Peripheral NeuropathyNCT03965884
Clinical Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life
A study testing Physical therapy and rehabilitation in people with Peripheral Neuropathy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Physical therapy and rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2018to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed small fiber neuropathy
- Score-4 and over from the -DN4 score
- 18-65 years old adults
- Volunteers to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
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
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
Read the 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.
- Conditions
- Peripheral Neuropathy
- Being tested
- Physical therapy and rehabilitation
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy and rehabilitationOther
Physical therapy and rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| lumbal stabilization exercise group | Experimental | Not described Receives: Other: Physical therapy and rehabilitation |
| connective tissue massage group | Experimental | Not described Receives: Other: Physical therapy and rehabilitation |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six week
Secondary outcomes (3)
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'.
Measured: six week
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
Measured: six week
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'.
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start18 Apr 2018
- Primary completion5 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, burcu şahin, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965884
- Sponsor's protocol ID
- Neuropathic pain
- Status last verified
- Oct 2019
- First submitted
- 12 May 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03965884
- Acronym / sponsor ID
- Neuropathic pain
- Conditions
- Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lumbal stabilization exercise group | Experimental | Other: Physical therapy and rehabilitation |
| connective tissue massage group | Experimental | Other: Physical therapy and rehabilitation |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed small fiber neuropathy
- Score-4 and over from the -DN4 score
- 18-65 years old adults
- Volunteers to participate in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy and rehabilitationPhysical therapy and rehabilitation | Other | connective tissue massage group, lumbal stabilization exercise group |
Primary outcome
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.
3 secondary outcomes
Short Pain Inventory
Time frame: six week
Neuropathic Pain Impact on Quality of Life questionnaire
Time frame: six week
Neuropathic Pain Scale
Time frame: six week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy and rehabilitation in people with Peripheral Neuropathy, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: six week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.