The Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise-induced Muscular Pain

NCT07827664 | Recruiting

• 1 other identifier: Insomnia-DOMS-2026
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep is a critical determinant of physiological recovery and pain regulation. Growing evidence suggests that sleep disruption directly heightens central and peripheral pain sensitivity to sensory stimuli (e.g., mechanical pressure, thermal stimuli), serving as a significant risk factor for the onset and persistence of musculoskeletal pain. However, the precise mechanisms through which sleep quality regulates bodily sensory sensitivity and influences the onset, progression, and recovery trajectories of acute musculoskeletal pain in the general public remain insufficiently understood. This study aims to investigate the relationship between sleep condition, pain sensitivity, and musculoskeletal pain dynamics in healthy adults from the general population, regardless of their physical activity levels. Utilizing a standardized, safe, and fully reversible exercise-induced muscle soreness (EIMS) protocol as an experimental pain model, this project will continuously evaluate participants' quantitative sensory testing (QST) profiles and sleep parameters. The findings from this study will advance the mechanistic understanding of sleep-mediated pain modulation, providing evidence-based insights to inform future targeted sleep management and pain prevention interventions.

Conditions

Insomnia; Musculoskeletal Pain; Pain Sensitivity; Healthy Adult

Keywords

Sleep Quality; Sleep Duration; Insomnia; Exercise-Induced Muscle Soreness; Eccentric exercise; Quantitative Sensory Testing (QST); Recovery Trajectory; Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• Muscle damage severity: Muscle pain

  Muscle pain will be measured by an 11-point NRS, with 0 represents "no pain" and 10 indicating "worst imaginable pain". The Outcome will be recorded at rest, reach for the floor with knees straight, and during a validated hamstring provocative manoeuvre, the "taking-off shoe" test.

  Day 0 to Day 14

• Muscle damage severity: Muscle soreness

  Muscle soreness will be measured by an 7-point Likert scale, with 0= A complete absence of soreness," 1 = "A light soreness in the muscle felt only when touched/a vague ache," 2 = "A moderate soreness felt only when touched/a slight persistent pain," 3 = "A light muscle soreness when walking up and down stairs," 4 = "A light muscle soreness when walking on flat surface," 5 = "A moderate muscle soreness, stiffness, or weakness when walking," 6 = "A severe muscle soreness, stiffness, or weakness that limits my ability to move."

  Day 0 to Day 14

• Pain Sensitivity: Thermal pain threshold

  Thermal thresholds will be measured with a 30 × 30 mm thermode (TSA 2, Medoc Ltd., Ramat Yishai, Israel). The thermode will be placed gently on the skin without causing deformation. Using the method of limits, temperature will increase or decrease at 1℃/second within a 0 - 51℃ range, with a baseline temperature of 32℃. Participants will press the stop button when the thermal sensation first becomes painful. The mean value of five consecutive trials will be used in the analysis.

  Day 7 and Day 9

• Pain Sensitivity: Mechanical pain threshold

  Mechanical pain threshold will be evaluated using standardised weighted pinprick stimulators (MRC System GmbH, Heidelberg, Germany) with a 0.25mm flat contact area. Seven fixed intensities (8 mN - 512 mN) will be applied. The final threshold will be calculated as the geometric mean of the ascending and descending stimulus intensities from five series.

  Day 7 and Day 9

• Pain Sensitivity: Pressure pain threshold

  Pressure pain threshold will be assessed with a digital pressure algometer (Medoc Ltd., Ramat Yishai, Israel) equipped with a 1 cm2 rubber probe. Pressure will be applied at 30 Kpa per second until participants perceive painful. Three trials will be performed, and the mean scores will be calculated to determine the PPT.

  Day 7 and Day 9

• Pain Sensitivity: Temporal summation of mechanical pain (TSP-M)

  The pinprick stimulator will assess TSP-M at 256 mN. Ten stimuli will be delivered at 1-second intervals over a 1 cm2 area. Pain intensity will be rated on an 11-point NRS after the first and the 10th stimuli. If the NRS pain rating remains 0 out of 10 for three consecutive 256 mN stimuli, intensity will be increased to 512 mN, and the trial will be repeated. TSP-M will be calculated as the NRS difference between the first stimulus and the 10th stimulus.

  Day 7 and Day 9

• Pain Sensitivity: Temporal summation of heat pain (TSP-H)

  TSP-H will be measured with a 9 cm2 thermode (TSA 2, Medoc Ltd., Ramat Yishai, Israel). Two sequences of 10 heat pulses at 46 ℃ and 48 ℃ will be delivered with a 5-minute interval. Each pulse has a 0.5 s duration and will be delivered from a 40 ˚C baseline at a 13°C/s ramp rate and 2.5 s interstimulus interval. The participant will rate pain intensity on an 11-point NRS after each stimulus. TSP-H will be defined as the NRS difference between the 10th stimulus and the first stimulus for each temperature.

  Day 7 and Day 9

• Pain Sensitivity: Conditioned pain modulation (CPM)

  CPM will be evaluated using a noxious conditioning stimulus (CS) and a test stimulus (TS). The CS will be contact heat applied to the dominant volar forearm between the distal third of the forearm and the ulnar styloid. Temperature will be set 1.1 °C above the participant's HPT for 120s, starting from 32 ℃ with an 8°C/s ramp using the TSA 2 device (Medoc Ltd., Ramat Yishai, Israel). During the CPM assessment, if participants could not tolerate the CS (i.e., pain intensity over 8 on the11-point NPRS) or if they reported a pain intensity below 4 on the 11-point NPRS, the temperature of the CS will be adjusted to ensure a safe and adequate stimulus intensity. The TS will be applied to the thenar eminence of the non-dominant hand using a pressure algometer (Medoc Ltd., Ramat Yishai, Israel) to determine PPT before and immediately after the CS. The CPM effect will be calculated by subtracting the PPT measured before the CS from the PPT measured after the CS.

  Day 7 and Day 9

Secondary Outcomes (15)

• Sleep Questionnaires: the Insomnia Severity Index (ISI)

  Day 0 and Day 7

• Sleep Questionnaires: The Pittsburgh Sleep Quality Index (PSQI)

  Day 0 and Day 7

• Sleep diary: Total Sleep Time

  Day 0 to Day 14

• Sleep diary: Sleep Onset Latency (SOL)

  Day 0 to Day 14

• Sleep diary: Wake After Sleep Onset (WASO)

  Day 0 to Day 14

Study Arms (2)

Insomnia

Other: Eccentric exercise

Healthy contry

Other: Eccentric exercise

Interventions

Eccentric exercise OTHER

Eccentric exercise

Healthy contry; Insomnia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Adult with or without insomnia

You may qualify if:

• Adults aged 18 to 60 years
• Right hand and foot dominant

You may not qualify if:

• History of any chronic musculoskeletal pain or presence of existing pain during recruitment
• Previous major injuries or surgery involving the lower limbs
• Sleep disorders other than insomnia
• Clinically diagnosed psychiatric disorders
• Contraindications to vigorous exercise identified through the physical activity readiness questionnaire (PAR-Q)
• Work night shifts or rotating shift schedules
• Pregnant

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

the Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Leo Guohui Lin

CONTACT

+852 94267004; guohui-leo.lin@connect.polyu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 18, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)