Chronic PainNCT03056417

Impact of Lifestyle Changes on Telomeric Activity in Patients With Chronic Pain

A study testing The Complete Health Improvement Program in people with Chronic Pain, run by Ohio University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Chronic Pain
What is being tested?: The Complete Health Improvement Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2017to May 2019
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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

40-70 years old
Physician confirmed chronic pain diagnosis for at least 6 months

Who cannot join

Pregnancy
Physical or mental condition that limits ability to provide consent or answer questionnaires

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio University
Athens, Ohio, 45701

Other trials in United States

About this study

Official title: Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain

The current project will use the Complete Health Improvement Program (CHIP) as an intervention for patients with chronic pain. CHIP is a nationally recognized program that encourages a diet of whole plant-based foods, moderate exercise, stress reduction, and social support. Patients with chronic pain who enroll in CHIP classes will be monitored and compared to patients with chronic pain who are not enrolled in CHIP classes. It is hypothesized that patients who complete CHIP will have increased telomerase activity and longer relative telomere length at follow-up when compared to those who do not enroll in the program. Chromosomes consist of DNA that contains the genetic makeup of an individual; and telomeres are the caps on these chromosomes that protect them from damage. Telomere shortening occurs normally with aging and once they are too short to replicate cellular death occurs. Telomerase is a ribonucleic protein that counterbalances this shortening by extending the ends of chromosomes. Research has shown that patients with chronic pain may have shorter telomeres relative to others of the same age. This study will investigate this association further.

Conditions: Chronic Pain
Being tested: The Complete Health Improvement Program
Keywords: chronic pain, telomere, telomerase, life style
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Complete Health Improvement ProgramBehavioural
The Complete Health Improvement Program is a nationally recognized program that encourages a diet of whole plant based foods, moderate exercise, stress reduction, and social support.

Study groups in NCT03056417
Study group	Role	What they receive
Intervention	Experimental	Participants in the Complete Health Improvement Program. Receives: Behavioral: The Complete Health Improvement Program
No Change to Treatment	No intervention	Participants who choose not to participate in the Complete Health Improvement Program.

What is being measured

The primary outcome is the main question the study is designed to answer.

Telomerase activity changes as a result of lifestyle change
Assessed via peripheral blood mononuclear cells
Measured: Change from baseline telomerase at 3 months
Subjective pain ratings as a function of positive lifestyle modifications
Assessed via the Brief Pain Inventory - Short Form. Measures pain intensity from 0 to 10, 10 being pain as bad as you can imagine. Also measures the extent to which pain interferes with daily functioning (0 - 10 possible, with 10 indicating completely interferes).
Measured: Change from baseline subjective pain at 3 months

Secondary outcomes (20)

Relative telomere length changes as a result of lifestyle change
Assessed via whole blood samples
Measured: Change from baseline telomere length at 3 months
Relative telomere length changes as a result of lifestyle change at 1-year follow-up
Assessed via whole blood samples
Measured: Change from 3 month follow-up data of telomere length at 1-year
Fasting glucose changes as a result of lifestyle change
Assessed via whole blood samples
Measured: Change from baseline fasting glucose at 3 months
Fasting glucose changes as a result of lifestyle change at 1-year follow-up
Assessed via whole blood samples
Measured: Change from 3 month follow-up data of fasting glucose at 1-year
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change
Assessed via whole blood
Measured: change from baseline fasting lipids at 3 months
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up
Assessed via whole blood
Measured: Change from 3 month follow-up data of fasting lipids at 1-year
C-reactive protein changes as a result of lifestyle change
Assessed via plasma
Measured: change from baseline C-reactive protein at 3 months
C-reactive protein changes as a result of lifestyle change at 1-year follow-up
Assessed via plasma
Measured: Change from 3 month follow-up data of C-reactive protein at 1-year
Overall well-being changes as a result of lifestyle change
The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.
Measured: change from baseline overall well-being at 3 months
Overall well-being changes as a result of lifestyle change at 1-year follow-up
The RAND-36 item short form survey. High score indicates more favorable health state. Minimum score 0 Maximum score 100.
Measured: Change from 3 month follow-up data of overall well-being at 1-year
Perceived Stress changes as a result of lifestyle change
The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.
Measured: change from baseline perceived stress at 3 months
Perceived Stress changes as a result of lifestyle change at 1-year follow-up
The 14-item Perceived Stress Scale. Minimum score 0 Maximum score 40. Higher scores indicate greater perceived stress.
Measured: Change from 3 month follow-up data of perceived stress at 1-year
Depressive symptom changes as a result of lifestyle change
Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.
Measured: change from baseline depressed mood at 3 months
Depressive symptom changes as a result of lifestyle change at 1-year follow-up
Center for Epidemiological Studies Depression Scale. Higher score indicates greater depressed mood. Minimum score 0 Maximum score 60.
Measured: Change from 3 month follow-up data of depressed mood at 1-year
Perceived social support modification as a result of lifestyle change
Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.
Measured: change from baseline perceived social support at 3 months
Perceived social support modification as a result of lifestyle change at 1-year follow-up
Multidimensional Scale of Perceived Social Support. Higher score indicates greater perceived social support. Minimum score 1 Maximum score 7.
Measured: Change from 3 month follow-up data of perceived social support at 1-year
Health-Promoting behavior change as a result of lifestyle modification
Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.
Measured: change from baseline health promoting behavior at 3 months
Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up
Health-Promoting Lifestyle Profile II questionnaire. Higher score indicate greater health promotion. Minimum score 1 Maximum score 4.
Measured: Change from 3 month follow-up data of health promoting behavior at 1-year
Telomerase activity changes as a result of lifestyle change at 1-year follow-up
Assessed via peripheral blood mononuclear cells
Measured: Change from 3 month follow-up data of telomerase activity at 1-year
Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up
Assessed via the Brief Pain Inventory - Short Form. Measures pain intensity from 0 to 10, 10 being pain as bad as you can imagine. Also measures the extent to which pain interferes with daily functioning (0 - 10 possible, with 10 indicating completely interferes).
Measured: Change from 3 month follow-up data of subjective pain at 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 2017May 2019

First posted17 Feb 2017
Study start10 Jan 2017
Primary completionMay 2019
Study completionMay 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03056417
Sponsor's protocol ID: 14X145
Status last verified: Sep 2020
First submitted: 13 Feb 2017
Last updated: 30 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Shcherbakova DM, Zvereva ME, Shpanchenko OV, Dontsova OA. [Telomerase: structure and properties of the enzyme, characteristics of the yeast telomerase]. Mol Biol (Mosk). 2006 Jul-Aug;40(4):580-94. Russian.
PubMed 16913218
Li B, Comai L. Requirements for the nucleolytic processing of DNA ends by the Werner syndrome protein-Ku70/80 complex. J Biol Chem. 2001 Mar 30;276(13):9896-902. doi: 10.1074/jbc.M008575200. Epub 2001 Jan 4.
PubMed 11152456
Drozek D, Diehl H, Nakazawa M, Kostohryz T, Morton D, Shubrook JH. Short-term effectiveness of a lifestyle intervention program for reducing selected chronic disease risk factors in individuals living in rural appalachia: a pilot cohort study. Adv Prev Med. 2014;2014:798184. doi: 10.1155/2014/798184. Epub 2014 Jan 16.
PubMed 24527219
Hassett AL, Epel E, Clauw DJ, Harris RE, Harte SE, Kairys A, Buyske S, Williams DA. Pain is associated with short leukocyte telomere length in women with fibromyalgia. J Pain. 2012 Oct;13(10):959-69. doi: 10.1016/j.jpain.2012.07.003.
PubMed 23031395

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Lifestyle Changes Via the Complete Health Improvement Program on Telomerase Activity and Telomere Length in Patients With Chronic Pain
ClinicalTrials.gov ID: NCT03056417
Acronym / sponsor ID: 14X145
Conditions: Chronic Pain
Keywords: chronic pain, telomere, telomerase, life style
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Ohio UniversityUniversity, hospital or other
Study start: 10 Jan 2017 (actual)
Primary completion: May 2019 (actual)
Study completion: May 2019 (actual)
First posted: 17 Feb 2017 (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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: The Complete Health Improvement ProgramParticipants in the Complete Health Improvement Program.
No Change to Treatment	No intervention	–Participants who choose not to participate in the Complete Health Improvement Program.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

40-70 years old
Physician confirmed chronic pain diagnosis for at least 6 months

Key exclusion criteria (2 listed)

Pregnancy
Physical or mental condition that limits ability to provide consent or answer questionnaires

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
The Complete Health Improvement ProgramThe Complete Health Improvement Program is a nationally recognized program that encourages a diet of whole plant based foods, moderate exercise, stress reduction, and social support.	Behavioural	Intervention

Primary outcome

Telomerase activity changes as a result of lifestyle change
Time frame: Change from baseline telomerase at 3 months
Assessed via peripheral blood mononuclear cells
Subjective pain ratings as a function of positive lifestyle modifications
Time frame: Change from baseline subjective pain at 3 months
Assessed via the Brief Pain Inventory - Short Form. Measures pain intensity from 0 to 10, 10 being pain as bad as you can imagine. Also measures the extent to which pain interferes with daily functioning (0 - 10 possible, with 10 indicating completely interferes).

20 secondary outcomes

Relative telomere length changes as a result of lifestyle change
Time frame: Change from baseline telomere length at 3 months
Relative telomere length changes as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of telomere length at 1-year
Fasting glucose changes as a result of lifestyle change
Time frame: Change from baseline fasting glucose at 3 months
Fasting glucose changes as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of fasting glucose at 1-year
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change
Time frame: change from baseline fasting lipids at 3 months
Fasting lipid profile (i.e., HDL, LDL, triglycerides) modification as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of fasting lipids at 1-year
C-reactive protein changes as a result of lifestyle change
Time frame: change from baseline C-reactive protein at 3 months
C-reactive protein changes as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of C-reactive protein at 1-year
Overall well-being changes as a result of lifestyle change
Time frame: change from baseline overall well-being at 3 months
Overall well-being changes as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of overall well-being at 1-year
Perceived Stress changes as a result of lifestyle change
Time frame: change from baseline perceived stress at 3 months
Perceived Stress changes as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of perceived stress at 1-year
Depressive symptom changes as a result of lifestyle change
Time frame: change from baseline depressed mood at 3 months
Depressive symptom changes as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of depressed mood at 1-year
Perceived social support modification as a result of lifestyle change
Time frame: change from baseline perceived social support at 3 months
Perceived social support modification as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of perceived social support at 1-year
Health-Promoting behavior change as a result of lifestyle modification
Time frame: change from baseline health promoting behavior at 3 months
Health-Promoting behavior change as a result of lifestyle modification at 1-year follow-up
Time frame: Change from 3 month follow-up data of health promoting behavior at 1-year
Telomerase activity changes as a result of lifestyle change at 1-year follow-up
Time frame: Change from 3 month follow-up data of telomerase activity at 1-year
Subjective pain ratings as a function of positive lifestyle modifications at 1-year follow-up
Time frame: Change from 3 month follow-up data of subjective pain at 1-year

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 30 Oct 2020.
Background: PubMed 16913218Shcherbakova DM, Zvereva ME, Shpanchenko OV, Dontsova OA. [Telomerase: structure and properties of the enzyme, characteristics of the yeast telomerase]. Mol Biol (Mosk). 2006 Jul-Aug;40(4):580-94. Russian.
Background: PubMed 11152456Li B, Comai L. Requirements for the nucleolytic processing of DNA ends by the Werner syndrome protein-Ku70/80 complex. J Biol Chem. 2001 Mar 30;276(13):9896-902. doi: 10.1074/jbc.M008575200. Epub 2001 Jan 4.
Background: PubMed 24527219Drozek D, Diehl H, Nakazawa M, Kostohryz T, Morton D, Shubrook JH. Short-term effectiveness of a lifestyle intervention program for reducing selected chronic disease risk factors in individuals living in rural appalachia: a pilot cohort study. Adv Prev Med. 2014;2014:798184. doi: 10.1155/2014/798184. Epub 2014 Jan 16.
Background: PubMed 23031395Hassett AL, Epel E, Clauw DJ, Harris RE, Harte SE, Kairys A, Buyske S, Williams DA. Pain is associated with short leukocyte telomere length in women with fibromyalgia. J Pain. 2012 Oct;13(10):959-69. doi: 10.1016/j.jpain.2012.07.003.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

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.

Katrina Hamilton, M.S. principal investigator

Ohio University

David Drozek, D.O. study director

Ohio University

Peggy Zoccola, Ph.D. study chair

Ohio University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Complete Health Improvement Program in people with Chronic Pain, run by Ohio University at 1 site in United States.

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 2 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 30 Oct 2020. 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 United States. 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?

Telomerase activity changes as a result of lifestyle change (time frame: Change from baseline telomerase at 3 months). The study lists 2 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 NCT03056417, which also lists 4 linked publications.

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 30 Oct 2020.