Sleep changes from exercise in chronic pain patients
| ISRCTN | ISRCTN16093248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16093248 |
| Secondary identifying numbers | HP-00085798 |
- Submission date
- 18/07/2023
- Registration date
- 07/08/2023
- Last edited
- 07/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Exercise could potentially improve chronic pain related outcomes including sleep disturbances, and chronic pain severity and mood. However, the underlying biological pathways are still unknown. This study aims to address the biological changes associated with an orofacial exercise which is designed for the chronic pain population suffering from temporomandibular disorders. Temporomandibular disorders (TMD) are disorders of the jaw muscles, temporomandibular joints, and the nerves associated with chronic facial pain. This study aims to explore the effects of exercise on OMICS, which are biological factors that may predetermine how we cope with pain.
Who can participate?
Adult participants with temporomandibular disorders for more than 3 months.
What does the study involve?
Enrolled participants undergo blood draws at the baseline and at the end of the 4 weeks monitoring. At the first visit, participants will be provided with study equipment and information, with instructions for use during a four-week study period, and then participants will be randomly assigned to one of two groups that will be asked to do different activities as part of the study. At the end of the study timeframe, participants will come to a second lab visit similar to the first day’s visit. Each visit will take approximately one hour. Participants will be in the study for
a total of four weeks.
What are the possible benefits and risks of participating?
Benefit: Participants may or may not benefit by taking part in this study. There is no guarantee that participants will receive direct benefit from your participation on this study. Exercises may help relieve the TMD pain. Findings from this study could add to research on how relief of TMD pain affects OMICS
The risks involved in this study are about the same as the risks involved in normal daily life.
1. Risks Associated with Blood Draw: participants may have some discomfort and bruising where the needle entered through the skin. There is also a very small risk of fainting. Infection in the area of needle entry is rare.
2. Risks Associated with Filling Forms and Questionnaires: Participants may experience some emotional discomfort, such as sadness or happiness, while answering questions on the forms or questionnaires.
3. Risks Associated with the Motionwatch 8: There is also the slight chance that the participants will experience some mild irritation or discomfort where the Motionwatch 8 is placed. If this occurs, participants may take off the device.
4. Risks Associated with the Exercises: There may be risks of some mild discomfort or muscle fatigue that feels like a light workout activity. These issues usually resolve in a day or two as participants continue to do the exercises.
Where is the study run from?
University of Maryland School of Nursing (USA)
When is the study starting and how long is it expected to run for?
January 2020 to July 2022
Who is funding the study?
1. National Institute of Nursing Research P30 (AD) (USA)
2. University of Maryland School of nursing start-ups (LC) (USA)
Who is the main contact?
Luana Colloca, MD, PhD, colloca@umaryland.edu
Contact information
Principal Investigator
University of Maryland School of Nursing
655 W Lombard Street
Baltimore City
21201
United States of America
 ORCID ID |
0000-0002-6503-4709 |
|---|---|
| Phone | +1 410-706-8244 |
| colloca@umaryland.edu |
Study information
| Study design | This study is a single center interventional randomized parallel design clinical trial where participants are randomly assigned to either 1) exercise group where they perform a set of orofacial exercise for 4 weeks, or 2) natural history group where they will keep their usual care for the chronic pain. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | 43974 PIS.pdf |
| Scientific title | Exercise improves sleep in chronic pain patients: A feasibility interventional study with ecological momentary assessment to capture long-term sleep patterns |
| Study acronym | EMASLEEPEXERCISETMD |
| Study hypothesis | Exercise improves total sleep time, sleep efficiency, sleep latency, and sleep fragmentation in chronic pain patients compared to non-exercise group. |
| Ethics approval(s) |
Approved 19/01/2020, University of Maryland Institutional Review Board (620 West Lexington Street, Baltimore, 21201, United States of America; +1 410-706-5037; hrpo@umaryland.edu), ref: HP-00085798 |
| Condition | Chronic temporomandibular pain disorder |
| Intervention | Each day, participants in exercise group will complete the following: chin tucks 10x/hour holding for 5 seconds, 30-60 seconds of closure-muscle stretching exercise 6x/day, 15 seconds of chest stretch 3x/day with 2 reps each, 15 seconds of wall stretch 3x/day with 2 reps each, 10 repetitions of on-your-back neck stretch before bed, 1x/day of face-down arm lifts for 5 days/week. Participants in the natural history group will keep their daily usual care and daily exercise if applicable. The randomization is conducted by an independent statistician where half of the participants are assigned to the exercise group while the other half are assigned to no exercise group. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Sleep quality is measured using Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbances, and an actigraph watch continuously for the 4 weeks of the study. PROMIS-sleep disturbance is measured at baseline, week 1 to week 4. Actigraphy is obtained continuously over the 4 weeks. 2. Chronic pain related outcomes including chronic pain interference, pain behavior, depression and anxiety were assessed weekly using PROMIS pain interference, pain behavior, depression and anxiety scales. Pain related outcomes are measured at baseline, week 1 to week 4. |
| Secondary outcome measures | Peripheral blood mononuclear cells RNA changes. Peripheral blood is withdrawn at the baseline enrollment visit and at the end of the intervention period for both exercise and no exercise groups. |
| Overall study start date | 19/01/2020 |
| Overall study end date | 15/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Participant inclusion criteria | 1. Aged 18 - 65 years 2. Can speak and write in English 3. Myogenous chronic non-neuropathic pain equal to at least 2 on a scale of 1-10 for orofacial pain 4. Pain duration longer than 3 months 5. Type of pain is in the jaw, temple, in ear, or in front of the ears 6. Pain is modified with jaw movement, function, or parafunction 7. Exam positive for confirmation of pain location(s) in the temporalis or masseter muscle(s) and reports familiar pain in the temporalis or masseter muscle(s) with at least one of the following provocation tests: Palpation of the temporalis or masseter muscle(s) or maximum unassisted or assisted opening movement(s). |
| Participant exclusion criteria | 1. Aged over 65 years 2. History of local or general trauma, degenerative neuromuscular diseases, cervical pain (ie. stenosis, radiculopathy) 3. Removable full dental prostheses 4. Neuropathic temporomandibular pain 5. Major neurological or psychiatric disorders (ie. schizophrenia, bipolar disorders, autism). |
| Recruitment start date | 02/02/2021 |
| Recruitment end date | 15/06/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Baltimore
21201
United States of America
Sponsor information
Research organisation
31 Center Drive, Room 5B03
Bethesda
MD 20892-2178
United States of America
| Phone | +1 301-496-0235 |
|---|---|
| edmond.byrnes@nih.gov | |
| Website | https://www.ninr.nih.gov/ |
"ROR" |
https://ror.org/01y3zfr79 |
University/education
School of Nursing
655 W Lombard Street
Baltimore City
21201
United States of America
| Phone | +1 (410) 706-0501 |
|---|---|
| NRScommunications@umaryland.edu | |
| Website | http://www.umaryland.edu/ |
|
"ROR" |
https://ror.org/04rq5mt64 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute of Nursing Research National Institutes of Health, NINR
- Location
- United States of America
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Maryland, College Park, The University of Maryland, College Park, Maryland Agricultural College, Maryland State College, UMD
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Colloca at colloca@umaryland.edu. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 20/07/2023 | No | Yes |
Additional files
Editorial Notes
20/07/2023: Trial's existence confirmed by University of Maryland Institutional Review Board.
