Chronic Low Back Pain Clinical Trial
Official title:
The Effectiveness of Neuroscience Pain Education Combining Manual Therapy in Patients With Chronic Low Back Pain: a Single-blinded Randomized Controlled Trial
Verified date | March 2019 |
Source | Kutahya Medical Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Therefore, the aim of this study was determining the short- and mid-term effects of neuroscience pain education combined with manual therapy and home exercise on pain level, disability, and kinesiophobia in patients with chronic low back pain.
Status | Completed |
Enrollment | 69 |
Est. completion date | January 1, 2019 |
Est. primary completion date | October 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Volunteered to participate in the study. - Patients with 18-65 years - Had low back pain for at least 6 months, - Reported pain severity of 5 or greater according to the numeric pain rating scale - Used pregabalin and gabapentin derivatives, Exclusion Criteria: - Previous spine or lower extremity surgery - Severe osteoporosis - Spondyloarthropathy - Spondylolisthesis - Lumbar stenosis - Systemic inflammatory diseases |
Country | Name | City | State |
---|---|---|---|
Turkey | Yoncali Physical Therapy and Rehabilitation Hospital | Kutahya |
Lead Sponsor | Collaborator |
---|---|
Kutahya Medical Sciences University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric pain rating scale (NPRS) | The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme. | Change from Baseline NPRS at 4th weeks and 12th weeks | |
Secondary | Oswestry Disability Index (ODI) | The participants' level of functioning was evaluated using the Turkish adaptation of the ODI. The scale comprises 10 items, each with 6 options worth 0 to 5 points. For each item, participants are asked to mark the option that best describes their current condition. 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 ODI at 4th weeks and 12th weeks | |
Secondary | Back Performance Scale (BPS) | The BPS includes five tests of trunk mobility. Each test is scored from 0 to 3 based on the observed level of physical performance, and total score ranges from 0 to 15 points (18). High score indicates poor performance. | Change from Baseline BPS at 4th weeks and 12th weeks | |
Secondary | Tampa Scale for Kinesiophobia (TSK) | TSK was used for the assessment of kinesiophobia. The items are rated on a 4-point Likert-type scale (1=definitely disagree, 4=completely agree) and the total score is between 17 and 68 points. Higher total score indicates higher level of kinesiophobia. | Change from Baseline TSK at 4th weeks and 12th weeks |
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