Low Back Pain, Non Specific Chronic Low Back Pain
Conditions
Keywords
Low Back Pain, Non Specific Low Back Pain, Chronic Low Back Pain, Cognitive Functional Therapy, Kinetic Control Training, Pain, Disability, Movement Control
Brief summary
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 * Is there difference between Cognitive Functional Therapy and Kinetic control training on pain intensity, disability and movement control in participants with Non Specific Low Back Pain? * Is there difference between Cognitive Functional Therapy and Kinetic control training on pain catastrophizing and self-efficacy in participants with Non Specific Low Back Pain? Researcher will compare the both CFT and KCT group to see if one treatment is superior to other in treating participants with non-specific back pain. Participants will * Attend treatment sessions based on the group they are placed in. * Take session three times each week for eight weeks. * They will be asked short questions about their pain, daily activity, and movement throughout the study.
Detailed description
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.
Interventions
BEHAVIORALCognitive Functional Therapy
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.
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.
Sponsors
Lahore University of Biological and Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes * Aged between 19 to 39 * Patients who score 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ) at the time of screening * Patients who will have Non-Specific Chronic Low Back pain for at least 3 months duration
Exclusion criteria
* If the primary pain area is not the lumbar spine. * If leg pain is the primary problem. * If patient have inflammatory disease. * If patient have progressive neurological disease. * If patient have red flag disorders (malignancy/cancer, traumas such as fracture). * Pregnant females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measured by Numeric Pain Rating Scale | It will be measured at baseline, 4 weeks and at 8 weeks. | 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. |
| Disability measured by Roland Morris Disability Questionnaire | It will be measured at baseline, 4 weeks and 8 weeks | 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). |
| Lumbar Motor Control measured by the Luomajoki Motor Control Test Battery | baseline, 4 week and 8 week | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catastrophizing pain will be measured by Pain Catastrophizing Scale. | baseline, 4 weeks and 8 weeks | 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. |
| Self-efficacy will be measured by Pain Self Efficacy Scale | Baseline, 4 weeks and 8 weeks | 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 |
Countries
Pakistan
Contacts
CONTACTNayab Naseem
CONTACTUmber Nawaz
PRINCIPAL_INVESTIGATORNayab Naseem
Lahore University of Biological and Applied Sciences
Outcome results
None listed