Delayed-onset Muscle SorenessNCT06699186
Sleep and Delayed-onset Muscle Soreness
A study testing Sleep and Non-sleep in people with Delayed-onset Muscle Soreness and Sleep, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
There is a need for further experimental research in order to gain a more in-depth understanding of this vicious cycle of pain and sleep disorders. Although the effects of chronic pain and its impact on sleep have been extensively researched, the influence of sleep on acute pain has been addressed in only a limited… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed-onset Muscle Soreness, Sleep, Pain
- What is being tested?
- Sleep and Non-sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 25 May 2024
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic individuals
- Aged 18-25 years
Who cannot join
- Those who have functional exercise restrictions,
- Those with chronic cardiac or pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease and heart failure that may affect respiratory muscle strength and respiratory functions,
- Those with orthopedic problems, persistent neck and back pain and/or radiculopathy that prevent them from participating in the study,
- Those with diagnosed psychiatric disorders,
- Participants with cooperation problems that may prevent evaluations and treatment will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Konya, Selcuklu, 42130
About this study
Official title: The Effects of Sleep After Delayed-onset Muscle Soreness, a Comparative Study
There is a need for further experimental research in order to gain a more in-depth understanding of this vicious cycle of pain and sleep disorders. Although the effects of chronic pain and its impact on sleep have been extensively researched, the influence of sleep on acute pain has been addressed in only a limited number of studies. A more comprehensive grasp of the manner in which sleep influences the pain sensory profile subsequent to an acute injury may offer insight into the significance of sleep during recovery stage. In this respect, the objective of this study was to examine the effect of sleep on pain perception, pain sensitivity and range of motion following the induction of delayed onset muscle soreness (DOMS) through eccentric loading, specifically through the performance of squat exercises.
Read the detailed description
Delayed onset muscle soreness (DOMS) represents a phenomenon characterised by a range of symptoms, encompassing varying degrees of muscle stiffness and pain, from mild to severe, with the potential to cause considerable functional impairment. This may be attributed to muscle damage and subsequent inflammation resulting from eccentric contractions or activities of an unusually intense nature. In accordance with these principles, exercise-induced DOMS typically manifests following an abrupt increase in exercise intensity, the execution of unconventional exercise movements, and most notably, following the performance of exercises that necessitate eccentric muscle actions . DOMS frequently results in a reduction in muscle function, including a decline in strength, a narrowing of the range of motion, increased pain sensitivity, and a decrease in the intensity of proprioception sensations within a period of 24 to 72 hours, with the potential for these effects to persist for several days. The processes underlying of DOMS comprise overstretching of sarcomeres, mechanical stresses in muscle structures, overlaps and disruption of filaments, and reactions of biochemical that affect contractile structures of muscle. Furthermore, inflammatory processes linked to oxidative stress and an increased pain receptors sensitivity is additional factors contributing to the development of DOMS .
One of the most significant factors affecting pain is sleep. Those suffering from persistent pain consistently indicate inferior sleep quality in comparison to controls , and a direct correlation has been observed between the quality of sleep and the severity of pain experienced by individuals. It is established in the literature that the sensitisation of pain mechanisms is raised in both intervention models of acute pain and chronic pain. Furthermore, individuals who experience primary insomnia without pain report heightened sensitivity to pain and an increased frequency of spontaneous pain episodes compared to control subjects. The findings of experimental studies indicate that sleep disruption in healthy individuals is linked to a considerable rise in pain sensitivity, potentially associated with elevated serum concentrations of pro-inflammatory biomarkers, even in the absence of tissue damage. This results in a vicious cycle of pain and sleep disorders, with each condition precipitating the other, thereby rendering the problem challenging to comprehend.
- Conditions
- Delayed-onset Muscle Soreness, Sleep, Pain
- Being tested
- Sleep, Non-sleep
- Keywords
- Acute Pain, Musculoskeletal Pain, Pain Threshold, Range of Motion, Sleep Deprivation
- Medical subject headings
- Pain, Acute Pain, Musculoskeletal Pain, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepOther
A training programme was devised which involved the participants performing maximum squat repetitions with their own body weight as a workload, in order to induce delayed-onset muscle soreness in the quadriceps. Before the maximum squat repetition, all participants performed a warm-up programme including 5 minutes of walking. Participants were instructed to perform the maximum number of repetitions within the one minute allotted for each set of squats and, after a 10-second rest period, to continue the programme in the same cycle until exhaustion. In the initial 24-hour period following the intervention, participants were instructed to maintain their habitual sleep schedules. In consideration of the delayed-onset muscle soreness, which typically occurs between 24 to 48 hours following maximal squat intervention.The sleep group was instructed to engage in a minimum of six hours of sleep over the course of the 24-hour observation period.
Non-sleepOther
A similar delayed-onset muscle soreness inducing protocol was applied to the sleep group.Participants in the non-sleep group were subjected to sleep restriction. The participants were permitted to sleep for a maximum of four hours in total over the course of the 24-hour period in non-sleep group.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Group | Experimental | The sleep group was instructed to engage in a minimum of six hours of sleep over the course of the 24-hour observation period. Individuals who slept for a duration of less than six hours were excluded from the study. Receives: Other: Sleep |
| Non-sleep group | Active comparator | The participants were permitted to sleep for a maximum of four hours in total over the course of the 24-hour period in non-sleep group. Receives: Other: Non-sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pressure pain thresholds
The pressure pain thresholds (PPT) were recorded at two pre-defined locations (tibialis anterior and quadriceps) using an electronic digital display algometer (Commander Echo® Algometer, JTECH Medical) with a 1-cm² probe. The tibialis region was measured by positioning the tibialis anterior muscle at a distance of 8 cm from the tibial tuberosity along a line extending from the tibial tuberosity to the lateral malleolus. For the quadriceps region, the measurement was made on the rectus femoris muscle at the point between the base of the patella and the anterior superior iliac spine.
Measured: 2 days
Numeric pain rating scale
The presence of DOMS was evaluated using a numeric pain rating scale (NPRS) with a range of 0 to 10. The participants were informed of the scale, which ranged from 0 (no pain) to 10 (extreme pain), and were subsequently asked to report the corresponding pain sensation.
Measured: 2 days
Range of motion evaluation
Range of motion evaluations were conducted through the assessment of knee and hip flexion using a universal goniometer
Measured: 2 days
Pittsburgh Sleep Quality Index
The sleep status of the participants was evaluated using the Pittsburgh Sleep Quality Index (PSQI) and routine sleep duration
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start10 Apr 2024
- Primary completion25 May 2024
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Delayed-onset Muscle SorenessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a randomised, single-blind, controlled trial. The patients were divided into two groups, designated as the "sleep group" and the "non-sleep group," through the implementation of a matched randomization method that considered both gender and age as variables.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşah ÖZSOY, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699186
- Sponsor's protocol ID
- SELCUKU_PT_GO_PAIN_001
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ducas J, Memari S, Houle M, Schwendenmann Y, Abboud J, Yiou E, Descarreaux M. Impact of lumbar delayed-onset muscle soreness on postural stability in standing postures. Gait Posture. 2024 Mar;109:201-207. doi: 10.1016/j.gaitpost.2024.02.001. Epub 2024 Feb 8.
PubMed 38350184Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
PubMed 12617692da Silva W, Machado AS, Lemos AL, de Andrade CF, Priego-Quesada JI, Carpes FP. Relationship between exercise-induced muscle soreness, pain thresholds, and skin temperature in men and women. J Therm Biol. 2021 Aug;100:103051. doi: 10.1016/j.jtherbio.2021.103051. Epub 2021 Jul 11.
PubMed 34503798Farias-Junior LF, Browne RAV, Freire YA, Oliveira-Dantas FF, Lemos TMAM, Galvao-Coelho NL, Hardcastle SJ, Okano AH, Aoki MS, Costa EC. Psychological responses, muscle damage, inflammation, and delayed onset muscle soreness to high-intensity interval and moderate-intensity continuous exercise in overweight men. Physiol Behav. 2019 Feb 1;199:200-209. doi: 10.1016/j.physbeh.2018.11.028. Epub 2018 Nov 22.
PubMed 30471384Njeim P, Faust A, Casgrain J, Karelis AD, Boutros GH. Delayed Onset Muscle Soreness Following Acute Resistance Exercise in Untrained Females: A Comparative Study Between Vegans and Omnivores. Int J Sports Med. 2024 Dec;45(14):1099-1106. doi: 10.1055/a-2350-8681. Epub 2024 Jul 31.
PubMed 39084325
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sleep After Delayed-onset Muscle Soreness, a Comparative Study
- ClinicalTrials.gov ID
- NCT06699186
- Acronym / sponsor ID
- SELCUKU_PT_GO_PAIN_001
- Conditions
- Delayed-onset Muscle Soreness, Sleep, Pain
- Keywords
- Acute Pain, Musculoskeletal Pain, Pain Threshold, Range of Motion, Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 21 Nov 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.
There is a need for further experimental research in order to gain a more in-depth understanding of this vicious cycle of pain and sleep disorders. Although the effects of chronic pain and its impact on sleep have been extensively researched, the influence of sleep on acute pain has been addressed in only a limited number of studies. A more comprehensive grasp of the manner in which sleep influences the pain sensory profile subsequent to an acute injury may offer insight into the significance of sleep during recovery stage. In this respect, the objective of this study was to examine the effect of sleep on pain perception, pain sensitivity and range of motion following the induction of delayed onset muscle soreness (DOMS) through eccentric loading, specifically through the performance of squat exercises.
Detailed description
Delayed onset muscle soreness (DOMS) represents a phenomenon characterised by a range of symptoms, encompassing varying degrees of muscle stiffness and pain, from mild to severe, with the potential to cause considerable functional impairment. This may be attributed to muscle damage and subsequent inflammation resulting from eccentric contractions or activities of an unusually intense nature. In accordance with these principles, exercise-induced DOMS typically manifests following an abrupt increase in exercise intensity, the execution of unconventional exercise movements, and most notably, following the performance of exercises that necessitate eccentric muscle actions . DOMS frequently results in a reduction in muscle function, including a decline in strength, a narrowing of the range of motion, increased pain sensitivity, and a decrease in the intensity of proprioception sensations within a period of 24 to 72 hours, with the potential for these effects to persist for several days. The processes underlying of DOMS comprise overstretching of sarcomeres, mechanical stresses in muscle structures, overlaps and disruption of filaments, and reactions of biochemical that affect contractile structures of muscle. Furthermore, inflammatory processes linked to oxidative stress and an increased pain receptors sensitivity is additional factors contributing to the development of DOMS .
One of the most significant factors affecting pain is sleep. Those suffering from persistent pain consistently indicate inferior sleep quality in comparison to controls , and a direct correlation has been observed between the quality of sleep and the severity of pain experienced by individuals. It is established in the literature that the sensitisation of pain mechanisms is raised in both intervention models of acute pain and chronic pain. Furthermore, individuals who experience primary insomnia without pain report heightened sensitivity to pain and an increased frequency of spontaneous pain episodes compared to control subjects. The findings of experimental studies indicate that sleep disruption in healthy individuals is linked to a considerable rise in pain sensitivity, potentially associated with elevated serum concentrations of pro-inflammatory biomarkers, even in the absence of tissue damage. This results in a vicious cycle of pain and sleep disorders, with each condition precipitating the other, thereby rendering the problem challenging to comprehend.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study was designed as a randomised, single-blind, controlled trial. The patients were divided into two groups, designated as the "sleep group" and the "non-sleep group," through the implementation of a matched randomization method that considered both gender and age as variables.
| Arm | Type | Receives |
|---|---|---|
| Sleep Group | Experimental | Other: SleepThe sleep group was instructed to engage in a minimum of six hours of sleep over the course of the 24-hour observation period. Individuals who slept for a duration of less than six hours were excluded from the study. |
| Non-sleep group | Active comparator | Other: Non-sleepThe participants were permitted to sleep for a maximum of four hours in total over the course of the 24-hour period in non-sleep group. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Asymptomatic individuals
- Aged 18-25 years
Key exclusion criteria (5 listed)
- Those who have functional exercise restrictions,
- Those with chronic cardiac or pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease and heart failure that may affect respiratory muscle strength and respiratory functions,
- Those with orthopedic problems, persistent neck and back pain and/or radiculopathy that prevent them from participating in the study,
- Those with diagnosed psychiatric disorders,
- Participants with cooperation problems that may prevent evaluations and treatment will not be included in the study.
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 |
|---|---|---|
| SleepA training programme was devised which involved the participants performing maximum squat repetitions with their own body weight as a workload, in order to induce delayed-onset muscle soreness in the quadriceps. Before the maximum squat repetition, all participants performed a warm-up programme including 5 minutes of walking. Participants were instructed to perform the maximum number of repetitions within the one minute allotted for each set of squats and, after a 10-second rest period, to continue the programme in the same cycle until exhaustion. In the initial 24-hour period following the intervention, participants were instructed to maintain their habitual sleep schedules. In consideration of the delayed-onset muscle soreness, which typically occurs between 24 to 48 hours following maximal squat intervention.The sleep group was instructed to engage in a minimum of six hours of sleep over the course of the 24-hour observation period. | Other | Sleep Group |
| Non-sleepA similar delayed-onset muscle soreness inducing protocol was applied to the sleep group.Participants in the non-sleep group were subjected to sleep restriction. The participants were permitted to sleep for a maximum of four hours in total over the course of the 24-hour period in non-sleep group. | Other | Non-sleep group |
Primary outcome
The pressure pain thresholds
Time frame: 2 days
The pressure pain thresholds (PPT) were recorded at two pre-defined locations (tibialis anterior and quadriceps) using an electronic digital display algometer (Commander Echo® Algometer, JTECH Medical) with a 1-cm² probe. The tibialis region was measured by positioning the tibialis anterior muscle at a distance of 8 cm from the tibial tuberosity along a line extending from the tibial tuberosity to the lateral malleolus. For the quadriceps region, the measurement was made on the rectus femoris muscle at the point between the base of the patella and the anterior superior iliac spine.
Numeric pain rating scale
Time frame: 2 days
The presence of DOMS was evaluated using a numeric pain rating scale (NPRS) with a range of 0 to 10. The participants were informed of the scale, which ranged from 0 (no pain) to 10 (extreme pain), and were subsequently asked to report the corresponding pain sensation.
Range of motion evaluation
Time frame: 2 days
Range of motion evaluations were conducted through the assessment of knee and hip flexion using a universal goniometer
Pittsburgh Sleep Quality Index
Time frame: 2 days
The sleep status of the participants was evaluated using the Pittsburgh Sleep Quality Index (PSQI) and routine sleep duration
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 21 Nov 2024.
- Background: PubMed 38350184Ducas J, Memari S, Houle M, Schwendenmann Y, Abboud J, Yiou E, Descarreaux M. Impact of lumbar delayed-onset muscle soreness on postural stability in standing postures. Gait Posture. 2024 Mar;109:201-207. doi: 10.1016/j.gaitpost.2024.02.001. Epub 2024 Feb 8.
- Background: PubMed 12617692Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
- Background: PubMed 34503798da Silva W, Machado AS, Lemos AL, de Andrade CF, Priego-Quesada JI, Carpes FP. Relationship between exercise-induced muscle soreness, pain thresholds, and skin temperature in men and women. J Therm Biol. 2021 Aug;100:103051. doi: 10.1016/j.jtherbio.2021.103051. Epub 2021 Jul 11.
- Background: PubMed 30471384Farias-Junior LF, Browne RAV, Freire YA, Oliveira-Dantas FF, Lemos TMAM, Galvao-Coelho NL, Hardcastle SJ, Okano AH, Aoki MS, Costa EC. Psychological responses, muscle damage, inflammation, and delayed onset muscle soreness to high-intensity interval and moderate-intensity continuous exercise in overweight men. Physiol Behav. 2019 Feb 1;199:200-209. doi: 10.1016/j.physbeh.2018.11.028. Epub 2018 Nov 22.
- Background: PubMed 39084325Njeim P, Faust A, Casgrain J, Karelis AD, Boutros GH. Delayed Onset Muscle Soreness Following Acute Resistance Exercise in Untrained Females: A Comparative Study Between Vegans and Omnivores. Int J Sports Med. 2024 Dec;45(14):1099-1106. doi: 10.1055/a-2350-8681. Epub 2024 Jul 31.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep and Non-sleep in people with Delayed-onset Muscle Soreness and Sleep, run by Selcuk University at 1 site in Turkey (Türkiye).
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 5 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 21 Nov 2024. 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 Turkey (Türkiye). 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 pressure pain thresholds (time frame: 2 days). The study lists 4 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 NCT06699186, which also lists 5 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 21 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.