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IRCT20210927052616N1 IRCT 2021-11-03 Kharazmi University Evaluation of the effect of patient-led goal-setting approach in combination with pain neuroscience training or manual therapy in patients with chronic low back pain Comparison the effect of patient-led goal setting with pain neuroscience education and Manual therapy in Patients with chronic low back pain. 2021-10-22 anticipated 45 Complete https://irct.ir/trial/59099 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Following the baseline examination, by using the method shown on the website http://randomizer.org/ (Social Psychology Network, Connecticut, USA), participants will be randomly assigned into the patient-led goal-setting approach group In combination with pain neuroscience education, the patient-led goal-setting approach group will be combined with manual therapy. Simple randomization will be used. Concealed allocation is performed using a computer-generated block randomized table of numbers (1 for patient-led goal-setting approach group In combination with pain neuroscience education and 2 for the patient-led goal-setting approach group will be combined with manual therapy) created before the start of data collection by a researcher who is not involved in the recruitment or treatment of patients. Then, the random numerical sequence is placed in sealed opaque envelopes. Another researcher, blind to the baseline examination, open an envelope and process with treatment according to the group assignment. An independent assessor who is not known about the study’s hypothesis and methods and is blind to the treatment group, assess the outcome measures before the interventions, 2 months after treatment, and 4 and 12 months after the end of the intervention, each time measured, Blinding description: In this study, the outcome assessor was blinded of the process of randomization and division of individuals into two experimental and control groups. N/A chronic low back pain. Intervention 1: Intervention group: patient-led goal setting group with Manual therapy. The goal-setting approach will be conducted over the course of 2 months through a one-hour face-to-face session followed by 4 sessions of 15 to 30 minutes over 2 weeks. Subsequently, two 30-minute sessions are performed with an interval of one month. Furthermore, twelve months after initiating the research the final session is performed and the results are collected. In this approach, the author has employed the SMART model which features measurable and achievable goal-setting processes that are specific to a time frame. In the aforementioned model, the researcher is trained in patient-led goal setting, takes the low back pain history of the patient into consideration, and engages in conversation regarding the consequences of their ailment. Moreover, the patient is asked to prioritize the problems based of their preferences. Afterward, strategies are considered based on evidence-based guidelines and the participant sets goals and chooses strategies to implement individually in between sessions. The participants will record their goals, progress, and obstacles and strategies to overcome the obstacles in their notebooks. If the target strategies include consultation with a healthcare professional, the participant is encouraged to pursue this independently. Manual therapy includes 18 sessions of 60 minutes over 6 weeks. For manual treatment, soft tissue mobilization techniques, muscle energy techniques, and joint mobilization are performed. Soft tissue mobilization includes myofascial stretching for superficial and deep muscles, transverse friction for intervertebral, and supraspinal ligaments. Muscle energy techniques include relaxation after isometric contraction for the quadratus lumbarum and piriformis muscles. The participant is asked to gently contract these muscles for 8 seconds with 30% of maximum contraction. This practice is repeated after each rest. The assessment of Joint mobilization is based on sacroiliac mobility test, sacroiliac mobility with standing flexion forward test, Gillet test, and Piedallu Sign. Intervention 2: Intervention group: patient-led goal setting group with Manual therapy.The goal-setting approach will be done with patient leadership over 2 months, which includes 5 face-to-face sessions, with the first session lasting one hour and the other four sessions lasting 15 to 30 minutes over two weeks. After that, two follow-up sessions (duration 30 minutes) are performed with an interval of one month. Also, one session is performed after 12 months after the first session and finally the results are collected. To perform this approach, a model called SMART is used, which includes a special process for goal setting that is measurable, achievable and related to a specific time return. In this model, the researcher is trained in setting goals by the patient, history of low back pain Considers the participant and talks about the problems caused by low back pain. Ask the participant to prioritize these problems based on what they want to focus on. Strategies are then discussed based on evidence-based guidelines, and the participant sets specific goals and strategies for the participants to work independently between sessions. They record what they agree to achieve in their workbook. If the target strategies include consultation with a healthcare professional, the participant is encouraged to pursue this independently. Manual therapy includes 18 sessions of treatment for 6 weeks and three times a week, each session lasting 60 minutes. For manual treatment, soft tissue mobilization techniques, muscle energy techniques and joint mobilization are performed. Soft tissue mobilization includes myofascial stretching for superficial and deep muscles, transverse friction for intervertebral and supraspinal ligaments. Muscle energy techniques include relaxation after isometric contraction for the quadratus lumbarum and piriformis muscles. We ask the participant to gently contract these muscles for 8 seconds with 30% of maximum contraction. This movement is repeated after each rest. Joint mobilization is assessed based on sacroiliac mobility test, sacroiliac mobility with standing flexion forward test, Gillet test, Piedallu Sign. Intervention 3: Control group: Without receiving any intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Sahar Soheili
no. 7, Ali Akbar Street, Above Pine Square, Sa'adat Abad
Tehran Iran (Islamic Republic of) 1998643541 +98 21 2237 2624 std_saharsoheili75@khu.c.ir Kharazmi University scientific Sahar Soheili
No. 7, Ali Akbar St., above Kaj Square, Saadat Abad
Tehran Iran (Islamic Republic of) 1998643541 +98 21 2237 2624 std_saharsoheili75@khu.ac.ir Kharazmi University Iran (Islamic Republic of) Having a history of nonspecific low back pain Minimum duration of low back pain is 3 months They reported pain intensity with 4 out of 11 points in the NRS questionnaire and at least 20 points in the QBPDS. 18 years 65 years Both Spinal surgery report in the last 12 months Severe osteoporosis Signs and symptoms reported from serious pathology Spondyloarthritis Spondylolisthesis Spinal canal stenosis Traumatic spinal cord injury such as a fracture or car accident Spinal dislocation Spinal cord metastasis Has symptoms of Cauda Equina syndrome Structural scoliosis Pregnancy History of seizures, epilepsy, stroke or head injuries Taking medications for patients with mental health problems M54.5 Low back pain Other Other Other Intervention group: patient-led goal setting group with Manual therapy. The goal-setting approach will be conducted over the course of 2 months through a one-hour face-to-face session followed by 4 sessions of 15 to 30 minutes over 2 weeks. Subsequently, two 30-minute sessions are performed with an interval of one month. Furthermore, twelve months after initiating the research the final session is performed and the results are collected. In this approach, the author has employed the SMART model which features measurable and achievable goal-setting processes that are specific to a time frame. In the aforementioned model, the researcher is trained in patient-led goal setting, takes the low back pain history of the patient into consideration, and engages in conversation regarding the consequences of their ailment. Moreover, the patient is asked to prioritize the problems based of their preferences. Afterward, strategies are considered based on evidence-based guidelines and the participant sets goals and chooses strategies to implement individually in between sessions. The participants will record their goals, progress, and obstacles and strategies to overcome the obstacles in their notebooks. If the target strategies include consultation with a healthcare professional, the participant is encouraged to pursue this independently. Manual therapy includes 18 sessions of 60 minutes over 6 weeks. For manual treatment, soft tissue mobilization techniques, muscle energy techniques, and joint mobilization are performed. Soft tissue mobilization includes myofascial stretching for superficial and deep muscles, transverse friction for intervertebral, and supraspinal ligaments. Muscle energy techniques include relaxation after isometric contraction for the quadratus lumbarum and piriformis muscles. The participant is asked to gently contract these muscles for 8 seconds with 30% of maximum contraction. This practice is repeated after each rest. The assessment of Joint mobilization is based on sacroiliac mobility test, sacroiliac mobility with standing flexion forward test, Gillet test, and Piedallu Sign. Intervention group: patient-led goal setting group with Manual therapy.The goal-setting approach will be done with patient leadership over 2 months, which includes 5 face-to-face sessions, with the first session lasting one hour and the other four sessions lasting 15 to 30 minutes over two weeks. After that, two follow-up sessions (duration 30 minutes) are performed with an interval of one month. Also, one session is performed after 12 months after the first session and finally the results are collected. To perform this approach, a model called SMART is used, which includes a special process for goal setting that is measurable, achievable and related to a specific time return. In this model, the researcher is trained in setting goals by the patient, history of low back pain Considers the participant and talks about the problems caused by low back pain. Ask the participant to prioritize these problems based on what they want to focus on. Strategies are then discussed based on evidence-based guidelines, and the participant sets specific goals and strategies for the participants to work independently between sessions. They record what they agree to achieve in their workbook. If the target strategies include consultation with a healthcare professional, the participant is encouraged to pursue this independently. Manual therapy includes 18 sessions of treatment for 6 weeks and three times a week, each session lasting 60 minutes. For manual treatment, soft tissue mobilization techniques, muscle energy techniques and joint mobilization are performed. Soft tissue mobilization includes myofascial stretching for superficial and deep muscles, transverse friction for intervertebral and supraspinal ligaments. Muscle energy techniques include relaxation after isometric contraction for the quadratus lumbarum and piriformis muscles. We ask the participant to gently contract these muscles for 8 seconds with 30% of maximum contraction. This movement is repeated after each rest. Joint mobilization is assessed based on sacroiliac mobility test, sacroiliac mobility with standing flexion forward test, Gillet test, Piedallu Sign. Control group: Without receiving any intervention Pain intensity. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Numerical Rating Scale. Kinesophobia. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Tampa Scale For Kinesiophobia. Fear Avoidance Beliefs. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Fear Avoidance Beliefs Questionnare. Disability. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Qubec Back Pain Disability Scale. Quality Of Life. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: SF_36 Scale. Anxiety. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Depression Anxiety Stress Scale. Depression. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Depression Anxiety Stress Scale. Stress. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Depression Anxiety Stress Scale. Pain Self-efficacy. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Pain Self-Efficacy Questionnare. Central Sensitivity Inventory. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Central Sensitization Inventory. Catastrophic pain. Timepoint: First at the beginning of the work, 2 months after treatment, 4 and 12 months after the end of interventions. Method of measurement: Pain Catastrophizing Scale. Kharazmi University Approved 2021-08-21 Institute of Physical Education and Sports Sciences Saadat Abad, above Kaj Square, Ali Akbar St., No. 7 Tehran Tehran Iran (Islamic Republic of)