Chronic PainNCT06547723
MBSR Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly
A study testing MBSR and physiotherapy and physiotherapy in people with Chronic Pain, run by Mohammad Soukhtanlou, PhD at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- MBSR and physiotherapy and physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 15 Aug 2023to 10 Mar 2025
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Dose not have any diagnosed Cognitive Impairment
- Failure to approve the consent form
Trial locations and contacts
1 site in 1 country.
Iran1 site
Bahar physiotherapy clinic
Mashhad, Razavi Khorasan Province, 9188856473
About this study
Official title: Developing and Compiling a Mindfulness-Based Stress Reduction Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly
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
- Being tested
- MBSR and physiotherapy, physiotherapy
- Keywords
- Mindfulness-based stress reduction program, Chronic pain, Elderly, Physiotherapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSR and physiotherapyOther
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.
physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: At the baseline, immediately after last session, and 3-month follow-up.
Secondary outcomes (3)
The Tampa Scale Kinesiophobia (TKS-11).
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.
Measured: At the baseline, immediately after last session, and 3-month follow-up.
The Patient Reported Outcomes Measurement Information System (PROMIS-29 v2.0).
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.
Measured: At the baseline, immediately after last session, and 3-month follow-up.
The Patient Global Assessment of Treatment Satisfaction (PGATS)
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.
Measured: At the baseline, immediately after last session, and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start15 Aug 2023
- Primary completion1 Nov 2024
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad Soukhtanlou, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Soukhtanlou, PhD, University of Tehran
- Investigators
- Reza poorhosein, PhD, Study chair, Faculty of Psychology and Education, the University of Tehran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547723
- Sponsor's protocol ID
- UTehran
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to the results of the data starts simultaneously with the publication of an article based on them and presenting all the information in the doctoral thesis of the main researcher in 2024. The release of the raw data will be one year after the publication of the results, although the ethics committees and the doctoral thesis advising committee will have access to all the data at all stages.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Compiling a Mindfulness-Based Stress Reduction Program and Evaluating Its Effectiveness on Relieving Chronic Pain in the Elderly
- ClinicalTrials.gov ID
- NCT06547723
- Acronym / sponsor ID
- UTehran
- Conditions
- Chronic Pain
- Keywords
- Mindfulness-based stress reduction program, Chronic pain, Elderly, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mohammad Soukhtanlou, PhDUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: MBSR and physiotherapyParticipants 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. |
| control group | Active comparator | Other: physiotherapyParticipants in the control group receive 20 sessions physiotherapy (in first-4-week, three sessions and next-4-week two sessions on a weekly basis). |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Dose not have any diagnosed Cognitive Impairment
- Failure to approve the consent form
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 |
|---|---|---|
| MBSR and physiotherapyIn 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. | Other | experimental group |
| physiotherapyIn 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. | Other | control group |
Primary outcome
The Numerical Rating Scale-11 (NRS-11).
Time frame: 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").
3 secondary outcomes
The Tampa Scale Kinesiophobia (TKS-11).
Time frame: At the baseline, immediately after last session, and 3-month follow-up.
The Patient Reported Outcomes Measurement Information System (PROMIS-29 v2.0).
Time frame: At the baseline, immediately after last session, and 3-month follow-up.
The Patient Global Assessment of Treatment Satisfaction (PGATS)
Time frame: At the baseline, immediately after last session, and 3-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. Access to the results of the data starts simultaneously with the publication of an article based on them and presenting all the information in the doctoral thesis of the main researcher in 2024. The release of the raw data will be one year after the publication of the results, although the ethics committees and the doctoral thesis advising committee will have access to all the data at all stages.
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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.
Reza poorhosein, PhD study chair
Faculty of Psychology and Education, the University of Tehran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR and physiotherapy and physiotherapy in people with Chronic Pain, run by Mohammad Soukhtanlou, PhD at 1 site in Iran.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 4 Sep 2026. 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 Iran. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numerical Rating Scale-11 (NRS-11). (time frame: At the baseline, immediately after last session, and 3-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.