NCT07546838

Brief Summary

This randomized controlled trial investigated the acute effects of aerobic exercise (AE) and combined aerobic and cervical-upper extremity resistance exercise (CE) on the pressure pain threshold (PPT), pain perception, and fatigue in workers with high ergonomic risk and chronic non-specific neck pain (CNNP). A total of 78 workers were randomly assigned to AE, CE, or control groups. The AE and CE groups completed single 40-minute sessions, while the control group received a 30-minute educational session with additional seated rest periods before and after the session. PPT was assessed bilaterally at multiple anatomical sites using a digital pressure algometer. Neck pain, overall pain perception, and fatigue were evaluated using a numerical rating scale (NRS) before, immediately after, and 20 minutes after exercise. The study focused on exercise-induced hypoalgesia (EIH) and was intended to inform brief, workplace-compatible exercise strategies to reduce pain, fatigue, and work-related musculoskeletal risks in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

May 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 17, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

Exercise-induced hypoalgesiaAcute effect of exerciseChronic Neck PainPressure Pain ThresholdAerobic ExerciseResistance ExerciseErgonomic Risk

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold

    Pressure pain threshold is assessed using a digital algometer to evaluate pain sensitivity. The value at which the sensation of pressure first becomes painful is recorded in lbf/cm². Three consecutive measurements are obtained at each site, and the mean value is used for analysis. Measurements are obtained bilaterally at the C2 region, C5 region, and upper trapezius muscle.

    Three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).

Secondary Outcomes (3)

  • Acute Neck Pain Perception

    Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).

  • Acute Overall Body Pain Perception

    Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).

  • Acute Fatigue

    Assessments are performed at three time points: before the intervention (T0), immediately after the intervention (T1), and 20 minutes after the intervention (T2).

Other Outcomes (3)

  • Ergonomic Risk Level - Rapid Upper Limb Assessment (RULA)

    Baseline

  • Functional Aerobic Capacity 6-Minute Walk Test (6MWT)

    Baseline

  • Physical Activity Level (IPAQ-SF)

    Baseline

Study Arms (3)

Aerobic Exercise

EXPERIMENTAL

Participants performed moderate-intensity cycling using a recumbent ergometer in a single 40-minute session, including a 5-minute warm-up, 30 minutes of aerobic exercise, and a 5-minute cool-down.

Behavioral: Aerobic Exercise

Combined Exercise

EXPERIMENTAL

Participants performed a combination of aerobic and resistance exercises in a single 40-minute session, including a 5-minute warm-up, 15 minutes of aerobic exercise, 15 minutes of resistance training targeting cervical and upper-extremity muscles, and a 5-minute cool-down.

Behavioral: Combined Exercise

Informed Control

ACTIVE COMPARATOR

A 30-minute educational session on exercise benefits, workplace ergonomics, and postural recommendations. Participants remained seated for 5 minutes before and after the session.

Behavioral: Informed Control

Interventions

Moderate-intensity aerobic exercise performed using a recumbent cycle ergometer in a single 40-minute session. The protocol included a 5-minute warm-up, 30 minutes of continuous cycling, and a 5-minute cool-down. Exercise intensity was maintained at 64-76% of maximum heart rate and adjusted individually throughout the session. No resistance or strength training exercises were included.

Aerobic Exercise

Participants performed a combination of aerobic and resistance exercises in a single 40-minute session. The protocol included a 5-minute warm-up, 15 minutes of moderate-intensity aerobic exercise (64-76% HRmax, Borg RPE 11-14), 15 minutes of resistance exercises targeting cervical and upper-extremity muscles, and a 5-minute cool-down. The resistance program focused on cervical motor control and scapular stabilization, including chin tuck, cervical retraction with extension, scapular retraction, vertical pulling, horizontal shoulder abduction, scapular plane abduction, and shoulder elevation. Each exercise was performed for 8-10 repetitions in two sets with 30-second rest intervals. All exercises were supervised and performed with proper postural alignment.

Combined Exercise

Participants attended a 30-minute educational session on exercise benefits, workplace ergonomics, and postural recommendations. Participants remained seated for 5 minutes before and after the session.

Informed Control

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20-65 years
  • Diagnosed with chronic non-specific neck pain within the past year
  • Neck pain intensity ≥4 on a numerical rating scale for at least 3 months
  • Actively employed for at least 1 year in similar occupational conditions
  • High ergonomic risk (Rapid Upper Limb Assessment - RULA score ≥3)

You may not qualify if:

  • Neurological, cardiopulmonary, or rheumatological disorders
  • History of cervical surgery or traumatic injury
  • Specific cervical or lumbar pathology
  • Whiplash injury, or any traumatic musculoskeletal injury
  • Recent physical therapy or regular exercise in the past six months
  • Neck pain unresponsive to conservative treatment
  • Diagnosed thoracic outlet syndrome, rotator cuff pathology, vertebrobasilar insufficiency, or frozen shoulder
  • Pregnancy
  • Use of antidepressant medication
  • Positive clinical tests (Spurling, cervical distraction, Valsalva, radial, ulnar, and median nerve tension tests)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy adn Rehabilitation, Hacettepe University

Ankara, Çankaya, 06100, Turkey (Türkiye)

Location

Related Publications (3)

  • Rice D, Nijs J, Kosek E, Wideman T, Hasenbring MI, Koltyn K, Graven-Nielsen T, Polli A. Exercise-Induced Hypoalgesia in Pain-Free and Chronic Pain Populations: State of the Art and Future Directions. J Pain. 2019 Nov;20(11):1249-1266. doi: 10.1016/j.jpain.2019.03.005. Epub 2019 Mar 21.

    PMID: 30904519BACKGROUND
  • Senarath ID, Chen KK, Weerasekara I, de Zoete RMJ. Exercise-induced hypoalgesic effects of different types of physical exercise in individuals with neck pain: A systematic review and meta-analysis. Pain Pract. 2023 Jan;23(1):110-122. doi: 10.1111/papr.13150. Epub 2022 Aug 2.

    PMID: 35869789BACKGROUND
  • Anarte-Lazo E, Bernal-Utrera C, Lopez-Amor M, Porras-Valencia E, Ruy-Diaz-Rojas FJ, Falla D, Rodriguez-Blanco C. Exercise-induced hypoalgesia after aerobic versus neck-specific exercise in people with acute/subacute whiplash-associated disorders: protocol for a randomised controlled trial. BMJ Open. 2022 Sep 22;12(9):e061679. doi: 10.1136/bmjopen-2022-061679.

    PMID: 36137629BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD Candidate

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

May 22, 2025

Primary Completion

October 1, 2025

Study Completion

October 30, 2025

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations