WHIRLPOOL FOR OSTEOARHRITIS

Sponsor
Ufuk University (Other)
Overall Status
Completed
CT.gov ID
NCT03299114
Collaborator
(none)
60
1
2
2
29.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Whirlpool
N/A

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
THE EFFECTIVENESS OF WHIRLPOOL FOR PATIENTS WITH NEUROPATHIC PAIN DUE TO KNEE OSTEOARTHRITIS
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention Group

Treated with warm whirlpool

Other: Whirlpool

Placebo Comparator: Placebo group

Treated with sham whirlpool

Other: Whirlpool

Outcome Measures

Primary Outcome Measures

  1. visual analogue scale [one month]

Secondary Outcome Measures

  1. Short Form-36 Health Survey [one month]

  2. Western Ontario and McMaster Universities Osteoarthritis Index [one month]

  3. Pittsburgh Sleep Quality Index (PSQI) [one month]

  4. DN4 [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ufuk University Ankara Turkey 06520

Sponsors and Collaborators

  • Ufuk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ASLIHAN UZUNKULAOGLU, Ufuk University, Ufuk University
ClinicalTrials.gov Identifier:
NCT03299114
Other Study ID Numbers:
  • 30112015-6
First Posted:
Oct 2, 2017
Last Update Posted:
Oct 2, 2017
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ASLIHAN UZUNKULAOGLU, Ufuk University, Ufuk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 2, 2017