NCT06699186

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 19, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

Acute PainMusculoskeletal PainPain ThresholdRange of MotionSleep Deprivation

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    2 days

  • Range of motion evaluation

    Range of motion evaluations were conducted through the assessment of knee and hip flexion using a universal goniometer

    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

    2 days

Study Arms (2)

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.

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.

Other: Non-sleep

Interventions

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.

Sleep Group

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.

Non-sleep group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Asymptomatic individuals
  • Aged 18-25 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 38350184BACKGROUND
  • Cheung 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.

    PMID: 12617692BACKGROUND
  • da 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.

    PMID: 34503798BACKGROUND
  • Farias-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.

    PMID: 30471384BACKGROUND
  • Njeim 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.

    PMID: 39084325BACKGROUND

MeSH Terms

Conditions

PainAcute PainMusculoskeletal PainSleep Deprivation

Interventions

Sleep

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Prior to and following the interventions, all assessments were evaluated by a researcher who was blinded to the groups.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 21, 2024

Study Start

April 10, 2024

Primary Completion

May 25, 2024

Study Completion

May 25, 2024

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations