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

Primary Purpose

Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical therapy and rehabilitation
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

lumbal stabilization exercise group

connective tissue massage group

control group

Arm Description

Outcomes

Primary Outcome Measures

Visual Analog Scale
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.

Secondary Outcome Measures

Short Pain Inventory
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
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
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'.

Full Information

First Posted
May 12, 2019
Last Updated
October 11, 2019
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03965884
Brief Title
Clinical Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lumbal stabilization exercise group
Arm Type
Experimental
Arm Title
connective tissue massage group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Physical therapy and rehabilitation
Intervention Description
Physical therapy and rehabilitation
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
six week
Secondary Outcome Measure Information:
Title
Short Pain Inventory
Description
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'.
Time Frame
six week
Title
Neuropathic Pain Impact on Quality of Life questionnaire
Description
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
Time Frame
six week
Title
Neuropathic Pain Scale
Description
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'.
Time Frame
six week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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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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