CompletedNCT03299114Updated Oct 2, 2017

WHIRLPOOL FOR OSTEOARHRITIS

An interventional study of Whirlpool in Neuropathic Pain, Osteo Arthritis Knee and Sleep Disorder, sponsored by Ufuk University. Completed at 1 site in Turkey. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by Ufuk University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 50 Years to 75 Years
Sex: All

Study 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 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 studied

Neuropathic Pain
Osteo Arthritis Knee
Sleep Disorder

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Keywords

Neuropathic Pain
Whirlpool
Osteoarthritis
Sleep

Who can participate

Ages eligible: 50 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 60 participants (actual)

Study arms

Active comparator
Intervention Group
Treated with warm whirlpool
Other: Whirlpool
Placebo comparator
Placebo group
Treated with sham whirlpool
Other: Whirlpool

Interventions

OtherWhirlpool

What researchers measure

Primary outcomes

visual analogue scale
Time frame: one month

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

Study locations

1 site

Ufuk University
Ankara, 06520, Turkey

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03299114
Lead sponsor: Ufuk University
Responsible party: ASLIHAN UZUNKULAOGLU (Ufuk University, Ufuk University) — Principal investigator
First posted: Oct 2, 2017
Start date: Nov 1, 2015
Primary completion: Jan 1, 2016
Completion: Jan 1, 2016
Last update: Oct 2, 2017

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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