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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1331-9059 | Registry Identifier | WHO Universal Trial Number |
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The goal of this clinical trial is to compare Cognitive Functional Therapy (CFT) with Kinetic Control Training (KCT) in participants with non-specific low back pain. The study wants to see which approach helps lower pain, reduce disability and improve movement control. The main questions it aims to answer is
Participants will
Low back pain (LBP) has the highest prevalence globally among musculoskeletal disorders, affecting around 619 million people in 2020. It is projected that the number of cases will skyrocket to 843 million by 2050. LBP is defined as the localized pain below the costal margin and above the inferior gluteal folds. It is commonly categorized as specific and non-specific low back pain. Non-Specific Low Back Pain (NSLBP) accounts for nearly 90% of all cases.
NSLBP is multifactorial and mostly new cases recover within a short time but the condition frequently recurs and may become persistent. An extensive review regarding the management of LBP has stated that exercise plays a fundamental role in treating patients with NSLBP. However, the results regarding the appropriate type of exercise are the subject of controversy. Over the past decades, researchers have advised a variety of exercises. However, despite applying various treatment approaches, conservative treatment for NSLBP yields small effect sizes.
Cognitive Functional Therapy (CFT) is developed by Peter O'Sullivan, to address the multidimensional nature of non-specific low back pain. The CFT is structured into three phases: (1) making sense of pain, (2) exposure with control, and (3) lifestyle changes. Rather than adopting a one size fits all approach, CFT provides clinicians with the opportunity to explore the multidimensional nature of NSLBP.
Kinetic Control Training (KCT) developed by Comerford, is a clinical framework focused on the assessment and correction of uncontrolled movement. KCT utilizes a three-stage retraining process: (1) cognitive facilitation of correct muscle activation; (2) integration into low-load, non-provocative tasks; and (3) progression to complex, functional movements under load and fatigue.
Despite the promising evidence supporting both CFT and KCT, a clear comparative study of their effectiveness in addressing NSLBP is lacking. Most existing studies have focused on one technique or compared it with general exercise. This study seeks to address this gap by evaluating and comparing these two approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Functional Therapy | Experimental |
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| Kinetic Control Training | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Functional Therapy | Behavioral | Patients will receive 24 sessions over a period of 8 weeks. Each session will be of 1 hour 15 minutes. Standard Physical Therapy will be provided in which patient will receive Hot pack with TENS and perform a set of exercises including Curl up, Bird dog and side bridge back exercises for 5 repetitions. Then Cognitive Functional Therapy (CFT) will be applied from day one. CFT is structured into three phases: (1) making sense of pain, (2) exposure with control, and (3) lifestyle changes. Making Sense of Pain : This component reflects the cognitive aspect of Cognitive Functional Therapy. It involves hearing patient's personal narrative about their chronic pain. Exposure with Control: It involves graded exposure to feared movements and functional tasks. Lifestyle Changes: This component focuses on lifestyle factors that contribute to pain and disability. It involves modifying sedentary lifestyle behaviors and encouraging healthy routine. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Measured by Numeric Pain Rating Scale | Pain intensity will be measured with an 11 point Numeric Pain Rating Scale that is measured from 0 to 10. 0 is no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain and 7-10 is the most severe pain imaginable. | It will be measured at baseline, 4 weeks and at 8 weeks. |
| Disability measured by Roland Morris Disability Questionnaire | Disability will be measured by Roland Morris Disability Questionnaire (RMDQ). The RMDQ is a valid and reliable tool for estimating the level of disability in Low Back Pain patients. It is composed of 24 questions that are to be answered by the patients with answers of either 'Yes' or 'No'. The variation of the total score may range from a score of 0 (no disability) to a score of 24 (maximum disability). | It will be measured at baseline, 4 weeks and 8 weeks |
| Lumbar Motor Control measured by the Luomajoki Motor Control Test Battery | To evaluate lumbar motor control, the Luomajoki Motor Control Test Battery is employed. This battery includes six individual tests that examine movement control in various positions such as standing, sitting, quadruped, and prone. Each test is scored either 0 or 1, with a total score of 3 or higher indicates impaired motor control | baseline, 4 week and 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| Catastrophizing pain will be measured by Pain Catastrophizing Scale. | Catastrophizing pain will be measured by 13-item Pain Catastrophizing Scale (PCS). The PCS serves to evaluate catastrophic thinking related to pain. It includes four items rated on a 5-point Likert scale from 0 (not at all) to 4 (all the time), with total scores ranging from 0 to 52. | baseline, 4 weeks and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nayab Naseem | Lahore University of Biological and Applied Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Physical Therapy Clinic | Lahore | Punjab Province | Pakistan |
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| Kinetic Control Training | Other | Patients will receive 24 sessions. In each session, Standard Physical Therapy will be applied which will be the same in both groups. In Kinetic Control Training (KCT), patients will first undergo direction specific movement control tests. These tests will identify direction-specific movement faults (e.g., flexion, extension, rotation control deficits) that contribute to symptoms. Based on these tests, individualized retraining will be provided to the patients. This retraining will improve control of specific muscles which will help reduce pain and improve disability. |
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| Self-efficacy will be measured by Pain Self Efficacy Scale | Self-efficacy will be measured by Pain Self Efficacy Scale, a 10-item instrument evaluating a patient's confidence in carrying out daily activities despite experiencing pain. Each item is rated on a 7-point scale and higher scores indicate stronger self-efficacy | Baseline, 4 weeks and 8 weeks |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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