MBSR Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly

NCT06547723 | Enrolling By Invitation DMC

• 1 other identifier: UTehran
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Mindfulness-based stress reduction program; Chronic pain; Elderly; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• . The Patient Global Assessment of Treatment Satisfaction (PGATS)

  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.

  At the baseline, immediately after last session, and 3-month follow-up.

• The Numerical Rating Scale-11 (NRS-11).

  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").

  At the baseline, immediately after last session, and 3-month follow-up.

Secondary Outcomes (2)

• The Patient Reported Outcomes Measurement Information System (PROMIS-29 v2.0).

  At the baseline, immediately after last session, and 3-month follow-up.

• The Tampa Scale Kinesiophobia (TKS-11).

  At the baseline, immediately after last session, and 3-month follow-up.

Study Arms (2)

experimental group

EXPERIMENTAL

Participants in the experimental group receive 20 sessions physiotherapy (in first-4-week, three sessions and next-4-week two sessions on a weekly basis) along with one MBSR session (total MBSR sessions are eight sessions), which also include regular MBSR homework.

Other: MBSR and physiotherapy

control group

ACTIVE COMPARATOR

Participants in the control group receive 20 sessions physiotherapy (in first-4-week, three sessions and next-4-week two sessions on a weekly basis).

Other: physiotherapy

Interventions

MBSR and physiotherapy OTHER

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.

experimental group

physiotherapy OTHER

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.

control group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Dose not have any diagnosed Cognitive Impairment
• Failure to approve the consent form

Sponsors & Collaborators

• Mohammad Soukhtanlou: lead

Study Sites (1)

Bahar physiotherapy clinic

Mashhad, Razavi Khorasan Province, 9188856473, Iran

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Reza poorhosein, PhD

  Faculty of Psychology and Education, the University of Tehran.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mohammad Soukhtanlou M.Sc.

Model Details: This is a feasibility study with a control group along with randomized double-blind parallel groups on 40 elderly patients with chronic pain.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: March 15, 2024
• Primary Completion: November 1, 2024
• Study Completion: February 10, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 1 year after manuscript publication.
• Access Criteria: The data will be sent only to experts working in academic environments who have researches in line with the field of this study according to their request.To receive the data, one email should be send to corresponded author of this research.

Locations

IR (1)