An interventional study of Spiritual laying on of hands (SP) and Non-spiritual Laying on of Hands in Knee Osteoarthritis, sponsored by Federal University of Juiz de Fora. Status unknown at 1 site in Brazil. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-09-28.
Sponsored by Federal University of Juiz de Fora · Not applicable, Interventional, and Treatment
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.
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 105 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Federal University of Juiz de Fora is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
* 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 - 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
* 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 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
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."
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."
Change from baseline in pain on the WOMAC scale
Time frame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
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.
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.
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.
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.
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.
Change from baseline in spirituality on the FACIT Sp12
Time frame: 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
Time frame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Plan to share: Yes
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Federal University of Juiz de Fora