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

Federal University of Juiz de Fora

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Other: Spiritual laying on of hands (SP); Other: Non-spiritual Laying on of Hands; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02917356

CAAE52623115.0.0000.5147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups

Spiritual laying on of hands group

Experimental group

Description:

* 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)

Treatment:

Other: Spiritual laying on of hands (SP)

Non-spiritual Laying on of Hands group

Active Comparator group

Description:

* 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)

Treatment:

Other: Non-spiritual Laying on of Hands

Control Group (CG)

Sham Comparator group

Description:

* 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)

Treatment:

Other: Control group