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The Effectiveness of Dry Needling and Classic Physiotherapy Programs in The Patients Suffering From Chronic Low Back Pain Caused by Lumbar Disc Hernia

Primary Purpose

Metabolic Syndrome, Physical Activity, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry Needling Application
Classic Physiotherapy Program
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Nutrition, Public Health

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients among the ages of 35-70,
  • Suffering from LBP for at least 3 months,
  • Diagnosed with LDH having at least 1 active trigger point that can be cooperated .

Exclusion Criteria:

  • Those with LDH that show neurological symptom,
  • Having any orthopaedic problem at lower extremity and lower back region,
  • Having sacroiliac joint problem, diagnosed with lumbar spondylolisthesis,
  • Having any neurologic, rheumatic, oncologic problem,
  • Who received any physiotherapy program at least 6 months before, patients having any corticosteroid treatment or oral medication
  • Those having needle phobia were not included in the trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Dry Needling Application

    Classic Physiotherapy Program

    Arm Description

    Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique. The needles were kept on the body for 20 minutes and at the 10th minute, the needle was rolled and re-stimulation was enabled. The treatment was applied twice a week, which is equal to 6 sessions in total.

    Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again. The period of treatment was 6 sessions in total with 25 minutes of each. Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin.

    Outcomes

    Primary Outcome Measures

    Pain assessed using the Short Form of McGill Pain Questionnaire-Visual Analogue Scale
    The Short Form of McGill Pain Questionnaire-Visual Analogue Scale (MPQ-SF-VAS) was used in order to determine the pain intensity that the investigators use as primary outcome measure in the investigators study.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2016
    Last Updated
    August 11, 2016
    Sponsor
    Eastern Mediterranean University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02865200
    Brief Title
    The Effectiveness of Dry Needling and Classic Physiotherapy Programs in The Patients Suffering From Chronic Low Back Pain Caused by Lumbar Disc Hernia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim: This study was planned for comparing physical activity levels, nutrition quality and quality of life of the individuals that are diagnosed with and without metabolic syndrome (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC). Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic characteristics of the individuals that participated the study were registered with a survey form. The long form of the International Physical Activity Questionnaire was used for determining physical activity levels of the individuals; whereas total numbers of daily steps were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS) was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for the assessment of health-related qualities of life of individuals and Beck Depression Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis and anthropometric measurements of individuals were also taken.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Physical Activity, Quality of Life
    Keywords
    Nutrition, Public Health

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Dry Needling Application
    Arm Type
    Experimental
    Arm Description
    Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique. The needles were kept on the body for 20 minutes and at the 10th minute, the needle was rolled and re-stimulation was enabled. The treatment was applied twice a week, which is equal to 6 sessions in total.
    Arm Title
    Classic Physiotherapy Program
    Arm Type
    Experimental
    Arm Description
    Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again. The period of treatment was 6 sessions in total with 25 minutes of each. Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin.
    Intervention Type
    Other
    Intervention Name(s)
    Dry Needling Application
    Intervention Description
    Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique.
    Intervention Type
    Other
    Intervention Name(s)
    Classic Physiotherapy Program
    Intervention Description
    Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again. Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin.
    Primary Outcome Measure Information:
    Title
    Pain assessed using the Short Form of McGill Pain Questionnaire-Visual Analogue Scale
    Description
    The Short Form of McGill Pain Questionnaire-Visual Analogue Scale (MPQ-SF-VAS) was used in order to determine the pain intensity that the investigators use as primary outcome measure in the investigators study.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients among the ages of 35-70, Suffering from LBP for at least 3 months, Diagnosed with LDH having at least 1 active trigger point that can be cooperated . Exclusion Criteria: Those with LDH that show neurological symptom, Having any orthopaedic problem at lower extremity and lower back region, Having sacroiliac joint problem, diagnosed with lumbar spondylolisthesis, Having any neurologic, rheumatic, oncologic problem, Who received any physiotherapy program at least 6 months before, patients having any corticosteroid treatment or oral medication Those having needle phobia were not included in the trial.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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