Chronic Pain
Conditions
Keywords
Mindfulness-based stress reduction program, Chronic pain, Elderly, Physiotherapy
Brief summary
It has been shown that MBSR could be effective in different types of chronic pain in geriatrics, but more evidence in the interdisciplinary context is needed. This study is conducted to develop and compile a mindfulness-based stress reduction (MBSR) program within a context of physiotherapy rehabilitation to manage chronic pain in the elderly in an Iranian clinical setting. The 8-session MBSR treatment protocol was translated, revised for the Iranian elderlies, and compiled as a one-on-one therapy using a unique protocol with 20-session physiotherapy. 40 volunteers aged 65 or more with musculoskeletal chronic pain will be selected and receive the program for 8 consecutive weeks with a 3-month follow-up. Treatment satisfaction levels, adherence to treatment sessions, and patient-reported clinical outcome measures were used at baseline, immediately post-intervention, and three months following the intervention, measuring pain, anxiety, fatigue, sleep disturbance, pain interference levels, and kinesiophobia.
Interventions
OTHERMBSR and physiotherapy
In experimental group in the first session, the research program and plans for outcome assessment will be introduced. They will sign the research agreement form and will be interviewed to obtain information about their pain, their medication(s), and demographics. This will be followed by the first 70-80-minute physiotherapy session. During each session, the physiotherapist will administer the Transcutaneous electrical nerve stimulation (TENS), low-level laser therapy (LLLT), and ultrasound therapy to the painful body region. In addition, they will engage in 20 minutes of exercise during each session. After that, participants will be received their 8 MBSR session with a trained therapist. They will be given their assignments for the week, consisting of the content of that MBSR session. Finally, three months after the last study session, they will be asked to return to the clinic for the follow-up assessment to complete patient-reported outcome measures.
OTHERphysiotherapy
In control group in the first session, the research program and plans for outcome assessment will be introduced. The participants then will sign the research agreement form and will be interviewed to obtain information about their pain (i.e., duration, location, and course), their medication(s), and demographics. This will be followed by the first 70-80-minute physiotherapy session. During each session, the physiotherapist will administer the Transcutaneous electrical nerve stimulation (TENS), low-level laser therapy (LLLT), and ultrasound therapy to the painful body region. In addition, they will engage in 20 minutes of exercise during each session.
Sponsors
Mohammad Soukhtanlou, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In this study, simple individual randomization method is used. None of the participants and researchers will be informed about the placement of the participants in the groups until the start of the project, and for this purpose, spss software will be used.
Intervention model description
This is a study with an active control group along with randomized double-blind parallel groups on 40 elderly patients with chronic pain.
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Aged 65 or more * Have chronic pain * Have ability of reading and writing in Persian * Visiting the clinic in which the study was took place
Exclusion criteria
* Dose not have any diagnosed Cognitive Impairment * Failure to approve the consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Numerical Rating Scale-11 (NRS-11). | At the baseline, immediately after last session, and 3-month follow-up. | Average pain intensity in the past week and post-session current pain intensity were assessed at the end of each session using the NRS-11 (0 = "no pain" and 10 = "worst pain imaginable"). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Tampa Scale Kinesiophobia (TKS-11). | At the baseline, immediately after last session, and 3-month follow-up. | Fear of movement (i.e., kinesiophobia) was assessed using the brief (11-item) version of the TKS-1. Respondents are asked to indicate agreement with each item on a Likert scale from ("strongly disagree") to 4 ("strongly agree). The items are summed into a total score ranging from 11 to 44. Higher scores indicate a greater fear of movement. |
| The Patient Reported Outcomes Measurement Information System (PROMIS-29 v2.0). | At the baseline, immediately after last session, and 3-month follow-up. | Physical function, anxiety, depression, fatigue, sleep disturbances, ability to participate in social roles, and pain interference were assessed using the 4-item short form version of the PROMIS-29 v2.0. |
| The Patient Global Assessment of Treatment Satisfaction (PGATS) | At the baseline, immediately after last session, and 3-month follow-up. | Description: Treatment satisfaction was assessed with six questions asking the participants to rate six domains of treatment satisfaction using a 5-point Likert scale ranging from 0 ("Very dissatisfied") to 4 ("Very satisfied"). Specifically, satisfaction with the combined physiotherapy and MBSR protocol, the duration of the entire protocol, the duration of each treatment session, the content of the treatment sessions, and homework assignments were measured using this tool. Participants were also asked to rate their overall satisfaction with the treatment on the same Likert scale. |
Countries
Iran
Contacts
STUDY_CHAIRReza poorhosein, PhD
Faculty of Psychology and Education, the University of Tehran.
Outcome results
None listed