Chronic PainNCT04079985

AAI in Elderly Patient With Chronic Pain

A study testing Animal-assisted therapy in people with Chronic Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Animal-assisted therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: No sites listed yet
Study dates: 1 Oct 2013to 1 Oct 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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
Being tested: Animal-assisted therapy
Keywords: Animal-assisted therapy, Chronic Pain, Elderly, Primary Health Care
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Animal-assisted therapyOther
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.

Study groups in NCT04079985
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Animal-assisted therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index at 13 weeks
pain (0-20), stiffness (0-8), functional capacity (0-68)
Measured: This questionnaire was administered at baseline and at week 13.

Secondary outcomes (15)

Change from baseline Lattinen test at 13 weeks
Assesses pain and any incapacity caused by pain, as well as its frequency and intensity, the amount of painkillers taken, and whether sleep is disturbed
Measured: This questionnaire was administered at baseline and at week 13.
Change from baseline EuroQoL Health Questionnaire at 13 weeks
Is a generic self-administered instrument for measuring quality of life related to health
Measured: This questionnaire was administered at baseline and at week 13.
Change from baseline Health Assessment Questionnaire at 13 weeks
Is a self-administered questionnaire that assesses one's ability to perform day-to-day activities, as well as functional capacity
Measured: This questionnaire was administered at baseline and at week 13.
Change from baseline Visual Analog Scale at session 1
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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 3
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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 4
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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 5
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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 7
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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 8
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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 9
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: This questionnaire was administered at the baseline of session 9 and through session 9 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 10
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: This questionnaire was administered at the baseline of session 10 and through session 10 completion, an average of 1 hour
Change from baseline Visual Analog Scale at session 11
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 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
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: This questionnaire was administered at the baseline of session 12 and through session 12 completion, an average of 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20131 Oct 2014

First posted6 Sep 2019
Study start1 Oct 2013
Primary completion1 Jun 2014
Study completion1 Oct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-centre, two-arm randomized, controlled, open-label clinical trial
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04079985
Sponsor's protocol ID: IDIAPJordiGol
Status last verified: Jul 2019
First submitted: 5 Jul 2019
Last updated: 6 Sep 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Recruiting
SENECA - Smart Therapies for Chronic Pain
Chronic Low Back Pain (CLBP)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain
Not yet recruiting
Effects of Expectancy and Mindfulness Instructions on Chronic Pain
Chronic Pain
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
Chronic Pain, Low Back Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Animal-assisted Intervention in Geriatric Patients With Chronic Joint Pain and Polypharmacy
ClinicalTrials.gov ID: NCT04079985
Acronym / sponsor ID: IDIAPJordiGol
Conditions: Chronic Pain
Keywords: Animal-assisted therapy, Chronic Pain, Elderly, Primary Health Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
Study start: 1 Oct 2013 (actual)
Primary completion: 1 Jun 2014 (actual)
Study completion: 1 Oct 2014 (actual)
First posted: 6 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Single-centre, two-arm randomized, controlled, open-label clinical trial

Arm	Type	Receives
Experimental Group	Experimental	Other: Animal-assisted therapyThe 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.
Control Group	Active comparator	Other: Animal-assisted therapyThe 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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Animal-assisted therapyThe 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.	Other	Control Group, Experimental Group

Primary outcome

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)

15 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Recruiting
SENECA - Smart Therapies for Chronic Pain
Chronic Low Back Pain (CLBP)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain
Not yet recruiting
Effects of Expectancy and Mindfulness Instructions on Chronic Pain
Chronic Pain
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
Chronic Pain, Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marta Ortega Bravo, PhD study director

IDIAPJgol

Questions about this trial

What is this clinical trial studying?

A study testing Animal-assisted therapy in people with Chronic Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04079985.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.