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Clinical Trials/NCT04079985
NCT04079985
Completed
Not Applicable

Animal-assisted Intervention in Geriatric Patients With Chronic Joint Pain and Polypharmacy

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina0 sites69 target enrollmentOctober 1, 2013
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
69
Primary Endpoint
Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

BACKGROUND: Nowadays, there is a progressive aging of population. Chronic osteoarticular pain is associated to a bigger consumption of medication and a deterioration of life quality in elderly people that could be improved by boosting education for health from Primary Health Care. JUSTIFICATION: The need to develop non pharmacological treatments in order to get better results in people's global care. PURPOSE: To evaluate the effectivity of group intervention, based on Animal Assisted Therapy, on elderly people suffering from chronic osteoarticular pain and poli-medication; regarding decrease of chronic pain, use of analgesics and improvement of life quality. MATERIAL AND METHOD: Randomized clinical trial, two arms, controlled and open-label. Twelve group sessions of kinesiotherapy with the intervention of a therapy dog in the experimental group (EG), carried out in the Primary Health Centre.

Registry
clinicaltrials.gov
Start Date
October 1, 2013
End Date
October 1, 2014
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥65 years
  • diagnosis of chronic benign joint pain
  • polypharmacy (\>5 drugs or active ingredients, of which 2 or more had been prescribed for pain)

Exclusion Criteria

  • severe cognitive deterioration (GDS\> 5)
  • allergy to or fear of animals

Outcomes

Primary Outcomes

Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks

Time Frame: This questionnaire was administered at baseline and at week 13.

pain (0-20), stiffness (0-8), functional capacity (0-68)

Secondary Outcomes

  • Change from baseline Lattinen test at 13 weeks(This questionnaire was administered at baseline and at week 13.)
  • Change from baseline EuroQoL Health Questionnaire at 13 weeks(This questionnaire was administered at baseline and at week 13.)
  • Change from baseline Visual Analog Scale at session 1(This questionnaire was administered at the baseline of session 1 and through session 1 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 2(This questionnaire was administered at the baseline of session 2 and through session 2 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 7(This questionnaire was administered at the baseline of session 7 and through session 7 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 5(This questionnaire was administered at the baseline of session 5 and through session 5 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 6(This questionnaire was administered at the baseline of session 6 and through session 6 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 11(This questionnaire was administered at the baseline of session 11 and through session 11 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 12(This questionnaire was administered at the baseline of session 12 and through session 12 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 4(This questionnaire was administered at the baseline of session 4 and through session 4 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 9(This questionnaire was administered at the baseline of session 9 and through session 9 completion, an average of 1 hour)
  • Change from baseline Health Assessment Questionnaire at 13 weeks(This questionnaire was administered at baseline and at week 13.)
  • Change from baseline Visual Analog Scale at session 3(This questionnaire was administered at the baseline of session 3 and through session 3 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 8(This questionnaire was administered at the baseline of session 8 and through session 8 completion, an average of 1 hour)
  • Change from baseline Visual Analog Scale at session 10(This questionnaire was administered at the baseline of session 10 and through session 10 completion, an average of 1 hour)

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