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Effects of Slump Stretching vs Lumbar Mobilization With Exercises in Relieving Non-radiculating Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Slump stretching
Lumbar mobilization
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring effects, slump stretching, lumbar mobilization, non radiculating, Low back pain, exercises, quality of life, modified oswestry low back pain disability, numeric pain rating scale, fear avoidance beliefs

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Individuals with Non-Radiculating Low back pain

Test:

i. Slump test=positive ii. Straight leg raise=negative

Exclusion Criteria:

Individuals with Radiculating Low Back pain,History of spinal surgery, Disc herniation,Pregnant women, Major diseases (e.g. stroke)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Slump stretching group

    Lumbar mobilization group

    Arm Description

    Slump stretching will be performed with the patient in the long sitting position. The position will be held for 30 seconds. A total of 5 repetitions will be completed. Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, and quadruped alternate arms/legs activities as described by Cleland et al. Patients will perform 10 repetitions of each exercise.

    Maitland Grade 1 - 2 Posterior to anterior lumbar spine mobilization will be applied for 30 - 45 seconds for all segments through L1 to L5 at rate of 1 oscillation per 2 seconds. Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, quadruped alternate arms/legs activities as described by Cleland et al. Patients will perform 10 repetitions of each exercise.

    Outcomes

    Primary Outcome Measures

    Numeric pain rating scale
    On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.
    Modified Oswestry Low Back Pain Disability Questionnaire
    The questionnaire has been designed to give the therapist information as to how the back pain has affected the ability to manage in everyday life.
    Short-Form Health Survey (SF-36)
    SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.

    Secondary Outcome Measures

    Fear-Avoidance Beliefs Questionnaire
    It consist of two scales; Scale 1: fear-avoidance beliefs about work Scale 2: fear-avoidance beliefs about physical activity
    Active range of motion of lumbar spine.
    It includes; lumbar flexion lumbar extension left lateral flexion right lateral flexion

    Full Information

    First Posted
    August 12, 2018
    Last Updated
    August 12, 2018
    Sponsor
    Isra University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03631082
    Brief Title
    Effects of Slump Stretching vs Lumbar Mobilization With Exercises in Relieving Non-radiculating Low Back Pain
    Official Title
    Effects of Slump Stretching vs Lumbar Mobilization With Exercises in Relieving Non-radiculating Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2018 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    January 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Isra University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will be conducted to determine the effects of slump stretching vs lumbar mobilization with exercises in relieving non-radiculating low back pain. There will be two groups; Group I will receive Slump stretching along with standardized exercises and Group II will receive Lumbar mobilizations along with standardized exercises.
    Detailed Description
    Physical therapist commonly examines and treats patients with low back pain. For this purpose, they utilize a wide range of interventions for the management of Low back pain. The rhythmical movement is thought to modulate pain and muscle spasm by stimulating receptors within the mobilized structures while, In recent years, neurodynamic test procedures, have also been used as interventions to potentially resolve abnormal physiology within the nervous system. So for this purpose not only the present study can provide an additional evidence to the literature but also can can also demonstrates a structured Physiotherapy plan for treating the Non-Radiculating Low back pain

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    effects, slump stretching, lumbar mobilization, non radiculating, Low back pain, exercises, quality of life, modified oswestry low back pain disability, numeric pain rating scale, fear avoidance beliefs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The two groups will be Slump stretching group and Lumbar mobilization group. All physical therapy techniques in both groups will be applied 3 times in a week up to 2 weeks with each session consisting of 25-40 minutes. Group 1 will receive slump stretching along with standardized exercises while group 2 will recieve lumbar mobilization along with standardized exercises. Demographic details of the patients will be collected at baseline (1st Visit) while Modified Oswestry Low Back Pain Disability Questionnaire,Numeric pain rating scale,Fear-Avoidance Beliefs Questionnaire,Active range of motion (AROM) of lumbar spine and Short-Form Health Survey (SF-36) will be measured at baseline, 1st week, and final week.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Slump stretching group
    Arm Type
    Experimental
    Arm Description
    Slump stretching will be performed with the patient in the long sitting position. The position will be held for 30 seconds. A total of 5 repetitions will be completed. Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, and quadruped alternate arms/legs activities as described by Cleland et al. Patients will perform 10 repetitions of each exercise.
    Arm Title
    Lumbar mobilization group
    Arm Type
    Active Comparator
    Arm Description
    Maitland Grade 1 - 2 Posterior to anterior lumbar spine mobilization will be applied for 30 - 45 seconds for all segments through L1 to L5 at rate of 1 oscillation per 2 seconds. Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, quadruped alternate arms/legs activities as described by Cleland et al. Patients will perform 10 repetitions of each exercise.
    Intervention Type
    Other
    Intervention Name(s)
    Slump stretching
    Intervention Description
    Slump stretching will be provided to this group along with standardized exercises.
    Intervention Type
    Other
    Intervention Name(s)
    Lumbar mobilization
    Intervention Description
    Lumbar mobilizations will be provided to this group along with standardized exercises.
    Primary Outcome Measure Information:
    Title
    Numeric pain rating scale
    Description
    On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.
    Time Frame
    2 weeks
    Title
    Modified Oswestry Low Back Pain Disability Questionnaire
    Description
    The questionnaire has been designed to give the therapist information as to how the back pain has affected the ability to manage in everyday life.
    Time Frame
    2 weeks
    Title
    Short-Form Health Survey (SF-36)
    Description
    SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Fear-Avoidance Beliefs Questionnaire
    Description
    It consist of two scales; Scale 1: fear-avoidance beliefs about work Scale 2: fear-avoidance beliefs about physical activity
    Time Frame
    2 weeks
    Title
    Active range of motion of lumbar spine.
    Description
    It includes; lumbar flexion lumbar extension left lateral flexion right lateral flexion
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals with Non-Radiculating Low back pain Test: i. Slump test=positive ii. Straight leg raise=negative Exclusion Criteria: Individuals with Radiculating Low Back pain,History of spinal surgery, Disc herniation,Pregnant women, Major diseases (e.g. stroke)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of Slump Stretching vs Lumbar Mobilization With Exercises in Relieving Non-radiculating Low Back Pain

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