Exercise Training Clinical Trial
Official title:
Effectiveness of a Therapeutic Exercise Protocol Combined With Manual Therapy Techniques on the Diaphragm Muscle in Patients With Low Back Pain
Verified date | September 2021 |
Source | University of Alcala |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol. SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements. HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.
Status | Completed |
Enrollment | 42 |
Est. completion date | April 15, 2021 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Legal age - Non-specific Low-Back pain - Pain more 3 months Exclusion Criteria: - subjects with lumbar herniation. - Spine canal stenosis - Subjects with neurological disease. - Lumbar surgery |
Country | Name | City | State |
---|---|---|---|
Spain | Grupo Fisioterapia y Dolor | Alcala de Henares | Madrid |
Lead Sponsor | Collaborator |
---|---|
University of Alcala |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Low-back pain | The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with lowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale. | Change from Baseline disability at 3 months | |
Secondary | Disability with Oswestry Disability Index | The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible | Change from Baseline disability at 3 months | |
Secondary | Lumbar range of motion | Mobility. It will be measured using an electronic inclinometer.The TiltMeter© -advanced level and inclinometer app is an inclinometer app of iPhone®. The investigation has demonstrated that the app possesses good to excellent reliability (ICC = 0.77) and concurrent validity with a gravity-based inclinometer (r = 0.86) for measuring standing isolated lumbar flexion and extension range of movement | Change from Baseline disability at 3 months | |
Secondary | Kinesiophobia | Kinesiophobia was measured by an 11-item version of the Tampa Scale of Kinesiophobia (TSK-11). The 11 items of the scale each have 4 response options; all anchored with the answers "strongly disagree", which scores 1 point, and "strongly agree", which scores 4 points. The total sum score is calculated and can range between 11 and 44 points. A high score indicates strong fear of movement/(re)injury, i.e. high kinesiophobia. TSK-11 has been psychometrically evaluated and has shown good construct validity and reliability among older people (i.e. internal consistency (Cronbach alpha, 0.74-0.87) and test-retest reliability (ICC r = 0.747) | Change from Baseline disability at 3 months |
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