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The Effect of "Laying on of Hands" in Older Women With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Spiritual laying on of hands (SP)
Non-spiritual Laying on of Hands
Control group
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Healing touch, Faith Healing, Pain, Joint stiffness, Functional status, Mental health, Osteoarthritis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically and radiographically diagnosed with OA in both knees, according to the criteria set by the American College of Rheumatology
  • Knee OA grade II or III, according to the criteria by Kellgren and Lawrence
  • Moderate to very severe pain, according to the Western Ontario and McMaster Universities (WOMAC) pain subscale) (score between 10 and 20)
  • Using stable doses of analgesics and NSAIDs during the intervention;
  • Do not perform physical therapy or other complementary therapies with laying on of hands different from those proposed in the current study;
  • Being able to travel to the rehabilitation site;
  • Being able to read, understand and speak Portuguese;
  • Preserved cognition

Exclusion Criteria:

  • Having made use of oral or intra-articular corticosteroids for at least 3 months before the intervention;
  • Having made use of intra-articular hyaluronate for at least three months before the intervention;
  • Having full or partial prosthetic hips and/or knees;
  • Presenting neurological diseases or other rheumatic diseases;
  • Presenting medical contraindications to perform light to moderate physical activity;
  • Being absent for two consecutive or three non-consecutive times.

Sites / Locations

  • Juiz de Fora Department of elderly affairsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Spiritual laying on of hands group

Non-spiritual Laying on of Hands group

Control Group (CG)

Arm Description

Spiritist Passe - performed by spiritual healers from the religion Spiritism (5 min, once a week, for 8 weeks) Physical therapy: Kinesiotherapy (45 min, twice a week, for 8 weeks)

Non-spiritual Laying on of Hands - performed by lay persons (5 min, once a week, for 8 weeks) Physical therapy: Kinesiotherapy (45 min, twice a week, for 8 weeks)

Sham/ Control Group (CG) - performed by lay persons. They will stay in the room and move slowly and randomly in order to sham the presence of someone performing the laying on of hands. However, they will not perform the laying on of hands (5 min, once a week, for 8 weeks) Physical therapy: Kinesiotherapy (45 min, twice a week, for 8 weeks)

Outcomes

Primary Outcome Measures

Change from baseline in pain on the WOMAC scale
Change from baseline in joint stiffness on the WOMAC scale
Change from baseline in functional capacity on the WOMAC scale
Change from baseline in pain on the visual analog scale

Secondary Outcome Measures

Changes in depressive and anxiety symptoms on the HADS scale
Changes in Quality of life on the WHOQOL-Bref scale
Change from baseline in spirituality on the FACIT Sp12
Change from baseline in mobility through the "Timed Up and Go" test

Full Information

First Posted
September 25, 2016
Last Updated
September 26, 2016
Sponsor
Federal University of Juiz de Fora
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1. Study Identification

Unique Protocol Identification Number
NCT02917356
Brief Title
The Effect of "Laying on of Hands" in Older Women With Knee Osteoarthritis
Official Title
The Effect of Laying on of Hands on the Pain, Joint Stiffness and Functional Capacity of Older Women With Knee Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Juiz de Fora

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Osteoarthritis (OA) is the most common form of chronic degenerative joint disease, as well as the main cause of pain and disability in older persons worldwide. The limited results of physical therapy in OA makes OA patients potential candidates for complementary therapies, such as laying on of hands. The present study aims to investigate the effect of Laying on of Hands on the Pain, Joint Stiffness and Functional Capacity of Elderly Women With Knee Osteoarthritis. This is a randomized controlled trial with three allocation groups: spiritual laying on of hands ("passe espiríta" - Spiritist passe/spiritual healing) (SP), non-spiritual laying on of hands (LH) and Control Group without laying on of hands (CG). All subjects will participate in a 45-minute kinesiotherapy program. After that, groups will be directed to the 5-minute session of laying on of hands according to their groups. During the application of SP, LH and CG, the subjects will remain in a sitting position, blindfolded with dark goggles, and receive the following verbal command: "Relax and calm your mind." The intervention will happen twice a week for eight weeks and a blinded physical therapist will assess the pre and post scores of pain, functionality, joint stiffness (through WOMAC and visual analogic scale), anxiety and depression (HADS), religiosity (DUREL) and spirituality (FACIT Sp12) and quality of life (WHOQOL-Bref), among other secondary outcomes.
Detailed Description
Osteoarthritis (OA) is the most common form of chronic degenerative joint disease, as well as the main cause of pain and disability in older persons worldwide. The limited results of the medical and physical therapy approach in the OA treatment make patients with such disorder into possible candidates for complementary and alternative therapies (CAT) aiming to obtain a relieve in their symptoms. Given the importance of providing alternative scientific evidence-based, painless and low cost treatments, it is necessary to carry out studies in order to investigate the impact of CAT in culturally accepted contexts, such as laying on of hands with spiritual or non-spiritual contexts. The present study aims to investigate the effect of Laying on of Hands on the Pain, Joint Stiffness and Functional Capacity of Elderly Women With Knee Osteoarthritis. This is a randomized controlled trial with three allocation groups: spiritual laying on of hands ("passe espiríta" - Spiritist passe/spiritual healing) (SP), non-spiritual laying on of hands (LH) and Control Group without laying on of hands (CG). All subjects will participate in a 45-minute kinesiotherapy program. After that, groups will be directed to the 5-minute session of laying on of hands according to their groups. During the application of SP, LH and CG, the subjects will remain in a sitting position, blindfolded with dark goggles, and receive the following verbal command: "Relax and calm your mind." The intervention will happen twice a week for eight weeks and a blinded physical therapist will assess the pre and post scores of pain, functionality, joint stiffness (through WOMAC and visual analogic scale), anxiety and depression (HADS), religiosity (DUREL) and spirituality (FACIT Sp12) and quality of life (WHOQOL-Bref), among other secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Healing touch, Faith Healing, Pain, Joint stiffness, Functional status, Mental health, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spiritual laying on of hands group
Arm Type
Experimental
Arm Description
Spiritist Passe - performed by spiritual healers from the religion Spiritism (5 min, once a week, for 8 weeks) Physical therapy: Kinesiotherapy (45 min, twice a week, for 8 weeks)
Arm Title
Non-spiritual Laying on of Hands group
Arm Type
Active Comparator
Arm Description
Non-spiritual Laying on of Hands - performed by lay persons (5 min, once a week, for 8 weeks) Physical therapy: Kinesiotherapy (45 min, twice a week, for 8 weeks)
Arm Title
Control Group (CG)
Arm Type
Sham Comparator
Arm Description
Sham/ Control Group (CG) - performed by lay persons. They will stay in the room and move slowly and randomly in order to sham the presence of someone performing the laying on of hands. However, they will not perform the laying on of hands (5 min, once a week, for 8 weeks) Physical therapy: Kinesiotherapy (45 min, twice a week, for 8 weeks)
Intervention Type
Other
Intervention Name(s)
Spiritual laying on of hands (SP)
Other Intervention Name(s)
Spiritist Healing, Spiritist passe
Intervention Description
The SP will be applied after physical therapy (kinesiotherapy). Spiritual healers from Spiritism will perform the SP. In order to produce a culturally acceptable environment, the Spiritist therapists will 'prepare' the environment by praying for 5 minutes. The Spiritist therapists will hold both hands 10-15 cm above the patients' head. Then, they will longitudinally lower their hands starting from the patients' head towards their legs, for four times. Subsequently, the therapists shall lay their hands on patients' head and on their knees. The therapists will remain silent during these procedures and try to 'heal' the patients. The subjects will remain in a seated position, blindfolded with dark-blinded goggles, and will receive the following verbal command: "Relax and calm your mind."
Intervention Type
Other
Intervention Name(s)
Non-spiritual Laying on of Hands
Intervention Description
The non-spiritual laying on of hands will be applied after physical therapy (kinesiotherapy), for 5 minutes, without touching the patients and without 'preparing' the environment. They will hold their hands 10-15 cm above patient's head and will focus on healing the patients. They will visualize the following sentence: "I want you to heal"; without saying prayers or invocations. The subjects will remain in a seated position, blindfolded with dark-blinded goggles, and will receive the following verbal command: "Relax and calm your mind."
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The patients will be subjected to physical therapy (kinesiotherapy), only. However, they will be accompanied by people who will stay in the room and move slowly and randomly in order to sham the presence of someone performing the laying on of hands. However, they will not perform the laying on of hands. These people will not focus on healing the patients and they will be asked to mentally count 5 minutes while they are with the patients. The subjects will remain in a seated position, blindfolded with dark-blinded goggles, and will receive the following verbal command: "Relax and calm your mind."
Primary Outcome Measure Information:
Title
Change from baseline in pain on the WOMAC scale
Time Frame
At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Title
Change from baseline in joint stiffness on the WOMAC scale
Time Frame
At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Title
Change from baseline in functional capacity on the WOMAC scale
Time Frame
At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Title
Change from baseline in pain on the visual analog scale
Time Frame
At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Secondary Outcome Measure Information:
Title
Changes in depressive and anxiety symptoms on the HADS scale
Time Frame
At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Title
Changes in Quality of life on the WHOQOL-Bref scale
Time Frame
At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Title
Change from baseline in spirituality on the FACIT Sp12
Time Frame
At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Title
Change from baseline in mobility through the "Timed Up and Go" test
Time Frame
At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically and radiographically diagnosed with OA in both knees, according to the criteria set by the American College of Rheumatology Knee OA grade II or III, according to the criteria by Kellgren and Lawrence Moderate to very severe pain, according to the Western Ontario and McMaster Universities (WOMAC) pain subscale) (score between 10 and 20) Using stable doses of analgesics and NSAIDs during the intervention; Do not perform physical therapy or other complementary therapies with laying on of hands different from those proposed in the current study; Being able to travel to the rehabilitation site; Being able to read, understand and speak Portuguese; Preserved cognition Exclusion Criteria: Having made use of oral or intra-articular corticosteroids for at least 3 months before the intervention; Having made use of intra-articular hyaluronate for at least three months before the intervention; Having full or partial prosthetic hips and/or knees; Presenting neurological diseases or other rheumatic diseases; Presenting medical contraindications to perform light to moderate physical activity; Being absent for two consecutive or three non-consecutive times.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katy A Zacaron, MSc
Phone
55 (33) 99153-5366
Email
katy.andrade.3@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Giancarlo Lucchetti, MD, PhD
Phone
55 (32) 2102-3841
Email
gian.tln@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katy A Zacaron, MSc
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juiz de Fora Department of elderly affairs
City
Juiz de Fora
State/Province
Minas Gerais
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy A Zacaron, MSc
Phone
55 (32) 3031-0656
Email
katy.andrade.3@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29526233
Citation
Zacaron KAM, da Silva Mendes N, E Silva YC, Lucchetti G. Effects of laying on of hands with and without a spiritual context on pain and functionality of older women with knee osteoarthritis: study protocol for a randomized controlled trial. J Integr Med. 2018 Mar;16(2):106-112. doi: 10.1016/j.joim.2018.02.002. Epub 2018 Feb 3.
Results Reference
derived

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The Effect of "Laying on of Hands" in Older Women With Knee Osteoarthritis

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