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

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

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

Condition or disease	Intervention/treatment	Phase
Peripheral Neuropathy	Other: Physical therapy and rehabilitation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 18, 2018
• Actual Primary Completion Date: June 5, 2019
• Actual Study Completion Date: June 15, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: lumbal stabilization exercise group	Other: Physical therapy and rehabilitation; Physical therapy and rehabilitation
Experimental: connective tissue massage group	Other: Physical therapy and rehabilitation; Physical therapy and rehabilitation
No Intervention: control group

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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'.
2. 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
3. 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'.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Turkey

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

Ankara, Turkey, 06100

Sponsors and Collaborators

Hacettepe University

More Information

• Responsible Party: burcu şahin, physiotherapist, Hacettepe University
• ClinicalTrials.gov Identifier: NCT03965884
• Other Study ID Numbers: Neuropathic pain
• First Posted: May 29, 2019
• Last Update Posted: October 15, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations