Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112720946276 Date of Approval: 24/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE EFFECT OF ADDITION OF HIP STRENGTHENING EXERCISES TO LUMBAR STABILIZING EXERCISES ON GAIT FOR THE TREATMENT OF NON-SPECIFIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL
Official scientific title THE EFFECT OF ADDITION OF HIP STRENGTHENING EXERCISES TO LUMBAR STABILIZING EXERCISES ON GAIT FOR THE TREATMENT OF NON-SPECIFIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Chronic nonspecific low back pain results in both physical and psychological deconditioning that traps the patient in a wrong circle described by decreased physical performance, exacerbated nociceptive sensations, impaired social functioning, work disability, and depression (Demoulin et al., 2006). There is evidence that persisting LBP influences lumbar motor control (Luomajokiet al., 2008), alters brain function and structure (Wand et al., 2011), changes lumbar tactile acuity (Luomajoki and Moseley, 2011), decreases spinal mobility (Hodges et al., 2009)and compromises postural control (Mok et al., 2010). Nonspecific chronic LBP results from a variety of factors which can interact with each other. These include biomechanical, psychosocial, physical, environmental, genetic and cultural factors, also it results from a loss of lumbar spinal stability (Lee and Kim, 2015). If a state of lumbar instability is not appropriately resolved chronic recurrent LBP might occur (Macdonald et al., 2009). There is also a close association between lumbar pain and the muscles of the hip also the muscle of the waist significantly and positively have an impact on low back pain. Hip-extensor strength and hip-adductor endurance might contribute to pain in the lumbar area (Jeong U.C. et al., 2015). Hip abductor weakness is common within patients with low back pain (Cooper N.A. et al., 2016). Purpose of study: To investigate the efficacy of two exercise programs in reducing pain and disability for individuals with non-specific low back pain and to examine the underlying mechanical factors related to pain and disability for individuals with NSLBP. Also to assess the impact of strength exercises targeted at the hip had on pain and function and changes in spatio-temporal gait parameters in individuals with NSLBP through valid and reliable 2D free software.
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 22/11/2021
Actual trial start date 22/11/2021
Anticipated date of last follow up 22/10/2022
Actual Last follow-up date 22/10/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group only lumbar stabilizing exercises All patients will participate for 30 min, 3 times/week, over a 6 week period 1. Abdominal hollowing The patient lies down with his/her knees in 90º flexion. With the lower back and pelvis aligned. Then forcefully contracts his/her abdominal muscles to increase the internal pressure and holds the contraction also this phase can be done from sitting or kneeling positions. Fig.6. Abdominal hollowing. Fig.7. Abdominal hollowing in sitting. Fig.8.Abdominal hollowing in four point kneeling. 2. Side Bridge The patient’s left forearm is placed on the ground below the shoulder. The participant lifts his/her body to form a side bridge, or "plank" position. This position is maintained using the forearm and foot to support the body. The exercise is repeated for the right side. Fig.9. lateral bridge 3. Supine Extension Bridge The patient adopts a hook-lying position with both feet below the knees. The patient slowly lifts his/her hips until their knees and shoulders are aligned in a straight line, taking care to support the weight of the body with shoulders rather than neck. After holding this static position, the patient slowly lowers his/her hips to the ground. Fig.10. bridge in supine position 4. Straight leg rise from prone The patient adopts a prone position with his/her head on the arms. Then contracts the gluteus and hamstring muscles of the right leg and raises his/her leg as high as possible towards the ceiling. After holding this static position, the patient slowly lowers his/her leg. The exercise is repeated for the left side. Fig.11. straight leg rise from prone 5. Alternate arm and leg raise from quadruped The participant adopts a four-point kneeling position. If necessary, a cushion is placed under the knees for comfort. The participant contracts his/her abdominal muscles to stabilize the spine. While maintaining tension in the abdomen, the participant lifts one arm and the contralateral leg. After holding this position, the participant slowly lowers the arm and leg and repeats the exercise, alternating sides. Fig12.A 30 Active-Treatment of Control Group
Experimental Group Lumbar Stabilizing exercises and Hip strengthening exercises All patients will participate for 30 min, 3 times/week, for 6 weeks Lumbar Stabilizing exercises There are phases of stabilization exercises, and will be performed consecutively and in order for total 18 sessions (Luque-Suárez et al., 2012). All patients will participate for 30 min, 3 times/week, for 6 weeks. For each exercise, isometric contraction was maintained for 7-8 s. Each exercise was reported 10 times, and there was a brief rest interval of 3 s between repetitions. Patients were provided a 1-min rest in between exercises (McGill 2015). 1. Abdominal hollowing The patient lies down with his/her knees in 90º flexion. With the lower back and pelvis aligned. Then forcefully contracts his/her abdominal muscles to increase the internal pressure and holds the contraction also this phase can be done from sitting or kneeling positions. Fig.6. Abdominal hollowing. Fig.7. Abdominal hollowing in sitting. Fig.8.Abdominal hollowing in four point kneeling. 2. Side Bridge The patient’s left forearm is placed on the ground below the shoulder. The participant lifts his/her body to form a side bridge, or "plank" position. This position is maintained using the forearm and foot to support the body. The exercise is repeated for the right side. Fig.9. lateral bridge 3. Supine Extension Bridge The patient adopts a hook-lying position with both feet below the knees. The patient slowly lifts his/her hips until their knees and shoulders are aligned in a straight line, taking care to support the weight of the body with shoulders rather than neck. After holding this static position, the patient slowly lowers his/her hips to the ground. Fig.10. bridge in supine position 4. Straight leg rise from prone The patient adopts a prone position with his/her head on the arms. Then contracts the gluteus and hamstring muscles of the right leg and raises his/her leg as high as possible towards the ceiling. After holding this static position, the patient slowly lowers his/her leg. The exercise is repeated for the left side. Fig.11. straight leg ris 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age from 20–60 years (Bhadauria et al., 2017). • Patients with chronic nonspecific LBP (more than12 weeks). • Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line). • Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation. • Spinal tumors. • Unexplained weight loss. • History of fractures or significant trauma. • History of spinal surgery. • Vestibular dysfunction. • Visual dysfunction. • Neurological dysfunction affecting balance. • Current pregnancy. • Presence of severe postural abnormality. • Neuromuscular disorder. Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 10/11/2020 Cairo university faculty of physical therapy ethical committee
Ethics Committee Address
Street address City Postal code Country
el zyate st, dokki ,giza giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome kinematic parameters of gait using Kinovea 2D free software pre and post intervention
Secondary Outcome Arabic version of modified Oswestry Disability Questionnaire (MODQ) to measure a patient's permanent functional disability pre and post intervention
Secondary Outcome Visual Analogue Scale to asses pain level pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university el-doky Giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ebrahim El doki giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university El doki Giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amir mohamed morsi saleh El-doki Giza 12511 Egypt
Nabil mahmoud ismail El-doki Giza 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AHMED EBRAHIM Ahmedbayuomy@gmail.com 00201099723986 el-doki
City Postal code Country Position/Affiliation
giza 12511 Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries Amir saleh Ahmedbayuomy@gmail.com 00201099723986 El-doki
City Postal code Country Position/Affiliation
giza 12511 Egypt prof
Role Name Email Phone Street address
Public Enquiries nabil ismail Ahmedbayuomy@gmail.com 00201099723986 el-doki
City Postal code Country Position/Affiliation
giza 12511 Egypt assist prof
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol 12 months the criteria will be accessed by the publication of trials in international journal all data will be open access and every one can reach it
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