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WHIRLPOOL FOR OSTEOARHRITIS

Primary Purpose

Neuropathic Pain, Osteo Arthritis Knee, Sleep Disorder

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Whirlpool

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic Pain, Whirlpool, Osteoarthritis, Sleep

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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.

Sites / Locations

Ufuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group

Placebo group

Arm Description

Treated with warm whirlpool

Treated with sham whirlpool

Outcomes

Primary Outcome Measures

visual analogue scale

Secondary Outcome Measures

Short Form-36 Health Survey

Western Ontario and McMaster Universities Osteoarthritis Index

Pittsburgh Sleep Quality Index (PSQI)

DN4

Full Information

NCT ID

NCT03299114

First Posted

September 27, 2017

Last Updated

September 27, 2017

Sponsor

Ufuk University

1. Study Identification

Unique Protocol Identification Number

NCT03299114

Brief Title

WHIRLPOOL FOR OSTEOARHRITIS

Official Title

THE EFFECTIVENESS OF WHIRLPOOL FOR PATIENTS WITH NEUROPATHIC PAIN DUE TO KNEE OSTEOARTHRITIS

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

November 1, 2015 (Actual)

Primary Completion Date

January 1, 2016 (Actual)

Study Completion Date

January 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ufuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain, Osteo Arthritis Knee, Sleep Disorder

Keywords

Neuropathic Pain, Whirlpool, Osteoarthritis, Sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Active Comparator

Arm Description

Treated with warm whirlpool

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Treated with sham whirlpool

Intervention Type

Other

Intervention Name(s)

Whirlpool

Primary Outcome Measure Information:

Title

visual analogue scale

Time Frame

one month

Secondary Outcome Measure Information:

Title

Short Form-36 Health Survey

Time Frame

one month

Title

Western Ontario and McMaster Universities Osteoarthritis Index

Time Frame

one month

Title

Pittsburgh Sleep Quality Index (PSQI)

Time Frame

one month

Title

DN4

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Facility Information:

Facility Name

Ufuk University

City

Ankara

ZIP/Postal Code

06520

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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