date
Anticipated date of last follow up 01/07/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group stretching and strengthening exercises Stretching exercises for three times, each stretch time is 30 seconds. Strengthening Exercises: High repetition with low load exercise, for 3 sets, each set 10 times. 2 times per week for one month stretching exercises for iliopsoas from side lying position, back extensors from supine position( knee to chest) strengthening exercises for abdominal muscles from crook lying with arms side and raise the head and shoulders with arms forward, back strengthening from prone position and arms side then raise the head and shoulders, pelvic rocking (posterior pelvic tilt and anterior pelvic tilt. 15 Active-Treatment of Control Group
Experimental Group instrument assisted soft tissue mobilization from 40 to 120 seconds for each side of low back 2 times per week one month Before applying IASTM, the conventional treatment will be applied. The IASTM group during 4 weeks (two sessions per week with 30° to 60° for 40–120 sec): posterior fascia and sacrum IASTM will be applied from prone position. The instrument will be rubbed on each subject 30 times for 60 seconds. The posterior fascia IASTM will be microtrauma to stimulate lumbar posterior muscle erector spinae (iliocostalis, longissimus), and multifidus. It will be applied for approximately 20-seconds in a direction parallel to the muscle fibers being treated with the instrument at a 45° angle. Following immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45° angle for additional 20-seconds, resulting in a total treatment time of approximately 40 seconds. At the end of session, ice pack will be applied on the back 15
Experimental Group kinesiotape 2 times per week one month Before applying kinesiotape, the conventional treatment will be applied. Then, the two I-Tapes will be applied from the origin of the lumbar erector spinae (iliocostalis lumborum) to its insertion. It will be positioned on the paravertebral muscles (bilaterally) parallel to the spinous processes of the lumbar spine. The area to be treated will be cleaned, free of hair and the tape was measured while the lumbar spine will be flexed to the maximum. Firstly, the first 4-5 cm of tape will be carefully removed from its paper backing and the initial anchor point will be applied to the sacral region (at the S1) at the level of PSIS without tension (zero %). After that, the participant will be asked to maximum flex the trunk, the paper backing of the tape will be removed, except for the final 4-5 cm. it will be applied in the shape of an “I” over the skin in the paravertebral region up to the 12th thoracic vertebra at 10-15% tension Finally the final anchor point will be fixed directly above the T12 without tension (zero %). The same procedure will be then applied to the other side. The tape will be rubbed by hand several times to warm the adhesive film to achieve adhesion 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Each patient has the diagnosis of chronic mechanical low back pain for more than 3 months due to chronic lumbar sprain, strain, postural strain due to prolonged sitting or standing, physically inactive or physical exercising less than one hour per week. 2. Both genders will be included with Age range between (18- 45 years old) 3. Body mass index (BMI) is (< 30 kg/m²) 1) Neurological, infectious, and systemic diseases, including cerebrovascular disease, spinal cord disease, ankylosing spondylitis, cancer, rheumatologic disorders, spinal stenosis, and other chronic diseases that cause long-term immobilization. 2) Patients who have radicular pain due to nerve root involvement. 3) Patients with osteoporosis or lumbar compression fracture. 4) Patients have spondylolisthesis and spondylosis. 5) Spinal deformities as scoliosis, and kyphosis. 6) Previous spinal surgery. 7) Patients have cardiac pacemakers. 8) Disruption of the major ligaments: supraspinous, interspinous or longitudinal. 9) Obesity with BMI > 30 kg/m². Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 45 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 12/03/2019 Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7th Ahmed El-Zayat street in front of Ben El-Sarayat Trafficm Dokki Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity before and after treatment
Secondary Outcome pain pressure threshold before and after treatment
Primary Outcome range of motion before and after treatment
Secondary Outcome functional disability before and after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mennat allah mohammed abdellatif 7th ahmed el-zayat in front of ben el-sarayat traffic giza 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Egyptian ministry of health Al Inshaa Wa Al Munirah, El-Sayeda Zainab, Cairo Governorate Cairo 11516 Egypt educational and treatment
COLLABORATORS
Name Street address City Postal code Country
Prof.Dr. Haytham Mohamed Elhafez 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Haytham Elhafez elhafez@yahoo.com 00201001909630 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt professor of Physical Therapy
Role Name Email Phone Street address
Principal Investigator Haytham Elhafez elhafez@yahoo.com 00201001909630 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Mennat Allah Mohammed mannosh.mohammed1@gmail.com 00201111488032 7th Ahmed El-Zayat street in front of Ben El-Sarayat Traffic, Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt Physical Therapist in Egyptien Ministry of Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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