免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Clinical Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life
Clinical Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life
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 :
- 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 :
- 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'.
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
| 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 |
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 |
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 |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| 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 |
|
||||
| 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 |
8 | ||||
| Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| 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 |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| 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 |
|||||
