Neuropathic PainNCT03299114
WHIRLPOOL FOR OSTEOARHRITIS
A study testing Whirlpool in people with Neuropathic Pain and Osteo Arthritis Knee, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims: The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain, Osteo Arthritis Knee, Sleep Disorder
- What is being tested?
- Whirlpool
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2015to 1 Jan 2016
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- suffering from knee pain at least 3 months
- radiological manifestations considering were consistent with grade 3 and 4 knee OA due to Kellgren and Lawrence criteria had DN4 scores ≥4.
Who cannot join
- lower extremity surgery history, knee infection inflammatory disease like rheumatoid arthritis back or pelvic pain related with knee pain another cause of polyneuropathy (diabetes mellitus, vitamin B 12 deficiency, toxic or neurological disease like stroke, spinal cord injury) lumbar disc herniation malignancy or active systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECTIVENESS OF WHIRLPOOL FOR PATIENTS WITH NEUROPATHIC PAIN DUE TO KNEE OSTEOARTHRITIS
Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims: The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.
Read the detailed description
Whirlpool treatment method is used for medical and surgical conditions. In literature there are studies which recommend whirlpool therapy as a treatment for reducing pain in patients with osteoarthritis. The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.
- Conditions
- Neuropathic Pain, Osteo Arthritis Knee, Sleep Disorder
- Being tested
- Whirlpool
- Keywords
- Neuropathic Pain, Whirlpool, Osteoarthritis, Sleep
- Medical subject headings
- Neuralgia, Sleep Wake Disorders, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhirlpoolOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Treated with warm whirlpool Receives: Other: Whirlpool |
| Placebo group | Placebo comparator | Treated with sham whirlpool Receives: Other: Whirlpool |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
Measured: one month
Secondary outcomes (4)
Short Form-36 Health Survey
Measured: one month
Western Ontario and McMaster Universities Osteoarthritis Index
Measured: one month
Pittsburgh Sleep Quality Index (PSQI)
Measured: one month
DN4
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Nov 2015
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASLIHAN UZUNKULAOGLU, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299114
- Sponsor's protocol ID
- 30112015-6
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 2 Oct 2017
- 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 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTIVENESS OF WHIRLPOOL FOR PATIENTS WITH NEUROPATHIC PAIN DUE TO KNEE OSTEOARTHRITIS
- ClinicalTrials.gov ID
- NCT03299114
- Acronym / sponsor ID
- 30112015-6
- Conditions
- Neuropathic Pain, Osteo Arthritis Knee, Sleep Disorder
- Keywords
- Neuropathic Pain, Whirlpool, Osteoarthritis, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 2 Oct 2017 (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.
Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims: The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.
Detailed description
Whirlpool treatment method is used for medical and surgical conditions. In literature there are studies which recommend whirlpool therapy as a treatment for reducing pain in patients with osteoarthritis. The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: WhirlpoolTreated with warm whirlpool |
| Placebo group | Placebo comparator | Other: WhirlpoolTreated with sham whirlpool |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suffering from knee pain at least 3 months
- radiological manifestations considering were consistent with grade 3 and 4 knee OA due to Kellgren and Lawrence criteria had DN4 scores ≥4.
Key exclusion criteria (1 listed)
- lower extremity surgery history, knee infection inflammatory disease like rheumatoid arthritis back or pelvic pain related with knee pain another cause of polyneuropathy (diabetes mellitus, vitamin B 12 deficiency, toxic or neurological disease like stroke, spinal cord injury) lumbar disc herniation malignancy or active systemic disease.
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 |
|---|---|---|
| Whirlpool | Other | Intervention Group, Placebo group |
Primary outcome
visual analogue scale
Time frame: one month
4 secondary outcomes
Short Form-36 Health Survey
Time frame: one month
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: one month
Pittsburgh Sleep Quality Index (PSQI)
Time frame: one month
DN4
Time frame: one month
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 2 Oct 2017.
- 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 Whirlpool in people with Neuropathic Pain and Osteo Arthritis Knee, run by Ufuk 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 2 inclusion and 1 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 2 Oct 2017. 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. Some participants in this study may receive a placebo. 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 analogue scale (time frame: one month). 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 2 Oct 2017.