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

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Spiritual laying on of hands (SP); Other: Non-spiritual Laying on of Hands; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katy A Zacaron, MSc; Phone Number: 55 (33) 99153-5366; Email: katy.andrade.3@gmail.com
• Study Contact Backup: Name: Giancarlo Lucchetti, MD, PhD; Phone Number: 55 (32) 2102-3841; Email: gian.tln@terra.com.br

Study Locations

• Brazil
  • Minas Gerais
    • Juiz de Fora, Minas Gerais, Brazil
      • Recruiting
      • Juiz de Fora Department of elderly affairs
      • Contact: Katy A Zacaron, MSc; Phone Number: 55 (32) 3031-0656; Email: katy.andrade.3@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spiritual laying on of hands group; 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); 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."; Other Names: Spiritist Healing; Spiritist passe
Active Comparator: Non-spiritual Laying on of Hands group; 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; 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."
Sham Comparator: Control Group (CG); 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; 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Federal University of Juiz de Fora
• Investigators: Principal Investigator: Katy A Zacaron, MSc, Federal University of Juiz de Fora

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: September 25, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 28, 2016

Study Record Updates

• Last Update Posted (Estimate): September 28, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Mental health; Functional status; Healing touch; Faith Healing; Joint stiffness
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CAAE52623115.0.0000.5147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES