Diabetic NeuropathyNCT05250999
Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy
A study testing Skin stretch sensory stimuli and Transcutaneous Electrical nerve stimulation in people with Diabetic Neuropathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the research was to find and compare the effects of skin stretch sensory stimuli and transcutaneous electrical nerve stimulation (TENS) on balance in diabetic neuropathy. Randomized controlled trial done at District Headquarter hospital Okara. The sample size was 46. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Skin stretch sensory stimuli and Transcutaneous Electrical nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2021to 15 Dec 2021
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants age ranged from 45 to 80 years' old
- Both genders.
- patients with moderate peripheral neuropathy 9-11 on Toronto Clinical Neuropathy Scoring system
- HbA1c levels
- peripheral neuropathic pain of >6 months' duration involving the lower extremities
- history of diabetes treated with diet, oral hypoglycemic or insulin therapy
Show all 9Show fewer
- lower extremity symptoms such as muscle pain, decrease in sensations, Achilles tendon reflex, joint position sense of thumb
- Sensory polyneuropathy because of type 2 diabetic diseases
- Ability to walk household distance without assistance or with the use of assistive device such as cane.
Who cannot join
- Considerable musculoskeletal deformity such as fracture, amputation, abnormality of ROM.
- Previous history of knee or back surgery
- Lower extremity arthritis that prevents standing
- History of cardiovascular problems such as angina, MI
- Symptomatic postural hypotension
- Foot ulceration.
- Skin problems such as rashes etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Skin Stretch Sensory Stimuli and Transcutaneous Electrical Nerve Stimulation on Balance in Patients With Diabetic Neuropathy
The aim of the research was to find and compare the effects of skin stretch sensory stimuli and transcutaneous electrical nerve stimulation (TENS) on balance in diabetic neuropathy. Randomized controlled trial done at District Headquarter hospital Okara. The sample size was 46. The subjects were divided into 3 groups, 15 subjects in skin stretch sensory stimuli group, 15 subjects in TENS group and 16 subjects in control group. Study duration was of 6 month. Sampling technique applied was convenient non-probability sampling. Patients aged range from 45 to 80 years, having moderate peripheral neuropathy, and decrease sensations were included. Tools used in this study were Berg Balance scale and Toronto clinical neuropathy score system. Data was being analyzed through Spss 21.
Read the detailed description
Literature shows that various studies was done on diabetic patients for pain reduction, increase proprioception, improve muscle function and muscle recruitment by using kinesio tape and transcutaneous electrical nerve stimulation. There is particularly limited literature available on the effects of skin stretch sensory stimuli on balance in DN patients. Therefore, based on the literature study, there is crucial need for studying the effects of skin stretch sensory stimuli and TENS as a treatment approach. Thus, the current study will be an attempt to know the results of skin stretch sensory stimuli and TENS in DN patients.
- Conditions
- Diabetic Neuropathy
- Being tested
- Skin stretch sensory stimuli, Transcutaneous Electrical nerve stimulation, Control Group
- Keywords
- Diabetic Neuropathy, TENS, Kinesiotape, Balance
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin stretch sensory stimuliOther
Skin stretch sensory stimuli will be exerted by a piece of kinesio tape that as applied above right and left lateral malleolus on posterior leg and on both side of spinous process of second thoracic vertebrae till 15cm below for 24 hours a day, 5 days/ week for 6 weeks along with conventional physiotherapy.
Transcutaneous Electrical nerve stimulationOther
TENS will be applied to patient while in sitting position for 30 minutes, twice a week, and for 6 weeks (12 treatment sessions along with conventional physiotherapy). A maximum of 25 m amp electrical stimulation with a biphasic square-wave pattern and a pulse width of 0.5ms in a continuous duty cycle will be used. The intensity of the electrical stimulation will be regulated to the high tolerable level without initiating muscle contractions.
Control GroupOther
This program include balance exercises performed twice a week for 6 weeks, which consists of balance, progressive strength, and functional mobility training. Static exercise consists of heel and toe raises, one-legged stance for each limb, weight shifting forward, backward, sideward and diagonally, and turning the head to the left and then to the right keeping the feet together. This exercise comprises two 10-min sessions each, with eyes opened and eyes closed, respectively. Dynamic exercise comprises of walking, step-ups, and bipedal jumps for 10 min. Progressive balance exercises comprises of narrow walking, walking backward, walking sideward, stepping over obstacles, passing, throwing and catching a ball.
| Study group | Role | What they receive |
|---|---|---|
| Skin stretch sensory stimuli | Experimental | Skin stretch sensory stimuli along with conventional physiotherapy Receives: Other: Skin stretch sensory stimuli |
| Transcutaneous Electrical Nerve Stimulation | Experimental | Transcutaneous electrical nerve stimulation along with conventional physiotherapy Receives: Other: Transcutaneous Electrical nerve stimulation |
| Control Group | Active comparator | Conventional physiotherapy included balance exercises, static exercise and dynamic exercise. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Berg balance scale is used to quantitively evaluate functional balance in older patients with balance disorders. It is a reliable, valid and sensitive to change scale, that include 14 items, maximum score 56 and required 20-40 minutes for completion. The score showed the patient's ability to control postural balance in which maximum score showed a good functional balance.
Measured: 6th week
Toronto Clinical Neuropathy scoring system
TCNS is a sensitive scoring system to diagnose diabetic neuropathy. The Toronto Clinical Neuropathy Score (TCNS) is for the diagnosis and staging of diabetic neuropathy. The score ranges from a minimum of 0 (no neuropathy) to a maximum of 19 points, and incorporates sensory and motor symptoms, as well lower limb sensory and reflex findings, and symptoms such as numbness, tingling, pain, weakness, ataxia and upper limb symptoms.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start15 Jul 2021
- Primary completion15 Sep 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Aabroo, PPDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250999
- Sponsor's protocol ID
- REC/Lhr/21/0213 Sobia Younas
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- 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 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Skin Stretch Sensory Stimuli and Transcutaneous Electrical Nerve Stimulation on Balance in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05250999
- Acronym / sponsor ID
- REC/Lhr/21/0213 Sobia Younas
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetic Neuropathy, TENS, Kinesiotape, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 22 Feb 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.
The aim of the research was to find and compare the effects of skin stretch sensory stimuli and transcutaneous electrical nerve stimulation (TENS) on balance in diabetic neuropathy. Randomized controlled trial done at District Headquarter hospital Okara. The sample size was 46. The subjects were divided into 3 groups, 15 subjects in skin stretch sensory stimuli group, 15 subjects in TENS group and 16 subjects in control group. Study duration was of 6 month. Sampling technique applied was convenient non-probability sampling. Patients aged range from 45 to 80 years, having moderate peripheral neuropathy, and decrease sensations were included. Tools used in this study were Berg Balance scale and Toronto clinical neuropathy score system. Data was being analyzed through Spss 21.
Detailed description
Literature shows that various studies was done on diabetic patients for pain reduction, increase proprioception, improve muscle function and muscle recruitment by using kinesio tape and transcutaneous electrical nerve stimulation. There is particularly limited literature available on the effects of skin stretch sensory stimuli on balance in DN patients. Therefore, based on the literature study, there is crucial need for studying the effects of skin stretch sensory stimuli and TENS as a treatment approach. Thus, the current study will be an attempt to know the results of skin stretch sensory stimuli and TENS in DN patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skin stretch sensory stimuli | Experimental | Other: Skin stretch sensory stimuliSkin stretch sensory stimuli along with conventional physiotherapy |
| Transcutaneous Electrical Nerve Stimulation | Experimental | Other: Transcutaneous Electrical nerve stimulationTranscutaneous electrical nerve stimulation along with conventional physiotherapy |
| Control Group | Active comparator | Other: Control GroupConventional physiotherapy included balance exercises, static exercise and dynamic exercise. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- participants age ranged from 45 to 80 years' old
- Both genders.
- patients with moderate peripheral neuropathy 9-11 on Toronto Clinical Neuropathy Scoring system
- HbA1c levels
- peripheral neuropathic pain of >6 months' duration involving the lower extremities
Key exclusion criteria (7 listed)
- Considerable musculoskeletal deformity such as fracture, amputation, abnormality of ROM.
- Previous history of knee or back surgery
- Lower extremity arthritis that prevents standing
- History of cardiovascular problems such as angina, MI
- Symptomatic postural hypotension
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 |
|---|---|---|
| Skin stretch sensory stimuliSkin stretch sensory stimuli will be exerted by a piece of kinesio tape that as applied above right and left lateral malleolus on posterior leg and on both side of spinous process of second thoracic vertebrae till 15cm below for 24 hours a day, 5 days/ week for 6 weeks along with conventional physiotherapy. | Other | Skin stretch sensory stimuli |
| Transcutaneous Electrical nerve stimulationTENS will be applied to patient while in sitting position for 30 minutes, twice a week, and for 6 weeks (12 treatment sessions along with conventional physiotherapy). A maximum of 25 m amp electrical stimulation with a biphasic square-wave pattern and a pulse width of 0.5ms in a continuous duty cycle will be used. The intensity of the electrical stimulation will be regulated to the high tolerable level without initiating muscle contractions. | Other | Transcutaneous Electrical Nerve Stimulation |
| Control GroupThis program include balance exercises performed twice a week for 6 weeks, which consists of balance, progressive strength, and functional mobility training. Static exercise consists of heel and toe raises, one-legged stance for each limb, weight shifting forward, backward, sideward and diagonally, and turning the head to the left and then to the right keeping the feet together. This exercise comprises two 10-min sessions each, with eyes opened and eyes closed, respectively. Dynamic exercise comprises of walking, step-ups, and bipedal jumps for 10 min. Progressive balance exercises comprises of narrow walking, walking backward, walking sideward, stepping over obstacles, passing, throwing and catching a ball. | Other | Control Group |
Primary outcome
Berg Balance Scale
Time frame: 6th week
Berg balance scale is used to quantitively evaluate functional balance in older patients with balance disorders. It is a reliable, valid and sensitive to change scale, that include 14 items, maximum score 56 and required 20-40 minutes for completion. The score showed the patient's ability to control postural balance in which maximum score showed a good functional balance.
Toronto Clinical Neuropathy scoring system
Time frame: 6th week
TCNS is a sensitive scoring system to diagnose diabetic neuropathy. The Toronto Clinical Neuropathy Score (TCNS) is for the diagnosis and staging of diabetic neuropathy. The score ranges from a minimum of 0 (no neuropathy) to a maximum of 19 points, and incorporates sensory and motor symptoms, as well lower limb sensory and reflex findings, and symptoms such as numbness, tingling, pain, weakness, ataxia and upper limb symptoms.
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 22 Feb 2022.
- 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.
Sara Aabroo, PPDPT 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 Skin stretch sensory stimuli and Transcutaneous Electrical nerve stimulation in people with Diabetic Neuropathy, 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 9 inclusion and 7 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 22 Feb 2022. 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?
Berg Balance Scale (time frame: 6th week). 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?
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 22 Feb 2022.