NCT03299114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

September 27, 2017

Last Update Submit

September 27, 2017

Conditions

Neuropathic PainOsteo Arthritis KneeSleep Disorder

Keywords

Neuropathic PainWhirlpoolOsteoarthritisSleep

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale

    one month

Secondary Outcomes (4)

  • Short Form-36 Health Survey

    one month

  • Western Ontario and McMaster Universities Osteoarthritis Index

    one month

  • Pittsburgh Sleep Quality Index (PSQI)

    one month

  • DN4

    one month

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Treated with warm whirlpool

Other: Whirlpool

Placebo group

PLACEBO COMPARATOR

Treated with sham whirlpool

Other: Whirlpool

Interventions

WhirlpoolOTHER
Intervention GroupPlacebo group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeuralgiaSleep Wake DisordersOsteoarthritis

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ufuk University

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 2, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)