AAI in Elderly Patient With Chronic Pain

NCT04079985 | Completed

• 1 other identifier: IDIAPJordiGol
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain

Keywords

Animal-assisted therapy; Chronic Pain; Elderly; Primary Health Care

Outcome Measures

Primary Outcomes (1)

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

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

  This questionnaire was administered at baseline and at week 13.

Secondary Outcomes (15)

• 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 Health Assessment 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental Group underwent a therapeutic intervention based on sessions of kinesitherapy , which is defined as a set of "therapeutic procedures that use movement for the treatment and prevention of diseases of the locomotive apparatus". The experimental group also underwent AAT. We conducted a total of 12 weekly sessions of 60 minutes each with 10 participants.

Other: Animal-assisted therapy

Control Group

ACTIVE COMPARATOR

The Control Group underwent a therapeutic intervention based on sessions of kinesitherapy , which is defined as a set of "therapeutic procedures that use movement for the treatment and prevention of diseases of the locomotive apparatus" without the presence of the therapy dog.

Other: Animal-assisted therapy

Interventions

Animal-assisted therapy OTHER

The sessions were held in the primary care centre, and had specific objectives agreed in advance by the research team. The sessions had the following schedule: Session 1, lower extremities in sitting position; Session 2, upper extremities in sitting position; Session 3, cervical spine in sitting position; Session 4, dorsal spine in sitting position; Session 5, lumbar spine in sitting position; Session 6, Static Standing and Upper Extremities; Session 7, Static Standing; Sessions 8, 9, 10 and 11, Dynamic Standing; and Session 12, Safety Reinforcement.

Control Group; Experimental Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Related Links

• Doctoral thesis

MeSH Terms

Conditions

Chronic Pain

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marta Ortega Bravo, PhD

  IDIAPJgol

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, two-arm randomized, controlled, open-label clinical trial

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 6, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share