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

NCT02917356 | Unknown DMC

• 1 other identifier: CAAE52623115.0.0000.5147
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Healing touch; Faith Healing; Pain; Joint stiffness; Functional status; Mental health; Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Change from baseline in pain on the WOMAC scale

  At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

• Change from baseline in joint stiffness on the WOMAC scale

  At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

• Change from baseline in functional capacity on the WOMAC scale

  At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

• Change from baseline in pain on the visual analog scale

  At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

Secondary Outcomes (4)

• Changes in depressive and anxiety symptoms on the HADS scale

  At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

• Changes in Quality of life on the WHOQOL-Bref scale

  At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

• Change from baseline in spirituality on the FACIT Sp12

  At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

• Change from baseline in mobility through the "Timed Up and Go" test

  At the beginning, after 8 weeks (end of intervention) and after 16 weeks.

Study Arms (3)

Spiritual laying on of hands group

EXPERIMENTAL

* 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)

Other: Spiritual laying on of hands (SP)

Non-spiritual Laying on of Hands group

ACTIVE COMPARATOR

* 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)

Other: Non-spiritual Laying on of Hands

Control Group (CG)

SHAM COMPARATOR

* 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)

Other: Control group

Interventions

Spiritual laying on of hands (SP) OTHER

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."

Also known as: Spiritist Healing, Spiritist passe

Spiritual laying on of hands group

Non-spiritual Laying on of Hands OTHER

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."

Non-spiritual Laying on of Hands group

Control group OTHER

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."

Control Group (CG)

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Study Sites (1)

Juiz de Fora Department of elderly affairs

Juiz de Fora, Minas Gerais, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 29526233 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Psychological Well-Being; Osteoarthritis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Katy A Zacaron, MSc

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katy A Zacaron, MSc

CONTACT

55 (33) 99153-5366; katy.andrade.3@gmail.com

Giancarlo Lucchetti, MD, PhD

CONTACT

55 (32) 2102-3841; gian.tln@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 28, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: March 1, 2020
• Last Updated: September 28, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)