Diabetic Peripheral Neuropathic PainNCT05349357
Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy
A study testing Sliding Neural mobilization, Tensioner Neural mobilization and Stretching exercises in people with Diabetic Peripheral Neuropathic Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Neurodynamics, i.e., the mobilization of the peripheral nervous system, is a physical approach to the treatment of pain; the method relies on influencing pain physiology via mechanical treatment of neural tissues and the non-neural structures surrounding the nervous system. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- Sliding Neural mobilization, Tensioner Neural mobilization and Stretching exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jun 2022to 28 Feb 2023
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient having≥12score on Self report Leads Assessment of Neuropathic Symptoms and Sign
- Patients with lower limb pain ≥4 to ≤7 on NPRS
Who cannot join
- Diabetic foot ulcer
- Complex regional pain syndrome
- Infection in lower limb
- Lower extremity amputation
- Discogenic pain
- Restricted joint deformity
- Dependency on chemical or drugs
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Effects of Sliding With Tensioner Technique of Neural Mobilization in Diabetic Peripheral Neuropathy Patients
Neurodynamics, i.e., the mobilization of the peripheral nervous system, is a physical approach to the treatment of pain; the method relies on influencing pain physiology via mechanical treatment of neural tissues and the non-neural structures surrounding the nervous system. Neural mobilization (NM) is used to treat various disorders of the nervous system concerning the length and mobility of peripheral nerves, as the nerve mobilizing refers to techniques that help to reestablish motion between a nerve and its surrounding soft tissues, thus to treat the nerves that have become entangled within the soft tissue, as it leads to tension release on a nerve by stretching and pulling one end of the nerve during keeping the other end in a relaxed state.
Read the detailed description
The neurodynamic technique both sliders and tensioners results in changes of the mechanical or physiological function of nerve tissues along with the interface; restoring pressure gradients, relieving hypoxia and pain resulting in reducing associated symptoms.
Through clinical reasoning the nervous system seems to be the logical place for treatment and explanations and previous descriptions of this method have clarified the overall impact on quality of life in diabetic peripheral neuropathy but it doesn't discuss which technique of neural mobilization is more effective and its effects on diabetic peripheral neuropathic population. Within this reasoning it is important to determine which neurodynamic technique is more effective in improving quality of life and reduce pain in patients with diabetic peripheral neuropathy.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- Sliding Neural mobilization, Tensioner Neural mobilization, Stretching exercises, TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sliding Neural mobilizationOther
Sliding neural mobilization to femoral, sciatic and tibial nerve
Tensioner Neural mobilizationOther
Tensioner neural mobilization to femoral, sciatic and tibial nerve
Stretching exercisesOther
Stretching exercises
TENSDevice
TENS
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | TENS, Stretching exercises, ROM exercises Sliding neural mobilization to femoral, sciatic, tibial nerve Receives: Other: Sliding Neural mobilization; Other: Stretching exercises; Device: TENS |
| Group B | Active comparator | TENS, Stretching exercises, ROM exercises Tensioner neural mobilization to femoral, sciatic, tibial nerve Receives: Other: Tensioner Neural mobilization; Other: Stretching exercises; Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan neuropathy screening instrument
For screening the neuropathy; The MNSI questionnaire is self-administered. Responses are added to obtain a total score. 'Yes' responses to questions 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. 'No' responses to questions 7 and 13 each count as one point. Question 4 was considered to be a measure of impaired circulation and question 10 a measure of general asthenia and were not included in the published scoring algorithm. A score of ≥ 7 was considered abnormal. All 15 questions were included in the new scoring algorithms.
Measured: 3 weeks
Numerical Pain Rating Scale
Quantify the pain ranging from 0 to 10 in which zero means no pain and 10 severe pain
Measured: 3 weeks
Secondary outcomes (1)
Quality of Life SF-36
to assess the quality of life, SF-36 ; Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start25 Jun 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT(NMR), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349357
- Sponsor's protocol ID
- REC01253 Aaseya Syed
- Status last verified
- Mar 2023
- First submitted
- 15 Apr 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
PubMed 27999003Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.
PubMed 29709457Feldman EL, Nave KA, Jensen TS, Bennett DLH. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22;93(6):1296-1313. doi: 10.1016/j.neuron.2017.02.005.
PubMed 28334605Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
PubMed 29496507
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effects of Sliding With Tensioner Technique of Neural Mobilization in Diabetic Peripheral Neuropathy Patients
- ClinicalTrials.gov ID
- NCT05349357
- Acronym / sponsor ID
- REC01253 Aaseya Syed
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 27 Apr 2022 (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.
Neurodynamics, i.e., the mobilization of the peripheral nervous system, is a physical approach to the treatment of pain; the method relies on influencing pain physiology via mechanical treatment of neural tissues and the non-neural structures surrounding the nervous system. Neural mobilization (NM) is used to treat various disorders of the nervous system concerning the length and mobility of peripheral nerves, as the nerve mobilizing refers to techniques that help to reestablish motion between a nerve and its surrounding soft tissues, thus to treat the nerves that have become entangled within the soft tissue, as it leads to tension release on a nerve by stretching and pulling one end of the nerve during keeping the other end in a relaxed state.
Detailed description
The neurodynamic technique both sliders and tensioners results in changes of the mechanical or physiological function of nerve tissues along with the interface; restoring pressure gradients, relieving hypoxia and pain resulting in reducing associated symptoms.
Through clinical reasoning the nervous system seems to be the logical place for treatment and explanations and previous descriptions of this method have clarified the overall impact on quality of life in diabetic peripheral neuropathy but it doesn't discuss which technique of neural mobilization is more effective and its effects on diabetic peripheral neuropathic population. Within this reasoning it is important to determine which neurodynamic technique is more effective in improving quality of life and reduce pain in patients with diabetic peripheral neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Sliding Neural mobilization, Other: Stretching exercises, Device: TENSTENS, Stretching exercises, ROM exercises Sliding neural mobilization to femoral, sciatic, tibial nerve |
| Group B | Active comparator | Other: Tensioner Neural mobilization, Other: Stretching exercises, Device: TENSTENS, Stretching exercises, ROM exercises Tensioner neural mobilization to femoral, sciatic, tibial nerve |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient having≥12score on Self report Leads Assessment of Neuropathic Symptoms and Sign
- Patients with lower limb pain ≥4 to ≤7 on NPRS
Key exclusion criteria (8 listed)
- Diabetic foot ulcer
- Complex regional pain syndrome
- Infection in lower limb
- Lower extremity amputation
- Discogenic pain
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 |
|---|---|---|
| Sliding Neural mobilizationSliding neural mobilization to femoral, sciatic and tibial nerve | Other | Group A |
| Tensioner Neural mobilizationTensioner neural mobilization to femoral, sciatic and tibial nerve | Other | Group B |
| Stretching exercisesStretching exercises | Other | Group A, Group B |
| TENSTENS | Device | Group A, Group B |
Primary outcome
Michigan neuropathy screening instrument
Time frame: 3 weeks
For screening the neuropathy; The MNSI questionnaire is self-administered. Responses are added to obtain a total score. 'Yes' responses to questions 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. 'No' responses to questions 7 and 13 each count as one point. Question 4 was considered to be a measure of impaired circulation and question 10 a measure of general asthenia and were not included in the published scoring algorithm. A score of ≥ 7 was considered abnormal. All 15 questions were included in the new scoring algorithms.
Numerical Pain Rating Scale
Time frame: 3 weeks
Quantify the pain ranging from 0 to 10 in which zero means no pain and 10 severe pain
1 secondary outcome
Quality of Life SF-36
Time frame: 3 weeks
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 9 Mar 2023.
- Background: PubMed 27999003Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
- Background: PubMed 29709457Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.
- Background: PubMed 28334605Feldman EL, Nave KA, Jensen TS, Bennett DLH. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22;93(6):1296-1313. doi: 10.1016/j.neuron.2017.02.005.
- Background: PubMed 29496507Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
- 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.
Mirza Obaid Baig, MSPT(NMR) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sliding Neural mobilization, Tensioner Neural mobilization and Stretching exercises in people with Diabetic Peripheral Neuropathic Pain, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 8 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 9 Mar 2023. 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 Pakistan. 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?
Michigan neuropathy screening instrument (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349357, which also lists 4 linked publications.
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 9 Mar 2023.