Clinical trial NCT02917356: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Healing touch
Faith Healing
Pain
Joint stiffness
Functional status
Mental health
Osteoarthritis
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 105
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in pain on the WOMAC scale
timeFrame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
measure: Change from baseline in joint stiffness on the WOMAC scale
timeFrame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
measure: Change from baseline in functional capacity on the WOMAC scale
timeFrame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
measure: Change from baseline in pain on the visual analog scale
timeFrame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Secondary outcomes:
measure: Changes in depressive and anxiety symptoms on the HADS scale
timeFrame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
measure: Changes in Quality of life on the WHOQOL-Bref scale
timeFrame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
measure: Change from baseline in spirituality on the FACIT Sp12
timeFrame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
measure: Change from baseline in mobility through the "Timed Up and Go" test
timeFrame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: Juiz de Fora Department of elderly affairs
state: Minas Gerais
Study officials:
affiliation: Federal University of Juiz de Fora
name: Katy A Zacaron, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.