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

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 |
- 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.
- 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'.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965884
Turkey | |
Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation | |
Ankara, Turkey, 06100 |
Responsible Party: | burcu şahin, physiotherapist, Hacettepe University |
ClinicalTrials.gov Identifier: | NCT03965884 |
Other Study ID Numbers: |
Neuropathic pain |
First Posted: | May 29, 2019 Key Record Dates |
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 |
Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Pain Neurologic Manifestations |