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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02917356
• Other study ID #: CAAE52623115.0.0000.5147
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2016
• Last updated: September 26, 2016
• Start date: August 2016
• Est. completion date: March 2020

Study information

• Verified date: September 2016
• Source: Federal University of Juiz de Fora
• Contact: Katy A Zacaron, MSc
• Phone: 55 (33) 99153-5366
• Email: katy.andrade.3[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: March 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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."
• 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."
• 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."

Locations

Country	Name	City	State
Brazil	Juiz de Fora Department of elderly affairs	Juiz de Fora	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain on the WOMAC scale		At the beginning, after 8 weeks (end of intervention) and after 16 weeks.	No
Primary	Change from baseline in joint stiffness on the WOMAC scale		At the beginning, after 8 weeks (end of intervention) and after 16 weeks.	No
Primary	Change from baseline in functional capacity on the WOMAC scale		At the beginning, after 8 weeks (end of intervention) and after 16 weeks.	No
Primary	Change from baseline in pain on the visual analog scale		At the beginning, after 8 weeks (end of intervention) and after 16 weeks.	No
Secondary	Changes in depressive and anxiety symptoms on the HADS scale		At the beginning, after 8 weeks (end of intervention) and after 16 weeks.	No
Secondary	Changes in Quality of life on the WHOQOL-Bref scale		At the beginning, after 8 weeks (end of intervention) and after 16 weeks.	No
Secondary	Change from baseline in spirituality on the FACIT Sp12		At the beginning, after 8 weeks (end of intervention) and after 16 weeks.	No
Secondary	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.	No