Chronic Non-specific Low Back Pain Clinical Trial
— METOfficial title:
Effectiveness of Muscles Energy Technique on Quality of Life and Trunk Muscles Functions in Patients With Chronic Non-specific Low Back Pain
Verified date | July 2021 |
Source | University of KwaZulu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Low back pain is the most common health problem that affects work performance and quality of life. Non-specific low back pain (NSLBP) is defined as low back pain not attributable to a recognizable, known specific pathology. NSLBP is the leading cause of disability among the major musculoskeletal conditions which leads to Impairments, Activity Limitations and participation restrictions. Therefore it becomes a psychosocial/economic burden on individuals, families, communities, industries and government. Existing literature shows globally 40% to 50% of people have LBP at some point in their lives and there exists a challenge in Africa on the best rehabilitation methods for low back pain management which could prevent chronic pain and disability. Therefore, this study aims to determine the effectiveness of MET when combined with DSE in the management of chronic NSLBP patients and to analyze the additional effect the MET procedure will provide relative to DSE.
Status | Completed |
Enrollment | 125 |
Est. completion date | December 20, 2019 |
Est. primary completion date | October 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility | Inclusion Criteria: 1. NSLBP history of about or more than 3 months and associated with referred lower extremity pain; pain in the lumbopelvic region; 2. Lumbar hypomobility; mobility deficits of the thorax and hip regions; 3. LBP not of specific origin diagnosed by a physician (due to fracture, tumours, malignancy, ankyloses, infections, and pregnancy); 4. Diminished trunk or pelvic region muscle strength and endurance; 5. Movement coordination impairments while performing community/work-related recreational or occupational activities. 6. Attending Outpatient clinics and Physiotherapy departments of Rasheed Shekoni Teaching Hospital Dutse and Federal medical centre Birnin-Kudu in Jigawa state, Northwest Nigeria. Exclusion Criteria: 1. Chronic NSLBP with radiating pain due to nerve root involvement in physical examination. 2. Patients using immunosuppression or steroid medication. 3. Patients with persistent severe pain. 4. Patients with spinal deformities. 5. Patients with widespread neurological symptoms; patients with peritonitis as at the time of recruitment; patients with a history of lumbar surgery; patients diagnosed with carcinoma or organ disease; and patients with a history of severe rheumatic, orthopaedic, cardiovascular, systemic, metabolic or neurologic disorders. |
Country | Name | City | State |
---|---|---|---|
Nigeria | Rasheed Shekoni Specialist Hospital | Dutse | Jigawa State |
Lead Sponsor | Collaborator |
---|---|
University of KwaZulu |
Nigeria,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medical Outcomes Survey Short-Form-36 (SF-36) | Quality of Life (QoL) will be assessed with SF-36, The questionnaire is divided into 10 segments with a total of 36 questions. The segments involve Demography, General Health, Limitation of Activities, Physical Health Problem, Emotional Health Problem, Social Activities, Pain, Energy and Emotion, Social Activities and General Health. | 6 month | |
Primary | Activity Limitation and Participation Restriction | Level of activity Limitation and Participation Restriction would be measured using Orebro Musculoskeletal Pain Screening Questionnaire. | 6 month | |
Secondary | Basal Mass Index (Demographic data) | Using formula; Body weight/Height square. | Once | |
Secondary | Skin fold thickness for percentage body fat (Demographic data) | Skin fold calliper would be used to measure participants skin fold thickness | Once | |
Secondary | Transverse abdominus muscles contraction rate | Pressure biofeedback unit | 6 months | |
Secondary | Level of pain perception | Level of Pain Perception would be measured using pain numeric rating scale, it has a scale of 0-10-mm (0 means no Pain, 1-3 means mild pain, 4-7 means moderate pain and 8-10 means severe pain) and the minimally important change for the visual analog scale is 2 (using a 0-10 self-report scale). The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. The average of the 3 scores will represent patient's level of pain perception. | 6 months | |
Secondary | Functional Disability | Level of Functional Disabilities of Participant resulting from CMLBP would be measured using Oswestry disability Index | 6 months | |
Secondary | Spine range of motion | Inclinometer would be used to measure trunk range of motion | 6 months | |
Secondary | Trunk extension endurance test | Biering-sorensen test | 6 months | |
Secondary | Trunk flexion endurance test | McGill's torso battery test | 6 months | |
Secondary | Trunk side flexion endurance test | McGill's torso battery test | 6 months | |
Secondary | Global Rating of Change Scale (GROC) | This scale will be used to evaluate the satisfaction of the participant with the study intervention in term of improvement on symptoms. | 6 months |
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