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Clinical Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life

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ClinicalTrials.gov Identifier: NCT03965884
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
burcu şahin, Hacettepe University

Tracking Information
First Submitted Date  ICMJE May 12, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE April 18, 2018
Actual Primary Completion Date June 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
Visual Analog Scale [ Time Frame: six week ]
visual analogue scale measures pain on a horizontal 100mm line. The most left side on this line is defined no pain and the most right side is defined as 'the most severe pain imaginable'. Patients mark a point on the line according to the pain they feel. The pain level is measured in millimeters from the left to the marked point. we evaluate the current pain, the usual pain in the last month, the worst pain in the last month.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2019)
Visual Analog Scale [ Time Frame: six week ]
Evaluate the severity of pain using a visual analog scale which numarate 0 to 10. Evaluate the current pain, the usual pain in the last month, the worst pain in the last month.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Short Pain Inventory [ Time Frame: six week ]
    Short pain inventory consists of 4 questions evaluating pain severity using number 0 to 10 and 7 questions evaluating the effect of pain on function. The questionnaire requires the patient to consider the current, worst, minimum and mean pain intensity by considering the last week. 0 is defined no pain and 10 is defined as 'the most severe pain imaginable'. Patients are also asked to assess how the pain affects overall activity, walking, normal work, relationships with others, mood, sleep, and enjoyment of life. 0 is defined 'pain has no effect on function', and 10 is defined 'pain has the highest effect on function'.
  • Neuropathic Pain Impact on Quality of Life questionnaire [ Time Frame: six week ]
    Neuropathic Pain Impact on Quality of Life questionnaire is a self-reported scale used to assess neuropathic pain and its impact on quality of life. The questionnaire contains 42 items in six parameters; psychological, physical, symptoms, personal care, relationships, and social/work activity. The lowest total score that can be obtained from the questionnaire is 42 and the highest score is 210. Increased total score indicates high quality of life
  • Neuropathic Pain Scale [ Time Frame: six week ]
    Neuropathic Pain Scale is a scale developed to evaluate neuropathic pain quality. The scale includes 2 items that assess the severity of pain and the discomfort of pain, and 8 items that question the character of neuropathic pain. Each item is evaluated with a scale between 0 and 10 points. 0 is defined no pain and 10 is defined as 'the most severe pain imaginable'.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2019)
  • Short Pain Inventory [ Time Frame: six week ]
    The Short Pain Inventory is a questionnaire that determines the presence, severity, character, treatment, response to this treatment and social-emotional effect based on the last 1 week of patients. It is rated between 0 and 10.
  • Neuropathic Pain Impact on Quality of Life questionnaire [ Time Frame: six week ]
    Neuropathic Pain Impact on Quality of Life questionnaire (NePIQoL) is a self-reported scale used to assess neuropathic pain and its impact on quality of life. The questionnaire contains six domains; psychological, physical, symptoms, personal care, relationships, and social/work activity. A high score on the scale indicates an increased level of quality of life.
  • Neuropathic Pain Scale [ Time Frame: six week ]
    The Neuropathic Pain Scale consists of 2 general and 8 specific parameters. General pain will be used to determine the quality of pain, such as localization and quality of pain.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life
Official Title  ICMJE Investigation of the Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life in Patients With Peripheral Neuropathy
Brief Summary The aim of the study is to investigate the efficacy of connective tissue massage and lumbar stabilization exercise treatment on pain severity, functional capacity and quality of life in those who have experienced peripheral neuropathy
Detailed Description

The patients diagnosed with fine fiber neuropathy by the neurology department of hacettepe university will be included and the patients referred to physical therapy will be included.

Patients meeting the inclusion criteria will be randomly divided into 3 groups by simple randomization. The first group consisted of lumbal stabilization exercises, the second group with connective tissue massage and the third group with only medical treatment. All patients will be evaluated 2 times before and after 6 weeks. The treatment will be 2 days per week for 6 weeks. Exercise programs of the patients will be performed under the supervision of physiotherapist. In the first group, lumbal stabilization exercises will be applied for 6 weeks and the second group will be given connective tissue massage.

Statistical analysis of the study will be done using SPSS 21 statistical program.

In the statistical analysis to be carried out within the scope of the study, p value will be selected as 0.05 and p <0.05 will be considered significant. Mean ± standard deviation, number, percentage, minimum and maximum values will be used as descriptive statistics. Wilcoxon test is used to compare the pre- and post-treatment values of the groups in the variables and the Kruskal-Wallis test will be used to compare the groups with each other.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Neuropathy
Intervention  ICMJE Other: Physical therapy and rehabilitation
Physical therapy and rehabilitation
Study Arms  ICMJE
  • Experimental: lumbal stabilization exercise group
    Intervention: Other: Physical therapy and rehabilitation
  • Experimental: connective tissue massage group
    Intervention: Other: Physical therapy and rehabilitation
  • No Intervention: control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2019)
10
Actual Study Completion Date  ICMJE June 15, 2019
Actual Primary Completion Date June 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosed small fiber neuropathy
  • Score-4 and over from the -DN4 score
  • 18-65 years old adults
  • Volunteers to participate in the study.

Exclusion Criteria:

  • Pain from different etiologies
  • Other neurological disorders involved in neuropathy evaluation
  • Cognitive or reading disorders to prevent the questionnaires from being filled
  • People with musculoskeletal or orthopedic disorders that affect exercise will not be included.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965884
Other Study ID Numbers  ICMJE Neuropathic pain
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party burcu şahin, Hacettepe University
Study Sponsor  ICMJE Hacettepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hacettepe University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP