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This study is to determine the effectiveness of Neural mobilization(NM) technique compared with lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT) in the physical therapy management of chronic low back pain (CLBP) with radiculopathy. Subjects will be randomly assigned into two groups. Group A (NM, LSE and rESWT) and Group B (LSE and rESWT).
Randomized clinical control trail will be conducted in the North West area of Saudi Arabia.
Patients diagnosed to have CLBP with radiculopathy at three different hospitals in Saudi Arabia will be recruited for this study.
Participants will be randomly assigned into treatment or control group. Before starting of the study, the author will designe the treatment and control group treatment program and instructed the treating physiotherapists in their implementation. An ethical approval was approved by the ethics committee of the University of Tabuk- Saudi Arabia. Participants in each group will receive 12 treatment sessions of 45 minutes each, 2 days a week for 6 consecutive weeks.
For each group, a menu of a lumbar stabilization program was designed. This program included 8 levels of exercise ( single leg knee to chest stretch, double leg knee to chest, supine piriformis stretch, supine hamstring stretch, lower trunk rotation stretch, lumbar rotation stretch, pelvic tilt, pelivic tilt with alternative legs). Exercises were tailored for each individual ability and, if possible, progressed at each session which would last approximately 30 minutes. Each single exercise was repeated many times based on the patient's clinical condition. All sessions were provided by physiotherapists. After finishing of session of lumbar stabilization program, a shock wave therapy was applied for each participant in a prone position over the region of low back pain (Figure 2 ).
Only participants in the treatment group were receive neural mobilization technique. This includes the following: sciatic neural mobilization technique (Figure 3), slump neural mobilization technique (Figure 4) and self neural mobilization (Figure 5 ).
OUTCOME MEASUREMENT TOOLS:
There were three outcome measures as following: pain, disability and lumbar spine range of motion. Subjected were tested three times as following: at the baseline (0 week), at the mid of treatment (3 weeks) and finally at the end of treatment (6 weeks).
DATA ANALYSIS:
A simple descriptive statistical analysis was adopted to describe the patient specific demographic characteristics with respect to outcomes parameters. Within group and between groups comparison was analyzed using ANOVA and Scheffes' post-hoc tests by using SPSS 20.0.
Work Plan:
Roles and responsibilities :
1. Principal Investigator-is responsible for the following:
1. The management and integrity of the research design 2. Approval from ethical board committee or its equivalent 3. Preparation and conduct of the study 4. Reporting of the research project 5. Managing, monitoring and ensuring the integrity of any collaborative relationships.
6. Directs and oversees compliance, financial, personnel, and other related aspects and resources of the research project 7. Coordination with department and central administration personnel to assure research in is conducted in accordance with regulations of the University and sponsoring agency policies and procedures.
8. Publication of the study, local and international. Work Flow
Utilization:
The outcomes of the research will be used to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Neural mobilization (NM), lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT) |
|
| Control group | Active Comparator | lumbar stabilization exercise (LSE) and Radial Extracorporeal Shock Wave Therapy (rESWT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise, manual therapy | Other | Participants were randomly assigned into treatment (n=15) or control group (n=15). Participants in each group received 12 treatment sessions of 45 minutes each, 2 days a week for 6 consecutive weeks. For each group, a menu of a lumbar stabilization program was designed. This program included 8 levels of exercise ( single leg knee to chest stretch, double leg knee to chest, supine piriformis stretch, supine hamstring stretch, lower trunk rotation stretch, lumbar rotation stretch, pelvic tilt, pelivic tilt with alternative legs). Exercises were tailored for each individual ability and, if possible, progressed at each session which would last approximately 30 minutes. Each single exercise was repeated many times based on the patient's clinical condition. All sessions were provided by physiotherapists. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain is being assessed using NPRS | Pain was assessed by using NPRS, where 0 represented no pain and 10 represented the worst pain possible, to indicate the intensity of pain in the lower back (Jensen et al., 1994). | baseline, 3 weeks and 6 weeks |
| Change in Disability is being assessed using the Modified Oswestry Disability Questionnaire | Disability was measured by using the Modified Oswestry Disability Questionnaire (MODQ) which is a self-rating questionnaire used to evaluate functional physical disability (Rajfur, et al., 2017). | baseline, 3 weeks and 6 weeks |
| Change in Lumbar flexion range of motion is being assessed using modified Schober method | Lumbar flexion range of motion was measured by using modified Schober method (Philadelphia Panel Members, 2001). | baseline, 3 weeks and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salem F Alatawi, PhD | Contact | 0549638301 | sfalatawi@ut.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Salem F Alatawi, PhD | University of Tabuk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salem F Alatawi | Recruiting | Tabuk | 71491 | Saudi Arabia |
After publication
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Experimental group: Group A (NM, LSE and rESWT) and Control group: Group B (LSE and rESWT).
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|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |