Knee OsteoarthritisNCT02917356
The Effect of "Laying on of Hands" in Older Women With Knee Osteoarthritis
A study testing Spiritual laying on of hands (SP) and Non-spiritual Laying on of Hands in people with Knee Osteoarthritis, run by Federal University of Juiz de Fora at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Spiritual laying on of hands (SP) and Non-spiritual Laying on of Hands
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Juiz de Fora Department of elderly affairs
Juiz de Fora, Minas Gerais
Katy A Zacaron, MSc, 55 (32) 3031-0656, katy.andrade.3@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Spiritual laying on of hands (SP), Non-spiritual Laying on of Hands, Control group
- Keywords
- Healing touch, Faith Healing, Pain, Joint stiffness, Functional status, Mental health, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Pain, Psychological Well-Being, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual laying on of hands (SP)Other
Also called Spiritist Healing, Spiritist passe
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 HandsOther
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 groupOther
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."
| Study group | Role | What they receive |
|---|---|---|
| Spiritual laying on of hands group | Experimental | * 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) Receives: Other: Spiritual laying on of hands (SP) |
| Non-spiritual Laying on of Hands group | Active comparator | * 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) Receives: Other: Non-spiritual Laying on of Hands |
| Control Group (CG) | Sham comparator | * 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) Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on the WOMAC scale
Measured: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Change from baseline in joint stiffness on the WOMAC scale
Measured: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Change from baseline in functional capacity on the WOMAC scale
Measured: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Change from baseline in pain on the visual analog scale
Measured: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Secondary outcomes (4)
Changes in depressive and anxiety symptoms on the HADS scale
Measured: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Changes in Quality of life on the WHOQOL-Bref scale
Measured: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Change from baseline in spirituality on the FACIT Sp12
Measured: 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
Measured: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giancarlo Lucchetti, Federal University of Juiz de Fora
- Investigators
- Katy A Zacaron, MSc, Principal investigator, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917356
- Sponsor's protocol ID
- CAAE52623115.0.0000.5147
- Status last verified
- Sep 2016
- First submitted
- 25 Sep 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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.
PubMed 29526233
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02917356
- Acronym / sponsor ID
- CAAE52623115.0.0000.5147
- Conditions
- Knee Osteoarthritis
- Keywords
- Healing touch, Faith Healing, Pain, Joint stiffness, Functional status, Mental health, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spiritual laying on of hands group | Experimental | Other: Spiritual laying on of hands (SP)* 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) |
| Non-spiritual Laying on of Hands group | Active comparator | Other: Non-spiritual Laying on of Hands* 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) |
| Control Group (CG) | Sham comparator | Other: Control group* 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiritual laying on of hands (SP)Also: Spiritist Healing, Spiritist passeThe 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 | Spiritual laying on of hands group |
| Non-spiritual Laying on of HandsThe 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." | Other | Non-spiritual Laying on of Hands group |
| Control groupThe 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." | Other | Control Group (CG) |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Derived from this study: PubMed 29526233Zacaron 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katy A Zacaron, MSc principal investigator
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiritual laying on of hands (SP) and Non-spiritual Laying on of Hands in people with Knee Osteoarthritis, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katy A Zacaron, MSc (55 (33) 99153-5366, katy.andrade.3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain on the WOMAC scale (time frame: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.