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Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis

Primary Purpose

Low Back Pain, Postural

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Frog Leg Exercise
Electrotherapy(Transcutaneous Electrical Nerve Stimulator)
Exercise Therapy
Sponsored by
Health Education Research Foundation (HERF)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Postural focused on measuring Low Back Pain, Frog Leg Technique, Exercise Therapy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Females with age between 20 and 45 years Patients with low back ache due to lumbar lordosis Exclusion Criteria: History of surgery Patients with discogenic backache. Backache in pregnancy. Patients with traumatic history. Patients with pain due to any reason other than lumbar lordosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Electrotherapy with Frog Leg Exercise Intervention

    Standard Exercise Therapy with Electrotherapy

    Arm Description

    Experimental group received Frog leg technique along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis.

    Control group received standard exercise therapy treatment along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis.

    Outcomes

    Primary Outcome Measures

    Change in Pain
    Visual Analogue Scale used to assess pain.
    Change in Disability Level
    Oswestry Low Back Pain Disability Questionnaire used to assess level of disability.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 26, 2023
    Last Updated
    July 11, 2023
    Sponsor
    Health Education Research Foundation (HERF)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05945056
    Brief Title
    Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis
    Official Title
    Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2015 (Actual)
    Primary Completion Date
    November 30, 2016 (Actual)
    Study Completion Date
    November 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Health Education Research Foundation (HERF)

    4. Oversight

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

    5. Study Description

    Brief Summary
    Condition in which lumbar region experiences stress or extra weight and is arched to point of muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the effectiveness of frog leg technique and standard exercise therapy in management of low back pain due to lumbar lordosis.
    Detailed Description
    In adult population, a major health problem is Low back pain. Postural change is one of the risk factor. Abnormal posture causes strain on ligaments and muscles, as a result indirectly affects the curvature of the lumbar spine.Condition in which lumbar region experiences stress or extra weight and is arched to point of muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the effectiveness of frog leg technique and standard exercise therapy in management of low back pain due to lumbar lordosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Postural
    Keywords
    Low Back Pain, Frog Leg Technique, Exercise Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Electrotherapy with Frog Leg Exercise Intervention
    Arm Type
    Experimental
    Arm Description
    Experimental group received Frog leg technique along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis.
    Arm Title
    Standard Exercise Therapy with Electrotherapy
    Arm Type
    Active Comparator
    Arm Description
    Control group received standard exercise therapy treatment along with transcutaneous electrical nerve stimulation for 10 sessions of duration half hour each on regular basis.
    Intervention Type
    Other
    Intervention Name(s)
    Frog Leg Exercise
    Intervention Description
    The patient lies supine with legs flexed, knees apart and the soles of the feet put together on couch. The physiotherapist stands at the side of the table, moves one arm between the legs to place the hand under the sacrum and cup it. The fingers spread to accommodate the spinous process of the fifth lumbar vertebra. The tips of the fingers contact and grasp the junction of the fifth lumbar vertebra and the base of the sacrum. This hand will give traction in a caudal direction throughout the procedure to move the sacral base posteriorly and the apex interiorly. patient is asked to take a deep breath and hold it, while at the same time they steadily slide the feet downward toward the end of the table.Then patient brings their legs back to the frog leg position, but as they do so the therapist maintains traction preventing the sacrum from moving cephalad. Procedure is repeated for a total of 8 repetitions.
    Intervention Type
    Other
    Intervention Name(s)
    Electrotherapy(Transcutaneous Electrical Nerve Stimulator)
    Intervention Description
    TENS or transcutaneous electrical nerve stimulator is a low voltage electric current to relieve pain. A small battery-operated TENS device which has leads connected to sticky pads called electrodes was used in treatment. Patient in lying position gets pads directly attached to skin of lumbar region. Small electrical impulses delivered to the affected area of the patient's body when the machine is switched on, which patient feel as a tingling sensation.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise Therapy
    Intervention Description
    Stretching of tight muscles(hip flexors and lower back extensors) Abdominal Curl-Ups and Bridging exercises.
    Primary Outcome Measure Information:
    Title
    Change in Pain
    Description
    Visual Analogue Scale used to assess pain.
    Time Frame
    Data was Collected at Baseline, 5th Day & 10th Day.
    Title
    Change in Disability Level
    Description
    Oswestry Low Back Pain Disability Questionnaire used to assess level of disability.
    Time Frame
    Data was Collected at Baseline, 5th Day & 10th Day.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Females suffer more from lumbar lordosis,hence female participants were selected for study.
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females with age between 20 and 45 years Patients with low back ache due to lumbar lordosis Exclusion Criteria: History of surgery Patients with discogenic backache. Backache in pregnancy. Patients with traumatic history. Patients with pain due to any reason other than lumbar lordosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anam Javed, Master
    Organizational Affiliation
    Bashir Institute of Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis

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