Pain, NeuropathicNCT04721847
Pain Neuroscience Education in Diabetic Neuropathy
A study testing Pain Neuroscience Education and Conventional Physical therapy in people with Pain, Neuropathic and Diabetic Nephropathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Pain, Neuropathic, Diabetic Nephropathy
- What is being tested?
- Pain Neuroscience Education and Conventional Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Aug 2020to 31 Aug 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of diabetic ≥ 5 years
- HbA1C higher and equal to 6.5 %
- Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) ≥ 12
- Mini Mental State Examination (MMSE) score ≥ 24
Who cannot join
- Known neurological disorder
- Foot ulcers/candidate of amputation
- Hearing impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pain Neuroscience Education in Diabetic Neuropathy
To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy
Read the detailed description
Pain neuroscience education (PNE) has shown to have immediate effects on various clinical signs and symptoms associated with central sensitization. Using a model of (innocuous, noxious and allodynia) PNE can be used in combination with exercise therapy, especially treating patients in which the nervous system has become increasingly hypervigilant. Teaching patients about the neuroscience of pain and lead to healthier and more positive attitudes and beliefs regarding chronic pain. Pain in diabetic neuropathy restrict the activity participation and compromise their quality of life. PNE will be helpful in such patients so decreasing pain can improve their quality of life.
- Conditions
- Pain, Neuropathic, Diabetic Nephropathy
- Being tested
- Pain Neuroscience Education, Conventional Physical therapy
- Keywords
- Pain, Neuropathy, Diabetes
- Medical subject headings
- Neuralgia, Diabetic Nephropathies, Pain, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
In first part educational content will be designed to be given in group of patients in six sessions by PNE booklet. The six sessions are 1.5 hours long (9 hours) and will be given at a frequency of 1 session per week. Final session will be given to solve doubts, and to provide additional information to the educational program. Book for additional material will be delivered to participants.
Conventional Physical therapyOther
Control group will be treated by Conventional Physical therapy like TENS, stretching and strengthening exercises. Intervention will be initiated with warm up period (joint mobility exercises) for the duration of 5 mins and ended up with cool down period (relaxing exercises i.e. deep breathing) for the duration of 5 mins.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education | Experimental | Pain Neuroscience Education (PNE) sessions. Additionally, treated with Transcutaneous Electrical Nerve Stimulation (TENS), Stretching and Strengthening exercises similar as in control group Receives: Other: Pain Neuroscience Education |
| Conventional Physical therapy | Active comparator | Control group will be treated by TENS, stretching and strengthening exercises. Receives: Other: Conventional Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation.
Measured: 6 weeks
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
Total score is 24. If score < 12, neuropathic mechanisms are unlikely to be contributing to the patient's pain. If score ≥ 12, neuropathic mechanisms are likely to be contributing to the patient's pain. The S-LANSS has Cronbach α of .76 when completed unaided rising to α=.81 in neuropathic pain so this is reliable tool.
Measured: 6 weeks
Secondary outcomes (1)
Diabetic peripheral neuropathic pain impact measure
18 item DPNI is a reliable and valid Patient rating outcome measure disease impacts and treatment for DNP. Internal consistency ranged from 0.91 to 0.96 and test - retest from 0.84 to 0.91. All prespecified hypothesis for convergent and discriminant validity were met.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start13 Aug 2020
- Primary completion28 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeuropathicStudies 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
- 74 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
- NCT04721847
- Sponsor's protocol ID
- REC/00752 Rameeza Warraich
- Status last verified
- Sep 2021
- First submitted
- 19 Jan 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain Neuroscience Education in Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT04721847
- Acronym / sponsor ID
- REC/00752 Rameeza Warraich
- Conditions
- Pain, Neuropathic, Diabetic Nephropathy
- Keywords
- Pain, Neuropathy, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 25 Jan 2021 (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.
To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy
Detailed description
Pain neuroscience education (PNE) has shown to have immediate effects on various clinical signs and symptoms associated with central sensitization. Using a model of (innocuous, noxious and allodynia) PNE can be used in combination with exercise therapy, especially treating patients in which the nervous system has become increasingly hypervigilant. Teaching patients about the neuroscience of pain and lead to healthier and more positive attitudes and beliefs regarding chronic pain. Pain in diabetic neuropathy restrict the activity participation and compromise their quality of life. PNE will be helpful in such patients so decreasing pain can improve their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education | Experimental | Other: Pain Neuroscience EducationPain Neuroscience Education (PNE) sessions. Additionally, treated with Transcutaneous Electrical Nerve Stimulation (TENS), Stretching and Strengthening exercises similar as in control group |
| Conventional Physical therapy | Active comparator | Other: Conventional Physical therapyControl group will be treated by TENS, stretching and strengthening exercises. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of diabetic ≥ 5 years
- HbA1C higher and equal to 6.5 %
- Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) ≥ 12
- Mini Mental State Examination (MMSE) score ≥ 24
Key exclusion criteria (3 listed)
- Known neurological disorder
- Foot ulcers/candidate of amputation
- Hearing impaired
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 |
|---|---|---|
| Pain Neuroscience EducationIn first part educational content will be designed to be given in group of patients in six sessions by PNE booklet. The six sessions are 1.5 hours long (9 hours) and will be given at a frequency of 1 session per week. Final session will be given to solve doubts, and to provide additional information to the educational program. Book for additional material will be delivered to participants. | Other | Pain Neuroscience Education |
| Conventional Physical therapyControl group will be treated by Conventional Physical therapy like TENS, stretching and strengthening exercises. Intervention will be initiated with warm up period (joint mobility exercises) for the duration of 5 mins and ended up with cool down period (relaxing exercises i.e. deep breathing) for the duration of 5 mins. | Other | Conventional Physical therapy |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: 6 weeks
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation.
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
Time frame: 6 weeks
Total score is 24. If score < 12, neuropathic mechanisms are unlikely to be contributing to the patient's pain. If score ≥ 12, neuropathic mechanisms are likely to be contributing to the patient's pain. The S-LANSS has Cronbach α of .76 when completed unaided rising to α=.81 in neuropathic pain so this is reliable tool.
1 secondary outcome
Diabetic peripheral neuropathic pain impact measure
Time frame: 6 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 23 Sep 2021.
- 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 Pain Neuroscience Education and Conventional Physical therapy in people with Pain, Neuropathic and Diabetic Nephropathy, 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 4 inclusion and 3 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 23 Sep 2021. 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?
Numeric pain rating scale (NPRS) (time frame: 6 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?
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 23 Sep 2021.