- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04918238
Effect of Muscle Energy Techniques on Functional Abilities in Patients With Discogenic Unilateral Sciatica
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Disability and emotional distress among patients with lumbar spondylosis has a negative impact on well-being. Anxiety and depression are common emotional problems among patients with LBP.
The experience of pain interferes with different aspects of the patient's life, negatively affecting their daily activities, physical and mental health, family and social relationships, and their interactions in the workplace.
This problem also affects the health care system and what is known as economic well-being, the strong burden associated with Chronic Pain not only deriving from healthcare costs but also from the loss of productivity and from compensatory payments to patients as a result of the disability that pain produces.
Movement research has vast implications for muscle energy techniques for individuals with chronic low back pain and sciatica, the thoracolumbar normal range of motion plays an essential role in transferring the body weight and performing daily activities. Poor spinal range of motion and tightness of paraspinal muscles have previously been noted in individuals with chronic low back pain and sciatica.
Most of the previous studies focused on dealing with chronic low back pain and sciatica through using different medications and physical therapy modalities for the symptoms such as TENS. Since muscle energy techniques can decrease the tension of the muscles of the lumbar spine and gives a real chance to improve the flexibility of those muscles which might inhibit the severity of sciatica with low costs so it's recommended to study its effect on the functional abilities of the patients so that it can be the main part of physical therapy rehabilitation protocol.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Damietta, Egypt, 34518
- Outpatient clinic - Faculty of Physical Therapy - Horus University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
History of sciatica for more than 12 weeks or has at least 3 episodes of intermittent sciatica, each last for morethan 1 week eitheraccompanied with low back pain during the 3 months before thestudy. Medically and radiologically diagnosed as discogenic chronic sciatica with mild to moderate disability according to modified Rolland and Morris scale.
- Both males and females, aged from 25 to 40 years old.
- Be able to understand and follow the instructions during testing and treatment procedures
Exclusion Criteria:
Fracture of pelvis, spine or lower extremities.
- Hospitalization for severe trauma.
- Peripheral neuropathy of diabetes or any other autoimmune disease.
- Systematic autoimmune disease such as rheumatoid arthritis, systematic lupus
- People with red flags such as cancer or severe osteoporosis.
- Symptoms provoked while doing active hip joint extension and abduction.
- Previous surgery to the lumbar spine, abdomen, pelvis, or hip.
- Any contraindication for exercise therapy (e.g. uncontrolled hypertension, previous myocardial infarction, cardiovascular disease, peripheral vascular disease, respiratory disorders).
- Any pain originated because of SI pathology.
- Menstruation during testing days.
- Individuals incapable of understanding and answering the Questionnaire.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: conventional treatment Arm
All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
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All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
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Experimental: muscle energy technique arm
Group A received muscle energy technique with lateral recumbent positioning along with Conventional Physiotherapy Program
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All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
The patient was in the lateral recumbent position on the side opposite to his, her side-bending dysfunction while the physiotherapist stood facing the subject.
The physiotherapist monitored the lumbar area with one hand while with the other hand flexed the subject's knees and hips until the barrier was engaged at the vertebral segment being treated.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual analogue scale (VAS)
Time Frame: "through study completion, an average of 2 months"
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Change from baseline Pain and at 2 months
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"through study completion, an average of 2 months"
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Oswestry disability index scale
Time Frame: "through study completion, an average of 2 months"
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Change from baseline disability and at 2 months
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"through study completion, an average of 2 months"
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Basem_MSc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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