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Effect of PNF and Lumbar Stabilization Exercises on Muscle Strength and Endurance in Lumbar Disc Hernia (PNF)

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PNF
lumbar stabilization training
Physical Therapy
Control
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Disc herniation, Endurance, Lumbar stabilization exercise, PNF, Strength

Eligibility Criteria

15 Years - 69 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who were graded as "protrusion and bulging lumbar herniation" according to the Macnab Classification.

Exclusion Criteria:

  • Subjects with acute radicular signs or symptoms and those who had radiographic evidence of inflammatory disease affecting the spine, tumor, fracture, spondylolysis, spondylolisthesis, or scoliosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    lumbar stabilization training

    PNF training

    physical therapy

    control

    Arm Description

    lumbar stabilization training exercises

    PNF training exercises

    HP,TENS US

    NO APPLİCATİON

    Outcomes

    Primary Outcome Measures

    visual analog scale
    . A standard visual analog scale (VAS) was a used to assess pain. The patients graded their low back pain on a 10-point scale, anchored with the descriptors "no pain" at one end and "pain as bad as it could possibly be" at the other. Maximum pain severity was assessed by a blind-testing physician using the standard VAS

    Secondary Outcome Measures

    Oswestry Disability Index
    The Oswestry Disability Questionnare was used to assess pain. The maximum score in this questionnaire is 50, which represents 100% disability.

    Full Information

    First Posted
    August 8, 2018
    Last Updated
    August 28, 2018
    Sponsor
    Baskent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03651440
    Brief Title
    Effect of PNF and Lumbar Stabilization Exercises on Muscle Strength and Endurance in Lumbar Disc Hernia
    Acronym
    PNF
    Official Title
    Effect of PNF and Lumbar Stabilization Exercises on Muscle Strength and Muscle Endurance in Patients With Lumbar Disc Hernia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2014 (Actual)
    Primary Completion Date
    January 1, 2015 (Actual)
    Study Completion Date
    January 1, 2015 (Actual)

    3. Sponsor/Collaborators

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

    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
    Background/Objective: This study investigates the effect of lumbar stabilization and proprioceptive neuromuscular facilitation (PNF) training on muscle strength and muscle endurance. Methods: Sixty-four participants between the ages of 15 and 69 years, graded "protrusion and bulging lumbar herniation" according to the Macnab Classification, were divided into four groups of 16: lumbar stabilization training (strength training, 5 days/week for 4 weeks); PNF training (5 days/week for 4 weeks); physical therapy (hot pack, TENS, ultrasound, 5 days/week for 4 weeks); and control (without any application). Sociodemographic features were recorded and muscle strength tested. Before and after exercise, a visual analog scale (VAS) and Oswestry Disability Index (ODI) were measured by a physical therapist. After 4 weeks, the evaluations were repeated. Results: There were significant increases in muscle strength and muscle endurance in the lumbar stabilization group, who also showed significant improvement in pain intensity at rest and during activity, and in ODI (p<0.05). Similar results were observed in the PNF group (p<0.05), although not to the same extent. Patients undergoing physical therapy showed significant differences only in pain intensity at rest, at activity, and in ODI (p<0.05). Conclusion: Undertaking an appropriate physiotherapy and rehabilitation program aiming to reduce waist circumference of patients with low muscle strength and low muscle endurance will help to increase muscle strength and endurance and reduce pain, and contribute toward the correction of functional disabilities.
    Detailed Description
    Lumbar disc herniation (LDH) is a clinical entity characterized by compression of the spinal nerve roots and resultant back and leg pain. Though uncommon, LDH has been reported as a cause of recurrent low back pain. Although more than 100 risk factors have been identified for LDH, it is difficult to determine a specific etiology. The most important risk factors are intense sporting activity, heavy lifting, frequent rotation of the body, exposure to vibrations, age, tall stature, obesity, smoking, and psychological and genetic factors. It has been shown that in LDH patients; the strength and endurance of the back and abdominal muscles are reduced, and this aspect has been reported as a major predisposing factor for low back pain. Hence, an exercise program as part of conservative treatment of low back pain and after surgery would be of potential benefit for patients. Twomey and Taylor have shown that behavioral and cognitive principles combined with exercise programs can be effective in reducing disability in patients with chronic low back pain. The severity of symptoms in disc herniation depends not only on the amount of herniated disc pressure but also on nervous irritability. To reduce the sensitivity of nerve fibers to pain, symptomatic initiatives that include drugs, physical therapy, and psychological methods can be successful. The primary purpose of physical therapy is control of pain and inflammation, and secondarily to improve symptoms such as stiffness in the joints and muscle spasms. Physical therapy also delivers psychological effects. Agents used in physical therapy are generally administered in a combined regimen. We undertook this study to investigate the effect of lumbar stabilization training and proprioceptive neuromuscular facilitation (PNF) training on muscle strength and muscle endurance. Results The groups showed no difference in demographic and clinical characteristics( p>0.05). When groups' evaluations before and after treatment were compared, statistically significant differences were found in VAS after treatment (at rest), VAS (at activity), Oswestry Disability Index (ODI), abdominal strength, endurance of back extensor, left hip flexion flexibility, sit and reach flexibility, 60°/sec trunk flexion, 90°/sec trunk extension, 90°/sec trunk flexion, 120°/sec trunk flexion, and 120°/sec trunk extension. When pairwise comparisons of groups were conducted, there were significant differences in the stabilization group's ODI, left hip flexion flexibility, sit and reach flexibility, 90°/sec trunk extension, and 90°/sec trunk flexion muscle strength values when compared with values in the PNF group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation
    Keywords
    Disc herniation, Endurance, Lumbar stabilization exercise, PNF, Strength

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    lumbar stabilization training
    Arm Type
    Experimental
    Arm Description
    lumbar stabilization training exercises
    Arm Title
    PNF training
    Arm Type
    Experimental
    Arm Description
    PNF training exercises
    Arm Title
    physical therapy
    Arm Type
    Experimental
    Arm Description
    HP,TENS US
    Arm Title
    control
    Arm Type
    Sham Comparator
    Arm Description
    NO APPLİCATİON
    Intervention Type
    Other
    Intervention Name(s)
    PNF
    Intervention Description
    PNF
    Intervention Type
    Other
    Intervention Name(s)
    lumbar stabilization training
    Intervention Description
    lumbar stabilization training
    Intervention Type
    Other
    Intervention Name(s)
    Physical Therapy
    Intervention Description
    Physical Therapy
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Control group
    Primary Outcome Measure Information:
    Title
    visual analog scale
    Description
    . A standard visual analog scale (VAS) was a used to assess pain. The patients graded their low back pain on a 10-point scale, anchored with the descriptors "no pain" at one end and "pain as bad as it could possibly be" at the other. Maximum pain severity was assessed by a blind-testing physician using the standard VAS
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Oswestry Disability Index
    Description
    The Oswestry Disability Questionnare was used to assess pain. The maximum score in this questionnaire is 50, which represents 100% disability.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects who were graded as "protrusion and bulging lumbar herniation" according to the Macnab Classification. Exclusion Criteria: Subjects with acute radicular signs or symptoms and those who had radiographic evidence of inflammatory disease affecting the spine, tumor, fracture, spondylolysis, spondylolisthesis, or scoliosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    mitat koz, Prof.Dr.
    Organizational Affiliation
    Ankara University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    nilay comuk balcı, Assoc. Prof
    Organizational Affiliation
    Baskent University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    nuri çetin, MD.Prof.Dr.
    Organizational Affiliation
    Baskent University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    atakan yılmaz, Pt
    Organizational Affiliation
    Baskent University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of PNF and Lumbar Stabilization Exercises on Muscle Strength and Endurance in Lumbar Disc Hernia

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